Separable sealing module for insertion assembly of rapid insertion central venous catheter - Patents.com

Abstract

A splittable sealing module for an insertion assembly of a rapid insertion central venous catheter ("RICC") and method thereof are disclosed. The RICC insertion assembly can include a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle to one another. The introducer needle can include a proximal portion of a sealing module insert coupled to a distal portion of a needle hub. The coupler can include a coupler housing including a sealing module cavity and a distal portion of the sealing module insert disposed within the sealing module cavity. The sealing module cavity and the proximal and distal portions of the sealing module insert form a splittable sealing module of the RICC insertion assembly. The splittable sealing module can be configured to separately seal around the introducer needle and the access guidewire disposed therein when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

Description

[Technical field]

[0001] The present disclosure relates to a splittable sealing module for an insertion assembly of a rapid insertion central venous catheter. [Background technology]

[0002] Central venous catheters ("CVCs") are typically introduced into a patient and advanced through the patient's vascular system via the Seldinger technique. The Seldinger technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming and the handling of many of the medical devices is cumbersome, both of which can lead to trauma to the patient. In addition, due to the large number of medical devices that need to be replaced during the Seldinger technique, the potential for contact contamination is relatively high. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system.

[0003] Disclosed herein are rapidly insertable central catheter ("RICC") insertion assemblies and methods that address the above. In particular, the RICC insertion assembly disclosed herein includes a separable sealing module for sealing different components of the RICC insertion assembly therein. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a RICC insertion assembly including a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle to one another. The RICC includes a catheter tube and a primary lumen therethrough. The introducer needle includes a needle shaft, a needle hub around a proximal end portion of the needle shaft, and a sealing module insert coupled to a distal portion of the needle hub. The access guidewire includes a proximal portion disposed within the primary lumen of the RICC and a distal portion disposed within the needle shaft through a longitudinal needle slot of the needle shaft. The coupler includes a coupler housing including a sealing module cavity and a distal portion of the sealing module insert disposed within the sealing module cavity. The sealing module cavity and the proximal and distal portions of the sealing module insert form a splittable sealing module of the RICC insertion assembly. The splittable sealing module is configured to separately seal around the proximal portion of the introducer needle and the distal portion of the access guidewire when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

[0005] In some embodiments, each of the proximal and distal portions of the sealing module insert is formed from an elastomer.

[0006] In some embodiments, the proximal and distal portions of the sealing module insert, when combined within the sealing module cavity, complete both the introducer needle passage and the access guidewire passage.

[0007] In some embodiments, a proximal portion of the introducer needle passageway resides in a proximal portion of the sealing module insert, and a distal portion of the introducer needle passageway is completed by the proximal and distal portions of the sealing module insert combined within the sealing module cavity.

[0008] In some embodiments, the entire access guidewire passage is completed by the proximal and distal portions of the sealing module insert mated within the sealing module cavity.

[0009] In some embodiments, the distal end of the access guidewire passage connects to an inner portion of the introducer needle passage, such a connection allowing the distal portion of the access guidewire to be positioned through the needle slot and into the needle shaft.

[0010] In some embodiments, the introducer needle passage is configured to seal around a proximal portion of the introducer needle when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, and the access guidewire passage is configured to seal around a distal portion of the access guidewire when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

[0011] In some embodiments, the introducer needle passage includes an internal relief between the proximal and distal portions of the introducer needle passage such that when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, only the proximal and distal end portions of the introducer needle passage are configured to seal around the proximal portion of the introducer needle.

[0012] In some embodiments, the access guidewire passage includes an internal relief in at least a proximal portion of the access guidewire passage such that when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, only the proximal end portion of the access guidewire passage is configured to seal around the distal portion of the access guidewire.

[0013] In some embodiments, the sealing module insert is radially compressed within the sealing module cavity by the coupler housing.

[0014] In some embodiments, the sealing module insert is axially compressed within the sealing module cavity by the distal portion of the needle hub. The axial compression of the sealing module insert within the sealing module cavity in turn radially compresses the sealing module insert within the sealing module cavity.

[0015] In some embodiments, the coupler housing includes a longitudinal coupler housing slot configured to allow the access guidewire to escape from the coupler housing after the proximal portion of the sealing module insert is removed from the sealing module cavity by withdrawal of the introducer needle from the coupler.

[0016] In some embodiments, the introducer needle further includes a sheath covering the needle shaft and sealing a needle slot therebelow, the needle slot extending from a proximal portion of the needle shaft to the distal needle tip.

[0017] In some embodiments, the coupler includes a blade extending into the splittable sealing module such that the blade is positioned in the needle slot below the distal end of the sheath opening. The blade includes a distally facing blade edge configured to decouple the sheath from the needle shaft as the introducer needle is withdrawn from the coupler. Decoupling the sheath from the needle shaft allows the access guidewire to exit the needle shaft via the needle slot.

[0018] In some embodiments, the blades are overmolded into the coupler housing, thereby integrating the blades within the coupler housing.

[0019] In some embodiments, the sheath is splittable.

[0020] In some embodiments, the sheath is perforated with a pattern of holes, slits, or a combination thereof extending longitudinally across the sheath configured to split the sheath, the pattern being offset from the needle slot to maintain a seal of the needle slot by the sheath.

[0021] In some embodiments, the sheath includes one or more grooves extending longitudinally across the sheath that are configured to divide the sheath.

[0022] In some embodiments, the sheath includes an embedded tension cord extending longitudinally within the sheath that is configured to split the sheath when pulled away from the sheath.

[0023] In some embodiments, the sheath is formed from a polymeric material selected from polyethylene, polypropylene, polyurethane, and polytetrafluoroethylene.

[0024] In some embodiments, the coupler further includes an access guidewire connection side arm including a connector configured to connect to an access guidewire hub around a proximal end portion of the access guidewire, the distal portion of the access guidewire being disposed within the needle shaft and the access guidewire hub being connected to the connector of the access guidewire connection side arm, thereby forming a loop on the access guidewire over which the RICC is disposed, at least in a ready-to-operate state of the RICC insertion assembly.

[0025] In some embodiments, the RICC insertion assembly further includes a keeper that includes a splittable casing that covers both the catheter tube of the RICC and the extra-catheter portion of the access guidewire extending from the distal end of the RICC, the splittable casing configured to keep the catheter tube and the extra-catheter portion of the access guidewire sterile until deployment.

[0026] In some embodiments, the keeper further includes a catheter hub holder to which the proximal end of the splittable casing is attached, the catheter hub holder configured to retain the catheter hub of the RICC within the catheter hub holder and to hold the splittable casing in place over both the catheter tube and the external catheter portion of the access guidewire.

[0027] In some embodiments, the catheter hub holder includes a peripheral wall about at least a portion of a circumference of the catheter hub holder, the peripheral wall defining a recess into which the catheter hub fits with an engineered fit.

[0028] In some embodiments, the coupler further includes a splittable casing retaining side arm including a primary channel and a secondary channel, the primary channel configured to slidably retain the splittable casing therein, and the secondary channel configured to guide an access guidewire split off of the splittable casing through the needle slot, into the coupler and into the needle shaft.

[0029] In some embodiments, the coupler further includes an access guidewire connecting side arm including a connector configured to connect to an access guidewire hub around a proximal end portion of the access guidewire, a distal portion of the access guidewire being disposed within the needle shaft, a distal portion of the splittable casing being retained within the primary channel of the splittable casing retaining side arm, and the access guidewire hub being connected to the connector of the access guidewire connecting side arm, thereby forming a loop on the access guidewire over which the RICC is disposed, at least in the ready-to-operate state of the RICC insertion assembly.

[0030] In some embodiments, the RICC comprises a set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen, the set of three lumens being formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

[0031] 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 a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on a side of the distal portion of the catheter tube proximal to the secondary lumen opening.

[0032] Also disclosed herein is a method for inserting a RICC into a vascular lumen of a patient. The method, in some embodiments, includes an introducer assembly obtaining step, a needle path establishing step, an access guidewire advancing step, and a RICC advancing step. The insertion assembly obtaining step optionally includes obtaining a RICC insertion assembly already in its ready-to-operate state. The RICC insertion assembly includes a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle to each other. In addition, the RICC insertion assembly includes a splittable sealing module formed between at least a sealing module cavity of a coupler housing of the coupler, a proximal portion of a sealing module insert coupled to a distal portion of a needle hub of the introducer needle, and a distal portion of the sealing module insert disposed within the sealing module cavity. The splittable sealing module separately seals around a proximal portion of the introducer needle and a distal portion of the access guidewire. The establishing a path step includes establishing a path from the area of ​​skin to the vessel lumen with the introducer needle. The advancing an access guidewire step includes advancing a distal portion of the access guidewire through both the splittable sealing module and a longitudinal needle slot of the needle shaft of the introducer needle, such that a distal end of the access guidewire is advanced within the introducer needle from a position just proximal to the needle tip of the needle shaft and into the vessel lumen. The advancing an RICC step includes inserting the RICC into the vessel lumen by advancing a catheter tube of the RICC over the access guidewire and into the vessel lumen.

[0033] In some embodiments, the proximal and distal portions of the sealing module insert, when combined within the sealing module cavity, complete both the introducer needle passage and the access guidewire passage.

[0034] In some embodiments, a proximal portion of the introducer needle passageway resides in a proximal portion of the sealing module insert, and a distal portion of the introducer needle passageway is completed by the proximal and distal portions of the sealing module insert combined within the sealing module cavity.

[0035] In some embodiments, the entire access guidewire passage is completed by the proximal and distal portions of the sealing module insert mated within the sealing module cavity.

[0036] In some embodiments, the distal end of the access guidewire passage connects to an inner portion of the introducer needle passage such that the distal portion of the access guidewire can be positioned within the needle shaft through a longitudinal needle slot of the needle shaft.

[0037] In some embodiments, the introducer needle passage is configured to seal around a proximal portion of the introducer needle when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, and the access guidewire passage is configured to seal around a distal portion of the access guidewire when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

[0038] In some embodiments, the method further includes a status verification step, which includes verifying that the RICC insertion assembly is in its ready-to-operate state prior to the path establishment step. Such verification ensures that the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity to seal the introducer needle passage and the access guidewire passage around the introducer needle and the access guidewire, respectively.

[0039] In some embodiments, the access guidewire advancement step includes pinching an extracatheter portion of the access guidewire extending from a distal end of the RICC and pushing the access guidewire into the needle shaft through a splittable sealing module of the coupler. Advancement of the access guidewire in this manner reduces a loop on the access guidewire over which the RICC is disposed. The loop is formed by a distal portion of the access guidewire disposed within the needle shaft and an access guidewire hub of the access guidewire connected to a connector on an access guidewire connection side arm of the coupler.

[0040] In some embodiments, the access guidewire advancing step includes pinching a splittable casing over both the catheter tube of the RICC and the extra-catheter portion of the access guidewire extending from the distal end of the RICC. The access guidewire advancing step also includes forcing the splittable casing into a primary channel of a splittable casing-retaining side arm of the coupler while pinching the splittable casing. This pinching and forcing of the splittable casing into the primary channel of the splittable casing-retaining side arm splits the access guidewire away from the splittable casing into the secondary channel of the splittable casing-retaining side arm and then through the splittable sealing module of the coupler to the needle shaft.

[0041] In some embodiments, the access guidewire advancing step includes reducing a loop on the access guidewire over which the RICC is disposed, the loop being formed by the splittable casing held in the primary channel of the splittable casing-retaining side arm and the access guidewire hub of the access guidewire connected to a connector of the access guidewire-connecting side arm of the coupler.

[0042] In some embodiments, the method further includes a needle withdrawal step, which includes withdrawing the introducer needle from the coupler while leaving the access guidewire within the vessel lumen prior to the RICC advancement step. By withdrawing the introducer needle from the coupler, the needle hub of the introducer needle is removed from the needle hub receptacle and, together with the needle hub, the proximal portion of the sealing module insert is removed from the sealing module cavity, thereby splitting the proximal and distal portions of the sealing module insert apart from one another and unsealing the proximal portion of the introducer needle and the distal portion of the access guidewire, allowing the access guidewire to exit the splittable sealing module.

[0043] In some embodiments, the introducer needle withdrawal step includes decoupling a needle slot sealing sheath of the introducer needle from the needle shaft. The coupler includes a blade extending into the splittable sealing module such that the blade is positioned in the needle slot below the distal end of the sheath opening of the sheath with a distally facing blade edge for decoupling the sheath from the needle shaft.

[0044] In some embodiments, decoupling the sheath from the needle shaft allows the access guidewire to exit the needle shaft via the needle slot.

[0045] In some embodiments, a longitudinal coupler housing slot in the coupler housing allows the access guidewire to exit the coupler housing after the introducer needle withdrawal step.

[0046] In some embodiments, the needle path establishment step includes ensuring that blood flows back into the introducer needle or a syringe fluidly connected to the introducer needle, thereby confirming that the needle path extends into the blood vessel lumen.

[0047] In some embodiments, the method further comprises the step of aspirating blood, the step of aspirating blood comprising aspirating blood with a syringe to confirm that the needle tract extends into the lumen of the blood vessel.

[0048] In some embodiments, the method further comprises the step of withdrawing the access guidewire, the step of withdrawing the access guidewire comprising withdrawing the access guidewire while leaving the catheter tube within the blood vessel lumen.

[0049] In some embodiments, the method further includes a steering guidewire advancement step, an additional RICC advancement step, and a steering guidewire withdrawal step. The steering guidewire advancement step includes advancing a steering guidewire into the vessel lumen via the primary lumen of the RICC. The additional RICC advancement step includes further advancing a catheter tube over the steering guidewire into the vessel lumen to the lower third of the patient's heart's superior vena cava ("SVC"). The steering guidewire withdrawal step includes withdrawing the steering guidewire while leaving the catheter tube in the lower third of the SVC.

[0050] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0051] [Figure 1] 1 illustrates a RICC insertion assembly according to some embodiments. [Diagram 2] 1 illustrates a perspective view of a coupler of a RICC insertion assembly, according to some embodiments. [Diagram 3] 1 illustrates a side view of a coupler according to some embodiments. [Figure 4] 1 illustrates a longitudinal cross section of a coupler and its splittable sealing module according to some embodiments. [Diagram 5]1 illustrates a perspective view of a needle hub, an introducer needle, and a proximal and distal portion of a sealing module insert of a splittable sealing module, according to some embodiments. [Figure 6] 1 illustrates a longitudinal cross-section of a needle hub and proximal and distal portions of a sealing module insert according to some embodiments. [Figure 7] 1A-1D show longitudinal cross-sections of a splittable sealing module in two different states according to some embodiments. [Figure 8] 13A-13C show cross-sections of a proximal portion of a splittable sealing module in two different states according to some embodiments. [Figure 9] 13 illustrates radial compression of a sealing module insert within a sealing module cavity of a splittable sealing module defined by a coupler housing of a coupler, according to some embodiments. [Figure 10] 13A-13C illustrate radial compression of the sealing module insert within the sealing module cavity due to axial compression of the sealing module insert within the sealing module cavity by the needle hub, according to some embodiments. [Figure 11] 13 illustrates a longitudinal cross section of another sealing module insert having internal relief within the introducer needle passage and the access guidewire passage of the sealing module insert, according to some embodiments. [Figure 12] 1 illustrates a top view of an introducer needle, according to some embodiments. [Figure 13A] 1 illustrates a cuttable sheath for an introducer needle, according to some embodiments. [Figure 13B] 1 illustrates a splittable sheath for an introducer needle, according to some embodiments. [Figure 13C] 13 illustrates another splittable sheath for an introducer needle, according to some embodiments. [Figure 13D] 13 illustrates yet another splittable sheath for an introducer needle, according to some embodiments. [Figure 14]1 illustrates a needle shaft of an introducer needle, according to some embodiments. [Figure 15] 1 illustrates a RICC of a RICC insertion assembly, according to some embodiments. [Figure 16] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 17] 1 illustrates a transverse cross section of a distal portion of a catheter tube according to some embodiments. [Figure 18] 13 illustrates another transverse cross-section of a distal portion of a catheter tube according to some embodiments. [Figure 19] 1 shows a longitudinal cross-section of a distal portion of a catheter tube according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of several other embodiments disclosed herein.

[0053] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain particular embodiments, and that these terms are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not impose sequential or numerical limitations. For example, "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. 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", "upper", "lower", "front", "rear", etc. are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a," "an," and "the" include the plural forms unless the context clearly indicates otherwise.

[0054] With respect to "proximal," a "proximal portion" or "proximal end portion," e.g., of a catheter, includes the portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, a "proximal length," e.g., of a catheter, includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. A "proximal end," e.g., of a catheter, includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0055] With respect to "distal," a "distal portion" or "distal end portion," e.g., of a catheter, includes a portion of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, a "distal length," e.g., of a catheter, includes a length of a catheter that is intended to be near or within a patient when the catheter is used with a patient. A "distal end," e.g., of a catheter, includes an end of a catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0057] As discussed above with respect to the Seldinger procedure, many steps are time consuming and the handling of many medical devices is cumbersome, both of which can lead to trauma to the patient. In addition, due to the large number of medical devices that need to be exchanged during the Seldinger procedure, the potential for contact contamination is relatively high. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system.

[0058] Disclosed herein are RICC insertion assemblies and methods that address the above. In particular, the RICC insertion assembly disclosed herein includes a splittable sealing module for sealing different components of the RICC insertion assembly therein. For example, the RICC insertion assembly can include a RICC, an introducer needle, an access guidewire, and a coupler that couples the RICC and the introducer needle together. The introducer needle can include a proximal portion of a sealing module insert coupled to a distal portion of a needle hub. The coupler can include a coupler housing that includes a sealing module cavity and a distal portion of a sealing module insert disposed within the sealing module cavity. The sealing module cavity and the proximal and distal portions of the sealing module insert form a splittable sealing module of the RICC insertion assembly. The splittable sealing module can be configured to separately seal around the introducer needle and the access guidewire disposed therein when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

[0059] The foregoing and other features of the RICC insertion assembly and method disclosed herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of the RICC insertion assembly and method. However, it should be understood that the RICC of the RICC insertion assembly is only one type of catheter that may be incorporated into a catheter insertion assembly such as that disclosed herein. Indeed, peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like, may also be incorporated into a catheter insertion assembly and method such as that disclosed herein.

[0060] RICC Insertion Assembly FIG. 1 illustrates a RICC insertion assembly 100 according to some embodiments.

[0061] As shown, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104, an access guidewire 106, and a coupler 108 that couples the RICC 102, the introducer needle 104, and the access guidewire 106 together in a ready-to-operate state of the RICC insertion assembly 100. As described in more detail below, in a ready-to-operate state of the RICC insertion assembly 100, a proximal end of the access guidewire 106 is coupled to the coupler 108 and a distal end of the access guidewire 106 is disposed within a needle lumen 158 of the introducer needle 104. This causes the RICC 102 to form a loop 110 on the access guidewire 106 over which the RICC 102 is disposed in the ready-to-operate state of the RICC insertion assembly 100, keeping the RICC insertion assembly 100 in a relatively compact configuration.

[0062] The RICC insertion assembly 100 may further include a syringe 112 fluidly coupled to the introducer needle 104 in a ready-to-operate state of the RICC insertion assembly 100. As described below, the splittable sealing module 196 seals around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106 when the sealing module insert 198 is compressed within the sealing module cavity 178 in one or more states of the RICC insertion assembly 100. In particular, the splittable sealing module 196 covers and seals a sheath opening 162 of the sheath 142 that opens to a needle slot 150 of the needle shaft 144. Outside of the splittable sealing module 196, the sheath 142 seals the needle slot 150 of the needle shaft 144. Such a seal allows the syringe 112 to aspirate blood in accordance with a blood aspirating step of the method described below.

[0063] Finally, any component of the RICC insertion assembly 100 selected from at least the RICC 102, the introducer needle 104, the access guidewire 106, the coupler 108, and the syringe 110, or any portion of a component selected from the aforementioned components, can include an antimicrobial agent thereon or therein. In one example, the catheter tube 114 of the RICC 102 can include an antimicrobial coating on the abluminal surface of the catheter tube 114, the luminal surface of the catheter tube 114, or both. In another example, the pre-extrusion material of the catheter tube 114 can include an antimicrobial agent mixed therein, such that the antimicrobial agent is incorporated into the catheter tube 114, and upon extrusion, the antimicrobial agent protects both the abluminal surface of the catheter tube 114 and the luminal surface of the catheter tube 114 from microbial contamination.

[0064] FIG. 15 illustrates a RICC 102 of the RICC insertion assembly 100, according to some embodiments.

[0065] As shown, the RICC 102 includes a catheter tube 114 , a catheter hub 116 , one or more extension legs 118 , and one or more extension leg connectors 120 .

[0066] 16-19 show various views of the catheter tube 114 of the RICC 102, according to some embodiments.

[0067] The catheter tube 114 includes a first section 122 at a distal portion of the catheter tube 114, a second section 124 at a distal portion of the catheter tube 114 proximal to the first section 122, and a tapered junction 126 between the first section 122 and the second section 124 of the catheter tube 114.

[0068] The first section 122 of the catheter tube 114 includes a catheter tip 128 having a relatively short taper from an outer diameter of the distal portion of the first section 122 distal to the junction 126 to an outer diameter of the distal end of the first section 122. The taper of the catheter tip 128 is configured to immediately dilate tissue around the needle tract established by the introducer needle 104 to the outer diameter of the distal portion of the first section 122 of the catheter tube 114. As best shown in FIG. 19 , the first section 122 of the catheter tube 114 also includes a proximal portion that is disposed within a bore in the distal portion of the junction 126 and is fixedly attached thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0069] The second section 124 of the catheter tube 114 includes a constant outer diameter over its length from the distal end of the second section 124 to the proximal end of the second section 124. The constant diameter of the second section 124 of the catheter tube 114 is configured for smooth insertion into the needle tract and target vasculature after any expansion by the first section 122 of the catheter tube 114 and the junction 126. The distal end of the second section 124 of the catheter tube 114 has a flat surface that is flush with the flat surface proximal end of the junction 126 and is fixedly bonded thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0070] The junction 126 includes a taper over its length from the proximal end of the junction 126 to the distal end of the junction 126. The taper of the junction 126 is configured to instantly dilate tissue around the needle tract from the outer diameter of the proximal portion of the first section 122 of the catheter tube 114 to the outer diameter of the second section 124 of the catheter tube 114. The abluminal surface of the junction 126 smoothly transitions from the abluminal surface of the first section 122 of the catheter tube 114 to the abluminal surface of the second section 124 of the catheter tube 114 without creating edges that may catch on the skin when the catheter tube 114 is inserted into the needle tract. In addition to having minimal or negligible edges, the edges may include solvent interdiffusion polymeric material of the polymeric material forming the catheter tube 114, which provides a smooth transition from the first section 122 of the catheter tube 114 to the junction 126, and from the junction 126 to the second section 124 of the catheter tube 114. In particular, the junction 126 has a length that is approximately equal to the length of the exposed portion of the first section 122 of the catheter tube 114, or a length between the lengths of the exposed portions of the first section 122 and the second section 124 of the catheter tube 114. Thus, the length of the exposed portion of the first section 122 of the catheter tube 114 is less than the length of the junction 126, and at most approximately equal to the length of the junction 126.

[0071] The first section 122 of the catheter tube 114 is formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer. The second section 124 of the catheter tube 114 is formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer less than the first durometer. For example, the first section 122 of the catheter tube 114 can be formed from a first polyurethane having a first durometer, and the second section 124 of the catheter tube 114 can be formed from a second, different polyurethane (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, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or with different additives, etc.) having a second durometer that is less than the first durometer. Indeed, polyurethanes are advantageous for the catheter tube 114 in that they are relatively stiff at room temperature, but can become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall as well as phlebitis. Polyurethanes are also advantageous in that they can be less thrombogenic than some other polymers. The joint 126 is formed from a second polymeric material or a third polymeric material (e.g., yet another polyurethane) having a third durometer that is less than the first durometer and greater than, approximately equal to, or less than the second durometer.

[0072] It should be understood that the first durometer of the first polymeric material, the second durometer of the second polymeric material, and the third durometer of the third polymeric material may be of different scales (e.g., Type A or Type D). With this understanding, the second durometer of the second polymeric material or the third durometer of the third polymeric material may not be less than the first durometer of the first polymeric material in absolute terms when the second durometer or the third durometer is less than the first durometer. In fact, the hardness of the second polymeric material or the third polymeric material may still be less than the hardness of the first polymeric material, because the different scales, each ranging from 0 to 100, are designed to characterize different materials in a group of materials having similar hardness.

[0073] With the first section 122 of the catheter tube 114, the second section 124 of the catheter tube 114, and the junction 126 between the first section 122 and the second section 124 of the catheter tube 114 described above, the catheter tube 114 has sufficient column strength to prevent buckling of the catheter tube 114 when inserted into a needle tract established by an introducer needle 104, described below, and the column strength of the catheter tube 114 is also sufficient to prevent buckling of the catheter tube 114 when advanced through a patient's vasculature without pre-dilating the tissue around the needle tract or any of the vessels of the vasculature with a separate dilator.

[0074] The catheter tube 114 includes one or more catheter tube lumens extending therethrough. However, typically in a multi-lumen RICC (e.g., a 2-lumen RICC, a 3-lumen RICC, a 4-lumen RICC, a 5-lumen RICC, a 6-lumen RICC, etc.), there is only one catheter tube lumen extending from the proximal end of the catheter tube 114 to the distal end of the catheter tube 114. (See FIGS. 16-19.) In fact, the first section 122 of the catheter tube 114 typically includes a single lumen therethrough, as shown in FIGS. 17 and 19.

[0075] A catheter hub 116 is coupled to a proximal portion of the catheter tube 114. The catheter hub 116 includes one or more catheter hub lumens that correspond in number to the one or more catheter tube lumens. The one or more catheter hub lumens extend entirely through the catheter hub 116 from a proximal end of the catheter hub 116 to a distal end of the catheter hub 116.

[0076] Each of the one or more extension legs 118 is coupled by its distal portion to the catheter hub 116. Each of the one or more extension legs 118 includes one or more extension leg lumens, the number of which corresponds to the number of the one or more catheter hub lumens. Each of the one or more extension leg lumens extends entirely through the extension leg from a proximal end of the extension leg to a distal end of the extension leg.

[0077] Each of the one or more extension leg connectors 120 is on a proximal portion of one of the one or more extension legs 118. For example, each of the one or more extension leg connectors 120 can be a luer connector on a proximal portion of one of the one or more extension legs 118. Through such an extension leg connector, the corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen. However, in the ready-to-operate state of the RICC insertion assembly 100, at least one extension leg connector (e.g., an extension leg connector including a portion of the primary lumen 130 of the RICC 102) is indirectly connected to the access guidewire connection side arm 174 of the coupler 108 via the intervening access guidewire hub 218 to form a loop 110 on the access guidewire 106 and the RICC 102 thereon.

[0078] As shown, the RICC 102 is a three-lumen RICC including a set of three lumens. However, the RICC 102 is not limited to the set of three lumens as described above. The set of three lumens includes a primary lumen 130, a secondary lumen 132, and a tertiary lumen 134 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 130 has a primary lumen opening 136 at the distal end of the first section 122 of the catheter tube 114, which corresponds to the distal end of the catheter tube 114 and the distal end of the RICC 102. The secondary lumen 132 has a secondary lumen opening 138 on the side of the distal portion of the catheter tube 114. The tertiary lumen 134 has a tertiary lumen opening 140 on the side of the distal portion of the catheter tube 114 proximal to the secondary lumen opening 138.

[0079] Figure 12 shows a top view of the introducer needle 104 of the RICC insertion assembly 100, according to some embodiments. Figures 13A-13D show the sheath 142 of the introducer needle 104, according to some embodiments. Figure 14 shows the needle shaft 144 of the introducer needle 104, according to some embodiments.

[0080] As shown, the introducer needle 104 includes a needle shaft 144, a sheath 142 covering the needle shaft 144, and a needle hub 146 within a proximal portion of the introducer needle 104 that covers both the proximal end portion of the needle shaft 144 and the proximal end portion of the sheath 142. In addition, the introducer needle 104 can be considered to include a proximal portion 200 of the sealing module insert 198 coupled to a distal portion of the needle hub 146, particularly if the proximal portion 200 of the sealing module insert 198 is fixedly rather than removably coupled to the needle hub 146. At least in the ready-to-operate state of the RICC insertion assembly 100, the needle shaft 144 and sheath 142 extend from the needle hub 146, through the splittable sealing module 196, and out the distal end of the coupler housing 172.

[0081] The needle shaft 144 includes a needle tip 148 at a distal portion of the needle shaft 144 and a longitudinal needle slot 150 extending from a proximal portion of the needle shaft 144 to the needle tip 148 .

[0082] The needle tip 148 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, thereby providing the bevel with a smooth transition across the needle tip 148. Such a needle tip is thus configured to establish a needle path from an area of ​​skin into a vascular lumen of a patient, in accordance with the needle path establishment steps of the method described below.

[0083] The needle slot 150 extends from at least a proximal portion of the needle shaft 144 to the needle tip 148, thereby forming a needle channel 156 along a majority of the length of the needle shaft 144, as opposed to a needle lumen through the needle shaft 144. That is, the needle slot 150 can extend from the proximal end of the needle shaft 144 to the needle tip 148, thereby forming a needle channel 156 along the entire length of the needle shaft 144. The needle slot 150 has a width dimensioned according to the outer diameter of the access guidewire 106, which allows the access guidewire 106 to pass from the proximal portion of the needle shaft 144 to the needle tip 148 when the introducer needle withdrawal step of the method described below is performed.

[0084] In particular, the needle shaft 144 includes the needle channel 156 discussed above, whereas the introducer needle 104 includes a needle lumen 158. This is because the needle lumen 158 results from the combination of the needle shaft 144 and the sheath 142 that covers the needle shaft 144. In effect, the sheath 142 that covers the needle shaft 144 seals off the needle channel 156, forming the needle lumen 158 of the introducer needle 104 and allowing the syringe 112 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0085] The sheath 142 includes a sheath tip 160 at a distal portion of the sheath 142 and a sheath opening 162 on a side of a proximal portion of the sheath 142 .

[0086] 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, which corresponds to the outer diameter of the distal portion of the needle shaft 144. The taper has a taper angle that is less than the primary bevel angle of the primary bevel 154 of the needle tip 148, which in turn is less than the tip bevel angle of the tip bevel 152 of the needle tip 148. The sheath tip 160, including such a taper, is configured to provide a smooth transition from the needle tip 148 to the sheath body for the needle path establishment step of the method described below.

[0087] The sheath opening 162 is open to the needle slot 150 of the needle shaft 144 and allows the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 150 in the ready-to-operate state of the RICC insertion assembly 100. Thus, the sheath opening 162 has a width approximately corresponding to the width of the needle slot 150, which is sized according to the diameter of the access guidewire 106. The sheath opening 162 also has a length sufficient to accommodate the blade 212 of the splittable sealing module 196 below the distal end of the sheath opening 162 while allowing the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 150. In particular, the sheath 142 covering the needle shaft 144 seals the needle slot 150 below it, except below the sheath opening 162. However, the splittable sealing module 196 covers and seals the needle slot 150 exposed by the sheath opening 162 by sealing the needle shaft 144 and the proximal portion of the sheath 142 therein, thereby enabling the syringe 112 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0088] The sheath 142 may be a cuttable or splittable sheath configured to separate or split the sheath 142, respectively, from the needle shaft 144 to allow the access guidewire 106 to exit the needle shaft 144 via the needle slot 150. If configured to separate from the needle shaft 144, the sheath 142 may be formed from a polymeric material such as polyurethane that facilitates separating the sheath 142 from the needle shaft 144. If configured to split away from the needle shaft 144, the sheath 142 may include a splitting means for splitting the sheath 142 that facilitates separating the sheath 142 from the needle shaft 144.

[0089] The splitting means for splitting the sheath 142 may include one or more weakened portions of the sheath 142 that facilitate splitting the sheath 142 away from the needle shaft 144. Indeed, as shown in FIG. 13B, the sheath 142 may be perforated with a pattern 228 of holes, slits, or combinations thereof extending longitudinally across the sheath 142 to split the sheath 142 away from the needle shaft 144. Notably, the pattern 228 is offset from the needle slot 150, thereby maintaining the seal provided by the sheath 142 over the needle shaft 144 and its needle slot 150, regardless of the pattern 228 of holes, slits, or combinations thereof. Alternatively, as shown in FIG. 13C, the sheath 142 may include one or more grooves 230 extending longitudinally across the sheath 142. The sheath 142 is thinnest along the one or more grooves 230, allowing the sheath 142 to split away from the needle shaft 144 along the one or more grooves.

[0090] The splitting means for splitting the sheath 142 may include an embedded tension cord 232 extending longitudinally within the sheath 142, which facilitates splitting the sheath 142 away from the needle shaft 144. In fact, the tension cord 232 is configured to split the sheath 142 when the tension cord 232 is pulled away from the sheath 142. Optionally, the tension cord 232 includes a pull tab 234 on a proximal end portion of the tension cord 232 to pull the tension cord 232 away from the sheath 142. Whether the tension cord 232 includes the pull tab 234 or not, the proximal end portion of the tension cord 232 may extend from the coupler 108 at least in the ready-to-operate state of the RICC insertion assembly 100 to pull the tension cord 232 away from the sheath 142 along the coupler housing slot 182 when needed to split the sheath 142 away from the needle shaft 144.

[0091] The sheath 142, or sheath body thereof, is formed from a polymeric material configured to facilitate smooth and consistent insertion of the introducer needle 104 from an area of ​​the patient's skin into the vascular lumen in accordance with the needle path establishment step of the method described below. In addition, the polymeric material has sufficient mechanical properties at the thickness of the sheath 142 to withstand collapse of the sheath 142 into the needle slot 150 of the needle shaft 144 when the blood aspiration step of the method described below is performed, while also facilitating severing or splitting the sheath 142 from the needle shaft 144, particularly in accordance with at least the introducer needle withdrawal step of the method described below for severing the sheath 142 from the needle shaft 144. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, polyurethane, or polytetrafluoroethylene ("PTFE"). In one example, in an embodiment of the RICC insertion assembly 100 in which the sheath 142 is separated from the needle shaft 144 by the blade 212, the sheath 142 may be polyurethane. As another example, in embodiments of the RICC insertion assembly 100 in which the sheath 142 splits away from the needle shaft 144, the sheath 142 can be PTFE or even expanded PTFE ("ePTFE"). If the sheath 142 is ePTFE, for example, the sheath 142 does not need to include one or more weakened portions of the sheath 142 to split the sheath 142 away from the needle shaft 144 because the ePTFE itself is the splitting means for splitting the sheath 142 due to the longitudinal arrangement of the polymer chains within the ePTFE.

[0092] The needle hub 146 includes an access guidewire channel 164 at a distal portion of the needle hub 146 and a needle hub connector 166 at a proximal portion of the needle hub 146 .

[0093] The access guidewire channel 164 in the needle hub 146 is configured to allow the access guidewire 106 to pass over the needle hub 146 and guide the access guidewire 106 into the access guidewire passage 206 of the splittable seal module 196. The access guidewire channel 164 is open such that the access guidewire 106 is located within the access guidewire channel 164, at least in the ready-to-operate state of the RICC insertion assembly 100. Advantageously, the open access guidewire channel 164 allows the access guidewire 106 to remain in place when the introducer needle 104 is withdrawn from the RICC insertion assembly 100 in accordance with the introducer needle withdrawal step of the method described below.

[0094] In particular, the access guidewire channel 164 of the needle hub 146 transitions into the access guidewire channel 168 of the proximal portion 200 of the sealing module insert 198 coupled to the distal portion of the needle hub 146. When the proximal portion 200 of the sealing module insert 198 is mated with the distal portion 202 of the sealing module insert 198, the access guidewire channel 168 of the proximal portion 200 of the sealing module insert 198 combines with the access guidewire channel of the distal portion 202 of the sealing module insert 198 to form the access guidewire passageway 206 of the splittable sealing module 196. The needle hub 146, including the proximal portion 200 of the sealing module insert 198 coupled thereto, is configured to be removably positioned within the needle hub receptacle 180 and the sealing module cavity 178 of the coupler housing 172, respectively. As described below, the distal portion of the needle hub 146 axially compresses the proximal portion 200 of the sealing module insert 198 within the sealing module cavity 178 when the needle hub 146 is disposed within the needle hub receptacle 180 and the proximal portion 200 of the sealing module insert 198 is disposed within the sealing module cavity 178. The axial compression of the proximal portion 200 of the sealing module insert 198 within the sealing module cavity 178 in turn radially compresses both the proximal portion 200 and the distal portion 202 of the sealing module insert 198 within the sealing module cavity 178.

[0095] The needle hub connector 166 includes a needle hub hole 170 and an optional needle hub flange (not shown) around the needle hub connector 166 .

[0096] The needle hub bore 170 of the needle hub connector 166 is configured to receive the syringe tip of the syringe 112 therein to fluidly connect the introducer needle 104 to the syringe 112. Indeed, the needle hub bore 170 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip 116 therein, which can be complementarily configured with a luer taper.

[0097] The needle hub flange of the needle hub connector 166 is configured to threadably mate with the female threads of a threaded collar about the syringe tip of the syringe 112. While the threaded collar of the syringe 112 is optional, the needle hub flange advantageously provides a so-called luer lock type connection with the female threads of the threaded collar, if both are present, which provides greater security against inadvertent separation of the introducer needle 104 and the syringe 112 than would otherwise be provided by a luer slip type connection.

[0098] 2-11 show various views of the coupler 108 of the RICC insertion assembly 100, according to some embodiments.

[0099] As shown, the coupler 108 includes a coupler housing 172, an access guidewire connection side arm 174, and, optionally, if the RICC insertion assembly 100 also includes a keeper 220, a splittable casing retaining side arm 176.

[0100] The coupler housing 172 includes a sealing module cavity 178, a needle hub receptacle 180 proximal to the sealing module cavity 178, and a longitudinal coupler housing slot 182 formed along the length of the coupler housing 172. (See FIG. 4, which includes a proximal portion 200 and a distal portion 202 of a sealing module insert 198 disposed within the sealing module cavity 178. FIG. 4 also includes the needle hub 146 of the introducer needle 104 disposed within the needle hub receptacle 180.) In particular, the coupler housing 172 may be formed into a bullet-shaped body configured to be comfortably held underhand (e.g., cradle-like) or overhand with the RICC insertion assembly 100 in the left hand for left-handed venipuncture or in the right hand for right-handed venipuncture. To further facilitate such venipuncture, the exterior of coupler housing 172 may be textured with grip-enhancing ridges (eg, lateral or circumferential ridges), protrusions, or the like.

[0101] The sealing module cavity 178 is configured to hold a proximal portion 200 and a distal portion 202 of the sealing module insert 198 therein. In practice, the sealing module cavity 178 includes at least the distal portion 202 of the sealing module insert 198 disposed in a captured manner therein in each of the one or more states of the RICC insert assembly 100. For example, the sealing module cavity 178 can include a catch 184 in its distal portion, the catch 184 configured to receive a protrusion 186 of the distal portion 202 of the sealing module insert 198 therein for a captured arrangement of the distal portion 202 of the sealing module insert 198 in the sealing module cavity. The sealing module cavity 178 also includes the proximal portion 200 of the sealing module insert 198 disposed therein in at least some of the one or more states of the RICC insert assembly 100, such as a ready-for-operation state or one or more operational states of the RICC insert assembly 100.

[0102] The needle hub receptacle 180 is configured to hold the needle hub 146 of the introducer needle 104 therein. In effect, the needle hub receptacle 180 includes the needle hub 146 inserted therein in the ready-to-operate state of the RICC insertion assembly 100. Although not shown, the coupler 108 may include a needle hub lock around the needle hub receptacle 180 configured to lock the needle hub 146 within the needle hub receptacle 180. In effect, a pair of locking buttons (e.g., spring-loaded locking buttons) of the needle hub lock may be distributed between opposing sides of the coupler housing 172, such that each of the locking buttons extends through the coupler housing 172 on a respective side of the coupler 108. Such locking buttons may be configured to unlock the needle hub 146 when the locking buttons are pressed into the coupler housing 172 to withdraw the introducer needle 104 from the coupler 108. Releasing the lock button immediately releases the axial compression from the distal portion of the needle hub 146 compressing the proximal portion 200 of the sealing module insert 198 within the sealing module cavity 178. This allows the proximal and distal portions 200, 202 of the sealing module insert 198 to relax for withdrawal of the introducer needle 104 from the coupler 108. This also allows the proximal and distal portions of the sealing module insert 198 to be separated for escape of the access guidewire 106 when the introducer needle 104 is withdrawn from the coupler 108 during the introducer needle withdrawal step of the method described below.

[0103] The coupler housing slots 182 formed along the length of the coupler housing 172 are configured to allow the access guidewire 106 to exit the coupler housing 172 after the introducer needle 104 is withdrawn from the coupler 108 in an introducer needle withdrawal step of the method described below. Indeed, when the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step, the proximal portion 200 of the sealing module insert 198 is also withdrawn from the sealing module cavity 178, allowing the access guidewire 106 to exit the coupler housing 172 once the proximal portion 200 of the sealing module insert 198 is removed from the sealing module cavity 178.

[0104] An access guidewire connection side arm 174 extends from the coupler 108 or its coupler housing 172. The access guidewire connection side arm 174 includes a connector 188 configured to connect around a proximal end portion of the access guidewire 106 to an access guidewire hub 218 that extends from a proximal end of the RICC 102, at least in the ready-to-operate state of the RICC insertion assembly 100. During the ready-to-operate state of the RICC insertion assembly 100, a distal portion of the access guidewire 106 is disposed within the needle shaft 144 and the access guidewire hub 218 is connected to the connector 188 of the access guidewire connection side arm 174, thereby forming a loop 110 on the access guidewire 106 over which the RICC 102 is disposed. When both the keeper 220 and the splittable casing retaining side arm 176 are present in the RICC insertion assembly 100, the distal portion of the splittable casing 222 is also retained within the primary channel 190 of the splittable casing retaining side arm 176, thereby further forming a loop 110 on the access guidewire 106 over which the RICC 102 is disposed.

[0105] When present, the splittable casing retaining side arm 176 extends from the coupler 108 or its coupler housing 172 opposite the access guidewire connecting side arm 174. The splittable casing retaining side arm 176 includes a primary channel 190 and a secondary channel 192. The primary channel 190 is configured to slidably retain the splittable casing 222, or the splittable casing 222 and at least the longitudinal composite of the access guidewire 106 therein. The secondary channel 192 is configured to guide the access guidewire 106 split off of the splittable casing 222 into the coupler 108, into its splittable sealing module 196, and into the needle shaft 144 sealed therein via the needle slot 150. The branch point 194 of the splittable casing retaining side arm 176 between the primary channel 190 and the secondary channel 192 is configured to split and separate the access guidewire 106 from the splittable casing 222 when the splittable casing 222 and at least the longitudinal composite of the access guidewire 106 therein are pushed therein.

[0106] 4-11 show various views of a splittable sealing module 196 according to some embodiments.

[0107] The splittable sealing module 196 of the RICC insertion assembly 100 includes a sealing module cavity 178 of the coupler housing 172 and an elastomeric sealing module insert 198 disposed therein, the sealing module insert 198 being split between a captured proximal portion 200 and a removable distal portion 202, referred to herein as a proximal portion 200 of the sealing module insert 198 and a distal portion 202 of the sealing module insert 198, respectively (notably, the proximal portion 200 and the distal portion 202 of the sealing module insert 198 may be formed from the same elastomer (e.g., silicone) or different elastomers). The proximal portion 200 of the sealing module insert 198 is configured to be disposed or otherwise inserted within the sealing module cavity 178 of the coupler housing 172, and the proximal portion 200 of the sealing module insert 198 mates with the distal portion 202 of the sealing module insert 198 to complete a pair of passages through the splittable sealing module 196. By virtue of the aforementioned passages, the splittable sealing module 196 is configured to separately seal around the introducer needle 104 and the access guidewire 106 when the proximal and distal portions 200, 202 of the sealing module insert 198 are compressed within the sealing module cavity 178 in one or more states of the RICC insertion assembly 100 (e.g., in a ready-to-operate state or one or more operational states of the RICC insertion assembly 100), thereby enabling the syringe 112 to aspirate blood in accordance with the blood aspirating step of the method described below.

[0108] A pair of passageways completed when the proximal and distal portions 200, 202 of the sealing module insert 198 are combined within the sealing module cavity 178 of the coupler housing 172 includes an introducer needle passageway 204 and an access guidewire passageway 206. As shown in FIG. 7, a proximal portion of the introducer needle passageway 204 can reside within the proximal portion 200 of the sealing module insert 198, while a distal portion of the introducer needle passageway 204 is completed by the proximal and distal portions 200, 202 of the sealing module insert 198 when combined within the sealing module cavity 178 of the coupler housing 172. As further shown in FIG. 7, the entirety of the access guidewire passageway 206 can be completed by the proximal and distal portions 200, 202 of the sealing module insert 198 when combined within the sealing module cavity 178 of the coupler housing 172. Other configurations of the sealing module insert 198 are possible to provide the aforementioned passageways, ranging from alternative configurations of the proximal and distal portions 200, 202 of the sealing module insert 198 to the inclusion of one or more additional portions (e.g., inner portions) of the sealing module insert 198, but the splittable sealing module 196 is configured to separately seal around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 via the introducer needle passage 204 and the access guidewire passage 206, respectively, when the proximal and distal portions 200, 202 of the sealing module insert 198 are compressed within the sealing module cavity 178 in one or more states of the RICC insertion assembly 100. In particular, in contrast to the introducer needle passage 204, which passes through both the proximal and distal ends of the sealing module insert 198, the distal end of the access guidewire passage 206 connects to an inner portion of the introducer needle passage 204, thereby allowing a distal portion of the access guidewire 106 to be positioned within the needle shaft 144 while the distal portion of the access guidewire 106 is positioned within the splittable sealing module 196.In fact, the access guidewire passage 206 is configured to guide the access guidewire 106 from the access guidewire channel 164 in the needle hub 146 into both the sheath opening 162 of the sheath 142 and the needle slot 150 of the needle shaft 144 below, such that when the RICC insertion assembly 100 is in a ready-to-operate state, the access guidewire 106 can be positioned within the needle shaft 144 with the distal end of the access guidewire 106 just proximal to the needle tip 148.

[0109] FIG. 11 shows a longitudinal cross section of a sealing module insert 198 having internal reliefs 208 and 210 in the introducer needle passage 204 and the access guidewire passage 206 of the sealing module insert 198, according to some embodiments.

[0110] As shown, the introducer needle passage 204 formed between the proximal and distal portions 200, 202 of the sealing module insert 198 can include an internal relief 208 between the proximal and distal portions of the introducer needle passage 204 to reduce friction against the introducer needle 104 as it is withdrawn from the coupler 108 and its splittable sealing module 196 during an introducer needle withdrawal step of the method described below. Additionally or alternatively, the access guidewire passage 206 can include an internal relief 210 at least in a proximal portion of the access guidewire passage 206 to reduce friction against the access guidewire 106 as it is advanced into the coupler 108 and its splittable sealing module 196 during an access guidewire advancement step of the method described below. An internal relief 208 between the proximal and distal portions of the introducer needle passageway 204 ensures that only the proximal and distal end portions of the introducer needle passageway 204, including the proximal and distal ends of the introducer needle passageway 204, are configured to seal around the proximal portion of the introducer needle 104 when the proximal and distal portions 200, 202 of the seal module insert 198 are compressed within the seal module cavity 178 of the coupler housing 172. An internal relief 210 in the proximal portion of the access guidewire passageway 206 ensures that only the proximal end portion of the access guidewire passageway 206, including the proximal end of the access guidewire passageway 206, is configured to seal around the distal portion of the access guidewire 106 when the proximal and distal portions 200, 202 of the seal module insert 198 are compressed within the seal module cavity 178 of the coupler housing 172. In particular, the internal reliefs 208 and 210 are configured to reduce friction of the introducer needle passage 204 and the access guidewire passage 206 relative to the introducer needle 104 and the access guidewire 106, respectively, although a lubricant may additionally or alternatively be used in the sealing module insert 198 to reduce friction.

[0111] The splittable sealing module 196 is configured to separately seal around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 when the sealing module insert 198 is compressed within the sealing module cavity 178. In practice, the proximal and distal portions 200, 202 of the sealing module insert 198 may be radially compressed within the sealing module cavity 178, or may be both axially and radially compressed within the sealing module cavity 178 to seal around the introducer needle 104 and the access guidewire 106. With the seal around the introducer needle 104 and the access guidewire 106 as described above, the syringe 112 may aspirate blood in accordance with the blood aspirating step of the method described below.

[0112] In an example of radial compression of the sealing module insert 198 within the sealing module cavity 178, the proximal and distal portions 200, 202 of the sealing module insert 198 may be radially compressed within the sealing module cavity 178 by the coupler housing 172 itself, as shown in FIG. 9. Without limiting such an embodiment, the two halves of the coupler housing 172 may be clamshell-like coupled together by hinges on opposite sides of a coupler housing slot 182 formed between the two halves of the coupler housing 172. One or more clamps across the coupler housing slot 182 may be clamped at least in the ready-to-operate state of the RICC insertion assembly 100 to hold the two halves of the coupler housing 172 together and apply sufficient pressure to radially compress the proximal and distal portions 200, 202 of the sealing module insert 198 within the sealing module cavity 178, sealing the sealing module insert 198 around the introducer needle 104 and the access guidewire 106. One or more clamps may be unclamped in one or more operating states of the RICC insertion assembly 100 to release radial compression and then allow the introducer needle 104 to be withdrawn from the coupler 108 so that the access guidewire 106 can exit through the coupler housing slot 182.

[0113] In an example of both radial and axial compression of the seal module insert 198 within the seal module cavity 178, the proximal and distal portions 200, 202 of the seal module insert 198 may be both axially and radially compressed within the seal module cavity 178 by the distal portion of the needle hub 146. The distal portion of the needle hub 146 axially compresses the proximal and distal portions 200, 202 of the seal module insert 198 within the seal module cavity 178 when the needle hub 146 is disposed within the needle hub receptacle 180, such as in the ready-to-operate state of the RICC insertion assembly 100. The axial compression of the proximal and distal portions 200, 202 of the sealing module insert 198 within the sealing module cavity 178 then radially compresses the proximal and distal portions 200, 202 of the sealing module insert 198 within the sealing module cavity 178, thereby sealing the sealing module insert 198 around the introducer needle 104 and the access guidewire 106. The needle hub 146 may be removed from the needle hub receptacle in one or more operational states of the RICC insertion assembly 100 to release both the axial and radial compression and then allow the introducer needle 104 to be withdrawn from the coupler 108 for the access guidewire 106 to exit through the coupler housing slot 182.

[0114] The coupler housing 172 of the coupler 108 may further include a blade 212 extending into the introducer needle passage 204 of the splittable sealing module 196. The blade 212 may be overmolded onto the distal portion 202 of the sealing module insert 198, thereby integrating the blade 212 therein. The blade 212, or its blade tip 214, may be disposed within the needle slot 150 below the distal end of the sheath opening 162, at least in the ready-to-operate state of the RICC insertion assembly 100. The blade 212 includes a distally facing blade edge 216 configured to decouple the sheath 142 from the needle shaft 144 as the introducer needle 104 is withdrawn from the coupler 108 through the introducer needle passage 204 during an introducer needle withdrawal step of the method described below. Decoupling the sheath 142 from the needle shaft 144 as the introducer needle 104 is withdrawn from the coupler 108 allows the access guidewire 106 to exit the needle shaft 144 via the needle slot 150 .

[0115] 1, 4, 9 and 10 show various views of the access guidewire 106 of the RICC insertion assembly 100, according to some embodiments.

[0116] The access guidewire 106 includes a proximal portion including a proximal end and a distal portion including a distal end. In the ready-to-operate state of the RICC insertion assembly 100, the proximal end of the access guidewire 106 is coupled to the access guidewire connection side arm 174 by an access guidewire hub 218 around the proximal end portion of the access guidewire 106 including the distal end. In addition, the proximal portion of the access guidewire 106 extends along the primary lumen 130 of the RICC 102. The distal portion of the access guidewire 106 also extends along the primary lumen 130 of the RICC 102, but the distal portion of the access guidewire 106 further extends from the distal end of the RICC 102 as an extra-catheter portion of the access guidewire 106, by way of the access guidewire channel 164, into the splittable seal module 196 on the needle hub 146, through both the sheath opening 162 of the sheath 142 and the needle slot 150 of the needle shaft 144, and into the needle shaft 144, and extends along the needle lumen 158 of the introducer needle 104 in the ready-to-operate state of the RICC insertion assembly 100. As shown in FIG. 1, the distal end of the access guidewire 106 is disposed in the needle lumen 158 just proximal to the needle tip 148 in the ready-to-operate state of the RICC insertion assembly 100. Again, the proximal and distal ends of the access guidewire 106 form a loop 110 over which the RICC 102 is disposed on the access guidewire 106 when the RICC insertion assembly 100 is in a ready-to-operate state, thereby keeping the RICC insertion assembly 100 in a relatively compact configuration.

[0117] The access guidewire 106 can include a guidewire tip at a distal portion of the access guidewire 106, the guidewire tip assuming a "J" shape configured to prevent puncturing the posterior wall of a blood vessel. Such guidewire tip assumes a straight state in a ready-to-operate state of the RICC insertion assembly 100 and a curved state when the guidewire tip is advanced beyond the needle tip 148 (e.g., advanced into a blood vessel lumen) in one or more operational states of the RICC insertion assembly 100 in which the access guidewire 106 is deployed.

[0118] The access guidewire 106 may also include a bare wire portion and a wrapped wire portion distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, if present, the bare wire portion extends distally through the access guidewire passageway 206 of the splittable sealing module 196, at least in the ready-to-operate state of the RICC insertion assembly 100, such that the splittable sealing module 196 forms a fluid-tight seal around the bare wire portion of the access guidewire 106. Notably, the aforementioned bare wire portion may instead be a flat wrapped or grounded wrapped portion of the access guidewire 106, with the flat wrapped portion including a winding of tape instead of round wire, and the grounded wrapped portion including a winding of round wire that is grounded to make the winding flat.

[0119] FIG. 1 shows a keeper 220 of a RICC insertion assembly 100, according to some embodiments.

[0120] As shown, the keeper 220 can include a splittable casing 222 and a catheter hub holder 224 to which the proximal end of the splittable casing 222 is attached.

[0121] The splittable casing 222 can form a longitudinal composite with the catheter tube 114, with the access guidewire 106, or with both the catheter tube 114 and the access guidewire 106 in the RICC insertion assembly 100. For example, with respect to the RICC insertion assembly 100 of FIG. 1 , the splittable casing 222 overlies both the catheter tube 114 and the access guidewire 106 in the portion of the RICC insertion assembly 100 closest to the catheter hub holder 224, thus forming a longitudinal composite with both the catheter tube 110 and the access guidewire 106, where the access guidewire 106 is disposed within the primary lumen 130 of the RICC 102. 1, the splittable casing 222 overlies only the access guidewire 106 in the portion of the RICC insertion assembly 100 closest to the coupler 108 or its splittable casing retaining side arm 176, and thus forms a longitudinal composite with only that access guidewire 106, where the extra-catheter portion of the access guidewire 106 extends from the distal end of the RICC 102. The splittable casing 222 is configured to split along its length, for example, as it slides over the bifurcation point 194 of the splittable casing retaining side arm 176 of the coupler 108, thereby exposing the extra-catheter portion of the access guidewire 106 first and the distal portion of the catheter tube 114 thereafter. In this manner, the splittable casing 222 is configured to keep the catheter tube 114 and at least the distal portion of the access guidewire 106 sterile until deployment.

[0122] The catheter hub holder 224 is configured to hold the catheter hub 116 therein and to hold the splittable casing 222 in place over the catheter tube 114 and the access guidewire 106, particularly the extra-catheter portion of the access guidewire 106. The catheter hub holder 224 includes a peripheral wall 226 around at least a portion (e.g., a proximal portion) of the circumference of the catheter hub holder 224. The peripheral wall 226 defines a recess into which the catheter hub 116 fits with an engineered fit (e.g., a clearance fit, such as a running fit, a sliding fit, or a location fit, or an intermediate fit, such as a similar fit and a fixed fit, as classified by the International Organization for Standardization ["ISO"]), as well as one or more gaps for extending through the one or more extension legs 118. Additionally or alternatively, the catheter hub holder 224 can include wings that correspond to the suture wings of the catheter hub 116. Such wings may include posts configured for insertion into suture wing holes in the suture wing of the catheter hub 116 via an optical fit.

[0123] method The RICC insertion system 100 method includes a method for inserting a RICC 102 into a vascular lumen of a patient, the method including one or more steps selected from an insertion assembly acquisition step, a status check step, a needle path establishment step, a blood aspiration step, an access guidewire advancement step, a sheath splitting step, an introducer needle withdrawal step, a RICC advancement step, an access guidewire withdrawal step, a steering guidewire advancement step, another RICC advancement step, and a steering guidewire withdrawal step.

[0124] The insertion assembly obtaining step optionally includes obtaining a RICC insertion assembly 100 already in its ready-to-operate state. As described above, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104, an access guidewire 106, and a coupler 108 coupling the RICC 102 and the introducer needle 104 to one another. In addition, the RICC insertion assembly 100 includes a splittable sealing module 196 formed between at least a sealing module cavity 178 of a coupler housing 172 of the coupler 108, a distal portion 202 of a sealing module insert 198 disposed within the sealing module cavity 178, and a proximal portion 200 of the sealing module insert 198 coupled to a distal portion of a needle hub 146 of the introducer needle 104. The splittable sealing module 196, at least in the ready-to-operate state of the RICC insertion assembly 100, separately seals around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106. Within the splittable sealing module 196, the distal portion of the access guidewire 106 is disposed through the needle slot 150 and into the needle shaft 144. This is accomplished by a connection between the distal end of the access guidewire passageway 206 and an inner portion of the introducer needle passageway 204 within the sealing module insert 198.

[0125] The state verification step includes verifying that the RICC insertion assembly 100 is in its ready-to-operate state prior to the path establishment step. Such verification ensures that the proximal and distal portions 200, 202 of the sealing module insert 198 are compressed within the sealing module cavity 178 to seal the introducer needle passage 204 and the access guidewire passage 206 around the introducer needle 104 and the access guidewire 106, respectively. In particular, if the RICC insertion assembly 100 is not in a ready-to-operate state when it is acquired in the insertion assembly acquisition step, the RICC insertion assembly 100 may be adjusted to place it in a ready-to-operate state for subsequent steps.

[0126] The needle path establishment step includes establishing a needle path from the area of ​​skin to the blood vessel lumen with the introducer needle 104. The needle path establishment step may also include ensuring that blood flows back into the introducer needle 104 (e.g., the needle hub 146 of the introducer needle 104), into the syringe 112 fluidly connected to the introducer needle 104 (e.g., the syringe tip, the barrel of the syringe 112, or both), or into both the introducer needle 104 and the syringe 112, thereby confirming that the needle path extends into the blood vessel lumen. To enhance blood backflow, a slight vacuum may be drawn with the syringe 112 while establishing the needle path.

[0127] The blood aspirating step includes aspirating blood using the syringe 112 to ensure that the needle tract extends into the blood vessel lumen prior to withdrawing the introducer needle 104 from the coupler 108 in the introducer needle withdrawal step. The sheath 142 above the needle shaft 144 also seals the needle slot 150 of the needle shaft 144 below it. In particular, the sheath 142 seals the needle slot 150 outside of the splittable sealing module 196. The splittable sealing module 196 then seals over the sheath opening 162 of the sheath 142, which allows the access guidewire 106 to pass from the access guidewire passage 206 formed between the proximal and distal portions 200 and 202 of the sealing module insert 198, through the needle slot 150, and into the needle shaft 144. The splittable sealing module 196 also seals around the distal portion of the access guidewire 106. Such a seal allows the syringe 112 to draw blood during the blood drawing step.

[0128] The access guidewire advancement step involves advancing a distal portion of the access guidewire 106 through both the splittable sealing module 196 and the needle slot 150 of the needle shaft 144, thereby advancing the distal end of the access guidewire 106 from its initial position within the introducer needle 104 into the blood vessel lumen. As described above, when the RICC insertion assembly 100 is in its ready-to-operate state, the initial position of the distal end of the access guidewire 106 is just proximal to the needle tip 148.

[0129] If the RICC insertion assembly 100 does not include a keeper 220 and splittable casing 222 on both the catheter tube 114 of the RICC 102 and the extra-catheter portion of the access guidewire 106, the access guidewire advancement step includes pinching the extra-catheter portion of the access guidewire 106 extending from the distal end of the RICC 102 and forcing the access guidewire 106 into the needle shaft 144 via the splittable sealing module 196 of the coupler 108. Advancing the access guidewire 106 in this manner reduces a loop 110 on the access guidewire 106 over which the RICC 102 is disposed. As described above, the loop 110 is formed by the distal portion of the access guidewire 106 disposed within the needle shaft 144 and the access guidewire hub 218 of the access guidewire 106 connected to the connector 188 of the access guidewire connection side arm 174 of the coupler 108.

[0130] If the RICC insertion assembly 100 includes a keeper 220 and a splittable casing 222 over both the catheter tube 114 of the RICC 102 and the extra-catheter portion of the access guidewire 106, the access guidewire advancement step includes pinching the splittable casing 222 over both the catheter tube 114 of the RICC 102 and the extra-catheter portion of the access guidewire 106 extending from the distal end of the RICC 102. The access guidewire advancement step also includes pushing the splittable casing 222 into the primary channel 190 of the splittable casing retaining side arm 176 of the coupler 108 while pinching the splittable casing 222. Pinching and forcing the splittable casing 222 into the primary channel 190 of the splittable casing retaining side arm 176 in this manner causes the access guidewire 106 to split away from the splittable casing 222, across the branch point 194 of the splittable casing retaining side arm 176 between the primary channel 190 and the secondary channel 192, into the secondary channel 192 of the splittable casing retaining side arm 176, and through the splittable sealing module 196 of the coupler 108 into the needle shaft 144. Advancing the access guidewire 106 in this manner reduces the loops 110 on which the RICC 102 and splittable casing 222 are disposed. The loop 110 is formed by at least a splittable casing 222 held within the primary channel 190 of the splittable casing retaining side arm 176 and the access guidewire hub 218 of the access guidewire 106 connected to the connector 188 of the access guidewire connecting side arm 174 of the coupler 108.

[0131] The introducer needle withdrawal step involves withdrawing the introducer needle 104 from the coupler 108 prior to the RICC advancement step, thereby leaving the access guidewire 106 within the vessel lumen. Withdrawing the introducer needle 104 from the coupler 108 removes the needle hub 146 of the introducer needle 104 from the needle hub receptacle 180 and, along with the needle hub 146, removes the proximal portion 200 of the sealing module insert 198 from the sealing module cavity 178, thereby splitting the proximal and distal portions 200, 202 of the sealing module insert 198 away from one another and unsealing the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106, allowing the access guidewire 106 to exit the splittable sealing module 196.

[0132] The introducer needle withdrawal step may also include decoupling the needle slot sealing sheath 142 of the introducer needle 104 from the needle shaft 144. As described above, the coupler housing 172 of the coupler 108 may include a blade 212 extending into the splittable sealing module 196 such that the blade 212 is positioned in the needle slot 150 below the distal end of the sheath opening 162 of the sheath 142 with a distally facing blade edge 216 for decoupling the sheath 142 from the needle shaft 144. If the coupler housing 172 does not include a blade 212, the method may further include a sheath splitting step, which includes splitting the sheath 142 by a splitting means for splitting the sheath 142 as described above. Decoupling or splitting the sheath 142 from the needle shaft 144 allows the access guidewire 106 to exit the needle shaft 144 via the needle slot 150. Additionally, the coupler housing slot 182 in the coupler housing 172 allows the access guidewire 106 to exit the coupler housing 172 after the introducer needle 104 is withdrawn from the coupler 108 .

[0133] The RICC advancement step involves inserting the RICC 102 into the vessel lumen by advancing the catheter tube 114 of the RICC 102 over the access guidewire 106 into the vessel lumen.

[0134] The access guidewire withdrawal step involves withdrawing the access guidewire 106 while leaving the catheter tube 114 within the vessel lumen.

[0135] The steering guidewire advancement step involves advancing a steering guidewire through the primary lumen 130 of the RICC 102 and into the lumen of the blood vessel, and advancing the steering guidewire to the lower third of the SVC of the patient's heart.

[0136] Another RICC advancement step involves advancing the catheter tube 114 further into the vessel lumen over the steering guidewire to the lower third of the SVC of the patient's heart.

[0137] The steering guidewire withdrawal step involves withdrawing the steering guidewire, leaving the catheter tube 114 in the lower third of the SVC.

[0138] Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects of the invention encompass these adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter ("RICC") insertion assembly comprising: a RICC including a catheter tube and a primary lumen therethrough; an introducer needle, a needle shaft including a longitudinal needle slot; a needle hub around a proximal end portion of the needle shaft; a proximal portion of a sealing module insert coupled to a distal portion of the needle hub; an introducer needle including: an access guidewire including a proximal portion disposed within the primary lumen of the RICC and a distal portion disposed within the needle shaft through the needle slot; a coupler for coupling the RICC and the introducer needle together, the coupler comprising: a coupler housing including a sealed module cavity; a distal portion of the sealing module insert disposed within the sealing module cavity, wherein the sealing module cavity and the proximal and distal portions of the sealing module insert form a splittable sealing module of the RICC insertion assembly configured to separately seal around the proximal portion of the introducer needle and the distal portion of the access guidewire when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity; a coupler including: Equipped with A rapid insertion central venous catheter ("RICC") insertion assembly.

2. The RICC insertion assembly of claim 1 , wherein each of the proximal and distal portions of the sealing module insert is formed from an elastomer.

3. The RICC insertion assembly of claim 1 , wherein the proximal and distal portions of the sealing module insert, when combined within the sealing module cavity, complete both an introducer needle passageway and an access guidewire passageway.

4. 4. The RICC insertion assembly of claim 3, wherein a proximal portion of the introducer needle passage resides within the proximal portion of the sealing module insert, and a distal portion of the introducer needle passage is completed by the proximal and distal portions of the sealing module insert combined within the sealing module cavity.

5. The RICC insertion assembly of claim 3 , wherein the entire access guidewire passage is completed by the proximal and distal portions of the sealing module insert combined within the sealing module cavity.

6. 4. The RICC insertion assembly of claim 3, wherein a distal end of the access guidewire passage connects to an inner portion of the introducer needle passage, thereby enabling the distal portion of the access guidewire to be positioned through the needle slot and within the needle shaft.

7. 4. The RICC insertion assembly of claim 3, wherein the introducer needle passage is configured to seal around the proximal portion of the introducer needle and the access guidewire passage is configured to seal around the distal portion of the access guidewire when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity.

8. 4. The RICC insertion assembly of claim 3, wherein the introducer needle passage includes an internal relief between a proximal portion and a distal portion of the introducer needle passage, such that when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, only the proximal and distal end portions of the introducer needle passage are configured to seal around the proximal portion of the introducer needle.

9. 4. The RICC insertion assembly of claim 3, wherein the access guidewire passage includes an internal relief in at least a proximal portion of the access guidewire passage such that when the proximal and distal portions of the sealing module insert are compressed within the sealing module cavity, only a proximal end portion of the access guidewire passage is configured to seal around the distal portion of the access guidewire.

10. The RICC insert assembly of claim 1 , wherein the sealing module insert is radially compressed within the sealing module cavity by the coupler housing.

11. 2. The RICC insertion assembly of claim 1, wherein the sealing module insert is axially compressed within the sealing module cavity by the distal portion of the needle hub, and the axial compression of the sealing module insert within the sealing module cavity in turn radially compresses the sealing module insert within the sealing module cavity.

12. 2. The RICC insertion assembly of claim 1, wherein the coupler housing includes a longitudinal coupler housing slot configured to allow the access guidewire to exit the coupler housing after the proximal portion of the sealing module insert is removed from the sealing module cavity by withdrawal of the introducer needle from the coupler.

13. 2. The RICC insertion assembly of claim 1, wherein the introducer needle further comprises a sheath covering the needle shaft that seals the needle slot below the needle shaft, the needle slot extending from a proximal portion of the needle shaft to a distal needle tip.

14. 14. The RICC insertion assembly of claim 13, wherein the coupler includes a blade extending into the splittable sealing module such that the blade is positioned within the needle slot below a distal end of a sheath opening, the blade including a distally facing blade edge configured to decouple the sheath from the needle shaft when the introducer needle is withdrawn from the coupler, thereby allowing the access guidewire to exit the needle shaft via the needle slot.

15. The RICC insertion assembly of claim 14 , wherein the blade is overmolded within the coupler housing, thereby integrating the blade within the coupler housing.

16. The RICC insertion assembly of claim 13 , wherein the sheath is splittable.

17. 17. The RICC insertion assembly of claim 16, wherein the sheath is perforated with a pattern of holes, slits, or a combination thereof extending longitudinally across the sheath configured to split the sheath, the pattern being offset from the needle slot to maintain sealing of the needle slot by the sheath.

18. 17. The RICC insertion assembly of claim 16, wherein the sheath includes one or more grooves extending longitudinally therethrough configured to divide the sheath.

19. 17. The RICC insertion assembly of claim 16, wherein the sheath includes an embedded tension cord extending longitudinally within the sheath configured to split the sheath when pulled away from the sheath.

20. 14. The RICC insertion assembly of claim 13, wherein the sheath is formed from a polymeric material selected from polyethylene, polypropylene, polyurethane, and polytetrafluoroethylene.

21. 2. The RICC insertion assembly of claim 1, wherein the coupler further includes an access guidewire connection side arm including a connector configured to connect to an access guidewire hub around a proximal end portion of the access guidewire, and the distal portion of the access guidewire disposed within the needle shaft and the access guidewire hub connected to the connector of the access guidewire connection side arm form a loop on the access guidewire over which the RICC is disposed, at least in a ready-to-operate state of the RICC insertion assembly.

22. 2. The RICC insertion assembly of claim 1, further comprising a keeper including a splittable casing that covers both the catheter tube of the RICC and an extra-catheter portion of the access guidewire extending from a distal end of the RICC, the splittable casing configured to keep the catheter tube and the extra-catheter portion of the access guidewire sterile until deployed.

23. 23. The RICC insertion assembly of claim 22, wherein the keeper further comprises a catheter hub holder to which a proximal end of the splittable casing is attached, the catheter hub holder configured to retain a catheter hub of the RICC within the catheter hub holder and to hold the splittable casing in place over both the catheter tube and the extra-catheter portion of the access guidewire.

24. 24. The RICC insertion assembly of claim 23, wherein the catheter hub holder includes a peripheral wall around at least a portion of the circumference of the catheter hub holder, the peripheral wall defining a recess into which the catheter hub fits with an engineering fit.

25. 23. The RICC insertion assembly of claim 22, wherein the coupler further comprises a splittable casing retaining side arm including a primary channel and a secondary channel, the primary channel configured to slidably retain the splittable casing therein, and the secondary channel configured to guide the access guidewire split away from the splittable casing through the needle slot and into the coupler and the needle shaft.

26. the coupler further includes an access guidewire connection side arm including a connector configured to connect to an access guidewire hub around a proximal end portion of the access guidewire; 26. The RICC insertion assembly of claim 25, wherein the distal portion of the access guidewire disposed within the needle shaft, the distal portion of the splittable casing held within the primary channel of the splittable casing holding side arm, and the access guidewire hub connected to the connector of the access guidewire connecting side arm form a loop on the access guidewire over which the RICC is disposed, at least in a ready-to-operate state of the RICC insertion assembly.

27. 27. The RICC insertion assembly of any one of claims 1 to 26, wherein the RICC includes a set of three lumens, including the primary lumen, secondary lumen, and tertiary lumen, formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

28. 28. The RICC insertion assembly of claim 27, wherein the primary lumen has a primary lumen opening at a distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of a distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on a side of the distal portion of the catheter tube proximal to the secondary lumen opening.

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