Sealing module for insertion assembly of rapid insertion central venous catheter and method thereof

Abstract

A rapid insertion central venous catheter ("RICC") with sealing module insertion assembly may include a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle together. A proximal portion of the access guidewire is disposed within a primary lumen of the RICC. A distal portion of the access guidewire is disposed within a needle shaft of the introducer needle and through a needle slot thereof. A coupler housing of the coupler includes a sealing module cavity of the sealing module. An elastomeric sealing module insert of the sealing module is inserted within the sealing module cavity. The sealing module insert is configured to separately seal around a proximal portion of the introducer needle and a distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity. A method may include inserting the RICC described above into a vascular lumen of a patient.

Description

[Technical field]

[0001] The present disclosure relates to a sealing module for an insertion assembly of a rapid insertion central venous catheter and a method thereof. [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 is a rapidly insertable central catheter ("RICC") insertion assembly and method that addresses the above. In particular, the RICC insertion assembly disclosed herein includes a 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 comprising a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle to one another. The introducer needle comprises a needle shaft having a longitudinal needle slot. The access guidewire has a proximal portion and a distal portion. The proximal portion of the access guidewire is disposed within a primary lumen of the RICC. The distal portion of the access guidewire is disposed within the needle shaft through the needle slot. The coupler comprises a coupler housing. The coupler housing includes a sealing module cavity of a sealing module. An elastomeric sealing module insert of the sealing module is inserted into the sealing module cavity. The sealing module insert is configured to separately seal around a proximal portion of the introducer needle and a distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity in one or more states of the RICC insertion assembly.

[0005] In some embodiments, the sealing module insert includes an introducer needle passage and an access guidewire passage, the introducer needle passage configured to seal around a proximal portion of the introducer needle when the sealing module insert is compressed within the sealing module cavity, and the access guidewire passage configured to seal around a distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity.

[0006] In some embodiments, the introducer needle passage comprises an internal relief between the proximal and distal portions of the introducer needle passage such that only the proximal and distal end portions of the introducer needle passage are configured to seal around the proximal portion of the introducer needle when the sealing module insert is compressed within the sealing module cavity.

[0007] In some embodiments, the access guidewire passage comprises an internal relief in at least a proximal portion of the access guidewire passage such that only a proximal end portion of the access guidewire passage is configured to seal around a distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity.

[0008] In some embodiments, the distal end of the access guidewire passage connects to an intermediate portion of the introducer needle passage. Connecting the access guidewire passage to the introducer needle passage allows a distal portion of the access guidewire to be positioned through the needle slot and into the needle shaft.

[0009] In some embodiments, the sealing module insert includes a partial-length longitudinal slit between the access guidewire passage and the introducer needle passage configured to allow the access guidewire to escape from the access guidewire passage into the introducer needle passage after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passage.

[0010] In some embodiments, the sealing module insert includes a full-length longitudinal slit between the introducer needle passage and an outer surface of the sealing module insert, the full-length longitudinal slit being configured to allow the access guidewire to exit the introducer needle passage after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passage.

[0011] In some embodiments, a full-length longitudinal slit in the sealing module insert opens into a longitudinal coupler housing slot in the coupler housing configured to allow the access guidewire to exit the coupler housing after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passageway.

[0012] In some embodiments, the sealing module insert comprises an external relief coextensive with the full-length longitudinal slit in the sealing module insert between the sealing module insert and the coupler housing, the external relief configured to allow the access guidewire to exit the introducer needle passage without constraining the access guidewire within the full-length longitudinal slit.

[0013] In some embodiments, the sealing module insert is radially compressed within the sealing module cavity. In some embodiments, the sealing module insert is axially compressed within the sealing module cavity by a follower located proximally of the sealing module insert. 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.

[0014] In some embodiments, the follower is a distal portion of a needle hub of the introducer needle that is removably disposed within a needle hub receptacle of the coupler housing. The needle hub has a proximal portion that includes a luer connector for fluidly connecting a syringe to the introducer needle.

[0015] In some embodiments, the coupler includes a needle hub lock configured to lock the needle hub within the needle hub receptacle. A pair of locking buttons of the needle hub lock are disposed on opposing sides of the coupler. The pair of locking buttons are configured to unlock the needle hub when the locking buttons are depressed into the coupler to withdraw the introducer needle from the coupler through the introducer needle passageway.

[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 sealing module comprises a blade disposed in a needle slot located beneath the distal end of the sheath opening, the blade comprising a distally facing blade edge configured to decouple the sheath from the needle shaft as the introducer needle is withdrawn from the coupler through the introducer needle passage, allowing the access guidewire to exit the needle shaft via the needle slot.

[0018] In some embodiments, the blade is overmolded onto the sealing module insert, thereby making the blade integral to the sealing module insert. In some embodiments, the blade extends from a blade holder of the blade module. The blade module is disposed within a sealing module insert cavity of the sealing module insert.

[0019] In some embodiments, the proximal end of the access guidewire is coupled to a swivel arm that is pivotally coupled to the coupler housing. Coupling the proximal end of the access guidewire to the swivel arm forms a loop on the access guidewire with a distal portion of the access guidewire disposed within the needle shaft. The RICC is disposed on the loop, at least in the ready-to-operate state of the RICC insertion assembly.

[0020] Also disclosed herein in some embodiments is a RICC insertion assembly comprising a RICC, an introducer needle, a coupler coupling the RICC and the introducer needle to one another, and an access guidewire disposed in both the RICC and the introducer needle at least in a ready-to-operate state of the RICC insertion assembly. The RICC comprises a catheter tube, a catheter hub coupled to a proximal portion of the catheter tube, one or more extension legs, and one or more extension leg connectors. Each extension leg of the one or more extension legs is coupled by its distal portion to the catheter hub. Each extension leg connector of the one or more extension leg connectors is located on a proximal portion of one of the one or more extension legs. The introducer needle comprises a needle shaft, a sheath covering the needle shaft, and a needle hub covering a proximal portion of the needle shaft and a proximal portion of the sheath. The needle shaft comprises a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip. The sheath comprises a sheath opening at a proximal portion of the sheath. The coupler includes a coupler housing and an extension arm coupled to the coupler housing. The coupler housing includes a sealing module cavity of the sealing module and a needle hub receptacle located proximal to the sealing module cavity. An elastomeric sealing module insert of the sealing module is inserted into the sealing module cavity and the needle hub is inserted into the needle hub receptacle. The extension arm includes an extension arm connector that is connected to one of the one or more extension leg connectors. The access guidewire includes a proximal portion having a proximal end and a distal portion having a distal end. The proximal end of the access guidewire is coupled to the extension arm connector. The proximal portion of the access guidewire extends along the primary lumen of the RICC. The distal portion of the access guidewire extends along the primary lumen of the RICC and from the distal end of the RICC, into the sealing module covering the needle hub, through both the sheath opening and the needle slot, into the needle shaft, and along the needle lumen of the introducer needle.The distal end of the access guidewire is placed into the needle lumen just proximal to the needle tip, thereby forming a loop on the access guidewire over which the RICC is placed. The sealing module insert separately seals around both the proximal portion of the introducer needle and the distal portion of the access guidewire with the sealing module insert compressed within the sealing module cavity by the needle hub.

[0021] Also disclosed herein is a method of inserting a RICC into a vascular lumen of a patient. The method, in some embodiments, includes an insertion assembly obtaining step, a needle path establishing step, an access guidewire advancing step, and a RICC advancing step. The insertion assembly obtaining step includes obtaining a RICC insertion assembly, optionally 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. A sealing module of the coupler formed at least between a sealing module cavity of the coupler housing and an elastomeric sealing module insert disposed in the sealing module cavity separately seals around a proximal portion of the introducer needle and a distal portion of the access guidewire at least in the ready-to-operate state of the RICC insertion assembly. The needle path establishing step includes establishing a needle path with the introducer needle from the skin area to the vascular lumen. The access guidewire advancing step includes advancing a distal portion of the access guidewire through both the sealing module and a longitudinal needle slot in the needle shaft of the introducer needle. In the access guidewire advancing step, the distal end of the access guidewire is advanced into the vessel lumen from a position in the introducer needle just proximal to the needle tip of the needle shaft. The RICC advancing step includes advancing a catheter tube of the RICC over the access guidewire into the vessel lumen, thereby inserting the RICC into the vessel lumen.

[0022] In some embodiments, the distal end of the access guidewire passage in the sealing module insert connects to an intermediate portion of the introducer needle passage in the sealing module insert. Connecting the distal end of the access guidewire passage to the intermediate portion of the introducer needle passage allows the distal portion of the access guidewire to be positioned within the needle shaft through a needle slot in the needle shaft.

[0023] In some embodiments, the method further includes an introducer needle withdrawal step, which includes withdrawing the introducer needle from the coupler, leaving the access guidewire in place within the vessel lumen. The introducer needle withdrawal step removes the needle hub of the introducer needle from the needle hub receptacle of the coupler housing, thereby removing both axial and radial compression against the sealing module insert and unsealing the proximal portion of the introducer needle and the distal portion of the access guidewire. The introducer needle withdrawal step is performed prior to the RICC advancement step of advancing the catheter tube over the access guidewire into the vessel lumen.

[0024] In some embodiments, the method further includes an unlocking step, which includes depressing a pair of locking buttons of a needle hub lock located on either side of the coupler into the coupler to unlock the needle hub, which is performed prior to an introducer needle withdrawal step of withdrawing the introducer needle from the coupler.

[0025] In some embodiments, the introducer needle withdrawal step of withdrawing the introducer needle from the coupler includes decoupling a needle slot sealing sheath of the introducer needle from the needle shaft, the sealing module comprising a blade disposed in the needle slot beneath the distal end of the sheath opening of the sheath with a distally facing blade edge for decoupling the sheath from the needle shaft.

[0026] In some embodiments, decoupling the sheath from the needle shaft allows the access guidewire to exit the needle shaft via the needle slot. 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 of withdrawing the introducer needle from the coupler.

[0027] 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.

[0028] In some embodiments, the method further includes a blood aspirating step, which includes aspirating blood with a syringe to ensure that the needle track extends into the blood vessel lumen prior to an introducer needle withdrawing step of withdrawing the introducer needle from the coupler.

[0029] 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 vessel lumen.

[0030] 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 distal portion of the catheter tube over the steering guidewire into the vessel lumen to the lower third of the superior vena cava ("SVC") of the patient's heart. The steering guidewire withdrawal step includes withdrawing the steering guidewire while leaving the catheter tube in the lower third of the SVC.

[0031] 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]

[0032] [Figure 1] 1 illustrates a top view of a RICC insertion assembly, according to some embodiments. [Diagram 2] 1 illustrates a perspective view of a RICC insertion assembly, according to some embodiments. [Diagram 3] 1 illustrates a bottom view of a RICC insertion assembly, according to some embodiments. [Figure 4] 1 illustrates a cutaway view of a coupler of a RICC insertion assembly, according to some embodiments. [Diagram 5] 4 illustrates another cutaway view of a coupler according to some embodiments. [Figure 6] 13 illustrates yet another cutaway view of a coupler according to some embodiments. [Figure 7] 1 illustrates a longitudinal cross-sectional view of a coupler, a sealing module of the coupler, and an introducer needle of a RICC insertion assembly, according to some embodiments. [Figure 8] 1A-1D are longitudinal cross-sectional views of a coupler, a sealing module of the coupler, an introducer needle, and an access guidewire of a RICC insertion assembly, according to some embodiments. [Figure 9] 13 is a perspective view of a proximal end of a sealing module insert of a sealing module, according to some embodiments. FIG. [Figure 10] 1 is a perspective view of a distal end of a sealing module insert according to some embodiments. FIG. [Figure 11] 1 illustrates a longitudinal cross-sectional view of a sealing module insert according to some embodiments. [Figure 12] 11A-11C illustrate radial compression of a sealing module insert within a sealing module cavity of a coupler housing of a coupler, according to some embodiments. [Figure 13]13A-13D illustrate radial compression of the sealing module insert within the sealing module cavity through axial compression of the sealing module insert within the sealing module cavity by the needle hub, according to some embodiments. [Figure 14] 13A is a longitudinal cross-sectional view of another sealing module insert having internal relief in the introducer needle passage and the access guidewire passage of the sealing module insert, according to some embodiments. FIG. [Figure 15] 13A-13C are cross-sectional views of a distal portion of a sealing module according to some embodiments. [Figure 16] 13A-13C are cross-sectional views of a distal portion of a sealing module having an external relief between the sealing module insert and the coupler housing, according to some embodiments. [Figure 17] 13A-13C are cross-sectional views of a distal portion of a coupler and its sealing module having an external relief between the sealing module insert and the coupler housing, according to some embodiments. [Figure 18] 1 illustrates a sealing module insert having a first shape according to some embodiments. [Figure 19] 1 illustrates a sealing module insert having a second shape according to some embodiments. [Figure 20] 13A-13C illustrate a sealing module insert having a third shape according to some embodiments. [Figure 21] 13A-13C illustrate a sealing module insert having a fourth shape disposed within a sealing module cavity of a coupler housing according to some embodiments. [Figure 22] FIG. 13 is a top view of an introducer needle, according to some embodiments. [Figure 23] 13A-13D illustrate a sheath for an introducer needle, according to some embodiments. [Figure 24] 1 illustrates a needle shaft of an introducer needle, according to some embodiments. [Diagram 25] 1 illustrates a RICC of a RICC insertion assembly, according to some embodiments. [Figure 26]FIG. 13 is a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 27] FIG. 2 is a cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Figure 28] FIG. 13 is another cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Figure 29] FIG. 2 is a longitudinal cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Diagram 30] 13A-13D illustrate needle path establishment steps of a method of using a RICC insertion assembly, according to some embodiments. [Diagram 31] FIG. 1 illustrates a blood drawing step of a method according to some embodiments. [Diagram 32] 1A-1C illustrate an access guidewire advancement step of a method according to some embodiments. [Diagram 33] 13A-13D illustrate an introducer needle withdrawal step of a method according to some embodiments. [Diagram 34] FIG. 2 illustrates a RICC advancement step of a method according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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. 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.

[0038] Disclosed herein is an insertion assembly and method of a RICC that addresses the above. Among other things, the RICC insertion assembly disclosed herein includes a sealing module for sealing various components of the RICC insertion assembly in the assembly. 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. A proximal portion of the access guidewire is disposed within the primary lumen of the RICC. A distal portion of the access guidewire is disposed within the needle shaft of the introducer needle through its needle slot. The coupler housing of the coupler includes a sealing module cavity of the sealing module. An elastomeric sealing module insert of the sealing module is inserted into the sealing module cavity. The sealing module insert is configured to separately seal around the proximal portion of the introducer needle and the distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity.

[0039] 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 the catheter insertion assembly and method.

[0040] RICC Insertion Assembly 1-3 show a RICC insertion assembly 100 according to some embodiments. 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. In particular, 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, as described below. This causes the RICC 102 to form a loop around 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.

[0041] The RICC insertion assembly 100 may further include a syringe 110 fluidly coupled to the introducer needle 104 in the ready-to-operate state of the RICC insertion assembly 100. As described below, the sheath 142 seals the needle slot 148 of the needle shaft 140. In particular, the sheath 142 seals the needle slot 148 outside of the sealing module 180. The sealing module 180 then seals over the sheath opening 162 of the sheath 142 that opens to the needle slot 148. The sealing module 180 also seals around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106 when the sealing module insert 202 is compressed within the sealing module cavity 198 in one or more states of the RICC insertion assembly 100. Such a seal allows the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0042] FIG. 25 illustrates a RICC 102 of the RICC insertion assembly 100, according to some embodiments. As shown, the RICC 102 includes a catheter tube 112 , a catheter hub 114 , one or more extension legs 116 , and one or more extension leg connectors 118 .

[0043] 26-29 show various views of the catheter tube 112 of the RICC 102, according to some embodiments. The catheter tube 112 includes a first section 120 at a distal portion of the catheter tube 112, a second section 122 at a distal portion of the catheter tube 112 proximal to the first section 120, and a tapered junction 124 between the first section 120 and the second section 122 of the catheter tube 112.

[0044] The first section 120 of the catheter tube 112 includes a catheter tip 126 having a relatively short taper from an outer diameter of the distal portion of the first section 120 distal to the junction 124 to an outer diameter of the distal end of the first section 120. The taper of the catheter tip 126 is configured to immediately dilate tissue around the needle path established by the introducer needle 104 to the outer diameter of the distal portion of the first section 120 of the catheter tube 112. As best shown in FIG. 29 , the first section 120 of the catheter tube 112 also includes a proximal portion that is disposed within a bore in the distal portion of the junction 124 and is fixedly attached thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0045] The second section 122 of the catheter tube 112 includes a constant outer diameter over its length from the distal end of the second section 122 to the proximal end of the second section 122. The constant diameter of the second section 122 of the catheter tube 112 is configured for smooth insertion into the needle tract and target vasculature after any expansion by the first section 120 of the catheter tube 112 and the junction 124. The distal end of the second section 122 of the catheter tube 112 has a flat surface that is flush with the flat surface proximal end of the junction 124 and is fixedly bonded thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0046] The junction 124 includes a taper over its length from the proximal end of the junction 124 to the distal end of the junction 124. The taper of the junction 124 is configured to instantly dilate tissue around the needle track from the outer diameter of the proximal portion of the first section 120 of the catheter tube 112 to the outer diameter of the second section 122 of the catheter tube 112. The abluminal surface of the junction 124 smoothly transitions from the abluminal surface of the first section 120 of the catheter tube 112 to the abluminal surface of the second section 122 of the catheter tube 112 without creating edges that may catch on the skin when the catheter tube 112 is inserted into the needle track. In addition to having minimal or negligible edges, the edges may include solvent interdiffusion polymeric material of the polymeric material forming the catheter tube 112, which provides a smooth transition from the first section 120 of the catheter tube 112 to the junction 124, and from the junction 124 to the second section 122 of the catheter tube 112. In particular, the junction 124 has a length that is approximately equal to the length of the exposed portion of the first section 120 of the catheter tube 112, or a length between the lengths of the exposed portions of the first section 120 and the second section 122 of the catheter tube 112. Thus, the length of the exposed portion of the first section 120 of the catheter tube 112 is less than the length of the junction 124, and at most approximately equal to the length of the junction 124.

[0047] The first section 120 of the catheter tube 112 is formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer. The second section 122 of the catheter tube 112 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 120 of the catheter tube 112 can be formed from a first polyurethane having a first durometer, and the second section 122 of the catheter tube 112 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 112 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 124 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.

[0048] 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.

[0049] With the first section 120 of the catheter tube 112, the second section 122 of the catheter tube 112, and the junction 124 between the first section 120 and the second section 122 of the catheter tube 112 described above, the catheter tube 112 has sufficient column strength to prevent buckling of the catheter tube 112 when inserted into a needle path established by an introducer needle 104, described below. The column strength of the catheter tube 112, optionally in combination with the access guidewire 106, is also sufficient to prevent buckling of the catheter tube 112 when advanced through a patient's vasculature without pre-dilating the tissue around the needle path or any of the vessels of the vasculature with a separate dilator.

[0050] It should be understood that additional configurations of the catheter tube 112 and its catheter tip 126 are contemplated, including a single material catheter tube, a tapered catheter tube having a single taper from the outer diameter of the intermediate section of the catheter tube 112 or even the proximal section of the catheter tube 112 to the inner diameter of the catheter tube 112 at the catheter tip 126, a tapered catheter tip different from those disclosed herein, or even a flattened catheter tip.

[0051] The catheter tube 112 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 112 to the distal end of the catheter tube 112 (see Figures 26-29). In fact, the first section 120 of the catheter tube 112 typically includes a single lumen therethrough, as shown in Figures 27 and 29.

[0052] A catheter hub 114 is coupled to a proximal portion of the catheter tube 112. The catheter hub 114 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 114 from a proximal end of the catheter hub 114 to a distal end of the catheter hub 114.

[0053] Each of the one or more extension legs 116 is coupled by its distal portion to the catheter hub 114. Each of the one or more extension legs 116 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.

[0054] Each of the one or more extension leg connectors 118 is on a proximal portion of one of the one or more extension legs 116. For example, each of the one or more extension leg connectors 118 can be a luer connector on a proximal portion of one of the one or more extension legs 116. 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 128 of the RICC 102) is connected to the swivel arm connector 194 of the swivel arm 182 of the coupler 108 to form a loop around the access guidewire 106 and the RICC 102 thereon.

[0055] 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 128, a secondary lumen 130, and a tertiary lumen 132 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 128 has a primary lumen opening 134 at the distal end of the first section 120 of the catheter tube 112, which corresponds to the distal end of the catheter tube 112 and the distal end of the RICC 102. The secondary lumen 130 has a secondary lumen opening 136 on the side of the distal portion of the catheter tube 112. The tertiary lumen 132 has a tertiary lumen opening 138 on the side of the distal portion of the catheter tube 112 proximal to the secondary lumen opening 136.

[0056] 7, 8, and 22-24 show various views of the introducer needle 104 of the RICC insertion assembly 100, according to some embodiments. As shown, the introducer needle 104 includes a needle shaft 140, a sheath 142 that covers the needle shaft 140, and a needle hub 144 within a proximal portion of the introducer needle 104 that covers both the proximal portion of the needle shaft 140 and the proximal portion of the sheath 142. At least in the ready-to-operate state of the RICC insertion assembly 100, the needle shaft 140 and the sheath 142 extend from the needle hub 144, through a sealing module 180, and out a distal end of the coupler housing 178.

[0057] The needle shaft 140 includes a needle tip 146 at a distal portion of the needle shaft 140 and a longitudinal needle slot 148 extending from a proximal portion of the needle shaft 140 to the needle tip 146 . The needle tip 146 includes a bevel 150 having a tip bevel 152 and a primary bevel 154 proximal to the tip bevel 152. The tip bevel angle of the tip bevel 152 is greater than the primary bevel angle of the primary bevel 154, thereby providing the bevel 150 with a smooth transition across the needle tip 146. Such a needle tip is thus configured to establish a needle pathway from an area of ​​skin into a patient's vascular lumen in accordance with the needle pathway establishment steps of the method described below.

[0058] The needle slot 148 extends from the proximal portion of the needle shaft 140 to the needle tip 146, thereby forming a needle channel 156 along most of the length of the needle shaft 140, as opposed to a needle lumen through the needle shaft 140. The needle slot 148 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 140 to the needle tip 146 when the introducer needle withdrawal step of the method described below is performed.

[0059] It should be appreciated that while the needle shaft 140 includes the needle slot 148 described above, the introducer needle 104 includes a needle lumen 158 which arises from the combination of the needle shaft 140 and the sheath 142 which covers the needle shaft 140. In effect, the sheath 142 which covers the needle shaft 140 seals the underlying needle slot 148 to form the needle lumen 158 of the introducer needle 104 and enable the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0060] 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 . 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 140. The taper has a taper angle that is less than the primary bevel angle of the primary bevel 154 of the needle tip 146, which in turn is less than the tip bevel angle of the tip bevel 152 of the needle tip 146. The sheath tip 160, including such a taper, is configured to provide a smooth transition from the needle tip 146 to the sheath body for the needle path establishment step of the method described below.

[0061] The sheath opening 162 is open to the needle slot 148 of the needle shaft 140 and allows the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 148 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 148, 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 192 of the sealing module 180 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 148. In particular, the sheath 142 covering the needle shaft 140 seals the needle slot 148 below it, except below the sheath opening 162. However, the sealing module 180 covers and seals the needle slot 148 exposed by the sheath opening 162 by sealing the needle shaft 140 and the proximal portion of the sheath 142 therein, thereby enabling the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0062] 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 148 of the needle shaft 140 when the blood aspiration step of the method described below is performed, while also facilitating severing of the sheath 142 from the needle shaft 140, particularly in accordance with the introducer needle withdrawal step of the method described below. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, polyurethane, or polytetrafluoroethylene.

[0063] The needle hub 144 includes an access guidewire channel 164 at a distal portion of the needle hub 144 and a needle hub connector 166 at a proximal portion of the needle hub 144 . The access guidewire channel 164 in the needle hub 144 is configured to allow the access guidewire 106 to pass over the needle hub 144 and guide the access guidewire 106 into the access guidewire passage 190 of the sealing module 180. 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.

[0064] In particular, the distal portion of the needle hub 144, including the access guidewire channel 164, may be configured as a follower of the sealing module 180, described below. The needle hub 144, including the follower, is configured to be removably disposed within a needle hub receptacle 200 of the coupler housing 178. As described below, the follower axially compresses the sealing module insert 202 within the sealing module cavity 198 when the needle hub 144 is disposed within the needle hub receptacle 200. The axial compression of the sealing module insert 202 within the sealing module cavity 198, in turn, radially compresses the sealing module insert 202 within the sealing module cavity 198.

[0065] The needle hub connector 166 includes a needle hub hole 168 and an optional needle hub flange 170 around the needle hub connector 166 . The needle hub bore 168 of the needle hub connector 166 is configured to receive a syringe tip 172 of the syringe 110 therein to fluidly connect the introducer needle 104 to the syringe 110. In fact, the needle hub bore 168 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip 172 therein, which can be complementarily configured with a luer taper.

[0066] A needle hub flange 170 of the needle hub connector 166 is configured to threadably mate with internal threads 174 of a threaded collar 176 about a syringe tip 172 of the syringe 110. While the threaded collar 176 of the syringe 110 is optional, the needle hub flange 170 advantageously provides a so-called luer lock type connection with the internal threads 174 of the threaded collar 176, when both are present, which provides greater security against inadvertent separation of the introducer needle 104 and the syringe 110 than would otherwise be provided by a luer slip type connection.

[0067] 4-8 show various views of the coupler 108 of the RICC insertion assembly 100, according to some embodiments. As shown, coupler 108 includes a coupler housing 178 , a sealing module 180 , and a swivel arm 182 swivelably coupled to coupler housing 178 .

[0068] Coupler housing 178 comprises two molded halves joined together to form an oval-shaped body configured to be comfortably held underhand (e.g., encased) or overhand in the left hand for left-handed venipuncture or in the right hand for right-handed venipuncture with the RICC insertion assembly 100. To further facilitate such venipuncture, the exterior of each of the two molded halves may be textured, such as with an arcuate ridge 184 to enhance grip, as shown. The inside of each of the two molded halves includes a recess that, when the two molded halves are joined together, forms a sealing module cavity 198 and a needle hub receptacle 200 proximal to the sealing module cavity 198, as shown (see Figs. 4-8, which include a sealing module insert 202 disposed in a recess in one of the two molded halves that forms the sealing module cavity 198. Figs. 4-8 also include the needle hub 144 of the introducer needle 104 disposed in a recess in another of the two molded halves that forms the needle hub receptacle 200). Additionally, each of the two molded halves includes a lock button through hole for a corresponding one of the pair of lock buttons 188 of the needle hub lock (see Fig. 3 for a pair of lock buttons 188 extending through a corresponding pair of lock button through holes). Among other things, the coupler housing 178 includes a longitudinal coupler housing slot 186 formed between the two molded halves. The coupler housing slot 186 is configured to allow the access guidewire 106 to exit the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108 during the introducer needle withdrawal step of the method described below. Notwithstanding the above, it should be understood that the coupler housing 178 may be manufactured from one piece, two pieces different from the molded halves described above, or three or more pieces. Additionally, the lock button 188 may be configured with a different shape and position than shown in FIG. 3 and may optionally be configured with a different configuration for locking and unlocking the needle hub lock. The needle hub lock may also be realized through other means such as a lever, a different lock, or a switch.

[0069] The sealing module cavity 198 is configured to hold a sealing module insert 202 therein. Indeed, the sealing module cavity 198 includes the sealing module insert 202 disposed therein during one or more states of the RICC insertion assembly 100, such as the ready-to-operate state or one or more operational states of the RICC insertion assembly 100. Notably, the sealing module cavity 198 is further configured to have sufficient space to allow the sealing module insert 202, described below, to relax and separate for escape of the access guidewire 106 when the introducer needle 104 is withdrawn from the coupler 108 during an introducer needle withdrawal step of the method described below.

[0070] The needle hub receptacle 200 is configured to hold the needle hub 144 of the introducer needle 104 therein. In fact, the needle hub receptacle 200 includes the needle hub 144 inserted therein in the ready-to-operate state of the RICC insertion assembly 100. A needle hub lock configured to, among other things, lock the needle hub 144 within the needle hub receptacle 200 is disposed about the needle hub receptacle 200. A pair of locking buttons 188 (e.g., spring-loaded locking buttons) of the needle hub lock are disposed on both sides of the coupler 108, specifically within locking button through-holes of the two molded halves of the coupler housing 178, such that each locking button of the pair of locking buttons 188 extends through the coupler housing 178 on its respective side of the coupler 108. The locking button 188 is configured to unlock the needle hub 144 when the locking button 188 is depressed into the coupler 108 to withdraw the introducer needle 104 from the coupler 108. When the distal portion of the needle hub 144 is configured as a follower of the sealing module 180, unlocking the locking button 188 may immediately release the axial compression compressing the sealing module insert 202 within the sealing module cavity 198. This allows the sealing module insert 202 to relax for withdrawal of the introducer needle 104 from the coupler 108. This also allows the sealing modules to separate for escape of the access guidewire 106 when the introducer needle 104 is withdrawn from the coupler 108 during an introducer needle withdrawal step of the method described below.

[0071] Figures 9-11, 14, and 18-20 show various views of an elastomeric (e.g., silicone) sealing module insert 202 of a sealing module 180, according to some embodiments. Figures 12, 13, and 15-17 show a sealing module within a sealing module cavity 198 of a coupler housing 178, according to some embodiments.

[0072] As shown, the sealing module insert 202 is disposed or otherwise inserted into the sealing module cavity 198 of the coupler housing 178 where the sealing module insert 202 can be compressed to seal around the introducer needle 104 and the access guidewire 106. Indeed, the sealing module insert 202 can be radially compressed within the sealing module cavity 198, or can be both axially and radially compressed within the sealing module cavity 198 to seal around the introducer needle 104 and the access guidewire 106. With the above seal around the introducer needle 104 and the access guidewire 106, the syringe 110 can aspirate blood in accordance with the blood aspirating steps of the method described below.

[0073] In an example of radial compression, the sealing module insert 202 may be radially compressed by the coupler housing 178 itself within the sealing module cavity 198, as shown in FIG. 12. Without being limited to such an embodiment, the two halves of the coupler housing 178 may be clamshell-like coupled together by a hinge formed between the two halves of the coupler housing 178 on opposite sides of the coupler housing slot 186. One or more clamps across the coupler housing slot 186 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 178 together and apply sufficient pressure to radially compress the sealing module insert 202 within the sealing module cavity 198 and seal the sealing module insert 202 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 relieve radial compression and allow the sealing module insert 202 to relax so that the access guidewire 106 can escape through the slits 206, 208 described below when the introducer needle 104 is withdrawn from the coupler 108.

[0074] In an example of both radial and axial compression, the seal module insert 202 may be compressed both axially and radially within the seal module cavity 198 by a follower of the seal module 180 located proximal to the seal module insert 202, as shown in FIGS. 13 and 21. Without limiting such an embodiment, the follower may be a distal portion of the needle hub 144 that axially compresses the seal module insert 202 within the seal module cavity 198 when the needle hub 144 is disposed within the needle hub receptacle 200, such as in the ready-to-operate state of the RICC insertion assembly 100. The axial compression of the seal module insert 202 within the seal module cavity 198, in turn, radially compresses the seal module insert 202 within the seal module cavity 198, thereby sealing the seal module insert 202 around the introducer needle 104 and the access guidewire 106. The needle hub 144, and therefore the follower of the sealing module 180, may be removed from the needle hub receptacle in one or more operating states of the RICC insertion assembly 100 to relieve both axial and radial compression and allow the sealing module insert 202 to relax so that the access guidewire 106 can escape through the slits 206, 208 described below when the introducer needle 104 is withdrawn from the coupler 108.

[0075] The sealing module insert 202 and the sealing module cavity 198 in which the sealing module insert 202 is disposed can have any of a number of corresponding shapes. In one example, the sealing module insert 202 can be formed in a cylindrical shape and the sealing module cavity 198 can be formed in a corresponding shape for disposing the sealing module insert 202 therein. In addition to FIGS. 9, 10, and 18, such a sealing module insert is shown in FIG. 12 without the needle hub 144 or its follower because the sealing module insert 202 can be radially compressed within the sealing module cavity 198 by the coupler housing 178 itself in such an embodiment. In another example, the sealing module insert 202 can be formed in a tapered cylindrical shape and the sealing module cavity 198 can be formed in a corresponding shape for disposing the sealing module insert 202 therein. Such a sealing module insert is shown in Figures 13 and 21, where the tapered portion of the sealing module insert 202 in Figure 13 tapers in a distal direction, whereas the tapered portion of the sealing module insert 202 in Figure 21 tapers in a proximal direction. The needle hub 144 or its follower, which may axially compress the sealing module insert 202 in the sealing module cavity 198 in such an embodiment, may be correspondingly shaped to axially compress the sealing module insert 202 in the sealing module cavity 198. Further examples of at least the sealing module insert 202 are shown in Figures 19 and 20, where the sealing module insert 202 is oval like the coupler housing 178 or a frustum of an oval sealing module insert 202. It should be understood that the passages 190, 204 and slits 206, 208 described below may vary according to at least the shape of the sealing module insert 202.

[0076] The sealing module insert 202 includes a pair of passages 190, 204 such that the sealing module insert 202 is configured to separately seal around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106 when the sealing module insert 202 is compressed within the sealing module cavity 198 in one or more states of the RICC insertion assembly 100 (e.g., a ready-to-operate state or one or more operational states of the RICC insertion assembly 100). In effect, the passages 190, 204 of the sealing module insert 202 include an introducer needle passage 204 and an access guidewire passage 190. The introducer needle passage 204 is configured to seal around a proximal portion of the introducer needle 104 when the sealing module insert 202 is compressed within the sealing module cavity 198, and the access guidewire passage 190 is configured to seal around a distal portion of the access guidewire 106 when the sealing module insert 202 is compressed within the sealing module cavity 198. The above seal around the introducer needle 104 and access guidewire 106 allows the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0077] In contrast to the introducer needle passage 204, which passes through both the proximal and distal ends of the seal module insert 202, the access guidewire passage 190 passes through the proximal end of the seal module insert 202. The distal end of the access guidewire passage 190 connects to an intermediate portion of the introducer needle passage 204, thereby allowing a distal portion of the access guidewire 106 to be disposed within the needle shaft 140 through the needle slot 148. In fact, the access guidewire passage 190 is configured to guide the access guidewire 106 from the access guidewire channel 164 of the needle hub 144 into both the sheath opening 162 of the sheath 142 and the underlying needle slot 148 of the needle shaft 140, such that the access guidewire 106 can be disposed within the introducer needle 104 with the distal end of the access guidewire 106 located just proximal to the needle tip 146 in the ready-to-operate state of the RICC insertion assembly 100.

[0078] The sealing module insert 202 includes a pair of slits 206, 208 that are configured to at least partially separate the sealing module insert 202 when relaxed within the sealing module cavity 198 of the coupler housing 178. The slits 206, 208 allow the access guidewire 106 to exit both the access guidewire passage 190 and the introducer needle passage 204 after the introducer needle 104 has been withdrawn from at least the introducer needle passage 204 of the sealing module insert 202 when performing an introducer needle withdrawal step of the method described below to remove the introducer needle 104 from the RICC insertion assembly 100. In effect, the slits 206, 208 in the sealing module insert 202 include a partial-length longitudinal slit 206 and a full-length longitudinal slit 208, where the partial-length longitudinal slit 206 has a slit length less than the full length of the sealing module insert 202, and the full-length longitudinal slit 208 has a slit length equal to the length of the sealing module insert 202. The partial-length longitudinal slit 206 is between the access guidewire passage 190 and the introducer needle passage 204, and allows the access guidewire 106 to exit from the access guidewire passage 190 into the introducer needle passage 204 after the introducer needle 104 is withdrawn from the RICC insertion assembly 100 through the introducer needle passage 204. The full-length longitudinal slit 208 is between the introducer needle passage 204 and the outer surface of the sealing module insert 202 and allows the access guidewire 106 to subsequently exit the introducer needle passage 204 after the introducer needle 104 has been withdrawn from the RICC insertion assembly 100 through the introducer needle passage 204. In particular, the full-length longitudinal slit 208 opens into the coupler housing slot 186 of the coupler housing 178, which is configured to allow the access guidewire 106 to exit the coupler housing 178 after the introducer needle 104 has been withdrawn from the RICC insertion assembly 100 through the introducer needle passage 204, as described above.

[0079] FIG. 14 shows a longitudinal cross section of a sealing module insert 202 having internal reliefs 210 and 212 in the introducer needle passage 204 and the access guidewire passage 190 of the sealing module insert 202, according to some embodiments.

[0080] As shown, the introducer needle passage 204 of the sealing module insert 202 can include an internal relief 210 between a proximal portion and a distal portion of the introducer needle passage 204 to reduce friction against the introducer needle 104 as it is withdrawn from the coupler 108 and its sealing module 180 during an introducer needle withdrawal step of the method described below. Additionally or alternatively, the access guidewire passage 190 can include an internal relief 212 at least in a proximal portion of the access guidewire passage 190 to reduce friction against the access guidewire 106 as it is advanced into the coupler 108 and its sealing module 180 during an access guidewire advancement step of the method described below. An internal relief 210 between the proximal and distal portions of the introducer needle passage 204 ensures that only the proximal and distal end portions of the introducer needle passage 204, including the proximal and distal ends of the introducer needle passage 204, are configured to seal around the proximal portion of the introducer needle 104 when the sealing module insert 202 is compressed within the sealing module cavity 198. An internal relief 212 in the proximal portion of the access guidewire passage 190 ensures that only the proximal end portion of the access guidewire passage 190, including the proximal end of the access guidewire passage 190, is configured to seal around the distal portion of the access guidewire 106 when the sealing module insert 202 is compressed within the sealing module cavity 198. In particular, the internal reliefs 210 and 212 are configured to reduce friction in the introducer needle passage 204 and the access guidewire passage 190 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 202 to reduce friction.

[0081] 16 and 17 show cross-sectional views of at least a distal portion of the sealing module 180 with an external relief between the sealing module insert 202 and the coupler housing 178, according to some embodiments.

[0082] As shown, the sealing module insert 202 can include an external relief 214 between the sealing module insert 202 and the coupler housing 178, the external relief 214 having a length less than the full-length longitudinal slit 208 in the sealing module insert 202 to a length coextensive with the full-length longitudinal slit 208. The external relief 214 is configured to allow the access guidewire 106 to exit the introducer needle passageway 204 without constraining the access guidewire 106 within the full-length longitudinal slit 208.

[0083] Figure 17 also shows a cross-sectional view of the blade module 216 of the sealing module 180, according to some embodiments. Figures 5-8 show other views of the blade module 216, according to some embodiments.

[0084] As shown, the blade module 216 is disposed within the sealing module insert cavity 218 of the sealing module insert 202, with the blade 192 of the blade module 216 extending from the blade holder 220 of the blade module 216. However, notwithstanding the above, the blade 192 can instead be overmolded onto the sealing module insert 202, thereby allowing the blade 192 to be integrated into the sealing module insert 202 instead of disposing the blade module 216 within the sealing module insert cavity 218. In any event, the blade 192, or a blade tip thereof, is disposed within the needle slot 148 located beneath the distal end of the sheath opening 162, at least in the ready-to-operate state of the RICC insertion assembly 100. The blade 192 includes a distally facing blade edge 222 configured to decouple the sheath 142 from the needle shaft 140 as the introducer needle 104 is withdrawn from the coupler 108 through the introducer needle passageway 204 during an introducer needle withdrawal step of the method described below. As the introducer needle 104 is withdrawn from the coupler 108 , the sheath 142 is decoupled from the needle shaft 140 , allowing the access guidewire 106 to exit the needle shaft 140 via the needle slot 148 .

[0085] The swivel arm 182 includes a swivel arm connector 194 that connects to one of the one or more extension leg connectors 118 in the ready-to-operate state of the RICC insertion assembly 100. Although not shown, the swivel arm connector 194 includes an access guidewire attachment point therein to which a proximal end of the access guidewire 106 is attached in the ready-to-operate state of the RICC insertion assembly 100. This, combined with the distal end of the access guidewire 106 being disposed within the needle lumen 158 of the introducer needle 104, forms the loop of the access guidewire 106 discussed above. Advantageously, the swivel arm 182 is configured to flip the loop, or at least one or more extension legs 116 of the RICC 102, between the sinistral side of the RICC insert assembly 100 and the dextral side of the RICC insert assembly 100 to accommodate both left-handed and right-handed venipuncture with the RICC insert assembly 100. Indeed, the swivel arm 182 is configured to flip the loop from the left-handed side of the RICC insert assembly 100 shown in FIG. 1 to the right-handed side of the RICC insert assembly 100 to accommodate left-handed venipuncture with the RICC insert assembly 100. Similarly, the swivel arm 182 is configured to flip the loop from the right-handed side of the RICC insert assembly 100 to the left-handed side of the RICC insert assembly 100 to accommodate right-handed venipuncture with the RICC insert assembly 100. Notwithstanding the above, it should be understood that the swivel arm 182 is merely one example of an extension arm for connecting the extension leg connectors of one or more extension leg connectors 118 and the proximal end of the access guidewire 106 .Indeed, other forms of extension arms other than swivel arms 182 are contemplated, including fixed position arms, in which the extension leg connectors of one or more extension leg connectors 118 and the proximal end of the access guidewire 106 may be located in a fixed position on the patient-facing side of the RICC insertion assembly 100, the clinician-facing side of the RICC insertion assembly 100 opposite the patient-facing side of the RICC insertion assembly 100, the left-hand side of the RICC insertion assembly 100, or the right-hand side of the RICC insertion assembly 100.

[0086] 1, 2 and 8 show various views of the access guidewire 106 of the RICC insertion assembly 100, according to some embodiments. 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 swivel arm 182, specifically to an access guidewire attachment point within a swivel arm connector 194 of the swivel arm 182. Additionally, the proximal portion of the access guidewire 106 extends along the primary lumen 128 of the RICC 102. A distal portion of the access guidewire 106 also extends along the primary lumen 128 of the RICC 102, but the distal portion of the access guidewire 106 further extends from the distal end of the RICC 102, by way of an access guidewire channel 164, into a sealing module 180 above the needle hub 144, through both a sheath opening 162 of the sheath 142 and a needle slot 148 of the needle shaft 140, and into the needle shaft 140, 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. 8, the distal end of the access guidewire 106 is disposed within the needle lumen 158 just proximal to the needle tip 146 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 around the access guidewire 106, over which the RICC 102 is disposed, in the ready-to-operate state of the RICC insertion assembly 100, thereby keeping the RICC insertion assembly 100 in a relatively compact configuration.

[0087] The access guidewire 106 can include a guidewire tip 196 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 the ready-to-operate state of the RICC insertion assembly 100 and a curved state when the guidewire tip 196 is advanced beyond the needle tip 146 (e.g., advanced into the blood vessel lumen) in the deployed state of the RICC insertion assembly 100.

[0088] 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 190 of the sealing module 180, at least in the ready-to-operate state of the RICC insertion assembly 100, such that the sealing module 180 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.

[0089] method 30-34 illustrate various steps of a method of using the RICC insertion assembly 100 according to some embodiments.

[0090] As shown, a method of the RICC insertion assembly 100 includes a method for inserting a RICC 102 into a vascular lumen of a patient, such method including one or more steps selected from an insertion assembly obtaining step, a needle path establishing step, a blood aspiration step, an access guidewire advancing step, an unlocking step, an introducer needle withdrawal step, a RICC advancing step, an access guidewire withdrawal step, a steering guidewire advancing step, another RICC advancing step, and a steering guidewire withdrawal step.

[0091] If the RICC insert assembly 100 is not in an operational ready state when it is acquired in the insert assembly acquisition step, the RICC insert assembly 100 may be adjusted to make it operational ready for a subsequent step.

[0092] As described above, the RICC insertion assembly 100 includes the RICC 102, the introducer needle 104, the access guidewire 106, and the coupler 108 that couples the RICC 102 and the introducer needle 104 together at least in the ready-to-operate state of the RICC insertion assembly 100. Again, the sealing module 180 of the coupler 108, formed at least between the sealing module cavity 198 of the coupler housing 178 and the sealing module insert 202 disposed within the sealing module cavity 198, separately seals around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 at least in the ready-to-operate state of the RICC insertion assembly 100. Within the sealing module 180, the distal portion of the access guidewire 106 is disposed within the needle shaft 140 through the needle slot 148. This is accomplished by a connection between the distal end of the access guidewire passage 190 and an intermediate portion of the introducer needle passage 204 within the seal module insert 202 .

[0093] FIG. 30 illustrates the needle path establishment step of a method according to some embodiments. 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 144 of the introducer needle 104), into the syringe 110 fluidly connected to the introducer needle 104 (e.g., the syringe tip 172, the barrel of the syringe 110, or both), or into both the introducer needle 104 and the syringe 110, 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 110 while establishing the needle path.

[0094] FIG. 31 illustrates the blood drawing step of a method according to some embodiments. The blood aspirating step includes aspirating blood with the syringe 110 to ensure that the needle track extends into the blood vessel lumen before withdrawing the introducer needle 104 from the coupler 108 in the introducer needle withdrawal step. The sheath 142 above the needle shaft 140 also seals the needle slot 148 of the needle shaft 140 below it. In particular, the sheath 142 seals the needle slot 148 outside of the sealing module 180. The sealing module 180 then seals over the sheath opening 162 of the sheath 142, which allows the access guidewire 106 to pass from the access guidewire passage 190 of the sealing module insert 202, through the needle slot 148, and into the needle shaft 140. The sealing module 180 also seals around a distal portion of the access guidewire 106. Such a seal allows the syringe 110 to aspirate blood in the blood aspirating step.

[0095] FIG. 32 illustrates the access guidewire advancement step of a method according to some embodiments. The access guidewire advancement step involves advancing a distal portion of the access guidewire 106 through both the sealing module 180 and the needle slot 148 of the needle shaft 140. In the access guidewire advancement step, the distal end of the access guidewire 106 is advanced into the blood vessel lumen from its initial position within the introducer needle 104, just proximal to the needle tip 146 of the needle shaft 140.

[0096] The unlocking step involves depressing a pair of locking buttons 188 of the needle hub lock into the coupler 108 to unlock the needle hub 144, the locking buttons 188 being located on opposite sides of the coupler 108. The unlocking step is performed prior to the introducer needle withdrawal step of withdrawing the introducer needle 104 from the coupler 108.

[0097] FIG. 33 illustrates the introducer needle withdrawal step of a method according to some embodiments. The introducer needle withdrawal step includes withdrawing the introducer needle 104 from the coupler 108, leaving the access guidewire 106 in place within the vessel lumen. Withdrawing the introducer needle 104 from the coupler 108 removes the needle hub 144 of the introducer needle 104 from the needle hub receptacle 200 of the coupler housing 178, thereby removing both axial and radial compression against the sealing module insert 202 and unsealing the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106. Withdrawing the introducer needle 104 from the coupler 108 also includes disconnecting the needle slot sealing sheath 142 of the introducer needle 104 from the needle shaft 140. As discussed above, the sealing module 180 includes a blade 192 disposed in the needle slot 148 located beneath the distal end of the sheath opening 162 of the sheath 142, with a distally facing blade edge 222 for decoupling the sheath 142 from the needle shaft 140. Decoupling the sheath 142 from the needle shaft 140 allows the access guidewire 106 to exit the needle shaft 140 via the needle slot 148. Additionally, the coupler housing slot 186 in the coupler housing 178 allows the access guidewire 106 to exit the coupler housing 178 after the introducer needle 104 is withdrawn from the coupler 108 (see, e.g., FIG. 34, in which the distal portion of the access guidewire 106 has fully exited the coupler 108 and the proximal end of the access guidewire 106 is still attached to the access guidewire attachment point in the swivel arm connector 194). Notably, the introducer needle withdrawal step is performed prior to the RICC advancement step of advancing the catheter tube 112 over the access guidewire 106 into the vessel lumen.

[0098] FIG. 34 illustrates the RICC advancement step of a method according to some embodiments. The RICC advancement step involves inserting the RICC 102 into the vessel lumen by advancing the catheter tube 112 of the RICC 102 over the access guidewire 106 into the vessel lumen.

[0099] The access guidewire withdrawal step involves withdrawing the access guidewire 106 while leaving the catheter tube 112 within the vessel lumen. The steering guidewire advancement step includes advancing a steering guidewire through the primary lumen 128 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.

[0100] Another RICC advancement step involves advancing the distal portion of the catheter tube 112 further into the vascular lumen over the steering guidewire to the lower third of the SVC of the patient's heart. The steering guidewire withdrawal step involves withdrawing the steering guidewire, leaving the catheter tube 112 in the lower third of the SVC.

[0101] 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 primary lumen; an introducer needle including a needle shaft having a longitudinal needle slot; an access guidewire having 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, a coupler housing including a sealed module cavity for the sealed module; a coupler including: an elastomeric sealing module insert of the sealing module inserted into the sealing module cavity, the sealing module insert configured to separately seal around a proximal portion of the introducer needle and a distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity in one or more states of the RICC insertion assembly; 1. A RICC insertion assembly comprising:

2. 2. The RICC insertion assembly of claim 1, wherein the sealing module insert includes an introducer needle passage and an access guidewire passage, the introducer needle passage configured to seal around the proximal portion of the introducer needle and the access guidewire passage configured to seal around the distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity.

3. 3. The RICC insertion assembly of claim 2, wherein the introducer needle passage comprises an internal relief between a proximal portion and a distal portion of the introducer needle passage, whereby only the proximal and distal end portions of the introducer needle passage are configured to seal around the proximal portion of the introducer needle when the sealing module insert is compressed within the sealing module cavity.

4. 3. The RICC insertion assembly of claim 2, wherein the access guidewire passage comprises an internal relief in at least a proximal portion of the access guidewire passage, whereby only a proximal end portion of the access guidewire passage is configured to seal around the distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity.

5. 3. The RICC insertion assembly of claim 2, wherein a distal end of the access guidewire passage connects to an intermediate portion of the introducer needle passage, thereby allowing the distal portion of the access guidewire to be positioned through the needle slot and within the needle shaft.

6. 3. The RICC insertion assembly of claim 2, wherein the sealing module insert includes a partial-length longitudinal slit between the access guidewire passage and the introducer needle passage configured to allow the access guidewire to escape from the access guidewire passage into the introducer needle passage after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passage.

7. 3. The RICC insertion assembly of claim 2, wherein the sealing module insert includes a full-length longitudinal slit between the introducer needle passage and an outer surface of the sealing module insert configured to allow the access guidewire to exit the introducer needle passage after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passage.

8. 8. The RICC insertion assembly of claim 7, wherein the full-length longitudinal slit in the sealing module insert opens into a longitudinal coupler housing slot in the coupler housing, the coupler housing slot configured to allow the access guidewire to exit the coupler housing after the introducer needle is withdrawn from the RICC insertion assembly through the introducer needle passage.

9. 9. The RICC insertion assembly of claim 8, wherein the sealing module insert comprises an external relief between the sealing module insert and the coupler housing that is coextensive with the full-length longitudinal slit in the sealing module insert, the external relief configured to allow the access guidewire to exit the introducer needle passage without constraining the access guidewire within the full-length longitudinal slit.

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

11. 2. The RICC insert assembly of claim 1, wherein the sealing module insert is axially compressed within the sealing module cavity by a follower located proximally of the sealing module insert, the axial compression of the sealing module insert within the sealing module cavity in turn radially compressing the sealing module insert within the sealing module cavity.

12. 12. The RICC insertion assembly of claim 11, wherein the follower is a distal portion of a needle hub of the introducer needle removably disposed within a needle hub receptacle of the coupler housing, the needle hub having a proximal portion including a luer connector for fluidly connecting a syringe to the introducer needle.

13. 13. The RICC insertion assembly of claim 12, wherein the coupler comprises a needle hub lock configured to lock the needle hub within the needle hub receptacle, the pair of locking buttons of the needle hub lock being disposed on opposite sides of the coupler and configured to unlock the needle hub when the locking buttons are depressed into the coupler to withdraw the introducer needle from the coupler through the introducer needle passage.

14. 13. The RICC insertion assembly of claim 12, wherein the introducer needle further includes a sheath covering the needle shaft, the sheath sealing the needle slot therebelow, the needle slot extending from a proximal portion of the needle shaft to a distal needle tip.

15. 15. The RICC insertion assembly of claim 14, wherein the sealing module comprises a blade disposed in the needle slot located below a distal end of a sheath opening, the blade comprising a distally facing blade edge configured to decouple the sheath from the needle shaft as the introducer needle is withdrawn from the coupler through the introducer needle passage, thereby allowing the access guidewire to exit the needle shaft through the needle slot.

16. 16. The RICC insert assembly of claim 15, wherein the blade is overmolded onto the sealing module insert, thereby integrating the blade into the sealing module insert.

17. 16. The RICC insert assembly of claim 15, wherein the blade extends from a blade holder of a blade module, the blade module being disposed within a sealing module insert cavity of the sealing module insert.

18. 18. The RICC insertion assembly of claim 1, wherein a proximal end of the access guidewire is coupled to a swivel arm pivotally coupled to the coupler housing, thereby forming a loop on the access guidewire together with the distal portion of the access guidewire disposed within the needle shaft, and the RICC is disposed on the loop, at least in a ready-to-operate state of the RICC insertion assembly.

19. 1. A rapid insertion central venous catheter ("RICC") insertion assembly comprising: an RICC; an introducer needle; a coupler that couples the RICC and the introducer needle together; and an access guidewire that is disposed in both the RICC and the introducer needle, at least in a ready-to-operate state of the RICC insertion assembly; The RICC A catheter tube; a catheter hub coupled to a proximal portion of the catheter tube; one or more extension legs, each extension leg of the one or more extension legs being coupled by a distal portion thereof to the catheter hub; one or more extension leg connectors, each extension leg connector of the one or more extension leg connectors located on a proximal portion of one of the one or more extension legs; The introducer needle a needle shaft including a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip; a sheath covering the needle shaft, the sheath including a sheath opening at a proximal portion of the sheath; a needle hub covering the proximal portion of the needle shaft and the proximal portion of the sheath; The coupler comprises: A coupler housing, a sealed module cavity of the sealed module; a coupler housing including a needle hub receptacle located proximal to the sealing module cavity, the needle hub being inserted into the needle hub receptacle; an elastomeric sealing module insert of the sealing module inserted into the sealing module cavity; an extension arm coupled to the coupler housing, the extension arm including an extension arm connector that connects to one of the one or more extension leg connectors; The access guidewire comprises: a proximal end coupled to the extension arm connector; a proximal portion extending along the primary lumen of the RICC; a distal portion extending from the distal end of the RICC along the primary lumen of the RICC, into the sealing module covering the needle hub, through both the sheath opening and the needle slot, into the needle shaft, and along the needle lumen of the introducer needle; a distal end positioned within the needle lumen just proximal to the needle tip, thereby forming a loop around the access guidewire over which the RICC is positioned, the sealing module insert separately sealing around both the proximal portion of the introducer needle and the distal portion of the access guidewire when the sealing module insert is compressed within the sealing module cavity by the needle hub.

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