Rapid insertion central venous catheter insertion assembly

Abstract

Disclosed herein is a rapid insertion central venous catheter (RICC) insertion assembly and method. For example, a RICC insertion assembly (100) can include a RICC (102), an access guidewire (106), an introducer needle (104), and a coupler (108) connecting the aforementioned components together. The introducer needle (104) can include a needle shaft (140) and a sheath (142). The needle shaft (140) can include a longitudinally extending needle slot (148). The sheath (142) can seal the needle slot (148) below it, except for a sheath opening (162) at a proximal portion of the sheath (142). The coupler (108) can include a coupler housing (178) and a valve module (180) disposed within the coupler housing (178). The valve module (180) can have the needle shaft (140) and the sheath (142) sealed therein. The access guidewire (106) can include a proximal end coupled to the coupler (108) and a distal end disposed within the introducer needle (104), thereby forming a loop on the access guidewire (106). The RICC (102) can be disposed on the loop in the ready-to-deploy state of the RICC insertion assembly (100).

Description

Summary of the Invention

[0001] A central venous catheter (CVC) is generally introduced into a patient's body by the Seldinger method and advanced within the patient's vascular structure. In the Seldinger method, many steps and medical devices (such as needles, surgical scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.) are utilized. Although the Seldinger method is effective, many of the steps are time-consuming, handling a large number of medical devices is cumbersome, and all of these have the potential to cause trauma to the patient. In addition, since there are many medical devices that need to be replaced during the implementation of the Seldinger method, the possibility of contamination by contact is relatively high. Therefore, it is necessary to reduce the number of steps and medical devices involved in introducing a catheter such as a CVC into the patient's body and advancing the catheter within its vascular structure.

[0002] In this specification, a rapidly insertable central catheter (RICC) insertion assembly and method for addressing the above are disclosed.

[0003] In this specification, in some embodiments, an RICC insertion assembly is disclosed, which includes an RICC, an access guide wire disposed within the RICC, an introducer needle, and a coupler connecting the RICC and the introducer needle to each other. The introducer needle includes a needle shaft and a sheath covering the needle shaft. The needle shaft includes a needle slot extending longitudinally from the proximal portion of the needle shaft to the distal needle tip. The sheath seals the needle slot below the sheath, except for a portion of the needle slot below the sheath opening in the proximal portion of the sheath. The coupler includes a coupler housing and a valve module disposed within the coupler housing. The valve module seals the proximal portion of the needle shaft and the sheath within it. The access guide wire includes a proximal end connected to the swivel arm of the coupler and a distal end disposed within the introducer needle. The proximal and distal ends of the access guide wire form a loop in the access guide wire. The RICC is positioned on the loop of the access guide wire when the RICC insertion assembly is ready for deployment.

[0004] In some embodiments, the RICC insertion assembly further includes a syringe fluid-connected to the introducer needle in the deployment-ready state of the RICC insertion assembly. The sheath seals the needle slot of the needle shaft beneath the sheath outside the valve module. The valve module seals the sheath opening within the sheath. In addition, the valve module seals around the access guidewire, allowing the syringe to aspirate blood.

[0005] In some embodiments, the valve module includes an integrated blade positioned in a needle slot below the distal end of the sheath opening. The blade includes a distally oriented blade edge configured to detach the sheath from the needle shaft when the introducer needle is withdrawn from the coupler. Disconnecting the sheath from the needle shaft allows the access guide wire to exit the needle shaft via the needle slot of the needle shaft.

[0006] In some embodiments, the coupler housing includes a longitudinally extending coupler housing slot configured to allow the access guide wire to exit the coupler housing when the introducer needle is withdrawn from the coupler.

[0007] In some embodiments, the valve module includes separable components around the needle shaft and sheath. The separable components are configured to detach when the introducer needle is withdrawn from the coupler, allowing the access guide wire to exit the valve module.

[0008] In some embodiments, RICC insertion assemblies are also disclosed herein, each including an RICC, an access guidewire positioned within the RICC, an introducer needle, and a coupler connecting the RICC and the introducer needle to each other in a ready-to-deploy state of the RICC insertion assembly. The RICC includes a catheter tube, a catheter hub, one or more extension legs, and one or more extension leg connectors. The catheter hub is connected to the proximal portion of the catheter tube. Each of the one or more extension legs is connected to the catheter hub by its distal portion. Each of the one or more extension leg connectors is located on the proximal portion of one of the one or more extension legs. The introducer needle includes a needle shaft, a sheath covering the needle shaft, and a needle hub covering the proximal portion of the needle shaft and the proximal portion of the sheath. The needle shaft includes a needle slot extending longitudinally from the proximal portion of the needle shaft to the needle tip at the distal portion of the needle shaft. The sheath includes a sheath opening in the proximal portion of the sheath. The coupler includes a coupler housing, a valve module located within the coupler housing, and a swivel arm rotatably connected to the coupler housing. The coupler housing includes a needle hub receptacle, into which the needle hub is inserted. The needle shaft and sheath extend from the needle hub, through the valve module, and outward from the distal end of the coupler housing. The swivel arm includes a swivel arm connector connected to one of one or more extension leg connectors. The access guidewire includes a proximal portion including a proximal end and a distal portion including a distal end. The proximal end of the access guidewire is connected to the swivel arm connector. The proximal portion of the access guidewire extends along the primary lumen of the RICC. The distal portion of the access guidewire extends along the primary lumen of the RICC, exiting from the distal end of the RICC, entering the valve module on the needle hub, entering the needle shaft through both the sheath opening and the needle slot, and extending along the needle lumen of the introducer needle.The distal end of the access guidewire is positioned within the needle lumen, immediately proximal to the needle tip.

[0009] In some embodiments, the RICC insertion assembly further includes a syringe fluid-connected to the introducer needle in the deployment-ready state of the RICC insertion assembly. The sheath seals the needle slot of the needle shaft beneath the sheath outside the valve module. The valve module seals the sheath opening within the sheath. The valve module then seals around the access guidewire, allowing the syringe to draw blood.

[0010] In some embodiments, the proximal end of the access guidewire is connected to a swivel arm connector, and the distal end of the access guidewire is positioned within the needle lumen, thereby forming a loop within the access guidewire. The RICC is positioned on the loop of the access guidewire when the RICC insertion assembly is ready for deployment.

[0011] In some embodiments, the swivel arm is configured to reverse the loop between the left and right sides of the RICC insertion assembly to accommodate venous puncture by both left-handed and right-handed individuals using the RICC insertion assembly.

[0012] In some embodiments, the coupler includes a needle hub lock configured to lock the needle hub into a needle hub receptacle. A pair of locking buttons on the needle hub lock are positioned between the two sides of the coupler. The locking buttons are configured to unlock the needle hub when the locking buttons are pressed into the coupler to pull the introducer needle out of the coupler.

[0013] In some embodiments, the valve module includes an integrated blade positioned in a needle slot below the distal end of the sheath opening. The blade includes a distally oriented blade edge configured to detach the sheath from the needle shaft when the introducer needle is withdrawn from the coupler. Disconnecting the sheath from the needle shaft allows the access guide wire to exit the needle shaft via the needle slot of the needle shaft.

[0014] In some embodiments, the coupler housing includes a longitudinally extending coupler housing slot configured to allow the access guide wire to exit the coupler housing when the introducer needle is withdrawn from the coupler.

[0015] In some embodiments, the valve module includes separable components around the needle shaft and sheath. The separable components are configured to detach when the introducer needle is withdrawn from the coupler, allowing the access guide wire to exit the valve module.

[0016] In some embodiments, the catheter tube includes a first section distal to the catheter tube, a second section distal to the first section of the catheter tube, and a tapered joint between the first and second sections of the catheter tube. The first section is formed from a first polymer material having a first durometer hardness. The second section is formed from a second polymer material having a second durometer hardness less 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.

[0017] 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.

[0018] In some embodiments, the catheter tube has sufficient column strength to prevent buckling when inserted into a puncture route established by percutaneous puncture with an introducer needle. The column strength is also sufficient to prevent buckling when advancing the catheter tube through the patient's vascular system without pre-dilating any blood vessels in the surrounding tissue or vascular system using a separate dilator.

[0019] In some embodiments, the RICC includes a set of three lumens, the set of three lumens comprising a primary lumen, a secondary lumen, and a tertiary lumen, formed from fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

[0020] 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, and 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.

[0021] Furthermore, this specification discloses a method for inserting an RICC into the lumen of a patient's blood vessel. In some embodiments, the method includes a step of acquiring an insertion assembly, a step of establishing a puncture route, a step of advancing an access guidewire, a step of withdrawing an introducer sheath, and a step of advancing an RICC. The step of acquiring an insertion assembly includes acquiring an RICC insertion assembly. The RICC insertion assembly includes an RICC, an introducer needle including a sheath covering the needle shaft, and an access guidewire, all connected to each other by a coupler. The proximal end of the access guidewire is connected to the swivel arm of the coupler, and the distal end of the access guidewire is positioned within the introducer needle via the valve module of the coupler. The proximal and distal ends of the access guidewire consequently form a loop in the access guidewire. The RICC is positioned on the loop of the access guidewire in the deployed-ready state of the RICC insertion assembly. The step of establishing a puncture route includes establishing a puncture route from a region of skin to the lumen of a blood vessel using the introducer needle. The access guidewire advancement step includes advancing the distal end of the access guidewire into the vascular lumen from its initial position within the needle shaft, just proximal to the needle tip of the needle shaft. The introducer needle withdrawal step includes withdrawing the introducer needle from the coupler, leaving the access guidewire in place within the vascular lumen. The introducer needle includes a needle slot that extends longitudinally from the proximal portion of the needle shaft to the needle tip, thereby allowing the access guidewire to exit the introducer needle using the introducer needle withdrawal step. The RICC advancement step includes inserting the RICC into the vascular lumen by advancing the RICC catheter tube onto the access guidewire into the vascular lumen.

[0022] In some embodiments, the puncture route establishment step includes reversing the swivel arm, and thus the loop, between the left side of the RICC insertion assembly for left-handed venous puncture and the right side of the RICC insertion assembly for right-handed venous puncture, using the RICC insertion assembly.

[0023] In some embodiments, the puncture route establishment step includes ensuring that blood flows back into the needle hub of the introducer needle, the syringe tip of a syringe fluidized to the introducer needle, the barrel of the syringe, or a combination thereof. By ensuring that blood flows back as described above, it is confirmed that the puncture route extends into the lumen of a blood vessel.

[0024] In some embodiments, the puncture route establishment step includes drawing a slight vacuum using a syringe while establishing the puncture route so that blood flows back into at least the needle hub of the introducer needle when the puncture route is established.

[0025] In some embodiments, the method further includes a blood aspiration step. The blood aspiration step includes aspirating blood using a syringe to confirm that the puncture path extends into the lumen of a blood vessel before withdrawing the introducer needle from the coupler in the introducer needle withdrawal step. The sheath covering the needle shaft seals the needle slot beneath the sheath for the blood aspiration step.

[0026] In some embodiments, the valve module is sealed around the distal portion of the access guidewire and the sheath opening of the sheath. The sheath opening allows the access guidewire to pass through the needle slot into the needle shaft when the RICC insertion assembly is ready for deployment.

[0027] In some embodiments, the introducer needle withdrawal step includes simultaneously separating the sheath from the needle shaft using a blade integrated into the valve module while the introducer needle is withdrawn from the coupler. By separating the sheath from the needle shaft, the access guide wire can exit the needle shaft via the needle slot of the needle shaft.

[0028] In some embodiments, the separable component of the valve module around the needle shaft and sheath in the ready-to-deploy state of the RICC insertion assembly is separated to allow the access guide wire to exit the valve module when the introducer needle is withdrawn from the coupler during the introducer needle withdrawal step.

[0029] In some embodiments, the coupler housing includes a longitudinally extending coupler housing slot that allows the access guide wire to exit the coupler housing when the introducer needle is withdrawn from the coupler during the introducer needle withdrawal step.

[0030] In some embodiments, the method further includes an access guide wire withdrawal step. The access guide wire withdrawal step includes withdrawing the access guide wire while leaving the catheter tube within the blood vessel lumen.

[0031] In some embodiments, the method further includes a steering guide wire advancement step, another RICC advancement step, and a steering guide wire withdrawal step. The steering guide wire advancement step includes advancing a steering guide wire into the vascular lumen via the primary lumen of the RICC. The other RICC advancement step includes further advancing the distal portion of the catheter tube within the vascular lumen on the steering guide wire to the lower one-third of the superior vena cava (SVC) of the patient's heart above the heart. The steering guide wire withdrawal step includes withdrawing the steering guide wire while leaving the catheter tube in the lower one-third of the SVC.

[0032] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which more particularly describe certain embodiments of such concepts.

Brief Description of the Drawings

[0033] [Figure 1] Shows a top view of a RICC insertion assembly according to some embodiments. [Figure 2] Shows a perspective view of a RICC insertion assembly according to some embodiments. [Figure 3] Shows a bottom view of a RICC insertion assembly according to some embodiments. [Figure 4] Shows a cutaway view of a coupler of a RICC insertion assembly according to some embodiments. [Figure 5] Shows another cutaway view of a coupler according to some embodiments. [Figure 6] Shows yet another cutaway view of a coupler according to some embodiments. [Figure 7] Shows a longitudinal cross-section of a coupler and an introducer needle of a RICC insertion assembly according to some embodiments. [Figure 8]The longitudinal cross-sections of the coupler, introducer needle, and access guide wire of the RICC insertion assembly according to several embodiments are shown. [Figure 9] The following are top views of the introducer needle according to several embodiments. [Figure 10] The sheaths of the introducer needle in several embodiments are shown. [Figure 11] The needle shafts of the introducer needle are shown in several embodiments. [Figure 12] The RICC of an RICC insertion assembly according to several embodiments is shown. [Figure 13] Detailed diagrams of the distal portion of the RICC catheter tube in several embodiments are shown. [Figure 14] The images show cross-sections of the distal portion of a catheter tube according to several embodiments. [Figure 15] Another cross-section of the distal portion of the catheter tube according to several embodiments is shown. [Figure 16] The longitudinal cross-section of the distal portion of the catheter tube according to several embodiments is shown. [Figure 17] The diagrams show the puncture route establishment step in the method of using the RICC insertion assembly according to several embodiments. [Figure 18] The blood aspiration step of this method is shown in several embodiments. [Figure 19] The access guide wire advancement step of the method is shown in several embodiments. [Figure 20] The introducer needle withdrawal step of this method is shown in several embodiments. [Figure 21] The RICC advance step of this method is shown in several embodiments. [Modes for carrying out the invention]

[0034] Before certain specific embodiments are disclosed in more detail, 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 are easily separable from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0035] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or processes and do not provide a sequential limitation or numerical limit. For example, the "1st," "2nd," and "3rd" features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. In addition, any of the aforementioned features or steps may further include one or more features or steps unless otherwise specified. Labels such as "left," "right," "up," "down," "front," and "back" are used for convenience and do not, for example, imply a specific fixed position, orientation, or direction. Instead, such notations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the aforementioned" also include plural references unless explicitly indicated in the context.

[0036] Regarding "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, but the proximal portion, proximal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. In other words, unless suggested by the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0037] Regarding "distal," for example, the "distal portion" or "distal end portion" of a catheter includes the portion of the catheter that is near or intended to be within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is near or intended to be within the patient when the catheter is used in a patient. For example, the "distal end" of a needle includes the end of the catheter that is near or intended to be within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless suggested by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0038] Unless otherwise defined, all scientific and technical terms used herein have the same meaning as those commonly understood by those skilled in the art. As mentioned earlier regarding the Seldinger procedure, many steps are time-consuming, handling numerous medical devices is cumbersome, and all of these have the potential to cause trauma to the patient. In addition, the large number of medical devices that need to be replaced during the Seldinger procedure makes contact contamination relatively likely. Therefore, it is necessary to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into the patient's body and advancing the catheter within its vascular structure.

[0039] This specification discloses RICC insertion assemblies and methods that address the aforementioned needs. For example, an RICC insertion assembly may include an RICC, an access guidewire, an introducer needle, and a coupler connecting the aforementioned components to each other. The introducer needle may include a needle shaft and a sheath. The needle shaft may include a longitudinally extending needle slot. The sheath may seal the needle slot beneath it, except for a sheath opening in the proximal portion of the sheath. The coupler may include a coupler housing and a valve module disposed within the coupler housing. The valve module may seal the needle shaft and sheath within it. The access guidewire may include a proximal end connected to the coupler and a distal end disposed within the needle shaft, thereby forming a loop in the access guidewire. The RICC may be positioned on the loop in the deployment-ready state of the RICC insertion assembly.

[0040] The features described above, as well as other features of the RICC insertion assembly and the methods provided herein, will become more apparent to those skilled in the art with consideration of the accompanying drawings illustrating in more detail specific embodiments of the RICC insertion assembly and methods and the following description. However, it should be understood that the RICC in the RICC insertion assembly is only one type of catheter that can be incorporated into a catheter insertion assembly such as the RICC in the RICC insertion assembly provided herein. In fact, peripherally inserted central catheters (PICCs), dialysis catheters, and the like can also be incorporated into catheter insertion assemblies and methods.

[0041] RICC Insertion Assembly Figures 1 to 3 show various diagrams of the RICC insertion assembly 100 according to several embodiments.

[0042] As shown, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104, an access guide wire 106, and a coupler 108 that connects the RICC 102, the introducer needle 104, and the access guide wire 106 to each other in the ready-to-deploy state of the RICC insertion assembly 100. In particular, the proximal end of the access guide wire 106 is connected to the coupler 108, and the distal end of the access guide wire 106 is positioned in the needle lumen 158 of the introducer needle 104, as described below. This forms a loop in the access guide wire 106, on which the RICC 102 is positioned in the ready-to-deploy state of the RICC insertion assembly 100, keeping the RICC insertion assembly 100 in a relatively compact form.

[0043] The RICC insertion assembly 100 may further include a syringe 110 fluidly connected to the introducer needle 104 when the RICC insertion assembly 100 is ready for deployment. As described below, the sheath 142 seals the needle slot 148 of the needle shaft 140. In particular, the sheath 142 seals the needle slot 148 outside the valve module 180. The valve module 180 then covers and seals the sheath opening 162 of the sheath 142, which then opens to the needle slot 148. The valve module 180 also seals around the access guidewire 106. Such sealing allows the syringe 110 to aspirate blood according to the blood aspiration step of the method described later.

[0044] Figure 12 shows the RICC102 of the RICC insertion assembly 100 according to several embodiments. As shown, the RICC102 includes a catheter tube 112, a catheter hub 114, one or more extension legs 116, and one or more extension leg connectors 118.

[0045] Figures 13 to 16 show various diagrams of the catheter tube 112 of RICC102 according to several embodiments. The catheter tube 112 includes a first section 120 in the distal portion of the catheter tube 112, a second section 122 in the distal portion of the catheter tube 112 proximal to the first section 120, and a tapered joint 124 between the first section 120 and the second section 122 of the catheter tube 112.

[0046] The first section 120 of the catheter tube 112 includes a catheter tip 126 having a relatively short taper from the outer diameter of the distal portion of the first section 120 distal to the joint 124 to the outer diameter of the distal end of the first section 120. The taper of the catheter tip 126 is configured to immediately expand the tissue surrounding the puncture route established by the introducer needle 104 to the outer diameter of the distal portion of the first section 120 of the catheter tube 112. As best shown in Figure 16, the first section 120 of the catheter tube 112 also includes a proximal portion positioned within the hole in the distal portion of the joint 124 and fixedly bonded to that hole by solvent bonding, adhesive bonding, or heat welding, etc.

[0047] The second section 122 of the catheter tube 112 has a constant outer diameter along its length, from the distal end to the proximal end. The constant diameter of the second section 122 of the catheter tube 112 is configured for smooth insertion into the puncture route and target vascular system after any expansion by the first section 120 and joint 124 of the catheter tube 112. The distal end of the second section 122 of the catheter tube 112 lies coplanar with the proximal end of the flat surface of the joint 124 and has a flat surface that is fixedly connected to its proximal end by solvent bonding, adhesive bonding, or heat welding.

[0048] The joint 124 includes a taper along its length from its proximal end to its distal end. The taper of the joint 124 is configured to immediately expand the tissue surrounding the puncture route from the outer diameter of the proximal portion of the first section 120 of the catheter tube 112 to the outer diameter of the second section 122 of the catheter tube 112. The non-luminal surface of the joint 124 transitions smoothly from the non-luminal surface of the first section 120 of the catheter tube 112 to the non-luminal surface of the second section 122 of the catheter tube 112 without creating an edge that could catch on the skin when the catheter tube 112 is inserted into the puncture route. In addition to having minimal or negligible edges, the edges may include solvent interdiffusion polymer material among the polymer material forming the catheter tube 112, thereby smoothing the transition from the first section 120 to the joint 124 and from the joint 124 to the second section 122 of the catheter tube 112. In particular, the joint 124 has a length approximately equivalent to the length of the exposed portion of the first section 120 of the catheter tube 112, or a length between the length of the exposed portion of the first section 120 and the length of the exposed portion of the second section 122 of the catheter tube 112. Thus, the length of the exposed portion of the first section 120 of the catheter tube 112 is shorter than the length of the joint 124, and at most approximately equivalent to the length of the joint 124.

[0049] The first section 120 of the catheter tube 112 is formed from a first polymer material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer hardness. The second section 122 of the catheter tube 112 is formed from a second polymer material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer hardness less than the first durometer hardness. For example, the first section 120 of the catheter tube 112 can be formed from a first polyurethane having a first durometer hardness, and the second section 122 of the catheter tube 112 can be formed from a second different polyurethane having a second durometer hardness less than the first durometer hardness (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, different diisocyanates or triisocyanates reacted with the same diol or triol under different conditions or using different additives). In fact, polyurethane can be relatively rigid at room temperature but can become more flexible at body temperature in vivo, which is advantageous for the catheter tube 112 in that it reduces irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous in that it can be less thrombogenic than some other polymers. The joint 124 is formed from a second or third polymer material (e.g., yet another polyurethane) having a third durometer hardness that is less than the first durometer hardness and greater than, approximately equal to, or less than the second durometer hardness.

[0050] It should be understood that the first durometer hardness of the first polymer material, the second durometer hardness of the second polymer material, and the third durometer hardness of the third polymer material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer hardness of the second polymer material or the third durometer hardness of the third polymer material may not be smaller in absolute value than the first durometer hardness of the first polymer material if the second or third durometer hardness is smaller than the first durometer hardness. 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 different scales, each ranging from 0 to 100, are designed to characterize separate materials within a group of materials having similar hardness.

[0051] With respect to the first section 120 of the catheter tube 112, the second section 122 of the catheter tube 112, and the joint 124 between the first section 120 and the second section 122 of the catheter tube 112, the catheter tube 112 has sufficient column strength to prevent buckling of the catheter tube 112 when inserted into the puncture route established by the introducer needle 104. Furthermore, the column strength of the catheter tube 112 is also sufficient to prevent buckling of the catheter tube 112 when advancing the catheter tube 112 through the patient's vascular system without pre-dilating any blood vessels in the surrounding tissue or vascular system using a separate dilator.

[0052] The catheter tube 112 contains one or more catheter tube lumens extending through it. However, in multi-lumen RICCs (e.g., two-lumen RICCs, three-lumen RICCs, four-lumen RICCs, five-lumen RICCs, six-lumen RICCs, etc.), there is usually only one catheter tube lumen extending from the proximal end to the distal end of the catheter tube 112. (See Figures 13-16.) In fact, the first section 120 of the catheter tube 112 usually contains a single lumen through which it passes, as shown in Figures 14 and 16.

[0053] The catheter hub 114 is connected to the proximal portion of the catheter tube 112. The catheter hub 114 contains one or more catheter hub lumens, each corresponding to a number of catheter tube lumens. One or more catheter hub lumens extend throughout the entire catheter hub 114 from the proximal end to the distal end.

[0054] Each of the one or more extension legs 116 is connected to the catheter hub 114 by its distal portion. Each of the one or more extension legs 116 contains one or more extension leg lumens, and the number of these 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 of the extension leg.

[0055] Each of the one or more extension leg connectors 118 is located on the proximal portion of one of the one or more extension legs 116. For example, each of the one or more extension leg connectors 118 may be a Luer connector located on the proximal portion of one of the one or more extension legs 116. Through such extension leg connectors, the corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen. However, in the deployment-ready state of the RICC insertion assembly 100, at least one extension leg connector (for example, an extension leg connector including a portion of the primary lumen 128 of the RICC 102) is connected to the swivel arm connector 194 of the swivel arm 182 of the coupler 108, forming a loop to the access guide wire 106 and the RICC 102 thereon.

[0056] As shown, RICC102 is a trilumen RICC including three lumen sets. However, RICC102 is not limited to the three lumen sets described above. The three lumen sets include a primary lumen 128, a secondary lumen 130, and a tertiary lumen 132, formed from the fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 128 has a primary lumen opening 134 at the distal end of the first section 120 of the catheter tube 112, and the primary lumen opening 134 corresponds to the distal end of the catheter tube 112 and the distal end of RICC102. The secondary lumen 130 has a secondary lumen opening 136 on the side of the distal portion of the catheter tube 112. The tertiary lumen 132 has a tertiary lumen opening 138 on the side of the distal portion of the catheter tube 112 proximal to the secondary lumen opening 136.

[0057] Figures 7 to 11 show various diagrams of the introducer needle 104 of the RICC insertion assembly 100 according to several embodiments. As shown, the introducer needle 104 includes a needle shaft 140, a sheath 142 covering the needle shaft 140, and a needle hub 144 covering both the proximal portion of the needle shaft 140 and the proximal portion of the sheath 142. At least in the deployment-ready state of the RICC insertion assembly 100, the needle shaft 140 and the sheath 142 extend outward from the distal end of the coupler housing 178, through the valve module 180, from the needle hub 144.

[0058] The needle shaft 140 includes a needle tip 146 at the distal end of the needle shaft 140 and a needle slot 148 extending longitudinally from the proximal end of the needle shaft 140 to the needle tip 146.

[0059] The needle tip 146 includes a bevel 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 is greater than the primary bevel angle of the primary bevel 154 so that the bevel provides a smooth transition across the needle tip 146. Thus, such a needle tip is configured to establish a puncture route from a region of skin to the lumen of a patient's blood vessel, according to the puncture route establishment step of the method described later.

[0060] The needle slot 148 extends from the proximal portion of the needle shaft 140 to the needle tip 146, thereby forming a needle channel 156 along most of the length of the needle shaft 140, in contrast to the needle lumen that passes through the needle shaft 140. The needle slot 148 has a width dimensional to the outer diameter of the access guide wire 106, thereby allowing the access guide wire 106 to pass from the proximal portion of the needle shaft 140 to the needle tip 146 when the introducer needle withdrawal step of the method described later is performed.

[0061] It should be understood that the needle shaft 140 includes the aforementioned needle slot 148, while the introducer needle 104 includes a needle lumen 158. However, the needle lumen 158 is provided by the combination of the needle shaft 140 and the sheath 142 covering the needle shaft 140. In fact, the sheath 142 covering the needle shaft 140 seals the needle slot 148 beneath the sheath, forming the needle lumen 158 of the introducer needle 104, allowing the syringe 110 to aspirate blood according to the blood aspiration step described later.

[0062] The sheath 142 includes a sheath tip 160 at the distal end of the sheath 142 and a sheath opening 162 on the side surface of the proximal end of the sheath 142. The sheath tip 160 includes a relatively short taper from the outer diameter of the distal portion of the sheath 142 to the outer diameter of the distal end of the sheath 142, the latter corresponding to the outer diameter of the distal portion of the needle shaft 140. The taper has a smaller taper angle than the primary bevel angle of the primary bevel 154 of the needle tip 146, and consequently, this taper angle is smaller than the tip bevel angle of the tip bevel 152 of the needle tip 146. The sheath tip 160, including such a taper, is configured to provide a smooth transition from the needle tip 146 to the sheath body for the puncture route establishment step of the method described later.

[0063] The sheath opening 162 is open to the needle slot 148 of the needle shaft 140, allowing the access guide wire 106 to pass through the sheath opening 162 and enter the needle slot 148 when the RICC insertion assembly 100 is ready for deployment. Thus, the sheath opening 162 has a width approximately corresponding to the width of the needle slot 148, and the needle slot is dimensioned according to the diameter of the access guide wire 106. The sheath opening 162 is also long enough for the access guide wire 106 to pass through the sheath opening 162 and enter the needle slot 148, and accommodates the blade 192 of the valve module 180 below the distal end of the sheath opening 162. In particular, the sheath 142 covering the needle shaft 140 seals the needle slot 148 beneath the sheath, except below the sheath opening 162. However, the valve module 180 seals the needle shaft 140 and the proximal portion of the sheath 142 therein, thereby covering and sealing the needle slot 148 exposed by the sheath opening 162, thereby enabling the syringe 110 to aspirate blood according to the blood aspiration step of the method described later.

[0064] The sheath 142 or its sheath body is formed from a polymer material configured to facilitate the smooth and consistent insertion of the introducer needle 104 from a region of the patient's skin into the vascular lumen, in accordance with the puncture route establishment step of the method described later. In addition, the polymer material has mechanical properties at a thickness of the sheath 142 sufficient to withstand the crushing of the sheath 142 into the needle slot 148 of the needle shaft 140 when the blood aspiration step of the method described later is performed, and also facilitates the detachment of the sheath 142 from the needle shaft 140 in particular, in accordance with the introducer needle withdrawal step of the method described later. Such polymer materials may include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0065] The needle hub 144 may include an access guide wire channel 164 at the distal portion of the needle hub 144 and a needle hub connector 166 at the proximal portion of the needle hub 144.

[0066] The access guide wire channel 164 of the needle hub 144 is configured to allow the access guide wire 106 to pass over the needle hub 144 and to be directed into the access guide wire conduit 190 of the valve module 180. The access guide wire channel 164 is open so that the access guide wire 106 is located within the access guide wire channel 164 at least in the deployment-ready state of the RICC insertion assembly 100. Advantageously, the open access guide wire channel 164 allows the access guide wire 106 to remain in place when the introducer needle 104 is withdrawn from the RICC insertion assembly 100 according to the introducer needle withdrawal step of the method described later.

[0067] The needle hub connector 166 includes a needle hub hole 168 and an optional needle hub flange 170 surrounding the needle hub connector 166. The needle hub hole 168 of the needle hub connector 166 is configured to receive the syringe tip 172 of the syringe 110 into it in order to fluidly connect the introducer needle 104 to the syringe 110. In fact, the needle hub hole 168 may have a Luer taper (e.g., a 6% taper) configured to receive the syringe tip 172 into it, and the syringe tip 172 may be configured complementary using a Luer taper.

[0068] The needle hub flange 170 of the needle hub connector 166 is configured to screw onto the female thread 174 of the threaded collar 176 surrounding the syringe tip 172 of the syringe 110. The threaded collar 176 of the syringe 110 is optional, but the needle hub flange 170 advantageously provides a so-called Luer-lock connection with the female thread 174 of the threaded collar 176 when both are present. This provides greater security against accidental separation of the introducer needle 104 and the syringe 110 than the security provided by an alternative Luer-slip type connection.

[0069] Figures 4 to 8 show various diagrams of the coupler 108 of the RICC insertion assembly 100 according to several embodiments. As shown, the coupler 108 includes a coupler housing 178, a valve module 180 located within the coupler housing 178, and a swivel arm 182 rotatably connected to the coupler housing 178.

[0070] The coupler housing 178 includes two interconnected molded halves to form an oval body configured to be comfortably held underhand (e.g., cradle-like) or overhand with the RICC insertion assembly 100, either with the left hand for left-handed venous punctures or with the right hand for right-handed venous punctures. To further facilitate such venous punctures, the outer surface of each of the two molded halves may be textured, as shown, with arched ridges 184 or the like to enhance the grip. The inner surface of each of the two molded halves includes recesses that form a valve module compartment and a needle hub receptacle when the two molded halves are connected to each other as shown. (See Figures 4-8, which include a valve module 180 positioned in a recess of one of the two molded halves that form the valve module compartment. Figures 4-8 also include a needle hub 144 for an introducer needle 104 positioned in a recess of one of the two molded halves that form the needle hub receptacle.) In addition, each half of the two molded halves includes a lock button through-hole for a corresponding lock button of a pair of lock buttons 188 of the needle hub lock. (See Figure 3 for lock buttons 188 extending through the corresponding pair of lock button through-holes.) In particular, the coupler housing 178 includes a longitudinally extending coupler housing slot 186 formed between the two molded halves. The coupler housing slot is configured to allow an access guide wire 106 to exit the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step of the method described later.

[0071] The valve module compartment is configured to hold the valve module 180 therein. In fact, the valve module compartment includes the valve module 180 positioned therein when the RICC insertion assembly 100 is ready for deployment. In particular, the valve module compartment is further configured to have sufficient space to allow the separable components of the valve module 180, described later, to separate for the escape of the access guide wire 106 when the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step of the method described later.

[0072] The needle hub receptacle is configured to hold within it the needle hub 144 of the introducer needle 104. In fact, the needle hub receptacle includes the needle hub 144 inserted within it in the deployment-ready state of the RICC insertion assembly 100. In particular, the needle hub lock configured to lock the needle hub 144 within the needle hub receptacle is positioned around the needle hub receptacle. A pair of locking buttons 188 (e.g., spring-loaded locking buttons) of the needle hub lock are positioned between the two sides of the coupler 108, in particular, within two molded semi-body locking button through-holes in the coupler housing 178, so that each locking button of the locking buttons 188 extends through the coupler housing 178 on each side of the coupler 108. The lock button 188 is configured to unlock the needle hub 144 when the lock button 188 is pressed into the coupler 108 to pull the introducer needle 104 out of the coupler 108 during the introducer needle withdrawal step of the method described later.

[0073] The valve module 180 includes an access guide wire conduit 190, an integrated blade 192, and several detachable parts. The access guidewire conduit 190 is configured to direct the access guidewire 106 from the access guidewire channel 164 of the needle hub 144 into both the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140 below it. In practice, the access guidewire conduit 190 includes the access guidewire 106 positioned within it when the RICC insertion assembly 100 is ready for deployment. In particular, the valve module 180 seals around the access guidewire 106 within the access guidewire conduit 190 so that the syringe 110 can aspirate blood according to the blood aspiration step of the method described later.

[0074] The blade 192 extends from its mounting point in the valve module 180 into the needle slot 148 of the needle shaft 140, such that the blade 192 is positioned in the needle slot 148 below the distal end of the sheath opening 162 of the sheath 142. The blade 192 includes a distally oriented blade edge configured to detach the sheath 142 from the needle shaft 140 when the introducer needle 104 is pulled proximal to the coupler 108 in the introducer needle withdrawal step of the method described later. By detaching the sheath 142 from the needle shaft 140, the access guide wire 106 is made able to exit the needle shaft 140 through the needle slot 148.

[0075] The separable components of the valve module 180 are positioned around the needle shaft 140 and sheath 142 in the deployment-ready state of the RICC insertion assembly 100. For example, the separable components of the valve module 180 may be separable halves of the valve module 180 positioned around the needle shaft 140 and sheath 142. The separable components of the valve module 180 are configured to separate when the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step of the method described later, allowing the access guide wire 106 to exit the valve module 180.

[0076] The swivel arm 182 includes a swivel arm connector 194 connected to one of the extension leg connectors 118 in the ready-to-deploy state of the RICC insertion assembly 100. Although not shown, the swivel arm connector 194 includes an access guidewire attachment point within the swivel arm connector 194 to which the proximal end of the access guidewire 106 is attached in the ready-to-deploy state of the RICC insertion assembly 100. Combined with the distal end of the access guidewire 106 positioned in the needle lumen 158 of the introducer needle 104, a loop of the access guidewire 106 is formed. Advantageously, the swivel arm 182 is configured to reverse the loop or at least one of the extension legs 116 of the RICC 102 between the left and right sides of the RICC insertion assembly 100 to accommodate both left-handed and right-handed venous punctures using the RICC insertion assembly 100. In fact, the swivel arm 182 is configured to reverse the loop from the left side of the RICC insertion assembly 100 to the right side of the RICC insertion assembly 100, as shown in Figure 1, in order to accommodate left-handed venous puncture using the RICC insertion assembly 100. Similarly, the swivel arm 182 is configured to reverse the loop from the right side of the RICC insertion assembly 100 to the left side of the RICC insertion assembly 100, in order to accommodate right-handed venous puncture using the RICC insertion assembly 100.

[0077] Figures 1, 2, and 8 show various diagrams of the access guide wire 106 of the RICC insertion assembly 100 according to several embodiments. The access guidewire 106 includes a proximal portion, which includes a proximal end, and a distal portion, which includes a distal end. When the RICC insertion assembly 100 is ready for deployment, the proximal end of the access guidewire 106 is connected to the access guidewire attachment point in the swivel arm 182, in particular, in the swivel arm connector 194 of the swivel arm 182. In addition, the proximal portion of the access guidewire 106 extends along the primary lumen 128 of the RICC 102. The distal portion of the access guidewire 106 also extends along the primary lumen 128 of the RICC 102, but the distal portion of the access guidewire 106 further exits the distal end of the RICC 102 in the ready-to-deploy state of the RICC insertion assembly 100, enters the valve module 180 on the needle hub 144 via the access guidewire channel 164, enters the needle shaft 140 through both the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140, and extends along the needle lumen 158 of the introducer needle 104. As shown in Figure 8, the distal end of the access guidewire 106 is positioned just proximal to the needle tip 146 in the needle lumen 158 in the ready-to-deploy state of the RICC insertion assembly 100. Furthermore, the proximal and distal ends of the access guide wire 106 form a loop when the RICC insertion assembly 100 is ready for deployment, and the RICC 102 is placed on this loop, thereby keeping the RICC insertion assembly 100 in a relatively compact form.

[0078] The access guidewire 106 may include a guidewire tip 196 in its distal portion, which adopts a "J" shape configured to prevent puncturing the posterior wall of the blood vessel. Such a guidewire tip is straight when the RICC insertion assembly 100 is ready for deployment and becomes curved when the guidewire tip 196 is advanced beyond the needle tip 146 (for example, into the lumen of the blood vessel) in the deployed state of the RICC insertion assembly 100.

[0079] The access guide wire 106 may further include a bare wire portion and a wound portion located distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, the bare wire portion, if present, extends distally through the access guide wire conduit 190 of the valve module 180, at least in the ready-to-deploy state of the RICC insertion assembly 100, so that the valve module 180 forms a fluid seal around the bare wire portion of the access guide wire 106. In particular, the aforementioned bare wire portion may instead be a flat-wound or ground-wound portion of the access guide wire 106, the flat-wound portion including a tape winding instead of a circular wire, and the ground-wound portion including a circular wire winding grounded to flatten the winding.

[0080] method Figures 17 to 21 illustrate various steps of using the RICC insertion assembly 100 according to several embodiments.

[0081] As shown, the method of the RICC insertion system 100 includes a method for inserting an RICC 102 into the lumen of a patient's blood vessel. Such a method includes one or more steps selected from an insertion assembly acquisition step, a puncture route establishment step, a blood aspiration step, an access guidewire advance step, an introducer needle withdrawal step, an RICC advance step, an access guidewire withdrawal step, a maneuver guidewire advance step, another RICC advance step, and a maneuver guidewire withdrawal step.

[0082] The insertion assembly acquisition step includes acquiring the RICC insertion assembly 100. As described above, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104 including a sheath 142 covering a needle shaft 140, and an access guide wire 106, all connected to each other by a coupler 108. The proximal end of the access guide wire 106 is connected to the swivel arm 182 of the coupler 108, and the distal end of the access guide wire 106 is positioned inside the introducer needle 104 via the valve module 180 of the coupler 108. The proximal and distal ends of the access guide wire 106 also form a loop in the access guide wire 106. The RICC 102 is positioned on the loop of the access guide wire 106 when the RICC insertion assembly 100 is ready for deployment.

[0083] Figure 17 shows the puncture route establishment step of this method according to several embodiments. The puncture route establishment step includes establishing a puncture route from a skin area to the vascular lumen using the introducer 104. Such a puncture route establishment step may include reversing the swivel arm 182, and thus the loop between the two sides of the RICC insertion assembly 100, before puncturing the skin area with the introducer needle 104. The puncture route establishment step may also include ensuring blood reflux while establishing the puncture route.

[0084] Reversing the swivel arm 182, and thus reversing the loop between the two sides of the RICC insertion assembly 100, involves reversing the loop using the RICC insertion assembly 100 between the left side of the RICC insertion assembly 100 for left-handed venous puncture and the right side of the RICC insertion assembly 100 for right-handed venous puncture. In fact, reversing the loop from the left side of the RICC insertion assembly 100 to the right side of the RICC insertion assembly 100 corresponds to left-handed venous puncture using the RICC insertion assembly 100. Similarly, reversing the loop from the right side of the RICC insertion assembly 100 to the left side of the RICC insertion assembly 100 corresponds to right-handed venous puncture using the RICC insertion assembly 100.

[0085] Ensuring blood reflux during the establishment of the puncture route includes ensuring that blood refluxes into the needle hub 144 of the introducer needle 104, the syringe tip 172 of the syringe 110 fluid-connected to the introducer needle 104, the barrel of the syringe 110, or a combination thereof. Once the puncture route is established, a small vacuum can be drawn using the syringe 110 during the establishment of the puncture route so that blood refluxes at least into the needle hub 144 of the introducer needle 104. Ensuring blood reflux as described above confirms that the puncture route extends into the lumen of the blood vessel.

[0086] Figure 18 shows the blood aspiration step of the method in several embodiments. The blood aspiration step includes aspirating blood using a syringe 110 to confirm that the puncture path extends into the lumen of a blood vessel before withdrawing the introducer needle 104 from the coupler 108 in the introducer needle withdrawal step. The sheath 142 covering the needle shaft 140 also seals the needle slot 148 of the needle shaft 140 beneath the sheath 142. In particular, the sheath 142 seals the needle slot 148 outside the valve module 180. The valve module 180 then covers and seals the sheath opening 162 of the sheath 142, which allows the access guidewire 106 to pass through the needle slot 148 into the needle shaft 140 when the RICC insertion assembly 100 is ready for deployment. The valve module 180 also seals around the distal portion of the access guidewire 106. This type of sealing allows the syringe 110 to draw blood during the blood aspiration step.

[0087] Figure 19 shows the access guide wire advancement step of the method according to several embodiments. The access guidewire advancement step includes advancing the distal end of the access guidewire 106 into the vascular lumen within the needle shaft 140 from its initial position just proximal to the needle tip 146, thereby securing vascular access for the RICC 102 in the RICC advancement step.

[0088] Figure 20 shows the introducer needle withdrawal step of the method in several embodiments. The introducer needle withdrawal step includes withdrawing the introducer needle 104 from the coupler 108 while leaving the access guidewire 106 in place within the vascular lumen. The introducer needle withdrawal step also includes simultaneously detaching the sheath 142 from the needle shaft 140 with the blade 192 of the valve module 180 as the introducer needle 104 is withdrawn from the coupler 108. Detachment of the sheath 142 from the needle shaft 140 allows the access guidewire 106 to exit the needle shaft 140 through its needle slot 148. The introducer needle 104 also includes a needle slot 148 extending from the proximal portion of the needle shaft 140 to the needle tip 146, thereby allowing the access guidewire 106 to exit the introducer needle 104 by detaching the sheath 142 from the needle shaft 140. In particular, the separable parts of the valve module 180 around the needle shaft 140 and sheath 142 in the ready-to-deploy state of the RICC insertion assembly 100 are separable in such a way that, in the introducer needle withdrawal step, the access guide wire 106 can extend further out of the valve module 180 when the introducer needle 104 is withdrawn from the coupler 108. In addition, the coupler housing 178 includes a coupler housing slot 186 configured to allow the access guide wire 106 to extend further out of the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step. (See, for example, Figure 21, where the distal portion of the access guide wire 106 is fully out of the coupler 108 and the proximal end of the access guide wire 106 remains attached to the access guide wire mounting point in the swivel arm connector 194.) Figure 21 shows the RICC advancement steps of the method according to several embodiments.

[0089] The RICC advancement step includes advancing the catheter tube 112 of the RICC 102 on the access guidewire 106 and into the vascular lumen, thereby inserting the RICC 102 into the vascular lumen.

[0090] The access guidewire withdrawal step includes withdrawing the access guidewire 106 while leaving the catheter tube 112 in place within the vascular lumen. The maneuvering guidewire advancement step includes advancing the maneuvering guidewire through the primary lumen 128 of the RICC102 into the vascular lumen and to the lower one-third of the SVC of the patient's heart.

[0091] Other RICC advancement steps include further advancing the distal portion of the catheter tube 112 into the vascular lumen to the lower one-third of the SVC of the patient's heart on the maneuvering guidewire. The withdrawal step of the control guidewire includes withdrawing the control guidewire while leaving the catheter tube 112 in place within the lower one-third of the SVC.

[0092] While several specific embodiments are disclosed herein, and these specific embodiments are disclosed in some degree of detail, they are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may be apparent to those skilled in the art, and these adaptations or modifications are also encompassed in broader embodiments. Thus, it is possible to implement developments from specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A rapid insertion central venous catheter (RICC) insertion assembly, RICC and, It is an introducer needle, A needle shaft, the needle shaft including a needle slot extending longitudinally from the proximal portion of the needle shaft to the distal needle tip, A sheath, which covers the needle shaft sealing the needle slot except for a portion of the needle slot below the sheath opening in the proximal part of the sheath; The introducer needle includes, A coupler connecting the RICC and the introducer needle to each other, Coupler housing and A valve module disposed within the coupler housing, wherein the valve module seals the proximal portion of the needle shaft and the sheath internally. Couplers including, Access guide wire, The proximal end connected to the swivel arm of the coupler, The distal end and the introduced needle are located within the introduced needle. Access guide wires including Equipped with, A RICC insertion assembly in which the proximal and distal ends of the access guide wire form a loop on the access guide wire, and the RICC is positioned on the loop of the access guide wire when the RICC insertion assembly is ready to be deployed.

2. The RICC insertion assembly according to claim 1 further comprises a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the RICC insertion assembly, wherein the sheath seals the needle slot of the needle shaft below the sheath outside the valve module, the valve module seals the sheath opening of the sheath inward, and the valve module seals around the access guide wire, allowing the syringe to aspirate blood.

3. The RICC insertion assembly according to claim 1, wherein the valve module includes an integrated blade positioned in the needle slot below the distal end of the sheath opening, the blade including a distally oriented blade edge configured to detach the sheath from the needle shaft when the introducer needle is withdrawn from the coupler, the detachment allowing the access guide wire to exit the needle shaft via the needle slot of the needle shaft.

4. The RICC insertion assembly according to claim 1, wherein the coupler housing includes a longitudinally extending coupler housing slot configured to allow the access guide wire to exit the coupler housing when the introducer needle is withdrawn from the coupler.

5. The RICC insertion assembly according to any one of claims 1 to 4, wherein the valve module includes a separable component surrounding the needle shaft and sheath, the separable component being configured to separate when the introducer needle is withdrawn from the coupler, allowing the access guide wire to exit the valve module.

6. A rapid insertion central venous catheter (RICC) insertion assembly, It is RICC, Catheter tube and A catheter hub connected to the proximal portion of the catheter tube, One or more extension legs, each of which is connected to the catheter hub by its distal portion, One or more extension leg connectors, wherein each of the one or more extension leg connectors is located on the proximal portion of one of the extension legs and RICC, which includes, It is an introducer needle, A needle shaft, the needle shaft including a needle slot extending longitudinally from the proximal portion of the needle shaft to the needle tip of the distal portion of the needle shaft, A sheath covering the needle shaft, wherein the sheath includes a sheath opening in the proximal portion of the sheath, The needle hub covers the proximal portion of the needle shaft and the proximal portion of the sheath. The introducer needle includes, A coupler that connects the RICC and the introducer needle to each other in the state where the RICC insertion assembly is ready for deployment, A coupler housing including a needle hub receptacle, wherein the needle hub is inserted into the needle hub receptacle, A valve module disposed within the coupler housing, wherein the needle shaft and the sheath extend from the needle hub through the valve module outward from the distal end of the coupler housing, A swivel arm rotatably connected to the coupler housing, the swivel arm including a swivel arm connector connected to one of the extension leg connectors among the one or more extension leg connectors, and Couplers including, Access guide wire, The proximal end connected to the aforementioned swivel arm connector, The proximal portion extending along the primary lumen of the RICC, The distal portion of the RICC extending along the primary lumen, which exits the distal end of the RICC, enters the valve module on the needle hub, enters the needle shaft through both the sheath opening and the needle slot, and extends along the needle lumen of the introducer needle, The distal end, which is positioned immediately proximal to the tip of the needle within the needle lumen, Access guide wires including A RICC insertion assembly equipped with the following features.

7. The RICC insertion assembly according to claim 6 further comprises a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the RICC insertion assembly, wherein the sheath seals the needle slot of the needle shaft beneath the sheath outside the valve module, the valve module seals the sheath opening of the sheath inward, and the valve module seals around the access guide wire to allow the syringe to aspirate blood.

8. The RICC insertion assembly according to claim 6, wherein the proximal end of the access guide wire connected to the swivel arm connector and the distal end of the access guide wire positioned in the needle lumen form a loop within the access guide wire, and the RICC is positioned on the loop in the ready-to-deploy state of the RICC insertion assembly.

9. The RICC insertion assembly according to claim 8, wherein the swivel arm is configured to reverse the loop between the left side and the right side of the RICC insertion assembly in order to accommodate venous puncture by both left-handed and right-handed individuals using the RICC insertion assembly.

10. The RICC insertion assembly according to claim 6, wherein the coupler includes a needle hub lock configured to lock the needle hub of the needle hub receptacle, and a pair of locking buttons for the needle hub lock, positioned between the two sides of the coupler, configured to unlock the needle hub when the locking buttons are pressed into the coupler to pull the introducer needle out of the coupler.

11. The RICC insertion assembly according to claim 6, wherein the valve module includes an integrated blade positioned in the needle slot below the distal end of the sheath opening, the blade including a distally oriented blade edge configured to detach the sheath from the needle shaft when the introducer needle is withdrawn from the coupler, the detachment allowing the access guide wire to exit the needle shaft via the needle slot of the needle shaft.

12. The RICC insertion assembly according to claim 6, wherein the coupler housing includes a longitudinally extending coupler housing slot configured to allow the access guide wire to exit the coupler housing when the introducer needle is withdrawn from the coupler.

13. The RICC insertion assembly according to claim 6, wherein the valve module includes a separable component provided around the needle shaft and the sheath, the separable component being configured to separate when the introducer needle is withdrawn from the coupler, allowing the access guide wire to exit the valve module.

14. A RICC insertion assembly according to any one of claims 6 to 13, wherein the catheter tube is A first section formed of a first polymer material having a first durometer hardness, the first section located in the distal portion of the catheter tube, A second section formed of a second polymer material having a second durometer hardness lower than the first durometer hardness, the second section located proximal to the first section in the distal portion of the catheter tube, The tapered joint between the first section and the second section of the catheter tube A RICC insertion assembly comprising, wherein 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.

15. The RICC insertion assembly according to claim 14, wherein the proximal portion of the first section of the catheter tube is positioned in and bonded to the hole in the distal portion of the joint.

16. The RICC insertion assembly according to claim 14, 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.

17. The RICC insertion assembly according to claim 14, wherein the catheter tube has sufficient column strength to prevent buckling of the catheter tube when it is inserted into the puncture route established by percutaneous puncture with the introducer needle and advanced through the patient's vascular system without pre-dilating any blood vessels in the surrounding tissue or vascular system of the puncture route using a separate dilator.

18. The RICC insertion assembly according to claim 14, wherein the RICC includes a set of three lumens, the set of three lumens comprising a primary lumen, a secondary lumen, and a tertiary lumen, formed from fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

19. The RICC insertion assembly according to claim 18, 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 surface of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on the side surface of the distal portion of the catheter tube proximal to the secondary lumen opening.

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