Compact insertion assembly and method for rapid insertion central venous catheter - Patents.com

Abstract

A compact insertion assembly and method for a rapid insertion central venous catheter ("RICC") is disclosed. For example, the RICC insertion assembly includes a RICC, an introducer assembly, an access guidewire, and a coupler that couples the RICC and the introducer assembly together. The RICC may include a catheter tube, a catheter hub, and one or more extension legs, connected in that order. The introducer assembly may include an introducer needle coupled to a syringe. The introducer needle may include a needle hub through-hole that passes through the needle hub and connects to a needle shaft lumen of the needle shaft. The access guidewire may include a proximal portion disposed in the RICC and a distal portion disposed through the needle hub through-hole and into the needle shaft lumen. The coupler may force a loop in the access guidewire over which the catheter tube travels, making the RICC insertion assembly compact and easier to handle.

Description

[Technical field]

[0001] The present invention relates to a compact insertion assembly and method for a rapid insertion central venous catheter. [Background technology]

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

[0003] Disclosed herein is a compact rapid insertion central venous catheter ("RICC") insertion assembly and method that addresses at least the aforementioned needs. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a RICC insertion assembly including a RICC, an introducer assembly, an access guidewire, and a coupler that couples together the RICC and the introducer assembly, the RICC and the access guidewire, or the introducer assembly and the access guidewire. The RICC includes a catheter tube, a catheter hub coupled to a proximal portion of the catheter tube, and one or more extension legs. Each extension leg of the one or more extension legs is coupled to the catheter hub by its distal portion. The introducer assembly includes a syringe and an introducer needle coupled to the syringe. The introducer needle includes a needle shaft and a needle hub that covers a proximal portion of the needle shaft. The needle hub includes a needle hub through hole that penetrates a side of the needle hub and connects to the needle shaft lumen. The access guidewire includes a proximal portion disposed within the primary lumen of the RICC and a distal portion disposed within the needle shaft lumen via the needle hub through hole.

[0005] In some embodiments, the coupler that joins the RICC and introducer assembly together forces a loop in the access guidewire over which the catheter tube is advanced.

[0006] In some embodiments, the coupler includes a clip and a seat opposite the clip, the clip clips onto the barrel of the syringe, and the seat seats the catheter hub thereon.

[0007] In some embodiments, the coupler includes a clip and a seat opposite the clip, the clip clips onto the needle hub, and the seat seats the catheter hub thereon. In some embodiments, the seat includes a post extending from the seat that is inserted into a suture wing hole in a suture wing extending from the catheter hub, thereby securing the catheter hub on the seat.

[0008] In some embodiments, the clip and seat are fixed relative to one another. The coupler orients the catheter hub either longitudinally or transversely relative to the central axis of the introducer assembly.

[0009] In some embodiments, the clip and seat include a Haas-like coupler therebetween. The coupler allows the clinician to orient the catheter hub in any orientation the clinician desires relative to the central axis of the introducer assembly.

[0010] In some embodiments, the coupler is an access guidewire hub coupled to a proximal end of the access guidewire. In addition, the access guidewire hub is coupled to another side of the needle hub opposite the side containing the needle hub through hole. Finally, the access guidewire hub threads onto an extension leg connector extending from a proximal portion of one of the one or more extension legs.

[0011] In some embodiments, the coupler that joins the RICC and the access guidewire together forces a loop in the access guidewire over which the catheter tube is advanced. In some embodiments, the coupler includes a clip and a seat opposite the clip, the clip clips over the access guidewire, and the seat seats the catheter hub thereon.

[0012] In some embodiments, the clip is a groove in the coupler. In some embodiments, the seat includes a post extending from the seat that is inserted into a suture wing hole in a suture wing extending from the catheter hub, thereby securing the catheter hub on the seat.

[0013] In some embodiments, the coupler includes a clip integrated into the patient-facing side of the catheter hub, which clips onto the access guidewire. In some embodiments, the clip is a groove in the catheter hub.

[0014] In some embodiments, the coupler comprises a clip or releasable tie around the catheter tube and access guidewire of the RICC. In some embodiments, the coupler that couples the introducer assembly and the access guidewire together comprises a clip or releasable tie around the barrel of the syringe and the access guidewire.

[0015] In some embodiments, the coupler that couples together the introducer assembly and the access guidewire includes a rotatable lever of a coupler housing lock on the housing of the coupler that has a locked state and an unlocked state for locking and unlocking the needle hub to and from the distal coupler housing part of the coupler housing, respectively.

[0016] In some embodiments, the locked and unlocked states of the coupler housing lock are further for clamping and unclamping the access guidewire, respectively.

[0017] In some embodiments, the needle hub thru-hole includes a gasket disposed therein that is configured to seal around the access guidewire and allow a vacuum to be drawn with a syringe without leakage through the needle hub thru-hole.

[0018] In some embodiments, the gasket includes one or more "O" rings. In some embodiments, the RICC comprises a set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen, the set of three lumens being formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

[0019] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on a side of the distal portion of the catheter tube proximal to the secondary lumen opening.

[0020] In some embodiments, the RICC insertion assembly is in its ready-to-deploy state with the guidewire tip of the access guidewire positioned just proximal to the needle tip of the needle.

[0021] In some embodiments, the guidewire tip is straight within the needle shaft lumen in the ready-to-deploy state of the RICC insertion assembly, but assumes a "J" shape when advanced beyond the needle tip in the deployed state of the RICC insertion assembly.

[0022] Also disclosed herein, in some embodiments, is an introducer needle that includes a needle shaft and a needle hub that covers a proximal portion of the needle shaft. The needle hub includes a needle hub throughbore that passes through a side of the needle hub and connects to a needle shaft lumen. The needle hub throughbore is configured to pass an access guidewire therethrough.

[0023] In some embodiments, the needle hub thru-hole includes a gasket disposed therein that is configured to seal around the access guidewire and allow a vacuum to be drawn with a syringe without leakage through the needle hub thru-hole.

[0024] In some embodiments, the gasket includes one or more "O" rings. Also disclosed herein is a method of a RICC insertion assembly. The method, in some embodiments, includes the steps of obtaining an assembly, establishing a needle path, and advancing an access guidewire. The obtaining an assembly includes obtaining a RICC insertion assembly. The RICC insertion assembly includes a RICC in its ready-to-deploy state, an introducer assembly, an access guidewire, and a coupler that couples the RICC and the introducer assembly together. The introducer assembly includes a syringe coupled to an introducer needle. The introducer needle includes a needle hub that covers a proximal portion of a needle shaft. The access guidewire includes a proximal portion that is disposed within the primary lumen of the RICC. The access guidewire also includes a distal portion that is disposed within the needle shaft lumen of the needle shaft via a needle hub through-hole that penetrates the side of the needle hub. The coupler couples the RICC and introducer assembly together, thereby forcing a loop in the access guidewire over which the catheter tube travels. The needle pathway establishing step includes establishing a needle pathway from an area of ​​the patient's skin to the vessel lumen with an introducer needle. The access guidewire advancing step includes advancing a distal end of an access guidewire from its initial position within the needle shaft lumen just proximal to the needle tip of the needle shaft into the vessel lumen. The access guidewire advancing step ensures access to the vessel lumen by the access guidewire.

[0025] In some embodiments, the method further includes an assembly adjusting step, which includes adjusting the RICC insertion assembly to be in its ready-to-deploy state prior to establishing the needle trajectory if the RICC insertion assembly is not already in its ready-to-deploy state upon acquisition of the RICC insertion assembly in the assembly obtaining step.

[0026] In some embodiments, the needle path establishing step includes ensuring that blood flows back into the needle hub of the introducer needle, the syringe tip of the syringe, the barrel of the syringe, or a combination thereof. Ensuring that blood flows back into the needle hub of the introducer needle, the syringe tip of the syringe, the barrel of the syringe, or a combination thereof confirms that the needle path extends into the blood vessel lumen.

[0027] In some embodiments, the needle pathway establishment step includes drawing a slight vacuum with the syringe to ensure blood flows back into the needle hub of the introducer needle, the syringe tip of the syringe, the barrel of the syringe, or a combination thereof while establishing the needle pathway.

[0028] In some embodiments, the method further includes a blood aspirating step, which includes aspirating blood with a syringe to confirm that the needle track extends into the blood vessel lumen. The needle hub pierce includes a gasket disposed therein that forms a seal around the access guidewire. The seal allows a vacuum to be drawn with the syringe to aspirate blood with the syringe during the blood aspirating step.

[0029] In some embodiments, during the access guidewire advancing step, as the distal end of the access guidewire is advanced into the blood vessel lumen, advancement of the access guidewire simultaneously reduces the size of the loop.

[0030] In some embodiments, the method further comprises the step of withdrawing the introducer needle, which comprises withdrawing the introducer needle from the patient, leaving the access guidewire in place within the vessel lumen.

[0031] In some embodiments, the method further comprises a catheter tube advancing step, the catheter tube advancing step comprising advancing a catheter tube of the RICC over the access guidewire into the vessel lumen, the catheter tube advancing step positions the RICC within the vessel lumen.

[0032] 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.

[0033] In some embodiments, the method further includes the steps of advancing a steering guidewire, advancing an additional catheter tube, and withdrawing the steering guidewire. The step of advancing the steering guidewire includes advancing the steering guidewire into the vessel lumen via the primary lumen of the RICC. The step of advancing the additional catheter tube includes further advancing a distal portion of the catheter tube over the steering guidewire into the vessel lumen until it is in the lower third of the superior vena cava (SVC) of the patient's heart. The step of withdrawing the steering guidewire includes withdrawing the steering guidewire while leaving the catheter tube in the lower third of the SVC.

[0034] 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 following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0035] [Figure 1] 1 illustrates the RICC insertion assembly in its ready-to-deploy state, with a first coupler coupling together the catheter hub of the RICC and the barrel of the syringe of the introducer assembly, forcing a loop of the access guidewire in a first configuration, according to some embodiments. [Diagram 2]2 illustrates the RICC insertion assembly of FIG. 1 in its deployed state, according to some embodiments. [Diagram 3] 1 shows the RICC insertion assembly in its ready-to-deploy state, with the coupler coupling together the catheter hub of the RICC and the barrel of the syringe of the introducer assembly, forcing a loop of the access guidewire in a second configuration, according to some embodiments. [Figure 4] 4 illustrates the RICC insertion assembly of FIG. 3 in its deployed state, according to some embodiments. [Diagram 5] 1 illustrates the RICC insertion assembly in its ready-to-deploy state, with the first coupler coupling together the catheter hub of the RICC and the barrel of the syringe of the introducer assembly, forcing a loop of the access guidewire in a third configuration, according to some embodiments. [Figure 6] 6 illustrates the RICC insertion assembly of FIG. 5 in its deployed state, according to some embodiments. [Figure 7] 1 illustrates the RICC insertion assembly in its ready-to-deploy state, with the first coupler coupling together the catheter hub of the RICC and the barrel of the syringe of the introducer assembly, forcing a loop of the access guidewire in a fourth configuration, according to some embodiments. [Figure 8] 8 illustrates the RICC insertion assembly of FIG. 7 in its deployed state, according to some embodiments. [Figure 9] 13 shows the RICC insertion assembly in its ready-to-deploy state, with the second coupler coupling together the catheter hub of the RICC and the needle hub of the introducer needle of the introducer assembly, forcing a loop of the access guidewire in a fifth configuration, according to some embodiments. [Figure 10] 13 shows the RICC insertion assembly in its ready-to-deploy state, with the third coupler coupling together the extension leg connector of the extension leg of the RICC and the needle hub of the introducer needle of the introducer assembly, forcing a loop of the access guidewire in a sixth configuration, according to some embodiments. [Figure 11] 11 illustrates the RICC insertion assembly of FIG. 10 in its deployed state, according to some embodiments. [Figure 12] 13 shows the RICC insertion assembly in its ready-to-deploy state, with a fourth coupler coupling together the catheter hub of the RICC and the access guidewire, forcing a loop on the access guidewire in a seventh configuration, according to some embodiments. [Figure 13] 13 illustrates a RICC insertion assembly with a fifth coupler joining the catheter tube and the access guidewire of the RICC together, forcing a loop in the access guidewire in an eighth configuration, according to some embodiments. [Figure 14] 13 illustrates a RICC insertion assembly in which a sixth coupler couples together the barrel of the syringe and the access guidewire of the introducer assembly, according to some embodiments. [Figure 15] 13 illustrates a RICC insertion assembly with a seventh coupler coupling together the catheter tube of the RICC and the barrel of the syringe of the introducer assembly, forcing several loops of the catheter tube in a first configuration, according to some embodiments. [Figure 16] 13 illustrates a RICC insertion assembly in which a seventh coupler couples together the catheter tube of the RICC and the barrel of the syringe of the introducer assembly, forcing several loops of the catheter tube in a second configuration, according to some embodiments. [Figure 17] 13 illustrates a RICC insertion assembly having several loops of catheter tubing in a third configuration, according to some embodiments. [Figure 18] 13 illustrates a RICC insertion assembly with a seventh coupler coupling together the catheter tube of the RICC and the barrel of the syringe of the introducer assembly, forcing the protrusion of the catheter tube in a first configuration, according to some embodiments. [Figure 19]13 illustrates a RICC insertion assembly with a seventh coupler coupling together the catheter tube of the RICC and the barrel of the syringe of the introducer assembly, forcing the protrusion of the catheter tube in a second configuration, according to some embodiments. [Figure 20] 1 illustrates a longitudinal cross-sectional view of an introducer needle according to some embodiments. [Figure 21] 1 shows a longitudinal cross-sectional view of an introducer needle with an access guidewire disposed therein in its ready-to-deploy state, according to some embodiments. [Figure 22] 1 illustrates an introducer needle, according to some embodiments. [Diagram 23] 1 illustrates 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 according to some embodiments. [Figure 26] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 27] FIG. 1 shows a first cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 28] 14A-14C show second or third cross-sectional views of a distal portion of a catheter tube according to some embodiments. [Figure 29] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Diagram 30] 13 illustrates a RICC insertion assembly with an eighth actuating coupler coupling together the introducer assembly and the access guidewire in a first state of the actuating coupler, according to some embodiments. [Diagram 31] 1 illustrates a RICC insertion assembly with an actuating coupler coupling together an introducer assembly and an access guidewire in a second state of the actuating coupler, according to some embodiments. [Diagram 32]1 illustrates a detailed view of an actuating coupler in a first state of the actuating coupler according to some embodiments. [Diagram 33] 1 illustrates a detailed view of an actuating coupler in a second state of the actuating coupler according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] Before some specific embodiments are disclosed 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 can be combined or substituted in any way with any of the other several embodiments disclosed herein.

[0037] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain particular embodiments, and that the terms do not 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 within a group of features or steps, and do not provide sequentiality or numerical limitations. For example, the "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment that includes such features or steps be limited to those three features or steps. In addition, any of the features or steps described above can further include one or more features or steps, unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a particular fixed position, orientation, direction, etc. Rather, such designations are used to reflect, for example, a relative position, orientation, direction, etc. The singular forms "a," "an," and "the" include plural references unless the context clearly indicates a singular number.

[0038] For example, reference to the "proximal," "proximal portion," or "proximal section" of a catheter includes the portion or section of the catheter that is intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be located near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be located near the clinician when the catheter is used on a patient. The proximal portion, section, or length of a catheter may include the proximal end of the catheter. However, the proximal portion, section, or length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, section, or length of a catheter is not the terminal portion or length of the catheter.

[0039] For example, reference to the "distal," "distal portion," or "distal section" of a catheter includes the portion or section of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. The distal portion, section, or length of a catheter may include the distal end of the catheter. However, the distal portion, section, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, section, or length of a catheter is not the terminal portion or length of the catheter.

[0040] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0041] As described above with respect to the Seldinger technique, many steps can be time consuming and many medical devices can be awkward 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 exchanged during the Seldinger technique, there is a relatively high chance of contact contamination. Unfortunately, this is complicated by the fact that many of the aforementioned medical devices are cumbersome, elongated medical devices, further increasing the 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, as well as to reduce the awkwardness of the aforementioned medical devices.

[0042] Disclosed herein is a compact RICC insertion assembly and method thereof that addresses at least the aforementioned needs. For example, the RICC insertion assembly may include a RICC, an introducer assembly, an access guidewire, and a coupler that couples the RICC and the introducer assembly together. The RICC may include a catheter tube, a catheter hub, and one or more extension legs, connected in the aforementioned order. The introducer assembly may include an introducer needle coupled to a syringe. The introducer needle may include a needle hub through-hole that passes through the needle hub and connects to a needle shaft lumen of the needle shaft. The access guidewire may include a proximal portion disposed within the RICC and a distal portion disposed through the needle hub through-hole and into the needle shaft lumen. The coupler may force a loop in the access guidewire over which the catheter tube travels, making the RICC insertion assembly compact and easier to handle.

[0043] The foregoing and other features of the RICC insertion assembly and methods provided herein will become more apparent upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of the RICC insertion assembly and methods. 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 be modified to accommodate a RICC and incorporated into their respective catheter insertion assemblies for the methods provided herein.

[0044] RICC Insertion Assembly 1-19 show a RICC insertion assembly 100 according to some embodiments. As shown, the RICC insertion assembly 100 may include a RICC 102, an introducer assembly 104 including an introducer needle 106 or 206 coupled to a syringe 108, an access guidewire 110, and a coupler 112 coupling together the RICC 102 and the introducer assembly 104, the RICC 102 and the access guidewire 110, or the introducer assembly 104 and the access guidewire 110. As described in more detail below, a proximal portion of the access guidewire 110 is disposed within the primary lumen 132 of the RICC 102, and a distal portion of the access guidewire 110 is disposed within the needle shaft lumen 150 of the needle shaft 144 of the introducer needle 106 via a needle hub through hole 154 through the needle hub 146 of the introducer needle 106. Alternatively, the distal portion of the access guidewire 110 is disposed within the needle lumen of the introducer needle 206. The coupler 112 can force a loop 114 in the access guidewire 110 over which the RICC 102, and particularly its catheter tube 116, passes, at least in the ready-to-deploy state of the RICC insertion assembly 100, thereby keeping the RICC insertion assembly 100 relatively compact and easy to handle.

[0045] In particular, any component of the RICC insertion assembly 100 selected from at least the RICC 102, the introducer needle 104, the syringe 108, the access guidewire 110, and the coupler 112, or any portion of a component selected from the aforementioned components, may include an antimicrobial agent thereon or therein. In one example, the catheter tube 116 of the RICC 102 may include an antimicrobial agent coating on the abluminal surface of the catheter tube 116, the luminal surface of the catheter tube 116, or both. In another example, the pre-extrusion material of the catheter tube 116 may include an antimicrobial agent mixed therein such that the antimicrobial agent is incorporated into the catheter tube 116 upon extrusion, and the antimicrobial agent protects both the abluminal surface of the catheter tube 116 and the luminal surface of the catheter tube 116 from microbial contamination.

[0046] 25-29 show the RICC 102 of the RICC insertion assembly 100, according to some embodiments. As shown, the RICC 102 includes a catheter tube 116 , a catheter hub 118 , one or more extension legs 120 , and one or more extension leg connectors 122 .

[0047] 26-29 show various views of the catheter tube 116 of the RICC 102, according to some embodiments. The catheter tube 116 includes a first section 124 at a distal portion of the catheter tube 116, a second section 126 at a distal portion of the catheter tube 116 proximal to the first section 124, and a tapered junction 128 between the first section 124 and the second section 126 of the catheter tube 116.

[0048] The first section 124 of the catheter tube 116 includes a catheter tip 130 having a relatively short taper from an outer diameter of the distal portion of the first section 124 distal to the junction 128 to an outer diameter of the distal end of the first section 124. The taper of the catheter tip 130 is configured to immediately dilate tissue around the needle path established by the introducer needle 106 or 206 to the outer diameter of the distal portion of the first section 124 of the catheter tube 116. As best shown in FIG. 29 , the first section 124 of the catheter tube 116 also includes a proximal portion that is disposed within a bore of the distal portion of the junction 128 and fixedly bonded thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0049] The second section 126 of the catheter tube 116 includes a constant outer diameter over its length from the distal end of the second section 126 to the proximal end of the second section 126. The constant diameter of the second section 126 of the catheter tube 116 is configured for smooth insertion into the needle tract and target vasculature after any expansion by the first section 124 of the catheter tube 116 and the junction 128. The distal end of the second section 126 of the catheter tube 116 has a flat surface that is flush with and fixedly bonded to the flat surface proximal end of the junction 128, such as by solvent bonding, adhesive bonding, or heat welding.

[0050] The junction 128 includes a taper over the length from the proximal end of the junction 128 to the distal end of the junction 128. The taper of the junction 128 is configured to immediately expand the tissue around the needle track from the outer diameter at the proximal portion of the first section 124 of the catheter tube 116 to the outer diameter of the second section 126 of the catheter tube 116. The abluminal surface of the junction 128 smoothly transitions from the abluminal surface of the first section 124 of the catheter tube 116 to the abluminal surface of the second section 126 of the catheter tube 116 without creating an edge that may catch on the skin when the catheter tube 116 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 116, which provides a smooth transition from the first section 124 of the catheter tube 116 to the junction 128, and from the junction 128 to the second section 126 of the catheter tube 116. In particular, the junction 128 has a length that is approximately equal to the length of the exposed portion of the first section 124 of the catheter tube 116, or a length between the lengths of the exposed portions of the first section 124 and the second section 126 of the catheter tube 116. Thus, the length of the exposed portion of the first section 124 of the catheter tube 116 is less than the length of the junction 128, and at most approximately equal to the length of the junction 128.

[0051] The first section 124 of the catheter tube 116 is formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer, and the second section 126 of the catheter tube 116 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 124 of the catheter tube 116 can be formed from a first polyurethane having a first durometer, and the second section 126 of the catheter tube 116 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 116 in that they are relatively stiff at room temperature, but can become more flexible in vivo at body temperature, thereby reducing irritation and phlebitis to the vessel wall. Polyurethanes are also advantageous in that they can be less thrombogenic than some other polymers. The joint 128 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.

[0052] 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 on 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 numerically smaller than the first durometer of the first polymeric material when the second durometer or the third durometer is smaller than the first durometer. In fact, the hardness of the second polymeric material or the third polymeric material may still be lower 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.

[0053] With the first section 124 of the catheter tube 116, the second section 126 of the catheter tube 116, and the junction 128 between the first section 124 and the second section 126 of the catheter tube 116 described above, the catheter tube 116 has sufficient column strength to prevent buckling of the catheter tube 116 when inserted into the needle path established by the introducer needle 106 or 206. The column strength of the catheter tube 116 is also sufficient to prevent buckling of the catheter tube 116 when advanced through the patient's vasculature without pre-dilating the tissue surrounding the needle path or any of the vessels of the vasculature with a separate dilator.

[0054] The catheter tube 116 includes one or more catheter tube lumens extending therethrough. Typically, however, 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 116 to the distal end of the catheter tube 116. Indeed, the first section 124 of the catheter tube 116 typically has a single lumen therethrough, as shown in FIG.

[0055] A catheter hub 118 is coupled to a proximal portion of the catheter tube 116. The catheter hub 118 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 118 from the proximal end of the catheter hub 118 to the distal end of the catheter hub 118.

[0056] Each of the one or more extension legs 120 is coupled by its distal portion to the catheter hub 118. Each of the one or more extension legs 120 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.

[0057] Each of the one or more extension leg connectors 122 is on a proximal portion of one of the one or more extension legs 120. For example, each of the one or more extension leg connectors 122 may be a luer connector on a proximal portion of one of the one or more extension legs 120. 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 the ready-to-deploy state of the RICC insertion assembly 100 of FIGS. 10 and 11 , at least one extension leg connector (e.g., an extension leg connector including a portion of the primary lumen 132 of the RICC 102) is connected to an access guidewire hub 194, which is in turn coupled to a needle hub 146 or 246 of the introducer needle 106 or 206. The access guidewire hub 194 therefore also functions as a coupler 112 that couples together the RICC 102 and the introducer assembly 104 to force a loop 114 of both the access guidewire 110 and the RICC 102 thereover.

[0058] As shown, the RICC 102 is a three-lumen RICC including three sets of lumens. However, the RICC 102 is not limited to the three sets of lumens as described above. The three sets of lumens include a primary lumen 132, a secondary lumen 134, and a tertiary lumen 136 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 132 has a primary lumen opening 138 at the distal end of the first section 124 of the catheter tube 116, which corresponds to the distal end of the catheter tube 116 and the distal end of the RICC 102. The secondary lumen 134 has a secondary lumen opening 140 at the side of the distal portion of the catheter tube 116. The tertiary lumen 136 has a tertiary lumen opening 142 at the side of the distal portion of the catheter tube 116 proximal to the secondary lumen opening 140.

[0059] 20 and 21 show various views of the introducer needle 106 of the RICC insertion assembly 100, according to some embodiments. As shown, the introducer needle 106 includes a needle shaft 144 and a needle hub 146 that covers a proximal portion of the needle shaft 144. The introducer needle 106 further includes a needle lumen formed from the fluid connecting portions of a needle shaft lumen 150 and a needle hub lumen 158, which will be described below.

[0060] The needle shaft 144 includes a needle tip 148 at a distal portion of the needle shaft 144 and a needle shaft lumen 150 extending from the proximal end of the needle shaft 144 through the needle tip 148 . The needle tip 148 includes a bevel having a tip bevel 168, described below with respect to the needle tip 248 of the needle shaft 244 of the introducer needle 206, and a primary bevel 170 proximal to the tip bevel 168. The tip bevel angle of the tip bevel 168 is greater than the primary bevel angle of the primary bevel 170 such that the bevel provides a smooth transition across the needle tip 148. Such a needle tip is thus configured to establish a needle pathway from an area of ​​the patient's skin into the lumen of a blood vessel in accordance with the needle pathway establishment steps of the method described below.

[0061] The needle shaft lumen 150 is configured to receive the access guidewire 110 therein during at least the needle pathway establishment and blood aspiration steps of the method described below. Indeed, the annular space between the inner diameter of the needle shaft 144 and the outer diameter of the access guidewire 110 is narrow enough to prevent the access guidewire 110 from kinking, yet wide enough to allow blood reflux or aspiration therethrough.

[0062] The needle hub 146 includes a neck 152 or needle connection portion at a distal portion of the needle hub 146, a needle hub throughbore 154, and a needle hub connector 156 at a proximal portion of the needle hub 146. The needle hub 146 further includes a needle hub lumen 158 formed between the neck 152 and the needle hub connector 156, the needle hub lumen 158 notably not occupied by the proximal portion of the needle shaft 144 or syringe tip when disposed within the needle hub connector 156.

[0063] The needle hub through hole 154 passes through a side of the needle hub 146, such as the neck 152, and optionally through an intervening portion of the needle hub lumen 158, via the proximal end of the needle shaft 144, to connect to the needle shaft lumen 150. The needle hub through hole 154 has an inner diameter comparable to the inner diameter of the needle shaft lumen 150, such that the access guidewire 110 can pass through the needle hub through hole 154 and enter the needle shaft lumen 150. The needle hub through hole 154 may include a gasket 160 disposed therein. Such a gasket is configured to seal around the access guidewire 110 and allow a vacuum to be drawn with the syringe 108 without leakage through the needle hub through hole 154. The gasket 160 may be a septum or one or more "O" rings, but is not limited thereto.

[0064] The needle hub connector 156 includes a needle hub bore 162 and an optional needle hub flange (not shown) around the needle hub connector 156 . The needle hub bore 162 of the needle hub connector 156 is configured to receive the syringe tip of the syringe 108 therein to fluidly connect the introducer needle 106 to the syringe 108. Indeed, the needle hub bore 162 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip therein, which can be configured complementary to the luer taper.

[0065] If present, the needle hub flange of the needle hub connector 156 is configured to threadably mate with the female threads of a threaded collar about the syringe tip of the syringe 108. The threaded collar of the syringe 108 is also optional, but if both are present, the needle hub flange advantageously provides a so-called luer lock style connection with the female threads of the threaded collar, which provides additional security against inadvertent separation of the introducer needle 106 and the syringe 108 in addition to the security provided by a luer slip style connection.

[0066] 22-24 show various views of the introducer needle 206 of the RICC insertion assembly 100, according to some embodiments. As shown, the introducer needle 206 includes a needle shaft 244 , a sheath 164 that covers the needle shaft 244 , and a needle hub 246 that covers both a proximal portion of the needle shaft 244 and a proximal portion of the sheath 164 .

[0067] The needle shaft 244 includes a needle tip 248 at a distal portion of the needle shaft 244 and a longitudinal needle slot 166 extending from a proximal portion of the needle shaft 244 through the needle tip 248 .

[0068] The needle tip 248 includes a bevel having a tip bevel 168 and a primary bevel 170 proximal to the tip bevel 168. The tip bevel angle of the tip bevel 168 is greater than the primary bevel angle of the primary bevel 170 such that the bevel provides a smooth transition across the needle tip 248. Such a needle tip is thus configured to establish a needle pathway from an area of ​​the patient's skin into the lumen of a blood vessel in accordance with the needle pathway establishment steps of the method described below.

[0069] The needle slot 166 extends from the proximal portion of the needle shaft 244 through the needle tip 248, thereby forming a needle channel 172 along most of the length of the needle shaft 244, as opposed to a needle lumen through the needle shaft 244. The needle slot 166 has a width dimensioned according to the outer diameter of the access guidewire 110, which allows the access guidewire 110 to pass from the proximal portion of the needle shaft 244 through the needle tip 248 when the introducer needle withdrawal step of the method described below is performed.

[0070] It should be understood that while the needle shaft 244 includes the needle slot 166 discussed above, the introducer needle 206 includes a needle lumen. However, the needle lumen arises from the combination of the needle shaft 244 and the sheath 164 covering the needle shaft 244. In effect, the sheath 164 covering the needle shaft 244 seals the underlying needle slot 166 to form the needle lumen of the introducer needle 206 and allow the syringe 108 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0071] The sheath 164 includes a sheath tip 174 at a distal portion of the sheath 164 and a sheath opening 176 at a side of a proximal portion of the sheath 164 . The sheath tip 174 includes a relatively short taper from the outer diameter of the distal portion of the sheath 164 to the outer diameter of the distal end of the sheath 164, which is comparable to the outer diameter of the distal portion of the needle shaft 244. The taper has a taper angle that is less than the primary bevel angle of the primary bevel 170 of the needle tip 248, which in turn is less than the tip bevel angle of the tip bevel 168 of the needle tip 248. The sheath tip 174, including such a taper, is configured to provide a smooth transition from the needle tip 248 to the sheath body proximal to the sheath tip 174 for the needle path establishment step of the method described below.

[0072] The sheath opening 176 opens to the needle slot 166 of the needle shaft 244 and allows the access guidewire 110 to pass through and enter the needle slot 166 in the ready-to-deploy state of the RICC insertion assembly 100. Thus, the sheath opening 176 has a width approximately equal to the width of the needle slot 166, which is sized according to the outer diameter of the access guidewire 110. The sheath opening 176 also allows the access guidewire 110 to pass through and enter the needle slot 166 and has a length sufficient to accommodate a clinician-selected blade (e.g., scalpel blade) below the distal end of the sheath opening 176. In particular, the sheath 164 covering the needle shaft 244 seals the needle slot 166 below it, except where it is below the sheath opening 176. However, like the needle hub through hole 154 of the introducer needle 106, the sheath opening 176 can include a gasket 260 disposed therein that seals the needle shaft 244 and the proximal portion of the sheath 164 therein, thereby allowing the syringe 108 to aspirate blood in accordance with the blood aspirating steps of the method described below.

[0073] The sheath 164, or sheath body thereof, is formed from a polymeric material configured to facilitate smooth and consistent insertion of the introducer needle 206 from an area of ​​the patient's skin into the vascular lumen in accordance with the needle pathway establishment step of the method described below. In addition, the polymeric material has sufficient mechanical properties to resist collapse of the sheath 164 into the needle slot 166 of the needle shaft 244, particularly at the thickness of the sheath 164, when the blood aspiration step of the method described below is performed, while also facilitating detachment of at least a portion of the sheath 164 from the needle shaft 244. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0074] The needle hub 246 includes an access guidewire channel 178 at a distal portion of the needle hub 246 and a needle hub connector 156 at a proximal portion of the needle hub 246 . The access guidewire channel 178 in the needle hub 246 is configured to allow the access guidewire 110 to pass over the needle hub 246 and guide the access guidewire 110 to the sheath opening 176. The access guidewire channel 178 is open such that the access guidewire 110 is located within the access guidewire channel 178 at least in the ready-to-deploy state of the RICC insertion assembly 100. Advantageously, the open access guidewire channel 178 allows the access guidewire 110 to remain in place when the introducer needle 206 is withdrawn from the RICC insertion assembly 100 in accordance with the introducer needle withdrawal step of the method described below.

[0075] As described above, the needle hub connector 156 includes a needle hub bore 162 and an optional needle hub flange (not shown) about the needle hub connector 156 . The needle hub bore 162 of the needle hub connector 156 is configured to receive the syringe tip of the syringe 108 therein to fluidly connect the introducer needle 206 to the syringe 108. Indeed, the needle hub bore 162 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip therein, which can be configured complementary to the luer taper.

[0076] If present, the needle hub flange of the needle hub connector 156 is configured to threadably mate with the female threads of a threaded collar about the syringe tip of the syringe 108. The threaded collar of the syringe 108 is also optional, but if both are present, the needle hub flange advantageously provides a so-called luer lock type connection with the female threads of the threaded collar, which provides additional security against inadvertent separation of the introducer needle 206 and the syringe 108 in addition to the security provided by a luer slip type connection.

[0077] 1-9 show various views of a coupler 112 that couples together a RICC 102 and an introducer assembly 104 via a catheter hub 118, according to some embodiments.

[0078] As shown, the coupler 112 that couples the RICC 102 and introducer assembly 104 together can be a separate coupler that includes either a barrel clip 180 or a needle hub clip 182 with a catheter hub seat 184 opposite the clip 180 or 182. Being a separate coupler, the coupler 112 allows the catheter hub 118 to be separated from the coupler 112, thereby allowing suture wings 186 of the catheter hub 118 to be utilized to secure (with sutures) the catheter hub 118 to the patient when the RICC 102 is placed into the patient's vasculature.

[0079] The barrel clip 180 may be a Terry-style clip extending from the coupler 112 configured to securely, but slidably, clip onto the barrel 109 of the syringe 108, as shown in Figures 1-8. The needle hub clip 182 may also be a Terry-style clip extending from the coupler 112 configured to clip onto the needle hub 146 or 246 of the introducer needle 106 or 206, as shown in Figure 9.

[0080] Regardless of whether the coupler 112 includes a barrel clip 180 or a needle hub clip 182, the catheter hub seat 184 of the coupler 112 is configured to seat the catheter hub 118 thereon. In particular, the catheter hub seat 184 may include posts 188 extending therefrom, as shown in at least Figures 3-6 and 9. The posts 188 are configured to be inserted into suture wing holes 190 in the suture wings 186 extending from the catheter hub 118 to secure the catheter hub 118 onto the catheter hub seat 184.

[0081] The clip 180 or 182 and the catheter hub seat 184 of the coupler 112 may be fixed or rotatable relative to one another. When the clip 180 or 182 and the catheter hub seat 184 of the coupler 112 are fixed relative to one another, the coupler 112 typically orients the catheter hub 118 either longitudinally or transversely relative to the central axis of the introducer assembly 104, which in turn orients the catheter hub 118 either longitudinally or transversely relative to the barrel 109 of the syringe 108 or the needle hub 146 or 246. However, such couplers need not orient the catheter hub 118 longitudinally or transversely relative to the central axis of the introducer assembly 104. In fact, the clip 180 or 182 and the catheter hub seat 184 of the coupler 112 may be fixed relative to one another to orient the catheter hub 118 in any suitable orientation relative to the central axis of the introducer assembly 104. However, to provide the clinician with options for implementing a preferred orientation of the catheter hub 118 relative to the central axis of the introducer assembly 104, the clip 180 or 182 and the catheter hub seat 184 may include a Haas-like joint therebetween, thereby allowing the clip 180 or 182 and the catheter hub seat 184 to rotate relative to one another. Such a coupler allows the clinician to orient the catheter hub 118 in any orientation that the clinician desires relative to the central axis of the introducer assembly 104, which orientation may need to be changed depending on procedural or environmental circumstances. In particular, changing the orientation of the catheter hub 118 relative to the central axis of the introducer assembly 104 may change the orientation of the loop 114 of the access guidewire 110 and the catheter hub 118 thereon.

[0082] 10 and 11 show various views of the coupler 112 that couples together the RICC 102 and the introducer assembly 104 via the access guide wire hub 194, according to some embodiments.

[0083] As shown, the coupler 112 coupling the RICC 102 and the introducer assembly 104 together can be an integral coupler, such as a portion of an access guidewire hub 194. As described below, the proximal end of the access guidewire 110 is coupled to the access guidewire hub 194. In addition, the access guidewire hub 194 can be configured to threadably mate with an extension leg connector extending from a proximal portion of one of the one or more extension legs 120. When the coupler 112 is configured as an integral coupler, the proximal end of the access guidewire hub 194 is configured to couple to another side of the needle hub 146 or 246 opposite the side including the needle hub through hole 154 or sheath opening 176. Advantageously, when the coupler 112 is the aforementioned portion of the access guidewire hub 194, the coupler 112 does not interfere with the catheter hub 118 in any way, thereby keeping the catheter hub 118 available for securing the catheter hub 118 to the patient when the RICC 102 is positioned within the patient's vasculature.

[0084] In particular, to place the RICC insertion assembly 100 in a more compact configuration, portions of the RICC 102 other than the catheter hub 118 and one or more extension legs 120, optionally in combination with the catheter hub 118 or one or more extension legs 120, may be coupled to the introducer assembly 104. Indeed, any of several portions of the RICC 102 may be coupled to the introducer assembly 104 to force a loop 114 in the access guidewire 110 over which the catheter tube 116 travels. By forcing a loop 114 in the access guidewire 110 and catheter tube 116, the coupler 112 makes the RICC insertion assembly 100 more compact and easier to handle, thereby reducing the possibility of touch contamination.

[0085] 12 and 13 show various views of a coupler 112 that couples together the RICC 102 and the access guidewire 110, according to some embodiments. As shown in FIG. 12, the coupler 112 that couples the RICC 102 and the access guidewire 110 together can be a separate coupler that includes an access guidewire clip 192 and a catheter hub seat 184 opposite the access guidewire clip 192. As described above, the coupler 112 being a separate coupler allows the catheter hub 118 to be separated from the coupler 112, thereby allowing the suture wings 186 of the catheter hub 118 to be utilized to secure (by sutures) the catheter hub 118 to the patient when the RICC 102 is placed in the patient's vasculature. However, the coupler 112 does not have to be a separate coupler. Alternatively, the coupler 112 can be a one-piece coupler. In fact, the coupler 112 can be a part of the catheter hub 118, such as an access guidewire clip integrated into the patient-facing side of the catheter hub 118, or even an adhesive disposed on the patient-facing side of the catheter hub 118 configured to adhere the access guidewire 110 to the catheter hub 118. Advantageously, such an adhesive may also function to secure the catheter hub 118 to the patient's skin when the RICC 102 is placed within the patient's vasculature.

[0086] If the coupler 112 is a separate coupler, the access guidewire clip 192 of the coupler 112 can be a Terry-type clip extending from the coupler 112 and configured to be slidably clipped onto the access guidewire 110. If the coupler 112 is a one-piece coupler, the access guidewire clip of the coupler 112 can be a groove on the patient-facing side of the catheter hub 118 configured to be slidably clipped onto the access guidewire 110. The relatively narrow outer diameter of the access guidewire 110 (e.g., 0.035 inches or less) can result in the groove in the catheter hub 118 being relatively narrow as well. Such a relatively narrow groove in the catheter hub 118 minimally interferes with the patient-facing surface of the catheter hub 118 and keeps the catheter hub 118 available for securing the catheter hub 118 to the patient when the RICC 102 is positioned within the patient's vasculature.

[0087] When coupler 112 is a separate coupler, catheter hub seat 184 of coupler 112 is configured to seat catheter hub 118 thereon. In particular, catheter hub seat 184 may include posts 188 extending therefrom, such as those shown in at least Figures 3-6 and 9. Again, such posts are configured to be inserted into suture wing holes 190 in suture wings 186 extending from catheter hub 118 to secure catheter hub 118 onto catheter hub seat 184.

[0088] 13, the coupler 112 that couples the RICC 102 and the access guidewire 110 together may be a separate coupler that includes a clip, band, or releasable tie around both the catheter tube 116 and the access guidewire 110. Advantageously, such a clip, band, or tie does not interfere with the catheter hub 118 in any way, thereby leaving the catheter hub 118 available for securing the catheter hub 118 to the patient when the RICC 102 is placed within the patient's vasculature.

[0089] In particular, to place the RICC insertion assembly 100 in a more compact configuration, portions of the RICC 102 other than the catheter hub 118 and the catheter tube 116, optionally in combination with the catheter hub 118 or the catheter tube 116, may be coupled to the access guidewire 110. Indeed, any of several portions of the RICC 102 may be coupled to the access guidewire 110 to force a loop 114 in the access guidewire 110 over which the catheter tube 116 travels. By forcing a loop 114 in the access guidewire 110 and the catheter tube 116, the coupler 112 makes the RICC insertion assembly 100 more compact and easier to handle, thereby reducing the possibility of touch contamination.

[0090] 14-19 show various views of a coupler 112 that couples together the introducer assembly 104 and the access guidewire 110, according to some embodiments. As shown, the coupler 112 that couples the introducer assembly 104 and the access guidewire 110 together may be a separate coupler that includes a clip, band, or releasable tie around at least the access guidewire 110, and up to both the introducer assembly 104 (e.g., the barrel 109 of the syringe 108) and the access guidewire 110. Alternatively, the coupler 112 may be a one-piece coupler. Indeed, if the coupler 112 is a one-piece coupler, the coupler 112 may be a portion of the syringe 108, such as a clip incorporated into a barrel flange at the proximal end of the barrel 109 of the syringe 108, or an adhesive disposed on the barrel 109 of the syringe 108 and configured to adhere the access guidewire 110 to the barrel 109. Advantageously, such clips, bands, ties, or adhesives do not interfere with the catheter hub 118 in any way, thereby keeping the catheter hub 118 available for securing the catheter hub 118 to the patient when the RICC 102 is placed within the patient's vasculature.

[0091] In particular, to place the RICC insertion assembly 100 in a more compact configuration, portions of the RICC 102 as described above may be coupled to the introducer assembly 104 or the access guidewire 110 in combination with a coupler 112 that couples the introducer assembly 104 and the access guidewire 110 together. Indeed, any of several portions of the RICC 102 may be coupled to the introducer assembly 104 or the access guidewire 110 to force a loop 114 in the access guidewire 110 over which the catheter tube 116 travels. By forcing a loop 114 in the access guidewire 110 and the catheter tube 116, the coupler 112 makes the RICC insertion assembly 100 compact and easier to handle, thereby reducing the possibility of touch contamination.

[0092] In addition to the orientation of the loop 114, such as an orientation corresponding to the orientation of the catheter hub 118 relative to the central axis of the introducer assembly 104, it should be understood that the loop 114 of the access guidewire 110 and the catheter tube 116 thereon can have any of several configurations. Indeed, the loop 114 can be stretched in any direction, compressed in any other direction, crossed over itself, etc., so long as there is no permanent deformation of the access guidewire 110 or the catheter tube 116. In addition, the loop 114 can have a handedness in that the loop 114 can be a left-handed loop or a right-handed loop according to the so-called right-hand rule. For example, the loops shown in Figures 1-4 and 9 are left-handed loops, and the loops shown in Figures 5-8, 10, 11, 13 and 14 are right-handed loops. Finally, it should be understood that, in view of at least Figures 15-19, the access guidewire 110 and the catheter tube 116 thereon do not necessarily have to be forced into a loop 114. In fact, the access guidewire 110 and the catheter tube 116 thereon may instead be forced into any of several geometric shapes, including, but not limited to, multiple loops (see FIGS. 15-17), optionally coiled around the barrel 109 of the syringe 108 (see FIG. 17), a spiral, a "U" shape or an upside-down "U" shape (see FIG. 18), a "W" shape or an "M" shape (see FIG. 19), and the like. Different geometric shapes with different orientations, topological configurations, turning directions, and the like provide the clinician with different options for keeping the RICC insertion assembly 100 in a compact configuration in different procedural, environmental, or even personal situations. In fact, in a non-limiting example, a right-handed clinician may prefer the RICC insertion assembly 100 of FIGS. 1 and 2 with the left-handed loop 114 when performing the needle path establishment steps described below. In contrast, a left-handed clinician may prefer the RICC insertion assembly 100 of FIGS.

[0093] 30-33 show various views of a coupler 112 that couples together the introducer assembly 104 and the access guidewire 110, according to some embodiments. As shown, the coupler 112 may be an actuating coupler configured to couple together at least the introducer assembly 104 and the access guidewire 110. The coupler 112 may include a coupler housing 198 and a coupler housing lock associated with the coupler housing 198, which may be identified by a coupler housing lock lever 204 shown in each of Figures 30-33. Notably, the coupler housing lock may also be referred to as an access guidewire clamp, in that the access guidewire 110 may also be clamped by the coupler housing lock, at least in the ready-to-deploy state of the introducer assembly 104, as shown in Figures 30 and 32.

[0094] The coupler housing 198 may include a proximal coupler housing component 200 and a distal coupler housing component 202. However, since the needle hub of the introducer assembly 104, best shown in FIGS. 30 and 31, doubles as the proximal coupler housing component 200, the proximal coupler housing component 200 may also be referred to as the needle hub. As further shown in FIGS. 30 and 32, in at least the ready-to-deploy state of the introducer assembly 104, the proximal coupler housing component 200 is nested within the distal coupler housing component 202 and locked by a coupler housing lock. However, as shown in FIG. 31, when the proximal coupler housing component 200 is unlocked from the distal coupler housing component 202, the proximal coupler housing component 200 may still be nested within the distal coupler housing component 202. Thus, the coupler housing lock may include a cam 205 (described below) for pushing the distal coupler housing part 202 distally away from the proximal coupler housing part 200 when the coupler housing lock's lever 204 is rotated from a first state or locked state of the coupler housing lock or coupler 112 shown in FIG. 32 to a second state or unlocked state of the coupler housing lock or coupler 112 shown in FIG. 33.

[0095] Each of the proximal coupler housing component 200 and the distal coupler housing component 202 may comprise two molded components that are joined together, such as by fastening or threading with screws or bolts, gluing with adhesive, or a combination thereof. The inside of each of the two molded components of the distal coupler housing component 202 may include a recess that forms a receptacle for the proximal portion of the distal coupler housing component 202 when the two molded components are joined together. When the proximal coupler housing component 200 and the distal coupler housing component 202 are nested together, with the distal portion of the proximal coupler housing component 200 disposed within the receptacle of the distal coupler housing component 202, as shown in FIGS. 30-32, the proximal coupler housing component 200 and the distal coupler housing component 202 form a bullet-shaped body. The bullet-shaped body of coupler 112 is configured to be comfortably held in the hand (e.g., fit in the hand) in the left hand for left-handed venipuncture or in the right hand for right-handed venipuncture with RICC insertion assembly 100. However, it should be understood that the body of coupler 112 is not limited to being bullet-shaped.

[0096] The coupler housing lock may be incorporated into a coupler 112 in which the proximal coupler housing part 200 is a needle hub 246 but has a rotatable lever 204 that includes an extension channel 179 configured to extend the access guidewire channel 178 that directs the access guidewire 110 to the sheath opening 176 and the needle slot 166 of the introducer needle 206. (See, e.g., FIG. 33, in which the extension channel 179 extending the access guidewire channel 178 through the lever 204 is an open channel in the second or unlocked state of the coupler housing lock or coupler 112.) Alternatively, the coupler housing lock may be incorporated into a coupler 112 in which the proximal coupler housing part 200 is a needle hub 146 but has a lever 204 that includes an extension channel 179 configured to extend the needle hub through hole 154 of the introducer needle 106. When the lever 204 of the coupler housing lock is rotated to a first or locked state of the coupler housing lock or coupler 112 as shown in Figures 30 and 32, the clamping portion of the lever 204 can clamp or otherwise hold the access guidewire 110 in place, such as by rotating the clamping portion of the lever 204 on the access guidewire 110. The clamping portion of the lever 204 can itself be the extension channel 179 when flipped by rotating the lever 204 to mate with a mating part or portion inside the coupler housing 198 to clamp the access guidewire 110. Alternatively, the clamping portion of the lever 204 can itself be the extension channel 179 when flipped by rotating the lever 204 so as to be out of alignment with the access guidewire channel 178 or the needle hub through hole 154, thereby forming a tortuous path for holding the access guidewire 110.When the coupler housing lock lever 204 is rotated from a first state or locked state of the coupler housing lock or coupler 112 to a second state or unlocked state of the coupler housing lock or coupler 112 as shown in Figures 31 and 33, the clamping portion of the lever 204 can release the access guidewire 110, thereby allowing the access guidewire 110 to be advanced distally into the coupler 112 or withdrawn proximally from the coupler 112.

[0097] The coupler housing lock may also include a cam 205 (e.g., a wedge cam) configured to cooperate with an edge of the lever 204 as a follower of the cam 205 to urge the distal coupler housing part 202 distally away from the proximal coupler housing part 200 when the lever 204 of the coupler housing lock is rotated from a first state or locked state of the coupler housing lock or coupler 112 shown in FIGS. 30 and 32 to a second state or unlocked state of the coupler housing lock or coupler 112 shown in FIGS. 31 and 33. As shown in the aforementioned figures, the cam 205 may be a ramp or rake of the distal coupler housing part 202 that faces the lever 204, and the lever 204 may be captured and held within the proximal coupler housing part 200 such that as the lever 204 is rotated onto and travels along the ramp or rake of the distal coupler housing part 202 that forms the cam 205, the distal coupler housing part 202 is pushed distally away from the proximal coupler housing part 200. Notably, such a mechanical linkage between the cam 205 and the driven lever 204 is not limited to the aforementioned. In fact, the mechanical link may instead be the reverse of the above, where a cam protrudes from the lever 204 over which an edge of the distal coupler housing part 202 rides so that when the lever 204 of the coupler housing lock is rotated from a first state or locked state of the coupler housing lock or coupler 112 to a second state or unlocked state of the coupler housing lock or coupler 112, the distal coupler housing part 202 is pushed distally away from the proximal coupler housing part 200.

[0098] The coupler housing 198 may also include a catheter clip 208 configured to suspend the RICC 102 therefrom, at least in a ready-to-deploy state of the RICC insertion assembly 100. For example, the catheter clip 208 may be configured to suspend the RICC 102 by the catheter hub 118 or one or more extension legs 120, at a ready-to-deploy state of the RICC insertion assembly 100. At least in the ready-to-deploy state of the RICC insertion assembly 100, a proximal portion of the access guidewire 110 is disposed within the RICC 102 and a distal portion of the access guidewire 110 is disposed within the introducer needle 206, forcing a loop of the access guidewire 110 with the RICC 102 disposed thereon to provide the RICC insertion assembly 100 in a compact configuration.

[0099] The access guidewire 110 includes a proximal portion including a proximal end and a distal portion including a distal end. The proximal end of the access guidewire 110 is coupled to an access guidewire hub 194, which may be connected to one of the one or more extension leg connectors 122. In at least a ready-to-deploy state of the RICC insertion assembly 100, the proximal portion of the access guidewire 110 is disposed within and extends along the primary lumen 132 of the RICC 102. The distal portion of the access guidewire 110 is disposed within and extends along the needle shaft lumen 150 via the needle hub through hole 154. Alternatively, the distal portion of the access guidewire 110 is disposed within and extends along the needle lumen of the introducer needle 206. 21, in the ready-to-deploy state of the RICC insertion assembly 100, the guidewire tip 196 including the distal end of the access guidewire 110 is disposed within the needle shaft lumen 150 just proximal to the needle tip 148 of the introducer needle 106. In particular, the access guidewire 110 is similarly disposed within the RICC insertion assembly 100, in which the introducer assembly 104 includes the introducer needle 206. When so disposed within the RICC insertion assembly 100, the proximal and distal portions of the access guidewire 110 may force the loop 114 or another geometric shape of the access guidewire 110 in the ready-to-deploy state of the RICC insertion assembly 100. Because the RICC 102 is disposed over the access guidewire 110, the RICC insertion assembly 100 may have a relatively compact configuration in its ready-to-deploy state.

[0100] The access guidewire 110 can include a guidewire tip 196 at a distal portion of the access guidewire 110, the guidewire tip 196 assuming a "J" shape configured to prevent puncturing the posterior wall of a blood vessel. Such guidewire tip is straight in a ready-to-deploy state of the RICC insertion assembly 100 and assumes a curved state (i.e., "J" shape) when the guidewire tip 196 is advanced beyond the needle tip 148 or 248 (e.g., advanced into the lumen of a blood vessel) in a deployed state of the RICC insertion assembly 100.

[0101] The access guidewire 110 may further include a bare wire portion and a wound wire portion proximal to the bare wire portion. Although not shown, the wound wire portion of the access guidewire 110, if present, extends proximally from the guidewire tip 196 to the bare wire portion of the access guidewire 110. Although not shown, the bare wire portion of the access guidewire 110, if present, extends distally through the needle hub thru-hole 154 or the sheath opening 176 such that the gasket 160 or 260 forms a fluid-tight seal around the bare wire portion of the access guidewire 110, 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 110, where the flatwound portion includes windings of tape instead of round wire and the groundwound portion includes windings of round wire that have been ground to flatten the windings.

[0102] Optionally, in the ready-to-deploy state of the RICC insertion assembly 100, any exposed portion of the access guidewire 110, such as the portion between the catheter tip 130 and the needle hub through hole 154, may be placed in a sterile package, such as a sterile bag or tube. In this manner, the access guidewire 110 can remain sterile and free from touch contamination prior to use. In particular, the catheter tube 116 of the RICC 102 may also be placed in a sterile package, such that the catheter tube 116 remains sterile and free from touch contamination prior to use.

[0103] method Methods include using the RICC insertion assembly 100. For example, methods can include using the RICC insertion assembly 100 to gain access to a patient's blood vessel lumen, positioning the RICC 102 within the blood vessel lumen, etc. Such methods can include one or more steps selected from an assembly obtaining step, an assembly adjusting step, a needle path establishing step, a blood aspirating step, an access guidewire advancing step, an introducer needle withdrawing step, a catheter tube advancing step, an access guidewire withdrawing step, a steering guidewire advancing step, an additional catheter tube advancing step, and a steering guidewire withdrawing step.

[0104] The assembly obtaining step includes obtaining a RICC insertion assembly 100. As described above, the RICC insertion assembly 100, in its ready-to-deploy state, includes a RICC 102, an introducer assembly 104, an access guidewire 110, and a coupler 112 that couples the RICC 102 and the introducer assembly 104 together. The introducer assembly 104 includes a syringe 108 coupled to an introducer needle 106 or 206. The introducer needle 106 or 206 includes a needle hub 146 or 246 that covers a proximal portion of a needle shaft 144 or 244. The access guidewire 110 includes a proximal portion that is disposed within the primary lumen 132 of the RICC 102. The access guidewire 110 also includes a distal portion that is disposed within the needle shaft lumen 150 of the needle shaft 144 via a needle hub through hole 154 that penetrates the side of the needle hub 146. Alternatively, the distal portion of the access guidewire 110 is placed into the needle lumen of the introducer needle 206 via the sheath opening 176. The coupler 112 couples the RICC 102 and the introducer assembly 104 together, thereby forcing a loop 114 in the access guidewire 110 over which the catheter tube 116 passes. By forcing a loop 114 in the access guidewire 110 and the catheter tube 116, the coupler 112 makes the RICC insertion assembly 100 more compact and easier to handle, thereby reducing the chance of touch contamination.

[0105] The assembly adjustment step includes adjusting the RICC insertion assembly 100 to its deployment ready state prior to establishing a needle path if the RICC insertion assembly 100 is not already in its deployment ready state upon acquisition of the RICC insertion assembly 100 in the assembly acquisition step. In particular, the assembly adjustment step can include adjusting the orientation, topological configuration, rotation direction, etc. of the loop 114 to adapt the loop 114 to a procedural situation, an environmental situation, or even a personal situation in order to make the RICC insertion assembly 100 easier to handle.

[0106] The needle path establishment step includes establishing a needle path from the area of ​​the patient's skin to the lumen of the blood vessel with the introducer needle 106 or 206. The needle path establishment step includes ensuring that blood flows back into the needle hub 146 or 246 of the introducer needle 106 or 206, the syringe tip of the syringe 108, the barrel 109 of the syringe 108, or a combination thereof. Ensuring that blood flows back into the needle hub 146 or 246 of the introducer needle 106 or 206, the syringe tip of the syringe 108, the barrel 109 of the syringe 108, or a combination thereof confirms that the needle path extends into the lumen of the blood vessel. In particular, the needle path establishment step may include drawing a slight vacuum with the syringe 108 to ensure that blood flows back into the needle hub 146 or 246 of the introducer needle 106 or 206, the syringe tip of the syringe 108, the barrel 109 of the syringe 108, or a combination thereof while establishing the needle path.

[0107] The blood aspiration step includes aspirating blood with the syringe 108 to confirm that the needle track extends into the blood vessel lumen. The needle hub through hole 154 includes a gasket 160 disposed therein that forms a seal around the access guidewire 110. Similarly, the sheath opening 176 includes a gasket 260 disposed therein that forms a seal around the access guidewire 110. The seal allows a vacuum to be drawn with the syringe 108 to aspirate blood with the syringe 108 during the blood aspiration step. In addition, the sheath 164 covering the needle shaft 244 seals the underlying needle slot 166 of the needle shaft 244 to further allow a vacuum to be drawn with the syringe 108 to aspirate blood with the syringe 108 during the blood aspiration step.

[0108] The access guidewire advancement step involves advancing the distal end of the access guidewire 110 from its initial position within the needle shaft 144 or 244 just proximal to the needle tip 148 or 248 of the needle shaft 144 or 244 into the blood vessel lumen. The access guidewire advancement step secures access to the blood vessel lumen by the access guidewire 110. Notably, during the access guidewire advancement step, as the distal end of the access guidewire 110 is advanced into the blood vessel lumen, advancement of the access guidewire 110 simultaneously reduces the size of the loop 114.

[0109] The introducer needle withdrawal step involves withdrawing the introducer needle 106 or 206 from the patient, leaving the access guidewire 110 in place within the vascular lumen. For example, the introducer needle withdrawal step can include separating the sheath 164 from the needle shaft 244 along the needle slot 166 with a selected blade (e.g., a scalpel blade) before the introducer needle 206 is withdrawn from the patient, or at some point during the performance of the introducer needle withdrawal step. Separating the sheath 164 from the needle shaft 244 allows the access guidewire 110 to exit the needle shaft 244 via the needle slot 166. Again, the introducer needle 206 includes a needle slot 166 that extends from a proximal portion of the needle shaft 244 through the needle tip 248, thereby separating the sheath 164 from the needle shaft 244 to allow the access guidewire 110 to exit the introducer needle 206.

[0110] The catheter tube advancing step includes advancing the catheter tube 116 of the RICC 102 into the blood vessel lumen over the access guidewire 110. The catheter tube advancing step positions the RICC 102 within the blood vessel lumen, at least in its initial position.

[0111] The access guidewire withdrawal step involves withdrawing the access guidewire 110 from the primary lumen 132 of the RICC 102, optionally through the access guidewire hub 194, while leaving the catheter tube 116 in place within the blood vessel lumen.

[0112] The steering guidewire advancing step involves advancing a steering guidewire through the primary lumen 132 of the RICC 102 and into the lumen of the blood vessel. An additional catheter tube advancement step involves further advancing the distal portion of the catheter tube 116 of the RICC 102 within the vessel lumen over the steering guidewire until it reaches the lower third of the SVC of the patient's heart.

[0113] The steering guidewire withdrawal step involves withdrawing the steering guidewire, leaving the catheter tube 116 in the lower third of the SVC. Although the method described above relates to use of the RICC insertion assembly of Figures 1-11, the method can be modified for any of the RICC insertion assemblies 100 of Figures 12-19 in which a coupler 112 couples together the RICC 102 and the access guidewire 110, or the introducer assembly 104 and the access guidewire 110.

[0114] 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 improvements or modifications may be apparent to those skilled in the art, and the broader aspects of the present invention encompass these improvements or modifications as well. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter ("RICC") insertion assembly comprising: RICC and an introducer assembly; an access guidewire; a coupler; 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; The introducer assembly includes: A syringe and an introducer needle coupled to the syringe; The introducer needle A needle shaft; a needle hub covering a proximal portion of the needle shaft, the needle hub including a needle hub through-hole extending through a side of the needle hub and connecting to a needle shaft lumen; The access guidewire comprises: a proximal portion disposed within the primary lumen of the RICC; a distal portion disposed within the needle shaft lumen via the needle hub through-hole; The coupler couples together the RICC and the introducer assembly, the RICC and the access guidewire, or the introducer assembly and the access guidewire, a RICC insertion assembly.

2. The RICC insertion assembly of claim 1 , wherein the coupler joining the RICC and the introducer assembly together forces a loop in the access guidewire over which the catheter tube is advanced.

3. 3. The RICC insertion assembly of claim 2, wherein the coupler includes a clip and a seat opposite the clip, the clip fastening onto the syringe barrel and the seating onto which the catheter hub is seated.

4. 3. The RICC insertion assembly of claim 2, wherein the coupler includes a clip and a seat opposite the clip, the clip clipping onto the needle hub and the seat seating the catheter hub thereon.

5. 4. The RICC insertion assembly of claim 3, wherein the seat includes a post extending from the seat, the post being inserted into a suture wing hole in a suture wing extending from the catheter hub, thereby securing the catheter hub on the seat.

6. 4. The RICC insertion assembly of claim 3, wherein the clip and seat are fixed relative to one another and the coupler orients the catheter hub either longitudinally or transversely relative to a central axis of the introducer assembly.

7. 4. The RICC insertion assembly of claim 3, wherein the clip and the seat include a Haas-like coupling therebetween, the coupler allowing a clinician to orient the catheter hub relative to a central axis of the introducer assembly in any orientation desired by the clinician.

8. 3. The RICC insertion assembly of claim 2, wherein the coupler is an access guidewire hub coupled to a proximal end of the access guidewire, the access guidewire hub also coupled to another side of the needle hub opposite the side including the needle hub through-hole, and the access guidewire hub threadably engages with an extension leg connector extending from a proximal portion of one of the one or more extension legs.

9. 10. The RICC insertion assembly of claim 1, wherein the coupler that couples the RICC and the access guidewire together forces a loop in the access guidewire over which the catheter tube is advanced.

10. 10. The RICC insertion assembly of claim 9, wherein the coupler includes a clip and a seat opposite the clip, the clip clipped onto the access guidewire and the seat onto which the catheter hub is seated.

11. The RICC insertion assembly of claim 10 , wherein the clip is a groove in the coupler.

12. 11. The RICC insertion assembly of claim 10, wherein the seat includes a post extending from the seat, the post being inserted into a suture wing hole in a suture wing extending from the catheter hub, thereby securing the catheter hub on the seat.

13. The RICC insertion assembly of claim 9, wherein the coupler includes a clip integrated into a patient-facing side of the catheter hub, the clip being clipped onto the access guidewire.

14. The RICC insertion assembly of claim 13 , wherein the clip is a groove in the catheter hub.

15. The RICC insertion assembly of claim 9 , wherein the coupler comprises a clip or releasable tie around the catheter tube and the access guidewire of the RICC.

16. The RICC insertion assembly of claim 1 , wherein the coupler coupling the introducer assembly and the access guidewire together comprises a clip or releasable tie around the barrel of the syringe and the access guidewire.

17. 2. The RICC insertion assembly of claim 1, wherein the coupler coupling the introducer assembly and the access guidewire together includes a rotatable lever of a coupler housing lock on a housing of the coupler, the coupler housing lock having a locked state and an unlocked state for locking and unlocking the needle hub to and from a distal coupler housing component of the coupler housing, respectively.

18. 18. The RICC insertion assembly of claim 17, wherein the locked and unlocked states of the coupler housing lock are further for clamping and unclamping the access guidewire, respectively.

19. 2. The RICC insertion assembly of claim 1, wherein the needle hub through-hole includes a gasket disposed therein, the gasket configured to seal around the access guidewire and allow a vacuum to be drawn with the syringe without leakage through the needle hub through-hole.

20. 20. The RICC insertion assembly of claim 19, wherein the gasket includes one or more "O" rings.

21. 2. The RICC insertion assembly of claim 1, wherein the RICC includes a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen, formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

22. 22. The RICC insertion assembly of claim 21, wherein the primary lumen has a primary lumen opening at a distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on the side of the distal portion of the catheter tube proximal to the secondary lumen opening.

23. 23. The RICC insertion assembly of any one of claims 1 to 22, wherein the RICC insertion assembly is in its ready-to-deploy state with the guidewire tip of the access guidewire positioned just proximal to the needle tip of the needle.

24. 24. The RICC insertion assembly of claim 23, wherein the guidewire tip is straight within the needle shaft lumen in the ready-to-deploy state of the RICC insertion assembly, but assumes a "J" shape when advanced beyond the needle tip in the deployed state of the RICC insertion assembly.

25. an introducer needle, A needle shaft; a needle hub covering a proximal portion of the needle shaft; an introducer needle, the needle hub including a needle hub through-hole extending through the side of the needle hub and connecting to a needle shaft lumen, the needle hub through-hole configured to receive an access guidewire;

26. 26. The introducer needle of claim 25, wherein the needle hub through-hole includes a gasket disposed therein, the gasket configured to seal around the access guidewire and allow a vacuum to be drawn with a syringe without leakage through the needle hub through-hole.

27. 27. The introducer needle of claim 26, wherein the gasket includes one or more "O" rings.

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