Rapid Insertion Central Venous Catheter Insertion Assembly

Abstract

A rapid insertion central venous catheter (RICC) insertion assembly can include a RICC, an introducer needle, a coupler coupling the RICC and introducer needle, and a sheath splitting means for splitting the sheath body of the introducer needle away from the access guidewire. The sheath splitting means allows the access guidewire to exit the sheath body and remain within the needle path established by the introducer needle. Splitting of the sheath body by the sheath splitting means is initiated by withdrawing the sheath body by a pair of finger tabs extending from a sheath hub around a proximal portion of the sheath body, twisting the introducer needle or needle hub around a proximal portion of the needle shaft, triggering one or more triggers disposed within the coupler housing, or pushing the catheter tip of the RICC into the sheath body.

Description

[Technical field]

[0001] The present disclosure relates to a rapid insertion central venous catheter insertion assembly. [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, there is a relatively high chance of contact contamination. 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 rapid insertion central venous catheter ("RICC") insertion assembly and sheath removal method that addresses the foregoing. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a RICC insertion assembly including a RICC, an introducer needle, and a coupler coupling the RICC and the introducer needle to one another. The introducer needle includes a needle shaft and a sheath body covering the needle shaft. The needle shaft includes a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip. The sheath body seals the needle slot beneath the sheath body except where it is beneath a sheath opening to the needle slot at a proximal portion of the sheath body. The coupler includes a coupler housing and a valve module disposed within the coupler housing, the valve module sealing the needle shaft and the proximal portion of the sheath body therein. The RICC insertion assembly also includes an access guidewire including a proximal end coupled to the extension arm of the coupler and a distal end disposed within the introducer needle. The RICC insertion assembly also includes a sheath splitting means for splitting the sheath body away from the access guidewire following percutaneous puncture with the introducer needle. The sheath splitting means allows the access guidewire to exit the sheath body and remain within the needle path established by the percutaneous puncture. Splitting of the sheath body by the sheath splitting means is initiated by a) withdrawing the sheath body by a pair of finger tabs extending from the sheath hub around a proximal portion of the sheath body, b) twisting the introducer needle or needle hub around a proximal portion of the needle shaft, c) triggering one or more triggers disposed within the coupler housing, or d) pushing the catheter tip of the RICC into the sheath body.

[0005] In some embodiments, splitting by the same or a different sheath splitting means, once initiated, is continued by forcing the coupler onto the sheath body while holding the sheath body in place.

[0006] In some embodiments, division by the same or a different sheath division means, once initiated, is continued by withdrawing the introducer needle from the coupler. In some embodiments, division by the same or a different sheath dividing means, once initiated, is continued by withdrawing the sheath body from the coupler.

[0007] In some embodiments, splitting by the same or a different sheath splitting means, once initiated, is continued by pushing the catheter tip of the RICC into the sheath body. In some embodiments, division by the same or a different sheath dividing means, once initiated, is continued by pulling the access guidewire distally against the side of the sheath body.

[0008] In some embodiments, the sheath splitting means is a blade, an access guidewire, a catheter tip, or a combination thereof. In some embodiments, a blade is disposed within the valve module beneath the distal end of the sheath opening, the blade including a distally facing blade edge configured to slide along the needle slot and cut the sheath body away from the access guidewire.

[0009] In some embodiments, the blade is spring loaded with a compression spring that is configured to relax when the introducer needle or needle hub is twisted or when one or more triggers disposed within the coupler housing are triggered.

[0010] In some embodiments, the proximal and distal ends of the access guidewire are forced into a loop over which the RICC is placed in the ready-to-deploy state of the RICC insertion assembly.

[0011] In some embodiments, the RICC insertion assembly further includes a syringe fluidly coupled to the introducer needle in the ready-to-deploy state of the RICC insertion assembly, the sheath body seals the needle slot of the needle shaft outside of the valve module below it, the valve module seals the sheath opening of the sheath body therein, and the valve module seals around the access guidewire to allow the syringe to aspirate blood.

[0012] In some embodiments, the coupler housing includes a longitudinal coupler housing slot configured to allow the access guidewire to exit the coupler housing when the sheath body is split and clear of the access guidewire.

[0013] Also disclosed herein is a method for inserting a RICC into a vascular lumen of a patient. The method, in some embodiments, includes a RICC insertion assembly obtaining step, a needle path establishing step, an access guidewire advancing step, a sheath body splitting step, and a RICC advancing step. The RICC insertion assembly obtaining step includes obtaining a RICC insertion assembly. The RICC insertion assembly includes a RICC, an introducer needle including a sheath body covering a needle shaft, and an access guidewire, coupled together by a coupler. A proximal end of the access guidewire is coupled to an extension arm of the coupler, and a distal end of the access guidewire is disposed within the introducer needle via a valve module of the coupler. The needle path establishing step establishes a needle path from an area of ​​skin to the vascular lumen with the introducer needle. The access guidewire advancing step includes advancing a distal end of the access guidewire into the vascular lumen from its initial position within the needle shaft just proximal to the needle tip of the needle shaft. The sheath body splitting step includes splitting the sheath body away from the access guidewire, thereby allowing the access guidewire to exit the sheath body and remain within the needle track. The sheath body splitting step is initiated by a) withdrawing the sheath body by a pair of finger tabs extending from the sheath hub around a proximal portion of the sheath body, b) twisting the introducer needle or needle hub around a proximal portion of the needle shaft, c) triggering one or more triggers disposed within the coupler housing of the coupler, or d) pushing the catheter tip of the RICC into the sheath body. The RICC advancement step includes inserting the RICC into the vascular lumen by advancing the catheter tip of the RICC over the access guidewire into the vascular lumen.

[0014] In some embodiments, the sheath body splitting step is continued after initiation by forcing the coupler onto the sheath body while holding the sheath body in place. In some embodiments, once initiated, the sheath body splitting step is continued by withdrawing the introducer needle from the coupler.

[0015] In some embodiments, after the sheath body splitting step has begun, it is continued by withdrawing the sheath body from the coupler. In some embodiments, after initiation, the sheath body splitting step is continued by pushing the catheter tip of the RICC further into the sheath body and advancing the catheter tip over the access guidewire and into the vessel lumen.

[0016] In some embodiments, the sheath body splitting step is continued after initiation by pulling the access guidewire distally toward the patient against the side of the sheath body.

[0017] In some embodiments, splitting the sheath body away from the access guidewire is accomplished with a blade. In some embodiments, a blade is disposed within the valve module beneath the distal end of the sheath opening, the blade including a distally facing blade edge configured to slide along the needle slot and cut the sheath body away from the access guidewire.

[0018] In some embodiments, the blade is spring loaded with a compression spring that is configured to relax when the introducer needle or needle hub is twisted or when one or more triggers disposed within the coupler housing are triggered.

[0019] In some embodiments, the needle shaft includes a longitudinal needle slot extending from a proximal portion of the needle shaft through the needle tip, the needle slot allowing the access guidewire to exit the needle shaft as the sheath body continues to split and clear the access guidewire.

[0020] 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.

[0021] 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]

[0022] [Figure 1] 1 illustrates a top view of a RICC insertion assembly, according to some embodiments. [Diagram 2] 1 illustrates a bottom view of a RICC insertion assembly, according to some embodiments. [Diagram 3] 1 illustrates a longitudinal cross-section of a coupler and introducer needle of a RICC insertion assembly, according to some embodiments. [Figure 4] 1 illustrates a longitudinal cross-section of a coupler, introducer needle, and access guidewire of a RICC insertion assembly, according to some embodiments. [Diagram 5] 13 illustrates an introducer needle sheath having a sheath hub with a pair of finger tabs configured to pull the sheath away from the coupler to initiate splitting of the sheath, according to some embodiments. [Figure 6] 13 illustrates a trigger button disposed within a coupler housing of a coupler, the trigger button being configured to initiate splitting of a sheath when the button is pressed, according to some embodiments. [Figure 7] 14 illustrates an introducer needle or its needle hub configured to twist out of the coupler housing to initiate splitting of the sheath, according to some embodiments. [Figure 8] 13 illustrates a spring-loaded blade configured to initiate sheath splitting when triggered, according to some embodiments. [Figure 9]1 illustrates a top view of an introducer needle, according to some embodiments. [Figure 10] 1 illustrates a sheath for an introducer needle, according to some embodiments. [Figure 11] 1 illustrates a needle shaft of an introducer needle, according to some embodiments. [Figure 12] 1 illustrates a RICC of a RICC insertion assembly, according to some embodiments. [Figure 13] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 14] FIG. 1 shows a cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 15] 13 shows another cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 16] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter tube according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] 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 presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0024] With regard to the terms used herein, it should also be understood that each term is intended to describe certain embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps from one another within a group of features or steps, and do not impose any order or numerical limitations. For example, the "first," "second," and "third" features or steps do not necessarily have to appear in this order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Also, unless otherwise indicated, any of the features or steps may be sequential, and may further include one or more features or steps. Designations such as "left," "right," "upper," "lower," "front," and "rear" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such designations are used to indicate, for example, relative positions, orientations, or directions. Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural. With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter intended to be near a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter intended to be near a 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, but a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter. With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the 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, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0025] 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 many medical devices are cumbersome to handle, 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 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.

[0026] Disclosed herein is a RICC insertion assembly and a sheath removal method that address at least the aforementioned needs. For example, the RICC insertion assembly can include a RICC, an introducer needle, a coupler that couples the RICC and the introducer needle, and a sheath splitting means for splitting the sheath body of the introducer needle away from the access guidewire. The sheath splitting means allows the access guidewire to exit the sheath body and remain within the needle path established by the introducer needle. Splitting of the sheath body by the sheath splitting means is initiated by withdrawing the sheath body by a pair of finger tabs extending from a sheath hub around a proximal portion of the sheath body, twisting the introducer needle or needle hub around a proximal portion of the needle shaft, triggering one or more triggers disposed within the coupler housing, or pushing the catheter tip of the RICC into the sheath body.

[0027] The foregoing and other features of the RICC insertion assembly and method thereof, including sheath removal, 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 thereof. 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 those provided herein. Indeed, peripherally inserted central catheters ("PICC"), dialysis catheters, and the like, may also be incorporated into the catheter insertion assembly and method.

[0028] RICC Insertion Assembly 1 and 2 show different views of a RICC insertion assembly 100, according to some embodiments.

[0029] 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-deploy state of the RICC insertion assembly 100. Notably, as described below, 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 the needle lumen 158 of the introducer needle 104. This forces the access guidewire 106 into a loop that the RICC 102 places over in the ready-to-deploy state of the RICC insertion assembly 100, maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0030] The RICC insertion assembly 100 may further include a syringe 110 that is fluidly coupled to the introducer needle 104 in the ready-to-deploy state of the RICC insertion assembly 100. As described below, the sheath 141 or its sheath body 142 seals the needle slot 148 of the needle shaft 140. Specifically, the sheath 142 seals the needle slot 148 outside of the valve module 180. The valve module 180 then seals over the sheath opening 162 of the sheath body 142 that opens to the needle slot 148. The valve module 180 also seals around the access guidewire 106. Such a seal allows the syringe 110 to aspirate blood in accordance with the blood aspirating step of the method described below.

[0031] FIG. 12 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 .

[0032] 13-16 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.

[0033] The first section 120 of the catheter tube 112 includes a catheter tip 126 having a relatively short taper from an outer diameter of a 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 surrounding 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. 16 , the first section 120 of the catheter tube 112 also includes a proximal portion that is disposed within the bore of the distal portion of the junction 124 and is fixedly attached thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0034] The second section 122 of the catheter tube 112 includes a constant outer diameter along 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 flattened surface that is flush with the flattened proximal end of the junction 124 and is fixedly joined thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0035] The coupling portion 124 includes a taper over its length from the proximal end of the coupling portion 124 to the distal end of the coupling portion 124. The taper of the coupling portion 124 is configured to immediately expand the tissue surrounding 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 an edge that may catch on the skin as 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. Notably, 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. As such, 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 is at most approximately equal to the length of the junction 124.

[0036] 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 hardness. 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 hardness less than the first durometer hardness. For example, the first section 120 of the catheter tube 112 can be formed from a first polyurethane having a first durometer, and the second section 122 of the catheter tube 112 can be formed from a second, different polyurethane having a second durometer less than the first durometer (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or with different additives, etc.). Indeed, polyurethanes are advantageous for the catheter tube 112 in that they are relatively stiff at room temperature, but may become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous in that they may 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 hardness less than the first durometer hardness and greater than, about equal to, or less than the second durometer hardness.

[0037] It should be understood that the first durometer hardness of the first polymeric material, the second durometer hardness of the second polymeric material, and the third durometer hardness of the third polymeric material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer hardness of the second polymeric material or the third durometer hardness of the third polymeric material may not be numerically less than the first durometer hardness of the first polymeric material when the second durometer hardness or the third durometer hardness is less than the first durometer hardness. 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. This is because the different scales, each ranging from 0 to 100, are designed to characterize different materials in a group of materials having similar hardness.

[0038] 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 the needle path established by the introducer needle 104, optionally over the access guidewire 106. The column strength of the catheter tube 112 is also sufficient to prevent buckling of the catheter tube 112 when advanced through the patient's vasculature, optionally over a steering guidewire, without pre-dilating any of the tissue or vessels of the vasculature around the needle path with a separate dilator. The column strength of the catheter tube 112 is also sufficient to prevent buckling of the catheter tube 112 when the catheter tip 126 is pushed into the sheath body 142 to split the sheath body 142 and separate it from the access guidewire 106, in accordance with the sheath splitting step of the method described below.

[0039] The catheter tube 112 includes one or more catheter tube lumens extending therethrough. However, typically in a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-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 FIGS. 13-16.) In fact, the first section 120 of the catheter tube 112 typically includes a single lumen, as shown in FIGS. 14, 15, and 16.

[0040] 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.

[0041] 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.

[0042] Each of the one or more extension leg connectors 118 covers 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 that covers a proximal portion of one of the one or more extension legs 116. Through such an extension leg connector, a corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen. However, in a ready-to-deploy state of the RICC insertion assembly 100, at least one extension leg connector (e.g., an extension leg connector that includes a portion of the primary lumen 128 of the RICC 102) is connected to an extension arm connector 194 of the extension arm 182 of the coupler 108 to force a loop of the access guidewire 106 and the RICC 102 thereon.

[0043] As shown, the RICC 102 is a tri-lumen RICC including three sets of lumens, although the RICC 102 is not limited to the three sets of lumens described above. The three sets of lumens include a primary lumen 128, a secondary lumen 130, and a tertiary lumen 132 formed from fluidly connected portions of the three catheter tube lumens, the three catheter hub lumens, and the three extension leg lumens. The primary lumen 128 has a primary lumen aperture 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 aperture 136 on the side of the distal portion of the catheter tube 112. The tertiary lumen 132 has a tertiary lumen aperture 138 on the side of the distal portion of the catheter tube 112 proximal to the secondary lumen aperture 136 .

[0044] 3, 4, 5 and 9-11 show various views of the introducer needle 104 of the RICC insertion assembly 100, according to some embodiments. 3, 4, and 9-11, the introducer needle 104 includes a needle shaft 140, a sheath 141 or its sheath body 142 covering the needle shaft 140, and a needle hub 145 covering both the proximal portion of the needle shaft 140 and the proximal portion of the sheath body 142. However, as shown in FIG. 5, the sheath 141 can alternatively include a sheath hub 143 around the proximal portion of the sheath body 142, which is configured to nest with the needle hub 145, with the sheath hub 143 covering the proximal portion of the sheath body 142 and the needle hub 145 covering the proximal portion of the needle shaft 140. With the RICC insertion assembly 100 in at least a ready-to-deploy state, the needle shaft 140 and the sheath body 142 extend from the needle hub 145 and, optionally, from the sheath hub 143, respectively, through the valve module 180 to the distal end of the coupler housing 178.

[0045] 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 such that the bevel 150 provides 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.

[0046] 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 passing through the needle shaft. The needle slot 148 has a width dimensioned according to the outer diameter of the access guidewire 106, thereby allowing the access guidewire 106 to pass from the proximal portion of the needle shaft 140 to the needle tip 146 when the introducer needle 104 or its needle shaft 140 is withdrawn proximally from the coupler 108.

[0047] 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, however, the needle lumen 158 arises from the combination of the needle shaft 140 and the sheath body 142 that covers the needle shaft 140. In effect, the sheath body 142 that covers the needle shaft 140 seals the underlying needle slot 148 to form the needle lumen 158 of the introducer needle 104 and allow the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0048] The sheath 141 includes a sheath tip 160 at the distal portion of the sheath 142 and a sheath opening 162 at the side of the proximal portion of the sheath body 142 . The sheath tip 160 includes a relatively short taper from the outer diameter of the distal portion of the sheath body 142 to the outer diameter of the distal end of the sheath 141, which is comparable 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 142 for the needle path establishment step of the method described below.

[0049] 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 enter the needle slot 148 in the ready-to-deploy 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 allows the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 148, while at the same time having a length sufficient to accommodate the stationary blade 191 of the valve module 180, if present, below the distal end of the sheath opening 162. Notably, the sheath body 142 covering the needle shaft 140 seals the needle slot 148 below it, but excludes the needle slot below the sheath opening 162. However, the valve 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 body 142 therein, thereby enabling the syringe 110 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0050] The sheath 141 or its sheath body 142 is formed from a polymeric material configured to facilitate smooth and consistent insertion of the introducer needle 104 from an area of ​​skin into the patient's vascular lumen in accordance with the needle path establishment step of the method described below. In addition, the polymeric material has sufficient mechanical properties to resist collapse of the sheath body 142 into the needle slot 148 of the needle shaft 140, particularly at the thickness of the sheath body 142, when the blood aspiration step of the method described below is performed, while also facilitating splitting of the sheath body 142 away from the access guidewire 106 in accordance with the sheath splitting step of the method described below, either by cutting the sheath body 142 with the stationary blade 191 or the movable blade 192, pushing the catheter tip 126 of the RICC 102 into the sheath body 142, or pulling the access guidewire 106 distally against the side of the sheath body 142. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0051] The needle hub 145 includes an access guidewire channel 164 at a distal portion of the needle hub 145 and a needle hub connector 166 at a proximal portion of the needle hub 145 . The access guidewire channel 164 in the needle hub 145 is configured to allow the access guidewire 106 to pass over the needle hub 145 and guide the access guidewire 106 into the access guidewire conduit 190 of the valve 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-deploy state of the RICC insertion assembly 100. Advantageously, the access guidewire channel 164 is open to allow the access guidewire 106 to remain in place when the introducer needle 104 of the needle shaft 140 is withdrawn from the RICC insertion assembly 100 or its coupler 108.

[0052] The needle hub connector 166 includes a needle hub bore 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.

[0053] 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 around 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. This provides additional security against inadvertent separation of the introducer needle 104 and the syringe 110 over and above that provided by an otherwise luer slip type connection.

[0054] The sheath hub 143, if present, includes a pair of finger tabs 144 extending therefrom, which are configured to at least withdraw the sheath 141 from the coupler 108 by the finger tabs 144. Advantageously, division of the sheath body 142 by the sheath body division step of the method described below can be initiated by withdrawing the sheath 141 from the coupler 108 by the finger tabs 144. Indeed, withdrawal of the sheath 141 from the coupler 108 by the finger tabs 144 can initiate severing of the sheath 141 with a stationary blade 191, described below, if a stationary blade 191 is also present. Additionally, severing of the sheath body 142 by the stationary blade 191 or a movable blade 192, described below, can be continued once initiated by continuing to withdraw the sheath 141 from the coupler 108 by the finger tabs 144. Alternatively, the sheath hub 143 can be split and the splitting of the sheath body 142 can be initiated by pulling the finger tabs 144 apart to split the sheath hub 143 after the sheath hub 143 is withdrawn from and released from the coupler 108. Additionally, the splitting of the sheath body 142 can continue after it has been initiated by continuing to pull the finger tabs 144 apart. Notably, when the sheath 141 is rotated 90 degrees from the state shown in FIG. 5, one longitudinal half of the sheath body 142 can split from the other longitudinal half of the sheath body 142 and exit the coupler 108 via the coupler housing slot 186, thereby allowing the access guidewire 106 to exit the coupler 108 after the sheath 141 has completely split.

[0055] 3-8 show various views of the coupler 108 of the RICC insertion assembly 100, according to some embodiments. As shown, the coupler 108 includes a coupler housing 178 and a valve module 180 disposed within the coupler housing 178. Additionally, the coupler 108 may include an extension arm 182 coupled to the coupler housing 178.

[0056] The coupler housing 178 includes two molded halves joined to form an ovoid 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. (However, it should be understood that the coupler housing 178 may alternatively be two or more pieces other than two molded halves.) To further facilitate such venipuncture, the exterior of each of the two molded halves may be textured, such as with arcuate ridges 184 that enhance grip, as shown. The interior of each of the two molded halves includes recesses that form the valve module compartment and introducer needle receptacle when the two molded halves are joined as shown. (See FIGS. 3 and 4, which include a valve module 180 disposed within a recess in one of the two molded halves forming the valve module compartment. FIGS. 3 and 4 also include a needle hub 145 of the introducer needle 104 disposed within a recess in one of the two molded halves forming the introducer needle receptacle. FIG. 5, however, includes a sheath hub 143 of the introducer needle 104 disposed within the introducer needle receptacle). Additionally, each half of the two molded halves may include one or more through holes or portions thereof for one or more corresponding triggers, such as one or more buttons, switches, sliders, etc. (see, e.g., FIGS. 2, 5, and 6 for a pair of buttons 188 extending through a corresponding pair of through holes). Notably, 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 or its needle shaft 140 is withdrawn proximally from the coupler 108 .

[0057] The valve module compartment is configured to hold therein the valve module 180. Indeed, the valve module compartment includes the valve module 180 disposed therein in the ready-to-deploy state of the RICC insertion assembly 100. Notably, the valve module compartment is further configured with sufficient space to allow separable components of the valve module 180, described below, to separate to allow for withdrawal of the access guidewire 106 when the introducer needle 104 or its needle shaft 140 is withdrawn proximally from the coupler 108.

[0058] The introducer needle receptacle is configured to hold therein the needle hub 145 or sheath hub 143 of the introducer needle 104. As shown in Figures 3 and 4, for example, the introducer needle receptacle includes the needle hub 145 inserted therein in the ready-to-deploy state of the RICC insertion assembly 100. However, as shown in Figure 5, the introducer needle receptacle includes the sheath hub 143 inserted therein in the ready-to-deploy state of the RICC insertion assembly 100. Notably, an introducer needle locking portion configured to lock the needle hub 145 or sheath hub 143 in the introducer needle receptacle can be positioned around the introducer needle receptacle. If the introducer needle locking portion is present, a pair of buttons 188 can be configured as spring-loaded locking buttons of the introducer needle locking portion. Such a pair of buttons can be distributed between opposing sides of the coupler 108, specifically within a pair of through holes for those buttons in the two molded halves of the coupler housing 178, such that each button of the pair of buttons 188 extends through the coupler housing 178 on a respective side of the coupler 108. In addition, such a pair of buttons can be configured to unlock the needle hub 145 or the sheath hub 143 when triggered by depressing the pair of buttons 188 into the coupler 108 for subsequent withdrawal of the introducer needle 104 from the coupler 108.

[0059] Valve module 180 includes several separable components that, when combined, form an access guidewire conduit 190 as shown at least in Figures 3 and 4. Additionally, valve module 180 can include a stationary blade 191 disposed therein.

[0060] The separable parts of the valve module 180 are disposed about the needle shaft 140 and the sheath body 142 in the ready-to-deploy state of the RICC insertion assembly 100. For example, the separable parts of the valve module 180 may be separable halves of the valve module 180 disposed about the needle shaft 140 and the sheath body 142. The separable parts of the valve module 180 are configured to separate to allow the access guidewire 106 to exit the valve module 180 when the introducer needle 104 or its needle shaft 140 is withdrawn proximally from the coupler 108.

[0061] The access guidewire conduit 190 is configured to direct the access guidewire 106 from the access guidewire channel 164 of the needle hub 145 into both the sheath opening 162 of the sheath 141 or sheath body 142 thereof and into the needle slot 148 of the needle shaft 140 therebelow. In effect, the access guidewire conduit 190 contains the access guidewire 106 disposed therein in the ready-to-operate state of the RICC insertion assembly 100. Notably, the valve module 180 seals around the access guidewire 106 within the access guidewire conduit 190 such that the syringe 110 can aspirate blood in accordance with the blood aspirating step of the method described below.

[0062] The blade 191, when present, extends from an attachment point in the valve module 180 into the needle slot 148 of the needle shaft 140 such that the static blade 191 is disposed in the needle slot 148 below the distal end of the sheath opening 162 of the sheath body 142. The static blade 191 is configured to slide along the needle slot 148 as either the introducer needle 104 or its needle shaft 140 is withdrawn proximally from the coupler 108. The static blade 191 includes a distally facing blade edge configured to cut the sheath body 142 away from the access guidewire 106 as either the introducer needle 104 or its sheath body 142 is withdrawn proximally from the coupler 108. Indeed, in a sheath splitting step of the method described below, when the introducer needle 104 is fully withdrawn from the coupler 108, the stationary blade 191 is configured to slide along the needle slot 148, with the blade edges configured to cut the sheath body 142 away from the access guidewire 106 as the introducer needle 104 is withdrawn proximally from the coupler 108. However, when the introducer needle 104 is withdrawn in small increments from the coupler 108, the stationary blade 191 is configured to slide along the needle slot 148 as the needle shaft 140 is withdrawn proximally from the coupler 108, with the blade edges configured to cut the sheath body 142 away from the access guidewire 106 as the sheath body 142 is withdrawn proximally from the coupler 108. Cutting the sheath body 142 away from the access guidewire 106 allows the access guidewire 106 to exit the needle shaft 140 via the needle slot 148. Notably, cutting of the sheath body 142 by the stationary blade 191 can be continued after cutting has begun by continuing to retract the sheath 141 proximally from the coupler 108.

[0063] As an alternative to the static blade 191, a movable blade 192 may be spring loaded with a compression spring 193, as shown in FIG. 8. Such a movable blade may be located inside or outside the valve module 180. Like the static blade 191, when the movable blade 192 is located inside the valve module 180, it is disposed within the needle slot 148 below the distal end of the sheath opening 162 of the sheath body 142. Also like the static blade 191, the movable blade 192 is configured to slide along the needle slot 148 as either the introducer needle 104 or its needle shaft 140 is withdrawn proximally from the coupler 108. The movable blade 192 also includes a distally facing blade edge configured to cut the sheath body 142 away from the access guidewire 106 as either the introducer needle 104 or its sheath body 142 is withdrawn proximally from the coupler 108. However, cutting of the sheath body 142 off of the access guidewire 106 is initiated by triggering one or more triggers, which causes the movable blade 192 to protrude distally a short distance along the needle slot 148 as the compression spring 193 relaxes. Notably, cutting of the sheath body 142 by the movable blade 192 can be continued after cutting has been initiated by continuing to retract the sheath 141 proximally from the coupler 108.

[0064] The one or more triggers of the spring-loaded movable blade 192 can include a pair of buttons 188 that can be configured to unlock the needle hub 145 or the sheath hub 143 and release the compression spring 193 when triggered by pushing the pair of buttons 188 into the coupler 108. With or without the pair of buttons 188, the one or more triggers can include another trigger, such as a slider 189 as shown in FIG. 6. When there is a pair of buttons 188, the other trigger, such as the slider 189, can be configured to release the compression spring 193 when triggered by sliding the slider 189 along the coupler housing 178 either before or after the pair of buttons 188 are pushed into the coupler 108 to unlock the needle hub 145 or the sheath hub 143. In the absence of the pair of buttons 188, another trigger, such as a slider 189, can be configured to unlock the needle hub 145 or the sheath hub 143 and release the compression spring 193 when triggered by sliding the slider 189 along the coupler housing 178. However, it should be understood that the one or more triggers are not limited to one or more buttons, switches, or sliders. Indeed, in some embodiments, simply twisting the introducer needle 104 or a component thereof, such as the needle hub 145 or sheath hub 143, within the introducer needle receptacle can unlock the introducer needle 104 or its needle hub 145 or sheath hub 143, release the compression spring 193 to initiate cutting of the sheath body 142 away from the access guidewire 106, or both unlock the introducer needle 104 or its needle hub 145 or sheath hub 143 and release the compression spring 193 to initiate cutting of the sheath body 142 away from the access guidewire 106. (See, e.g., FIG. 7 for at least twisting the introducer needle 104 or a component thereof, such as the needle hub 145 or sheath hub 143, to unlock the needle hub 145 or sheath hub 143.)

[0065] The extension arm 182 includes an extension arm connector 194 that is connected to one of the one or more extension leg connectors 118 in the ready-to-deploy state of the RICC insertion assembly 100. Although not shown, the extension 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-deploy 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, forces the access guidewire 106 to loop as described above. Advantageously, the extension arm 182 is configured to flip the loop, or at least one or more extension legs 116 of the RICC 102, between the left side of the RICC insertion assembly 100 and the right side of the RICC insertion assembly 100 to accommodate both left-handed and right-handed venipuncture with the RICC insertion assembly 100. In fact, the extension arm 182 is configured to flip a loop from the left side of the RICC insert assembly 100 as shown in FIG 1 to the right side of the RICC insert assembly 100 to accommodate left-handed venipuncture using the RICC insert assembly 100. Similarly, the extension arm 182 is configured to flip a loop from the right side of the RICC insert assembly 100 to the left side of the RICC insert assembly 100 to accommodate right-handed venipuncture using the RICC insert assembly 100.

[0066] 1 and 4 show different 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 a ready-to-deploy state of the RICC insertion assembly 100, the proximal end of the access guidewire 106 is coupled to the extension arm 182, specifically, to an access guidewire attachment point within the extension arm connector 194 of the extension arm 182. In addition, 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, via the access guidewire channel 164, into the valve module 180 above the needle hub 145, through both the sheath opening 162 of the sheath body 142 and the needle slot 148 of the needle shaft 140, and into the needle shaft 140, and along the needle lumen 158 of the introducer needle 104 in the ready-to-deploy state of the RICC insertion assembly 100. As shown in FIG. 4, 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-deploy state of the RICC insertion assembly 100. Again, when the RICC insertion assembly 100 is in a ready-to-deploy state, the proximal and distal ends of the access guidewire 106 force the access guidewire 106 into a loop, and the RICC 102 is positioned over the loop, thereby maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0067] The access guidewire 106 can include a guidewire tip 196 at a distal portion of the access guidewire 106, the guidewire tip 196 having 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-deploy state of the RICC insertion assembly 100 and a curved state upon advancement of the guidewire tip 196 beyond the needle tip 146 (e.g., into a blood vessel lumen) in a deployed state of the RICC insertion assembly 100.

[0068] The access guidewire 106 may further include a bare wire portion and a wound wire portion proximal to the bare wire portion. Although not shown, the bare wire portion, if present, extends distally through the access guidewire conduit 190 of the valve module 180 such that the valve module 180 forms a fluid-tight seal around the bare wire portion of the access guidewire 106 at least in the ready-to-deploy state of the RICC insertion assembly 100. In particular, the aforementioned bare wire portion may instead be a flatwound or groundwound portion of the access guidewire 106, where the flatwound portion includes a turn of tape instead of a round wire and the groundwound portion includes a turn of round wire that has been polished to flatten the turn. Regardless of whether the access guidewire 106 includes any one of the aforementioned bare wire portion, roundwound portion, flatwound portion, or groundwound portion of the access guidewire 106, the access guidewire 106 may be configured with sufficient tensile strength to pull the access guidewire 106 through the sheath body 142. Indeed, in some embodiments, splitting or cutting the sheath body 142 away from the access guidewire 106 is initiated by pulling the access guidewire 106 distally against the side of the sheath body 142, continued by pulling the access guidewire 106 distally against the side of the sheath body, or initiated and continued by pulling the access guidewire 106 distally against the side of the sheath body 142.

[0069] As described above, the RICC insertion assembly 100 includes several sheath splitting means, such as the stationary blade 191 or movable blade 192, the access guidewire 106, or the catheter tip 126, and associated methods for splitting the sheath body 142 away from the access guidewire 106 after establishing a needle path to the vascular lumen via percutaneous puncture with the introducer needle 104. The sheath splitting means and the method by which the sheath splitting means splits the sheath body 142 away from the access guidewire 106 are notable because they allow the access guidewire 106 to exit the sheath body 142 and remain in the needle path for subsequent procedural steps in placing the RICC 102 in the patient. As described above, the division of the sheath body 142 may be accomplished by withdrawing the introducer needle 104 or the sheath body 142 by a pair of finger tabs 144 extending from the sheath hub 143 around a proximal portion of the sheath body 142 to initiate cutting of the sheath body 142 with the stationary blade 191; twisting the introducer needle 104, needle hub 145, or sheath hub 143 around its proximal portion to initiate cutting of the sheath body 142 with the movable blade 192; Cutting of the sheath body 142 using the catheter tip 126 can be initiated by triggering one or more triggers disposed within the coupler housing 178, pushing the catheter tip 126 of the RICC 102 into the sheath body 142 to initiate splitting of the sheath body 142 using the catheter tip 126, or pulling the access guidewire 106 distally against the side of the sheath body 142 to initiate splitting of the sheath body 142 using the access guidewire 106. After splitting of the sheath body 142 has been initiated, splitting of the sheath body 142 can be continued by the same or a different sheath splitting means than the means used to initiate splitting of the sheath body 142.

[0070] In one example, the division of the sheath body 142 can be continued by the same sheath dividing means after the division of the sheath body 142 has begun, such as by continuing to withdraw the introducer needle 104 or the sheath body 142 with a pair of finger tabs 144 and cutting the sheath body 142 with a stationary blade 191 or a movable blade 192, by pushing the catheter tip 126 of the RICC 102 into the sheath body 142 and continuing to divide the sheath body 142 using the catheter tip 126, or by pulling the access guidewire 106 distally against the side of the sheath body 142 and continuing to divide the sheath body 142 using the access guidewire 106. In another example, the division of the sheath body 142 can be continued by a different sheath division means after initiation of division of the sheath body 142 by another method described above, such as by withdrawing the introducer needle 104 or the sheath body 142 with a pair of finger tabs 144 and switching to cutting the sheath body 142 using a stationary blade 191 or a movable blade 192, by pushing the catheter tip 126 of the RICC 102 into the sheath body 142 and switching to dividing the sheath body 142 using the catheter tip 126, or by pulling the access guidewire 106 distally against the side of the sheath body 142 and switching to dividing the sheath body 142 using the access guidewire 106. In yet another example, the splitting of the sheath body 142 can be initiated by withdrawing the introducer needle 104 or the sheath body 142 with the finger tab 144 and then continued by a different sheath splitting means, such as by holding the sheath body 142 in place in the needle path while pushing the coupler 108 onto the sheath body 142 and switching to cut the sheath body 142 with either the stationary blade 191 or the movable blade 192.

[0071] method A method of the RICC insertion system 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 the steps of obtaining a RICC insertion assembly, establishing a needle path, aspirating blood, advancing an access guidewire, splitting a sheath body, advancing a RICC, withdrawing an access guidewire, advancing a steering guidewire, advancing another RICC, and withdrawing a steering guidewire.

[0072] The RICC insertion assembly obtaining step includes obtaining a RICC insertion assembly 100. As described above, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104 including a sheath body 142 covering a needle shaft 140, and an access guidewire 106, which are coupled together by a coupler 108. A proximal end of the access guidewire 106 is coupled to an extension arm 182 of the coupler 108, and a distal end of the access guidewire 106 is disposed within the introducer needle 104 via a valve module 180 of the coupler 108. Again, the proximal and distal ends of the access guidewire 106 result in forcing the access guidewire 106 into a loop. The RICC 102 is disposed to cover the loop of the access guidewire 106 in the ready-to-deploy state of the RICC insertion assembly 100.

[0073] 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. Such a needle path establishment step may include flipping the extension arm 182, and thus the loop, between the two sides of the RICC insertion assembly 100 before piercing the area of ​​skin with the introducer needle 104. The needle path establishment step may also include ensuring blood reflux while establishing the needle path.

[0074] Flipping the extension arm 182, and thus the loop, between the two sides of the RICC insert assembly 100 includes flipping the loop between the left side of the RICC insert assembly 100 for left-handed venipuncture and the right side of the RICC insert assembly 100 for right-handed venipuncture using the RICC insert assembly 100. Indeed, flipping the loop from the left side of the RICC insert assembly 100 to the right side of the RICC insert assembly 100 accommodates left-handed venipuncture using the RICC insert assembly 100. Similarly, flipping the loop from the right side of the RICC insert assembly 100 to the left side of the RICC insert assembly 100 accommodates right-handed venipuncture using the RICC insert assembly 100.

[0075] Ensuring blood backflow while establishing the needle track includes ensuring blood backflow into the needle hub 145 of the introducer needle 104, the syringe tip 172 of the syringe 110 fluidly connected to the introducer needle 104, the barrel of the syringe 110, or a combination thereof. A slight vacuum can be pulled on the syringe 110 while establishing the needle track such that blood backflows into at least the needle hub 145 of the introducer needle 104 when the needle track is established. Ensuring blood backflow as described above confirms that the needle track extends into the blood vessel lumen.

[0076] The blood aspiration step involves aspirating blood with the syringe 110 to ensure that the needle track extends into the vessel lumen before withdrawing the introducer needle 104 from the coupler 108 in the introducer needle withdrawal step. Again, the sheath body 142 over the needle shaft 140 seals the needle slot 148 of the needle shaft 140 underneath. Specifically, the sheath 142 seals the needle slot 148 outside the valve module 180. The valve module 180 in turn seals over the sheath opening 162 of the sheath body 142, which allows the access guidewire 106 to pass through and enter the needle shaft 140 via the needle slot 148 in the ready-to-deploy state of the RICC insertion assembly 100. The valve module 180 also seals around the distal portion of the access guidewire 106. Such a seal allows the syringe 110 to aspirate blood in the blood aspiration step.

[0077] The access guidewire advancement step involves advancing the distal end of the access guidewire 106 from its initial position within the needle shaft 140 just proximal to the needle tip 146 into the vascular lumen to secure vascular access for the RICC 102 in the RICC advancement step.

[0078] The sheath body splitting step involves splitting the sheath body 142 away from the access guidewire 106, thereby allowing the access guidewire 106 to exit the sheath body 142 and remain within the needle track. The sheath body splitting step can be initiated by withdrawing the introducer needle 104 or the sheath body 142 by a pair of finger tabs 144 extending from the sheath hub 143 around a proximal portion of the sheath body 142 to initiate cutting of the sheath body 142 with the stationary blade 191; twisting the introducer needle 104, needle hub 145 or sheath hub 143 about its proximal portion to initiate cutting of the sheath body 142 with the movable blade 192; triggering one or more triggers disposed within the coupler housing 178 to initiate cutting of the sheath body 142 with the movable blade 192; pushing the catheter tip 126 of the RICC 102 into the sheath body 142 to initiate cutting of the sheath body 142 with the catheter tip 126; or pulling the access guidewire 106 distally against the side of the sheath body 142 to initiate cutting of the sheath body 142 with the access guidewire 106. After the sheath body dividing step has been initiated, the sheath body dividing step may be continued by a sheath body dividing means that is the same or different from the means used to initiate the sheath body dividing step.Thus, after starting the sheath body splitting step, the steps include pushing the coupler 108 onto the sheath body 142 while holding the sheath body 142 in a fixed position to cut the sheath body 142 using the stationary blade 191 or the movable blade 192, withdrawing the introducer needle 104 from the coupler 108 to cut the sheath body 142 using the stationary blade 191 or the movable blade 192, and removing the sheath body 142 from the coupler 108 to cut the sheath body 142 using the stationary blade 191 or the movable blade 192. The sheath body splitting step can be continued by withdrawing the RICC 102 from the sheath body 142, pushing the catheter tip 126 of the RICC 102 further into the sheath body 142 and advancing the catheter tip 126 over the access guidewire 106 into the vessel lumen to split the sheath body 142 with the catheter tip 126, or pulling the access guidewire 106 distally toward the patient against the side of the sheath body 142 to split the sheath body 142 with the access guidewire 106. Notably, following the sheath splitting step, the entire introducer needle 104, including both the needle shaft 140 and the sheath body 142, is removed, thereby leaving the access guidewire 106 in place within the vessel lumen. If the sheath splitting step involves simply withdrawing the introducer needle 104, either completely or piecemeal, from the coupler 108 via the needle shaft 140 and subsequently the sheath body 142, the sheath splitting step can be referred to as an introducer needle withdrawal step.

[0079] The RICC advancement step involves inserting the RICC 102 into the vessel lumen by advancing the catheter tip 126, and subsequently the catheter tube 112 of the RICC 102, over the access guidewire 106 into the vessel lumen.

[0080] The access guidewire withdrawal step involves withdrawing the access guidewire 106 while leaving the catheter tube 112 in place 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 until the steering guidewire reaches the lower third of the SVC of the patient's heart.

[0081] Another RICC advancement step involves advancing the distal portion of the catheter tube 112 further into the vessel lumen over the steering guidewire to the lower third of the superior vena cava of the patient's heart.

[0082] The steering guidewire withdrawal step involves withdrawing the steering guidewire, leaving the catheter tube 112 in place in the lower third of the SVC. 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. Additional adaptations and / or modifications may be understood by those skilled in the art. In the broader aspects, these adaptations and / or modifications are also encompassed. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central catheter (RCC) insertion assembly comprising: RICC and 1. An introducer needle, comprising: a needle shaft including a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip; an introducer needle including a sheath body covering the needle shaft and sealing the needle slot underneath the sheath body except below a sheath opening to the needle slot at a proximal portion of the sheath body; A coupler for coupling the RICC and the introducer needle together, comprising: A coupler housing; a coupler including a valve module disposed within a coupler housing, the valve module sealing the needle shaft and a proximal portion of the sheath body therein; 1. An access guidewire, comprising: a proximal end coupled to the extension arm of the coupler; an access guidewire including a distal end disposed within the introducer needle; a sheath splitting means for splitting the sheath body away from the access guidewire following percutaneous puncture with an introducer needle, allowing the access guidewire to exit the sheath body and remain within the needle path established by the percutaneous puncture, wherein splitting of the sheath body by the sheath splitting means is initiated by withdrawing the sheath body by a pair of finger tabs extending from a sheath hub around a proximal portion of the sheath body, twisting the introducer needle or needle hub around a proximal portion of the needle shaft, triggering one or more triggers disposed within a coupler housing, or pushing a catheter tip of a RICC into the sheath body; 1. An RCC insertion assembly comprising:

2. 2. The RCC insertion assembly of claim 1, An RCC insertion assembly in which splitting with the same or a different sheath splitting means is continued after initiation by pushing the coupler onto the sheath body while holding the sheath body in place.

3. 2. The RCC insertion assembly of claim 1, An RCC insertion assembly, wherein division by the same or a different sheath division means, once initiated, is continued by withdrawing the introducer needle from the coupler.

4. 2. The RCC insertion assembly of claim 1, An RCC insertion assembly, wherein splitting by the same or a different sheath splitting means, once initiated, is continued by withdrawing the sheath body from the coupler.

5. 2. The RCC insertion assembly of claim 1, An RCC insertion assembly, wherein division by the same or a different sheath division means, once initiated, is continued by pushing the catheter tip of the RICC into the sheath body.

6. 2. The RCC insertion assembly of claim 1, An RCC insertion assembly, wherein division by the same or a different sheath division means, once initiated, is continued by pulling the access guidewire against the side of the sheath body.

7. The RCC insertion assembly according to any one of claims 1 to 6, The RCC insertion assembly, wherein the sheath splitting means is a blade, an access guidewire, a catheter tip, or a combination thereof.

8. 8. The RCC insertion assembly of claim 7, The blade is disposed within the valve module below the distal end of the sheath opening; The blade is configured to slide along the needle slot and cut the sheath body away from the access guidewire and includes a distally facing blade edge.

9. 9. The RCC insertion assembly of claim 7 or 8, The blade is spring loaded on a compression spring. The compression spring is configured to relax when the introducer needle or needle hub is twisted or when one or more triggers in the coupler housing are triggered, RCC insertion assembly.

10. The RCC insertion assembly according to any one of claims 1 to 9, The proximal and distal ends of the access guidewire are forced into a loop over which the RICC is placed in a ready-to-deploy state of the RICC insertion assembly, an RCC insertion assembly.

11. The RCC insertion assembly of claim 10 further comprising: a syringe fluidly coupled to the introducer needle in the ready-to-deploy state of the RICC insertion assembly; The sheath body seals the needle slot of the needle shaft underneath the outside of the valve module, the valve module seals the sheath opening of the sheath body therein, and the valve module seals around the access guidewire to allow the syringe to aspirate blood, RCC insertion assembly.

12. The RCC insertion assembly according to any one of claims 1 to 11, The RCC insertion assembly, wherein the coupler housing includes a longitudinal coupler housing slot configured to allow the access guidewire to exit the coupler housing when the sheath body is split and clear of the access guidewire.

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