Introducer assembly and valve module for rapid insertion central venous catheter insertion assembly and method

Abstract

A rapid insertion central venous catheter (RICC) insertion assembly and related methods include a valve module. For example, the RICC insertion assembly can include a RICC, an introducer needle, and an access guidewire coupled together by a coupler in which the valve module is disposed. The introducer needle includes a needle shaft with a longitudinal needle slot and a sheath covering the needle shaft, the sheath sealing the needle slot below it except for a portion of the sheath below the sheath opening. The valve module includes an elastomeric gasket surrounding at least a portion of the valve module compartment of the coupler housing. The gasket is compressed within the valve module compartment around both the introducer needle and the access guidewire where the access guidewire extends from the sheath opening, thereby creating a substantially airtight space within the gasket around the introducer needle and the access guidewire.

Description

[Background technology]

[0001] Central venous catheters (CVCs) are commonly introduced into a patient's body and advanced through the patient's vasculature using the Seldinger technique. The Seldinger technique involves many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, the many steps are time-consuming, and the handling of numerous medical devices is cumbersome, all of which can potentially cause trauma to the patient. Additionally, the large number of medical devices that need to be replaced during the Seldinger technique increases the likelihood of contamination through contact. Therefore, 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's body and advancing the catheter through its vasculature.

[0002] Disclosed herein are valve modules, insertion assemblies, and methods for insertion assemblies of rapidly insertable central catheters (RICCs) that address the above needs. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is a RICC insertion assembly including a RICC, an introducer needle, a coupler that couples the RICC and the introducer needle together, and an access guidewire disposed within the introducer needle. The introducer needle includes a needle shaft and a sheath that covers the needle shaft. The needle shaft includes a longitudinal needle slot that extends from a proximal portion of the needle shaft through a distal needle tip. The sheath that covers the needle shaft seals the needle slot below it except for a portion of the needle slot below a sheath opening in the proximal portion of the sheath. The coupler includes a coupler housing and a valve module disposed within a valve module compartment of the coupler housing. The valve module includes an elastomeric gasket that surrounds at least a portion of the valve module compartment of the coupler housing along the length of the valve module compartment. The gasket within the valve module compartment is compressed around a proximal portion of the introducer needle in the ready-to-deploy state of the RICC insertion assembly, thereby creating a substantially airtight space within the gasket around the proximal portion of the introducer needle. The access guidewire includes a distal portion that passes through both the sheath opening of the sheath and the needle slot of the needle shaft and enters the introducer needle. The gasket within the valve module compartment is also compressed around a distal portion of the access guidewire in the ready-to-deploy state of the RICC insertion assembly, thereby further creating a substantially airtight space within the gasket around the distal portion of the access guidewire. The access guidewire also includes a distal end that is positioned within the introducer needle proximally just before the needle tip at the distal end of the introducer needle.

[0004] In some embodiments, the gasket is formed from a single piece. In some embodiments, the gasket includes a proximal needle pierce through a proximal end portion of the gasket and a distal needle pierce through a distal end portion of the gasket that is aligned with the proximal needle pierce, and a proximal portion of the introducer needle passes through both the proximal and distal needle pierce holes in the ready-to-deploy state of the RICC insertion assembly.

[0005] In some embodiments, the gasket includes an access guidewire channel through a proximal end portion of the gasket that forms an acute angle with the proximal needle through-hole, thereby directing a distal portion of the access guidewire through both the sheath opening of the sheath and the needle slot of the needle shaft and into the proximal portion of the introducer needle.

[0006] In some embodiments, the access guidewire channel coincides with the end portion of a longitudinal slit through the top of the gasket. In some embodiments, the access guidewire channel has an inner diameter that is comparable to the outer diameter of the access guidewire.

[0007] In some embodiments, the distal needle through-hole coincides with another terminal portion of the slit through the top of the gasket. In some embodiments, the distal needle through-hole has an inner diameter equivalent to the outer diameter of the introducer needle.

[0008] In some embodiments, the slit is configured to separate the access guidewire and allow the access guidewire to exit through the top of the gasket when compression on the gasket is released and the introducer needle is withdrawn from the coupler.

[0009] In some embodiments, the gasket is formed from two complementary parts of the gasket that fit together. In some embodiments, the gasket is substantially symmetrical along a longitudinal plane of symmetry that passes through the majority of the gasket, with the two complementary parts of the gasket being substantially mirror images of each other.

[0010] In some embodiments, the gasket is asymmetric: the two complementary parts of the gasket are not related to each other by any symmetry operation. In some embodiments, the gasket includes a proximal needle pierce through a proximal end portion of the gasket and a distal needle pierce through a distal end portion of the gasket that is aligned with the proximal needle pierce. Each of the proximal and distal needle pierce holes is formed between two complementary mated parts of the gasket. A proximal portion of the introducer needle passes through both the proximal and distal needle pierce holes in the ready-to-deploy state of the RICC insertion assembly.

[0011] In some embodiments, the gasket includes an access guidewire channel through a proximal end portion of the gasket. The access guidewire channel is formed between two complementary mated parts of the gasket. The access guidewire channel forms an acute angle with the proximal needle through-hole, thereby directing a distal portion of the access guidewire through both the sheath opening of the sheath and the needle slot of the needle shaft and into the introducer needle.

[0012] In some embodiments, the two complementary parts of the gasket are configured to separate the access guidewire and allow the access guidewire to exit the gasket when compression on the gasket is released and the introducer needle is withdrawn from the coupler.

[0013] In some embodiments, the gasket approximates a rectangle in a side view of the gasket. In some embodiments, the gasket approximates a right angled trapezoid in a side view of the gasket.

[0014] In some embodiments, the coupler further includes a blade coupled to the coupler housing, the blade extending through the gasket into the valve module such that when the introducer needle is withdrawn from the coupler, a distally facing edge of the blade is positioned within a needle slot in the needle shaft below the distal end of the sheath opening of the sheath to decouple the sheath from the needle shaft, allowing the access guidewire to pass through the needle slot and out of the needle shaft.

[0015] 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 introducer needle is withdrawn from the coupler.

[0016] In some embodiments, the coupler further includes a compression clip that covers a complementary mating part of the coupler housing, the compression clip configured to compress the gasket within the valve module compartment.

[0017] In some embodiments, the coupler further includes one or more lubricant wells containing a lubricant, one or more lubricant receptacles configured to receive or redistribute a lubricant, or a combination thereof.

[0018] In some embodiments, the RICC insertion assembly further comprises a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the RICC insertion assembly.

[0019] Also disclosed herein, in some embodiments, is a valve module for a RICC insertion assembly that includes an elastomeric gasket configured to surround at least a portion of a valve module section of a coupler housing of a coupler along a length of the valve module section, and configured to compress within the valve module section of the coupler housing around a proximal portion of an introducer needle and a distal portion of an access guidewire, thereby creating a substantially airtight space within the gasket around the proximal portion of the introducer needle and the distal portion of the access guidewire.

[0020] In some embodiments, the gasket is formed from a single piece. In some embodiments, the gasket includes a proximal needle piercing hole through a proximal end portion of the gasket and a distal needle piercing hole aligned with the proximal needle piercing hole through a distal end portion of the gasket, both configured to receive a proximal portion of an introducer needle therethrough.

[0021] In some embodiments, the gasket includes an access guidewire channel through a proximal end portion of the gasket that forms an acute angle with the proximal needle through-hole, thereby directing a distal portion of the access guidewire through an opening in the side of the introducer needle and into the proximal portion of the introducer needle.

[0022] In some embodiments, the access guidewire channel coincides with the end portion of a longitudinal slit through the top of the gasket. In some embodiments, the distal needle through-hole coincides with another terminal portion of the slit through the top of the gasket.

[0023] In some embodiments, the gasket is formed from two complementary parts of the gasket that fit together. In some embodiments, the gasket is substantially symmetrical along a longitudinal plane of symmetry that passes through the majority of the gasket, with the two complementary parts of the gasket being substantially mirror images of each other.

[0024] In some embodiments, the gasket is asymmetric: the two complementary parts of the gasket are not related to each other by any symmetry operation. In some embodiments, the gasket includes a proximal needle piercing hole through a proximal end portion of the gasket and a distal needle piercing hole aligned with the proximal needle piercing hole through a distal end portion of the gasket, wherein each of the proximal and distal needle piercing holes is formed between two complementary mated parts of the gasket, and both the proximal and distal needle piercing holes are configured to receive a proximal portion of an introducer needle therethrough.

[0025] In some embodiments, the gasket includes an access guidewire channel through a proximal end portion of the gasket. The access guidewire channel is formed between two complementary mated parts of the gasket. The access guidewire channel forms an acute angle with the proximal needle through-hole, thereby directing a distal portion of the access guidewire into the introducer needle through an opening in the side of the introducer needle.

[0026] In some embodiments, the gasket approximates a rectangle in a side view of the gasket. In some embodiments, the gasket approximates a right angled trapezoid in a side view of the gasket.

[0027] In some embodiments, the gasket is further configured to receive a blade therethrough such that when the introducer needle is withdrawn from the coupler, the blade extends into the valve module to separate the sheath from the needle shaft of the introducer needle.

[0028] Also disclosed herein, in some embodiments, is a method for inserting a RICC into a patient's vascular lumen, the method including the steps of obtaining a RICC insertion assembly, establishing a puncture path, advancing an access guidewire, withdrawing an introducer needle, and advancing the RICC. The RICC insertion assembly obtaining step includes obtaining a RICC insertion assembly including a RICC, an introducer needle including a sheath covering the needle shaft, and an access guidewire coupled together by a coupler. The coupler includes a coupler housing having a valve module compartment and a valve module disposed within the valve module compartment. The valve module includes an elastomeric gasket surrounding at least a portion of the valve module compartment of the coupler housing along the length of the valve module compartment. The gasket within the valve module compartment of the coupler housing is compressed around a proximal portion of the introducer needle and a distal portion of the access guidewire when the RICC insertion assembly is ready to be deployed, thereby creating a substantially airtight space within the gasket around the proximal portion of the introducer needle and the distal portion of the access guidewire. The establishing a puncture path step includes establishing a puncture path from the region of skin to the lumen of the blood vessel using the introducer needle. The advancing an access guidewire step includes advancing a distal end of the access guidewire into the lumen of the blood vessel from its initial position within the needle shaft just proximal to the tip of the needle shaft. The withdrawing an introducer needle step includes withdrawing the introducer needle from the coupler, leaving the access guidewire in place within the lumen of the blood vessel. The introducer needle further includes a longitudinal needle slot extending from a proximal portion of the needle shaft through the tip. The gasket includes a longitudinal slit in at least an upper portion of the gasket, which allows the access guidewire to exit the introducer needle and the gasket, respectively, upon withdrawal of the introducer needle from the coupler.The RICC advancement step includes advancing the catheter tube of the RICC over the access guidewire and into the lumen of the blood vessel, thereby inserting the RICC into the lumen of the blood vessel.

[0029] In some embodiments, the method further includes a step of aspirating blood using a syringe fluidly connected to the introducer needle to confirm that the puncture path extends into the blood vessel lumen before performing the introducer needle withdrawal step. The sheath covering the needle shaft seals the needle slot below it except for a portion of the needle slot below a sheath opening in the sheath, and that portion of the needle slot is sealed by a substantially airtight space within the gasket for aspirating blood using the syringe.

[0030] In some embodiments, the introducer needle withdrawal step further comprises withdrawing the introducer needle from a gasket including a proximal needle piercing hole through a proximal end portion of the gasket and a distal needle piercing hole through a distal end portion of the gasket aligned with the proximal needle piercing hole.

[0031] In some embodiments, the access guidewire advancing step further includes advancing an access guidewire through a proximal end portion of the gasket and into an access guidewire channel, the access guidewire channel forming an acute angle with the proximal needle throughbore, thereby directing a distal portion of the access guidewire into the needle slot of the introducer needle.

[0032] In some embodiments, the gasket is formed from two complementary, substantially mirror-image parts of the gasket that are mated together to form the proximal needle through-hole, the distal needle through-hole, and the access guidewire channel across a longitudinal plane of symmetry between the two complementary parts of the mated gasket that coincides with a slit in at least the top of the gasket and continues to the bottom of the gasket.

[0033] In some embodiments, the gasket is formed from a single piece that includes a slit through the top of the gasket. In some embodiments, the introducer needle withdrawal step further includes simultaneously decoupling the sheath from the needle shaft using either the access guidewire itself or a blade extending through the gasket and into the valve module while the introducer needle is being withdrawn from the coupler, allowing the access guidewire to exit the needle shaft via a needle slot in the needle shaft.

[0034] Also disclosed herein, in some embodiments, is an introducer assembly including an introducer needle, a coupler, and an access guidewire. The introducer needle includes a needle shaft and a sheath 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 covering the needle shaft seals the needle slot below it except for a portion of the needle slot below a sheath opening in the proximal portion of the sheath. The coupler includes a coupler housing and a valve module disposed within a valve module compartment of the coupler housing. The valve module includes an elastomeric gasket surrounding at least a portion of the valve module compartment of the coupler housing along the length of the valve module compartment. The gasket within the valve module compartment is compressed around the proximal portion of the introducer needle when the introducer assembly is ready to be deployed, thereby creating a substantially airtight space within the gasket around the proximal portion of the introducer needle. The access guidewire includes a distal portion that passes through both the sheath opening of the sheath and the needle slot of the needle shaft and enters the introducer needle. The gasket within the valve module compartment is also compressed around the distal portion of the access guidewire in the ready-to-deploy state of the introducer assembly, thereby further creating a substantially airtight space within the gasket around the distal portion of the access guidewire. The access guidewire also includes a distal end that is positioned within the introducer needle proximally just before the needle tip at the distal end of the introducer needle.

[0035] In some embodiments, the introducer assembly further includes a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the introducer assembly.

[0036] Also disclosed herein, in some embodiments, is a method for establishing access to a patient's vascular lumen, the method including the steps of obtaining an introducer assembly, establishing a puncture path, advancing an access guidewire, and withdrawing an introducer needle. The introducer assembly obtaining step includes obtaining an introducer assembly including an introducer needle having a sheath covering the needle shaft, an access guidewire, and a coupler that couples the introducer needle and the access guidewire together. The coupler includes a coupler housing having a valve module compartment and a valve module disposed within the valve module compartment. The valve module includes an elastomeric gasket that surrounds at least a portion of the valve module compartment of the coupler housing along the length of the valve module compartment. The gasket within the valve module compartment of the coupler housing is compressed around a proximal portion of the introducer needle and a distal portion of the access guidewire in a ready-to-deploy state of the introducer assembly, thereby creating a substantially airtight space within the gasket around the proximal portion of the introducer needle and the distal portion of the access guidewire. The establishing a puncture path step includes establishing a puncture path from the region of skin to the lumen of the blood vessel using the introducer needle. The advancing an access guidewire step includes advancing a distal end of the access guidewire into the lumen of the blood vessel from its initial position within the needle shaft just proximal to the tip of the needle shaft. The withdrawing an introducer needle step includes withdrawing the introducer needle from the coupler, leaving the access guidewire in place within the lumen of the blood vessel. The introducer needle further includes a longitudinal needle slot extending from a proximal portion of the needle shaft through the tip. The gasket includes a longitudinal slit in at least an upper portion of the gasket, which allows the access guidewire to exit the introducer needle and the gasket, respectively, upon withdrawal of the introducer needle from the coupler.

[0037] In some embodiments, the method further includes a catheter threading step and a catheter advancing step. The catheter threading step includes threading a catheter tube of the CVC over a proximal portion of the access guidewire. The catheter advancing step includes advancing the catheter tube of the CVC over the access guidewire into the blood vessel lumen.

[0038] In some embodiments, the method further includes a dilating step, which includes dilating the tissue surrounding the puncture path with a dilator before passing the catheter tube of the CVC over the proximal portion of the access guidewire in the catheter passing step.

[0039] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon review of the following description and accompanying figures that describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0040] [Figure 1] 1 illustrates a top view of a RICC insertion assembly, according to some embodiments. [Figure 2] 1 illustrates a perspective view of a RICC insertion assembly, according to some embodiments. [Figure 3] 1 illustrates a bottom view of a RICC insertion assembly, according to some embodiments. [Figure 4] 1 shows a longitudinal cross-sectional view of a coupler and introducer needle of a RICC insertion assembly, with a gasket of the coupler's valve module positioned within the valve module compartment of the coupler's symmetrical coupler housing around the introducer needle, according to some embodiments. [Figure 5] 1 shows a longitudinal cross-sectional view of the coupler, introducer needle, and access guidewire of the RICC insertion assembly, with the valve module gasket positioned within the valve module compartment of the coupler housing around the introducer needle and access guidewire, according to some embodiments. [Figure 6] 10A shows a perspective view of another gasket of the valve module around the introducer needle and access guidewire, according to some embodiments. [Figure 7] 10A shows a perspective view of yet another gasket of the valve module around the introducer needle and access guidewire, according to some embodiments. [Figure 8A] 8 illustrates a detailed view of the gasket of FIG. 7 according to some embodiments. [Figure 8B] 8A-8C show detailed views of the gasket of FIG. 7 with different shaped proximal needle thru-holes, distal needle thru-holes, and access guidewire channels, according to some embodiments. [Figure 9] 8 illustrates an exploded view of a multi-piece alternative to the gasket of FIG. 7, according to some embodiments. [Figure 10] 8 illustrates an exploded view of a valve module including the blade and gasket of FIG. 7 and a valve module section of an asymmetric coupler housing, according to some embodiments. [Figure 11] 11 illustrates a valve module partially disposed within the coupler housing of FIG. 10 according to some embodiments. [Figure 12] 11 illustrates a valve module fully disposed within the coupler housing of FIG. 10 according to some embodiments. [Figure 13A] 8 illustrates an exploded view of a valve module including the gasket of FIG. 7 as well as a valve module section of an alternative symmetrical coupler housing, according to some embodiments. [Figure 13B] 8 illustrates an exploded view of a valve module including the gasket of FIG. 7 as well as a valve module section of another asymmetric coupler housing, along with a compression clip, according to some embodiments. [Figure 13C] 13C illustrates an assembly of a valve module including the gasket of FIG. 7, another asymmetric coupler housing of FIG. 13B, and a compression clip that clips the assembly together, according to some embodiments. [Figure 14]8 illustrates an exploded view of a valve module including the gasket of FIG. 7 partially disposed within a valve module compartment of another asymmetric coupler housing, according to some embodiments. [Figure 15] 8 illustrates another exploded view of a valve module including the gasket of FIG. 7 partially disposed within a valve module compartment of another asymmetric coupler housing, according to some embodiments. [Figure 16A] 12 shows a detailed view of a valve module disposed within the valve module compartment of the asymmetric coupler housing of FIG. 11 with the blades flanking the access guidewire, according to some embodiments. [Figure 16B] 12 shows a detailed view of a valve module disposed within the valve module compartment of the asymmetric coupler housing of FIG. 11 with the blade distal to the access guidewire, according to some embodiments. [Figure 17] 10 illustrates a lubrication mechanism for lubricating the introducer needle and access guidewire, according to some embodiments. [Figure 18] 1 illustrates a top view of an introducer needle, according to some embodiments. [Figure 19] 1 illustrates a sheath for an introducer needle, according to some embodiments. [Figure 20] 1 illustrates a needle shaft of an introducer needle, according to some embodiments. [Figure 21] 1 illustrates a RICC of a RICC insertion assembly, according to some embodiments. [Figure 22] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 23] 1 shows a cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Figure 24] 10 shows another cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Figure 25] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter tube, according to some embodiments. [Figure 26]1 shows a top view of an introducer assembly, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0041] 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 can have features that can be readily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0042] Regarding the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and 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 sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, unless otherwise specified, any of the aforementioned features or steps can include one or more additional features or steps. Labels such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "said" also include plural references unless the context clearly dictates otherwise.

[0043] With respect to "proximal," for example, the "proximal portion" or "proximal section" of a medical device disclosed herein includes the portion or section of the medical device intended to be near the clinician when the medical device is used on a patient. Similarly, the "proximal length" of a medical device includes the length of the medical device intended to be near the clinician when the medical device is used on a patient. The "proximal end" of a medical device includes the end of the medical device intended to be near the clinician when the medical device is used on a patient. The proximal portion, section, or length of a medical device can include the proximal end of the medical device, in which case the proximal portion, section, or length of the medical device may be further specified as the proximal end, proximal end section, or proximal end length of the medical device. That is, the proximal portion, section, or length of a medical device need not include the proximal end of the medical device. Indeed, unless the context suggests otherwise, a proximal portion, section, or length of a medical device is not a terminal portion, section, or length of the medical device.

[0044] With respect to "distal," for example, the "distal portion" or "distal end portion" of a medical device disclosed herein includes the portion or section of the medical device intended to be near or within a patient when the medical device is used on the patient. Similarly, the "distal length" of a medical device includes the length of the medical device intended to be near or within a patient when the medical device is used on the patient. The "distal end" of a medical device includes the end of the medical device intended to be near a clinician or within a patient when the medical device is used on a patient. The distal portion, section, or length of a medical device can include the distal end of the medical device, in which case the distal portion, section, or length of the medical device may be further specified as the distal end, section, or length of the medical device. That is, the distal portion, section, or length of a medical device need not include the distal end of the medical device. Indeed, unless the context suggests otherwise, a distal portion, section, or length of a medical device is not the terminal portion, section, or length of the medical device.

[0045] 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, performing the many steps of the Seldinger procedure is time-consuming, and handling the numerous medical devices of the Seldinger procedure is cumbersome, both of which can be traumatic for the patient. Additionally, because many medical devices must be replaced during the Seldinger procedure, the potential for contamination through contact is relatively high. Therefore, 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's body and advancing the catheter through its vasculature.

[0046] Disclosed herein are insertion assemblies and valve modules for RICC insertion assemblies and methods that address the aforementioned needs. The valve modules for RICC insertion assemblies and methods thereof will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which provide specific embodiments of the valve modules associated with the RICC insertion assemblies provided herein. However, it should be understood that the valve modules may be incorporated into other medical devices, including other catheter insertion assemblies, other than the RICC insertion assemblies provided herein. Indeed, the valve modules may be incorporated into catheter insertion assemblies, including peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like.

[0047] RICC Insertion Assembly 1-3 show various views of a RICC insertion assembly 100, according to some embodiments.

[0048] As shown, the RICC insertion assembly 100 may include 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. In particular, as described below, a proximal end of the access guidewire 106 may be coupled to the coupler 108, and a distal end of the access guidewire 106 may be disposed within the needle lumen 158 of the introducer needle 104. This forces the access guidewire 106 into a loop, allowing the RICC 102 to be positioned over the loop in the ready-to-deploy state of the RICC insertion assembly 100, maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0049] The RICC insertion assembly 100 may further include a syringe 110 fluidly connected to the introducer needle 104 when the RICC insertion assembly 100 is in a ready-to-deploy state. As described below, the sheath 142 may seal the needle slot 148 of the needle shaft 140. In particular, the sheath 142 may seal the needle slot 148 outside of the valve module 180. The valve module 180 or its gasket 198 may then seal over the sheath opening 162 of the sheath 142 that opens to the needle slot 148. The valve module 180 or its gasket 198 may also seal 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.

[0050] Finally, any component of the RICC insertion assembly 100 selected from at least the RICC 102, the introducer needle 104, the access guidewire 106, the coupler 108, and the syringe 110, or any portion of a component selected from the foregoing, can include an antimicrobial agent thereon or therein. In one example, the catheter tube 112 of the RICC 102 can include an antimicrobial agent coating on the abluminal surface of the catheter tube 112, the luminal surface of the catheter tube 112, or both. In another example, the pre-extrusion material of the catheter tube 112 can include an antimicrobial agent mixed therein such that the antimicrobial agent is incorporated into the catheter tube 112 upon extrusion, and the antimicrobial agent protects both the abluminal surface of the catheter tube 112 and the luminal surface of the catheter tube 112 from microbial contamination.

[0051] FIG. 21 illustrates the RICC 102 of the RICC insert assembly 100, according to some embodiments. As shown, the RICC 102 may include a catheter tube 112 , a catheter hub 114 , one or more extension legs 116 , and one or more extension leg connectors 118 .

[0052] 22-25 show various views of the catheter tube 112 of the RICC 102, according to some embodiments. The catheter tube 112 may include 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.

[0053] The first section 120 of the catheter tube 112 can include a catheter tip 126 having a relatively short taper from the outer diameter of a distal portion of the first section 120 distal to the junction 124 to the outer diameter of the distal end of the first section 120. The taper of the catheter tip 126 can be configured to immediately dilate tissue around the puncture 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. 25 , the first section 120 of the catheter tube 112 can also include a proximal portion that is disposed within a bore in the distal portion of the junction 124 and fixedly joined thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0054] The second section 122 of the catheter tube 112 can include 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 can be configured for smooth insertion into the puncture path and target vasculature after any expansion by the first section 120 of the catheter tube 112 and the connector 124. The distal end of the second section 122 of the catheter tube 112 can have a flattened surface that is flush with and fixedly bonded to the flattened proximal end of the connector 124, such as by solvent bonding, adhesive bonding, or heat welding.

[0055] The connector 124 may include a taper along its length from the proximal end of the connector 124 to the distal end of the connector 124. The taper of the connector 124 may be configured to immediately expand the tissue around the puncture path 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 connector 124 may smoothly transition 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 when the catheter tube 112 is inserted into the puncture path. In addition to minimal or negligible edges, the edges can include solvent interdiffusion polymer material from the polymer material forming the catheter tube 112, which provides a smooth transition from the first section 120 of the catheter tube 112 to the connector 124, and from the connector 124 to the second section 122 of the catheter tube 112. In particular, the connector 124 can have 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 that is 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 can be less than the length of the connector 124, and can be up to approximately equal to the length of the connector 124.

[0056] The first section 120 of the catheter tube 112 can be formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer, and the second section 122 of the catheter tube 112 can be formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer that is lower than the first durometer. For example, the first section 120 of the catheter tube 112 can be formed from a first polyurethane having a first durometer, and the second section 122 of the catheter tube 112 can be formed from a second, different polyurethane 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 link 124 can be formed from a second polymeric material or a third polymeric material (e.g., yet another polyurethane) having a third durometer hardness that is lower than the first durometer hardness and higher than, approximately equal to, or less than the second durometer hardness.

[0057] 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 lower than the first durometer hardness of the first polymeric material if the second durometer hardness or the third durometer hardness is lower than the first durometer hardness. 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 hardnesses.

[0058] The above-described first section 120 of the catheter tube 112, the second section 122 of the catheter tube 112, and the connection 124 between the first section 120 and the second section 122 of the catheter tube 112 may allow the catheter tube 112 to have sufficient column strength to prevent buckling of the catheter tube 112 when inserted into the puncture path established by the introducer needle 104. The column strength of the catheter tube 112 may also be sufficient to prevent buckling of the catheter tube 112 when advanced through the patient's vascular system without pre-dilating the tissue around the puncture path or any blood vessels in the vascular system using a separate dilator.

[0059] The catheter tube 112 may include 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. 22-25). In fact, the first section 120 of the catheter tube 112 typically has one lumen therethrough, as shown in FIGS. 23 and 25.

[0060] A catheter hub 114 can be coupled to a proximal portion of the catheter tube 112. The catheter hub 114 can include one or more catheter hub lumens corresponding to the number of the one or more catheter tube lumens. The one or more catheter hub lumens can extend entirely through the catheter hub 114 from the proximal end of the catheter hub 114 to the distal end of the catheter hub 114.

[0061] Each extension leg of the one or more extension legs 116 can be coupled by its distal portion to the catheter hub 114. Each of the one or more extension legs 116 can include one or more extension leg lumens, the number of extension leg lumens corresponding to the number of one or more catheter hub lumens. Each extension leg lumen of the one or more extension leg lumens can extend entirely through the extension leg, from the proximal end of the extension leg to the distal end of the extension leg.

[0062] Each of the one or more extension leg connectors 118 can cover 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 covering 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 the ready-to-deploy state of the RICC insertion assembly 100, at least one extension leg connector (e.g., an extension leg connector including a portion of the primary lumen 128 of the RICC 102) is typically connected to the swivel arm connector 194 of the swivel arm 182 of the coupler 108 to force a loop of the access guidewire 106 and the RICC 102 thereover.

[0063] As shown, the RICC 102 may be a tri-lumen RICC including a set of three lumens. However, the RICC 102 is not limited to the set of three lumens described above. The set of three lumens may include a primary lumen 128, a secondary lumen 130, and a tertiary lumen 132 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 128 may have 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 may have a secondary lumen aperture 136 on the side of the distal portion of the catheter tube 112. The tertiary lumen 132 may have a tertiary lumen aperture 138 on the side of the catheter tube 112 in the distal portion, proximal to the secondary lumen aperture 136 .

[0064] 4, 5, and 18-20 show various views of the introducer needle 104 of the RICC insertion assembly 100, according to some embodiments. As shown, the introducer needle 104 may include a needle shaft 140, a sheath 142 that covers the needle shaft 140, and a needle hub 144 that covers both a proximal portion of the needle shaft 140 and a proximal portion of the sheath 142. At least in the ready-to-deploy state of the RICC insertion assembly 100, the needle shaft 140 and the sheath 142 may extend from the needle hub 144, through the valve module 180 or its gasket 198, and out the distal end of the coupler housing 178.

[0065] The needle shaft 140 may include 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 through the needle tip 146 .

[0066] The needle tip 146 may include a bevel having a tip bevel 152 and a primary bevel 154 proximal to the tip bevel 152. The tip bevel angle of the tip bevel 152 may be greater than the primary bevel angle of the primary bevel 154 so that the bevel provides a smooth transition across the needle tip 146. Such a needle tip may therefore be configured to establish a puncture path from a region of skin into a vascular lumen of a patient in accordance with the puncture path establishment step of the method described below.

[0067] The needle slot 148 can extend from at least a proximal portion of the needle shaft 140 through 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 extending through the needle shaft. While the needle slot 148 is shown on the top of the needle shaft 140, it should be understood that the needle slot 148 can also be on the bottom of the needle shaft 140 or on a side of the needle shaft 140, and this needle slot location can be on the same or a different side of the RICC insertion assembly 100 as the coupler housing slot 186, the slit 200 in the gasket 198, or both. The needle slot 148 can have a width sized according to the outer diameter of the access guidewire 106, allowing the access guidewire 106 to pass from the proximal portion of the needle shaft 140 through the needle tip 146 when the introducer needle withdrawal step of the method described below is performed.

[0068] It should be understood that the needle shaft 140 may include the needle slot 148 described above, while the introducer needle 104 includes a needle lumen 158, however, the needle lumen 158 results from the combination of the needle shaft 140 and the sheath 142 that covers the needle shaft 140. In fact, the sheath 142 that covers the needle shaft 140 may seal the needle slot 148 therebelow 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 step of the method described below.

[0069] The sheath 142 may include a sheath tip 160 at a distal portion of the sheath 142 and a sheath opening 162 at a side of a proximal portion of the sheath 142 . The sheath tip 160 can include a relatively short taper from the outer diameter of the distal portion of the sheath 142 to the outer diameter of the distal end of the sheath 142, which can be comparable to the outer diameter of the distal portion of the needle shaft 140. The taper can have a taper angle that is less than the primary bevel angle of the primary bevel 154 of the needle tip 146, which may be less than the tip bevel angle of the tip bevel 152 of the needle tip 146. A sheath tip 160 including such a taper can be configured to provide a smooth transition from the needle tip 146 to the sheath body for the puncture path establishment step of the method described below.

[0070] The sheath opening 162 opens into the needle slot 148 of the needle shaft 140 and can form an opening on the side of the introducer needle 104, thereby allowing the access guidewire 106 to pass through the sheath opening 162 and needle slot 148 and enter the introducer needle 104 when the RICC insertion assembly 100 is in a ready-to-deploy state. Thus, the sheath opening 162 can have a width approximately equal to the width of the needle slot 148, which can be sized according to the diameter of the access guidewire 106. However, in some embodiments, the sheath opening 162 and needle slot 148 can be wider than the diameter of the access guidewire 106 to accommodate the blade 192 of the valve module 180 on the side of the access guidewire 106 within the sheath opening 162. Additionally, the sheath opening 162 may be long enough to accommodate the blade 192 of the valve module 180 beneath the distal end of the sheath opening 162 while still allowing the access guidewire 106 to pass through the sheath opening 162 and enter the needle slot 148. In particular, the sheath 142 covering the needle shaft 140 may seal the needle slot 148 below it except for a portion of the needle slot 148 below the sheath opening 162. However, the valve module 180 or its gasket 198 may seal over the needle slot 148 exposed by the sheath opening 162 by sealing the needle shaft 140 and the proximal portion of the sheath 142 therein, thereby allowing the syringe 110 to aspirate blood in accordance with the blood aspirating step of the method described below.

[0071] The sheath 142, or sheath body thereof, may be 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 following the puncture path establishment step of the method described below. Additionally, the polymeric material may have sufficient mechanical properties, particularly at the thickness of the sheath 142, to prevent the sheath 142 from collapsing into the needle slot 148 of the needle shaft 140 when the blood aspiration step of the method described below is performed, while also facilitating detachment of the sheath 142 from the needle shaft 140 following the introducer needle withdrawal step of the method described below. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0072] The needle hub 144 may include an access guidewire groove 164 at a distal portion of the needle hub 144 and a needle hub connector 166 at a proximal portion of the needle hub 144 .

[0073] The access guidewire groove 164 in the needle hub 144 can be configured to allow the access guidewire 106 to pass over the needle hub 144 and direct the access guidewire 106 into the access guidewire channel 206 in the gasket 198, which in turn directs the access guidewire 106 into both the sheath opening 162 in the sheath 142 and the needle slot 148 in the needle shaft 140 therebelow. The access guidewire groove 164 can be open such that the access guidewire 106 is located within the access guidewire groove 164 at least in the ready-to-deploy state of the RICC insertion assembly 100. Advantageously, an open access guidewire groove 164 can allow the access guidewire 106 to remain in place when the introducer needle 104 is withdrawn from the RICC insertion assembly 100 in accordance with the introducer needle withdrawal step of the method described below.

[0074] The needle hub connector 166 may include 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 can be configured to receive a syringe tip 172 of the syringe 110 therein to fluidly connect the introducer needle 104 to the syringe 110. Indeed, 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.

[0075] A needle hub flange 170 of the needle hub connector 166 can be 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 can advantageously provide a so-called luer lock connection with the internal threads 174 of the threaded collar 176, if both are present. This can provide additional security against inadvertent separation of the introducer needle 104 and syringe 110 beyond that provided by an otherwise luer slip connection.

[0076] 2-5 show various views of the coupler 108 of the RICC insert assembly 100, according to some embodiments. As shown, the coupler 108 may include a coupler housing 178 and a valve module 180 disposed within the coupler housing 178. However, it should be understood that in some embodiments, the coupler housing 178 and the valve module 180 or its gasket 198 may be molded together into a unitary elastomeric or thermoplastic part, whereby the unitary part includes portions corresponding to the coupler housing 178 and the valve module 180 or its gasket 198. Regardless of whether the coupler 108 has the aforementioned unitary or separate parts for the coupler housing 178 and the valve module 180, the coupler 108 may also include a pivot arm 182 pivotally coupled to the coupler housing 178.

[0077] The coupler housing 178 can include several complementary molded parts joined together, such as two molded parts joined together to form the body of the coupler housing 178. The body of the coupler housing 178 can be symmetrical, having two molded parts or halves that are substantially mirror images of each other, as shown, for example, in FIGS. 3 and 13A. Indeed, with respect to at least the coupler housing 178 of FIG. 13A, the two molded parts or halves are substantially mirror images of each other, in that they are mirror images except for the joining features 183 that join them. Alternatively, the body of the coupler housing 178 can be asymmetrical, having two molded parts, such as an open box part and a lid part, that are not related to each other by a symmetry operation, as shown, for example, in FIGS. 10-12, 13B, 13C, 14, 15, 16A, and 16B. The body of the coupler housing 178 can have any of several shapes that can be held in the hand. In one example, the body of the coupler housing 178 can be oval-shaped, as shown in FIG. 3 , and is configured to be comfortably held underhand (e.g., cradle-shaped) or overhand in either the left hand for left-handed venipuncture using the RICC insertion assembly 100 or the right hand for right-handed venipuncture. In another example, the body of the coupler housing 178 can be more rectangular-shaped, as shown in any of FIGS. 10-15 , 16A , and 16B , and is similarly configured to be comfortably held underhand or overhand in venipuncture using the RICC insertion assembly 100. To further facilitate such venipuncture, the exterior of each of the molded parts can be textured, such as with arcuate ridges 184 that enhance grip, as shown in FIG. 3 . The interior of each of the molded parts can include recesses that form the valve module section 185 and needle hub receptacle when the molded parts are joined together as shown. (See FIGS. 4 and 5, which show the valve module 180 or its gasket 198 disposed within a recess in a molded part (e.g., mold half) that forms part of the valve module section 185.4 and 5 also include the needle hub 144 of the introducer needle 104 positioned within a recess in the same molded part forming the needle hub receptacle.) Opposing molded parts of the coupler housing 178, such as the two molded parts shown in FIG. 3, can include lock button through-holes for a pair of lock buttons 188 in the needle hub lock. (See FIG. 3 for the pair of lock buttons 188 extending through a corresponding pair of lock button through-holes.) Additionally, opposing molded parts, such as the two molded parts shown in Figures 3, 13A, and 13B, can form an access guidewire conduit 190 of the coupler housing 178 between them. Alternatively, the access guidewire conduit 190 can be formed within a single part of the coupler housing 178, such as that shown in Figure 10. The access guidewire conduit 190 can be configured to direct the access guidewire 106 over the access guidewire groove 164 of the needle hub 144, to receive the access guidewire 106 from the access guidewire groove 164 of the needle hub 144, or both. The access guidewire 106 can then be directed by the access guidewire conduit 190 or the access guidewire groove 164 through the proximal end portion of the gasket 198 and into the access guidewire channel 206, which can then direct the access guidewire 106 into both the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140 therebelow. Finally, the coupler housing 178 can include a longitudinal coupler housing slot 186 formed between molded parts, such as between the two molded parts shown in FIG. 3. The coupler housing slot 186 can be configured to allow the access guidewire 106 to exit the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108 during an introducer needle withdrawal step of the method described below. In particular, the coupler housing slot 186 may be located on the bottom of the coupler housing 178 as shown in FIG. 3, on the top of the coupler housing 178, or on the side of the coupler housing 178. Additionally, the coupler housing slot 186 may be located on the same side of the RICC insertion assembly 100 as the needle slot 148, the slit 200 in the gasket 198, or both, or on a different side.

[0078] The valve module compartment 185 can be configured to retain the valve module 180 or its gasket 198 therein. Indeed, the valve module compartment 185 can include the valve module 180 or its gasket 198 disposed therein when the RICC insertion assembly 100 is in a ready-to-deploy state. The valve module compartment 185 can be configured, for example, to compress the gasket 198 of the valve module 180 with the sides of the coupler housing 178 (e.g., the sides of the open box and lid components shown between FIGS. 11 and 12 or between FIGS. 14 and 15 ) when the RICC insertion assembly 100 is in a ready-to-deploy state, while the valve module compartment 185 can be further configured to have sufficient space when the compression is released, when the introducer needle 104 is withdrawn from the coupler 108, or when they are combined, to allow any components, or components of the gasket 198 described below, to separate and allow the access guidewire 106 to exit.

[0079] The needle hub receptacle can be configured to hold the needle hub 144 of the introducer needle 104 therein. Indeed, the needle hub receptacle can include the needle hub 144 inserted therein when the RICC insertion assembly 100 is in a ready-to-deploy state. In particular, a needle hub lock configured to lock the needle hub 144 within the needle hub receptacle can be positioned around the needle hub receptacle. A pair of locking buttons 188 (e.g., spring-loaded locking buttons) of the needle hub lock can be distributed between opposite sides of the coupler 108, specifically within locking button through-holes in the two molded parts of the coupler housing 178 shown in FIG. 3 , such that each locking button of the pair of locking buttons 188 extends through the coupler housing 178 on each side of the coupler 108. The pair of locking buttons 188 can be configured to unlock the needle hub 144 when pressed into the coupler 108 to withdraw the introducer needle 104 from the coupler 108 during the introducer needle withdrawal step of the method described below.

[0080] The valve module 180 can include an elastomeric gasket 198 and, optionally, a braid 192. The gasket 198 can range from a relatively low Shore A durometer to a relatively high Shore A durometer or a relatively low Shore D durometer, although it should be understood that in some embodiments, the gasket 198 can alternatively be a rigid thermoplastic insert or the like. Such an insert can be formed from a single piece or from two or more complementary pieces mated together to form any of the shapes described below for the gasket 198, but the insert can be fitted with elastomeric components such as a relatively thin compressible gasket between any two pieces of the insert, compressible “O” rings within the proximal needle through-hole 202, the distal needle through-hole 204, and the access guidewire channel 206 to create a substantially airtight space within the insert around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106.

[0081] The gasket 198 can be configured to surround at least a portion of the valve module compartment 185 of the coupler housing 178 along the length of the valve module compartment 185. Such a gasket may approximate a rectangle or a right-angled trapezoid when viewed from its long side, as shown in FIGS. 6 and 7, respectively. However, it should be understood that the gasket 198 is not limited to the aforementioned shapes. The gasket 198 can be configured to be compressed around the proximal portion of the introducer needle 104 within the valve module compartment 185 by the sides of the coupler housing 178 (e.g., the sides of the open box and lid components) in the ready-to-deploy state of the RICC insertion assembly 100, for example, as shown between FIGS. 11 and 12 or between FIGS. 14 and 15, thereby creating a substantially airtight space within the gasket 198 around the proximal portion of the introducer needle 104, optionally with the aid of a lubricant, for aspirating at least blood in accordance with the blood aspirating step of the method described below. The gasket 198 can also be configured to be compressed around the distal portion of the access guidewire 106 within the valve module section 185 when the RICC insertion assembly 100 is in a ready-to-deploy state, thereby allowing the access guidewire 106 to pass through and enter the side openings of the introducer needle 104, specifically the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140, while also creating a substantially airtight space within the gasket 198 around the distal portion of the access guidewire 106, optionally using a lubricant. In particular, the compression of the gasket 198 within the valve module section 185 is optimized to meet at least the minimum pressure requirements for blood aspiration by the introducer needle 104 while maintaining the access guidewire insertion force of the access guidewire 106 as low as possible when the access guidewire 106 is inserted into the access guidewire channel 206 of the gasket 198 and passed through the access guidewire channel 206 into the side opening of the introducer needle 104.

[0082] The gasket 198 can be formed from a single piece or two or more complementary pieces that fit together. If the gasket 198 is formed from a single piece, it can include a longitudinal slit 200 through the top or bottom of the gasket 198 that is configured to separate the access guidewire 106 and allow it to exit the gasket 198 when compression on the gasket 198 is released, when the introducer needle 104 is withdrawn from the coupler 108, or when they are combined. Indeed, Figures 6, 7, 8A, 8B, 10, 13A, and 13B show a slit 200 through the top of the gasket 198 that separates the access guidewire 106 and allows it to exit the top of the gasket 198 when compression on the gasket 198 is released, when the introducer needle 104 is withdrawn from the coupler 108, or both. When the gasket 198 is formed from two or more complementary parts, the gasket 198 can be substantially symmetrical or asymmetrical. For example, when the gasket 198 is formed from two complementary parts that are substantially mirror images of each other, the gasket 198 can be substantially symmetrical along a longitudinal plane of symmetry that runs through the majority of the gasket 198. (See Figure 9.) However, when the gasket 198 is asymmetrical, the two or more complementary parts of the gasket 198 are not related to each other by a symmetry operation. In particular, when the gasket 198 is formed from two or more complementary parts, the gasket 198 does not need to include a slit 200 that penetrates the top or bottom of the gasket 198, because the two or more complementary parts of the gasket 198 can be configured to separate the access guidewire 106 and allow the access guidewire 106 to exit the gasket 198 when compression on the gasket 198 is released, when the introducer needle 104 is withdrawn from the coupler 108, or when they are combined.

[0083] Whether the gasket 198 is formed from a single piece or two or more complementary pieces, the gasket 198 can include a proximal needle through-hole 202 through a proximal end portion of the gasket 198 and a distal needle through-hole 204 through a distal end portion of the gasket 198 that is aligned with the proximal needle through-hole 202, and the proximal needle through-hole 202 and the distal needle through-hole 204 can be coincident with or offset from a central longitudinal axis of the gasket 198. Additionally, the gasket can include an access guidewire channel 206 through the proximal end portion of the gasket 198, proximal to the proximal needle through-hole 202. The proximal needle through hole 202 can be configured to align with the proximal needle through hole 203 of the coupler housing 178, if present, the distal needle through hole 204 can be configured to align with the distal needle through hole 205 of the coupler housing 178, if present, and the access guidewire channel 206 can be configured to align with the access guidewire conduit 190, the access guidewire groove 164, or both, if present. In particular, if the gasket 198 is formed from two or more complementary pieces, such as the two complementary pieces of the gasket 198 shown in FIG. 9 , the proximal needle through hole 202, the distal needle through hole 204, and the access guidewire channel 206 can be formed between two or more pieces of the gasket 198, such as between the two pieces of the gasket 198, when the two or more pieces of the gasket 198 are mated together. For example, half of each of the proximal needle through-hole 202, the distal needle through-hole 204, and the access guidewire channel 206 can be formed in each of the two aforementioned parts of the gasket 198, so that when the two parts of the gasket 198 are mated together, the proximal needle through-hole 202, the distal needle through-hole 204, and the access guidewire channel 206 are completed.

[0084] Each of the proximal needle through-hole 202 and the distal needle through-hole 204 may be circular in cross-section and have an inner diameter equal to, greater than, or less than the outer diameter of the introducer needle 104. If either the proximal needle through-hole 202 or the distal needle through-hole 204 is not circular in cross-section, the proximal needle through-hole 202 or the distal needle through-hole 204 may, in some cases, be elliptical in cross-section, as shown in FIG. 8B , with the major axis of the proximal needle through-hole 202 or the distal needle through-hole 204 equal to, greater than, or less than the outer diameter of the introducer needle 104 and the minor axis of the proximal needle through-hole 202 or the distal needle through-hole 204 equal to, greater than, or less than the outer diameter of the introducer needle 104, with the minor axis being less than the major axis. The proximal needle through-hole 202 and the distal needle through-hole 204 are thereby configured to receive a proximal portion of the introducer needle 104 therethrough, such that the proximal portion of the introducer needle 104 passes through the proximal needle through-hole 202 and the distal needle through-hole 204 when the RICC insertion assembly 100 is in a ready-to-deploy state. In particular, if the gasket 198 is formed from a single piece, the distal needle through-hole 204 may coincide with a distal terminal portion of the slit 200 through the top or bottom of the gasket 198, as the case may be. However, the inner diameter, major axis, or minor axis may again be equal to, greater than, or smaller than the outer diameter of the introducer needle 104.

[0085] Access guidewire channel 206 may be circular in cross section, have an inner diameter equal to, greater than, or less than the outer diameter of access guidewire 106, and may pass through the proximal end portion of gasket 198, as described above. If access guidewire channel 206 is not circular in cross section, access guidewire channel 206 may be elliptical in cross section, as shown in FIG. 8B, with the major axis of access guidewire channel 206 equal to, greater than, or less than the outer diameter of access guidewire 106 and the minor axis of access guidewire channel 206 equal to, greater than, or less than the outer diameter of access guidewire 106, the minor axis being less than the major axis. The access guidewire channel 206 can form an acute angle with the proximal needle through-hole 202, thereby directing the distal portion of the access guidewire 106 through both the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140 and into the proximal portion of the introducer needle 104. Notably, if the gasket 198 is formed from a single piece, the access guidewire channel 206 may coincide with the proximal terminal portion of the slit 200 that passes through the top or bottom of the gasket 198, as the case may be. However, the inner diameter, major axis, or minor axis of the access guidewire channel 206 may again be equal to, larger than, or smaller than the outer diameter of the access guidewire 106, but need not be different from the slit 200 itself. That is, the access guidewire channel 206 can be the proximal terminal portion of the slit 200.

[0086] The blade 192 can extend into the valve module 180 from an attachment point in the coupler housing 178 to which the blade 192 is to be coupled, through a slit 200 or between two of two or more parts of the gasket 198. Alternatively, the blade 192 may be incorporated into the gasket 198 itself, for example, such that the blade 192 extends from the top of the gasket 198. Whether the blade 192 extends into the valve module 180 through the gasket 198 or from the top of the gasket 198 itself, the blade 192 can extend into the needle slot 148 of the needle shaft 140 such that the blade 192 is positioned in the needle slot 148 distal to the access guidewire 106 below the distal end of the sheath opening 162 of the sheath 142 as shown in FIG. 16B or to the side of the access guidewire 106 as shown in FIG. 16A. The blade 192 may include a distally facing blade edge configured to decouple the sheath 142 from the needle shaft 140 as the introducer needle 104 is withdrawn proximally from the coupler 108 during an introducer needle withdrawal step of the method described below. Decoupling the sheath 142 from the needle shaft 140 allows the access guidewire 106 to exit the needle shaft 140 via the needle slot 148. Notwithstanding the above, it should be understood that, particularly in embodiments lacking the blade 192, the guidewire itself may instead decouple the sheath 142 from the needle shaft 140 as the introducer needle 104 is withdrawn proximally from the coupler 108.

[0087] 13B and 13C show at least a portion of the coupler housing 178 including the gasket 198 of the valve module 180 disposed within the valve module compartment 185 of the coupler housing 178, along with the compression clip 193, according to some embodiments.

[0088] As shown, the coupler 108 can further include a compression clip 193 in addition to the coupler housing 178 and the valve module 180. The compression clip 193, if present, can be configured to fit over opposing molded parts of the coupler housing 178 and clip those molded parts together with a gasket 198 of the valve module 180 disposed within the valve module compartment 185 of the coupler housing 178, thereby compressing the gasket 198 under a spring-like load applied by the compression clip 193. Compressing the gasket 198 under such a load seals both the introducer needle 104 and the access guidewire 106 within the valve module 180 or its gasket 198, for example, in the ready-to-deploy state of the RICC insertion assembly 100. In particular, the compression clip 193 can be advantageous in reducing or eliminating the effects of any manufacturing variations across the coupler housing 178, the valve module 180, or both the coupler housing 178 and the valve module 180, thereby reducing or eliminating sealing-related issues resulting from such manufacturing variations.

[0089] The compression clip 193 may vary in configuration and with respect to various additional features, if any. For example, the compression clip 193 may further include a secondary clip 195 at a portion of the compression clip 193, such as at its proximal end portion, where the secondary clips 195 are biased toward one another. When such a secondary clip 195 is present in the compression clip 193, the opposing molded parts of the coupler housing 178 may include a complementary recess 197 in an outward-facing wall of a portion of the coupler housing 178, such as at its proximal end portion, where the recess 197 is configured to receive the biased secondary clip 195 therein. When the secondary clip 195 of the compression clip 193 is positioned within the recess 197 of the coupler housing 178, the compression clip 193 and the coupler housing 178 together prevent the compression clip 193 and the coupler housing 178 from moving proximally or distally relative to one another. Alternatively, the secondary clip 195 of the compression clip 193 can extend from an end portion of the compression clip 193 as shown, but can extend beyond an end portion of the wall of the coupler housing 178 when the compression clip 193 fits over opposing molded parts of the coupler housing 178 to clip these molded parts together. In such a configuration, the secondary clip 195 can prevent the compression clip 193 and the coupler housing 178 from moving relative to one another in at least one direction. For example, if the secondary clip 195 of the compression clip 193 extends from a proximal end portion of the compression clip 193 as shown, but extends beyond an end portion of the wall of the coupler housing 178 at the proximal end portion of the coupler housing 178, the secondary clip 195 can prevent the compression clip 193 from moving distally on the coupler housing 178, which is the opposite direction from the location of the secondary clip 195 on the compression clip 193.To prevent the compression clip 193 and the coupler housing 178 from moving in both directions relative to one another, opposing end portions of the compression clip 193 (e.g., the distal end portion of the compression clip 193) may also include secondary clips 195 that extend from the opposing end portions of the compression clip 193 and beyond opposing end portions of the walls of the coupler housing 178 (e.g., the end portions of the walls of the coupler housing 178 at the distal end portion of the coupler housing 178) when the compression clip 193 fits over opposing molded parts of the coupler housing 178 to clip those molded parts together. That said, one or more protrusions extending from the end portions of the walls of the coupler housing 178 beyond the end portions of the compression clip 193, such as protrusion 199 shown in FIGS. 13B and 13C , may be used like the secondary clips 195 to prevent the compression clip 193 and the coupler housing 178 from moving relative to one another. Indeed, any combination of one or more clips of the secondary clip 195 and one or more of the protrusions described above may be used to prevent movement of the compression clip 193 and the coupler housing 178 relative to one another.

[0090] FIG. 17 illustrates a lubrication mechanism for lubricating the introducer needle 104 and the access guidewire 106, according to some embodiments. The lubrication mechanism for lubricating the introducer needle 104 and the access guidewire 106 may include applying a lubricant to the introducer needle 104 and the access guidewire 106 prior to assembling the RICC insertion assembly 100, but the lubrication mechanism may alternatively or additionally include one or more lubricant wells 201, one or more lubricant receptacles 207, or a combination thereof, distributed around the coupler housing 178, the gasket 198, or both the coupler housing 178 and the gasket 198.

[0091] One of the one or more lubricant wells 201 may be a compartment or chamber in the coupler housing 178 or gasket 198 that is at least partially filled with lubricant prior to inserting the introducer needle 104 or access guidewire 106 into the coupler 108 during assembly of the RICC insertion assembly 100. One of the one or more lubricant receptacles 207 may be a recess in the coupler housing 178 or gasket 198 that is optionally smaller than the compartment or chamber corresponding to said lubricant well 201, and in particular, does not contain any lubricant therein prior to inserting the introducer needle 104 or access guidewire 106 into the coupler 108 during assembly of the RICC insertion assembly 100. Indeed, such a lubricant receptacle 207 may be configured to be lubricated with a lubricant before the introducer needle 104 or access guidewire 106 is inserted into the coupler 108, or to receive lubricant from either the introducer needle 104 or access guidewire 106 as they are inserted into the coupler 108 and pass through one or more lubricant wells 201 during assembly of the RICC insertion assembly 100. Then, once such a lubricant receptacle 207 receives lubricant as described above, the lubricant receptacle 207 may redistribute the lubricant onto the introducer needle 104 or access guidewire 106 as they are further inserted into or withdrawn from the coupler 108.

[0092] The one or more lubricant wells 201 and the one or more lubricant receptacles 207 are not limited in number, shape, size, or location in the coupler 108. In one example, the lubricant well 201 shown in FIG. 17 resembles an eccentric annular compartment within the coupler housing 178 and, when at least partially filled with lubricant, interfaces with both the introducer needle 104 and the access guidewire 106 due to its size, but partially with the access guidewire 106. However, the lubricant well 201 shown in FIG. 17 may instead resemble two concentric annular compartments stacked around the introducer needle 104 and the access guidewire 106, respectively, which are optionally fluidly connected at their edges to facilitate filling the annular compartments with lubricant. Furthermore, the lubricant well 201 shown in FIG. 17 may alternatively be located in a distal portion of the coupler housing 178 instead of in a proximal portion of the coupler housing 178 as shown. 17 may alternatively approximate a single concentric annular recess around the introducer needle 104. In another example, the lubricant receptacle 207 shown in FIG. 17 may alternatively approximate two linearly separated concentric annular recesses in the gasket 198, which interface only with the introducer needle 104. However, two additional lubricant receptacles 207, such as the lubricant receptacle shown in FIG. 17, may be added to the gasket 198 to also interface with the access guidewire 106. Furthermore, the lubricant receptacle 207 shown in FIG. 17 may alternatively approximate a single concentric annular recess around the introducer needle 104. Furthermore, the lubricant receptacle 207 shown in FIG. 17 may alternatively be located in a distal portion of the gasket 198 instead of in a proximal portion of the gasket 198 as shown.

[0093] The pivot arm 182 may include a pivot arm connector 194 that is connected to one of the one or more extension leg connectors 118 when the RICC insertion assembly 100 is in a ready-to-deploy state. Although not shown, the pivot arm connector 194 may include an access guidewire attachment point therein to which a proximal end of the access guidewire 106 is attached when the RICC insertion assembly 100 is in a ready-to-deploy state. This, combined with the distal end of the access guidewire 106 being disposed within the needle lumen 158 of the introducer needle 104, may force the access guidewire 106 into a loop as described above. Advantageously, the pivot arm 182 may be configured to flip a 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 using the RICC insertion assembly 100. In fact, the pivot arm 182 can be configured to flip the 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 pivot arm 182 can be configured to flip the 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.

[0094] 1, 2, and 5 show various views of the access guidewire 106 of the RICC insertion assembly 100, according to some embodiments. The access guidewire 106 may include a proximal portion including a proximal end and a distal portion including a distal end. When the RICC insertion assembly 100 is in a ready-to-deploy state, the proximal end of the access guidewire 106 may be coupled to the pivot arm 182, specifically, to an access guidewire attachment point within the pivot arm connector 194 of the pivot arm 182. Additionally, the proximal portion of the access guidewire 106 may extend along the primary lumen 128 of the RICC 102. A distal portion of the access guidewire 106 may also extend along the primary lumen 128 of the RICC 102, but the distal portion of the access guidewire 106 may further extend from the distal end of the RICC 102, via the access guidewire groove 164, into the valve module 180 or its gasket 198 on the needle hub 144, through both the sheath opening 162 of the sheath 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 when the RICC insertion assembly 100 is in the ready-to-deploy state. As shown in FIG. 5 , the distal end of the access guidewire 106 may be positioned within the needle lumen 158 proximally just before the needle tip 146 when the RICC insertion assembly 100 is in the ready-to-deploy state. Again, when the RICC insertion assembly 100 is ready to be deployed, the proximal and distal ends of the access guidewire 106 can be forced into a loop around the access guidewire 106, with the RICC 102 positioned over the loop, thereby maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0095] 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 a guidewire tip can be straight in a ready-to-deploy state of the RICC insertion assembly 100 and curved when the guidewire tip 196 is advanced beyond the needle tip 146 (e.g., into the lumen of a blood vessel) in a deployed state of the RICC insertion assembly 100.

[0096] The access guidewire 106 may also include a bare wire portion and a wound wire portion distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, the bare wire portion, if present, may extend distally through the access guidewire channel 206 of the gasket 198 such that the gasket 198 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. Notably, the aforementioned bare wire portion may instead be a flatwound or groundwound portion of the access guidewire 106, where a flatwound portion includes a wrap of tape instead of a round wire and a groundwound portion includes a wrap of round wire that has been polished to flatten the wrap.

[0097] Introducer Assembly FIG. 26 shows a top view of the introducer assembly 208, according to some embodiments.

[0098] As shown, the introducer assembly 208 may include an introducer needle 104, a coupler 108, an access guidewire 106, and optionally, a syringe 110 fluidly connected to the introducer needle 104 when the introducer assembly 208 is in a ready-to-deploy state. As described above, the introducer needle 104 may include a needle shaft 140 and a sheath 142 covering the needle shaft 140. The needle shaft 140 may include a needle slot 148 extending from a proximal portion of the needle shaft 140 through a distal needle tip 146. The sheath 142 covering the needle shaft 140 may seal the needle slot 148 below it, except for a portion of the needle slot 148 below a sheath opening 162 in the proximal portion of the sheath 142. The coupler 108 can include a coupler housing 178 and a valve module 180 disposed within a valve module compartment 185 of the coupler housing 178. The valve module 180 can include a gasket 198 that surrounds at least a portion of the valve module compartment 185 of the coupler housing 178 along the length of the valve module compartment 185. The gasket 198 within the valve module compartment 185 can be compressed around a proximal portion of the introducer needle 104 in a ready-to-deploy state of the introducer assembly 208, thereby creating a substantially airtight space within the gasket 198 around the proximal portion of the introducer needle 104. The access guidewire 106 can include a distal portion that passes through both the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140 and enters the introducer needle 104. The gasket 198 within the valve module section 185 can also be compressed around the distal portion of the access guidewire 106 when the introducer assembly 208 is in a ready-to-deploy state, thereby further creating a substantially airtight space within the gasket 198 around the distal portion of the access guidewire 106.The access guidewire 106 also includes a distal end that is positioned within the introducer needle 104, proximally just prior to the needle tip 146 at the distal end of the introducer needle 104. Further details of the introducer needle 104, coupler 108, access guidewire 106, and syringe 110 are described above in the context of the RICC insertion assembly 100.

[0099] method A method of the RICC insertion assembly 100 can include a method for inserting or placing a RICC 102 into a vascular lumen of a patient. Such a method can include one or more steps selected from the steps of obtaining a RICC insertion assembly, establishing a puncture path, aspirating blood, advancing an access guidewire, withdrawing an introducer needle, advancing a RICC, withdrawing an access guidewire, advancing a steering guidewire, advancing another RICC, and withdrawing a steering guidewire.

[0100] The RICC insertion assembly obtaining step can include obtaining a RICC insertion assembly 100. As described above, the RICC insertion assembly 100 can include a RICC, an introducer needle 104, and an access guidewire 106 coupled together by a coupler 108. The coupler 108 can include a coupler housing 178 having a valve module compartment 185 and a valve module 180 disposed within the valve module compartment 185. The valve module 180 can include a gasket 198 that surrounds at least a portion of the valve module compartment 185 of the coupler housing 178 along the length of the valve module compartment 185. The gasket 198 within the valve module section 185 of the coupler housing 178 can be compressed around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 in the ready-to-deploy state of the RICC insertion assembly 100, thereby creating a substantially airtight space within the gasket 198 around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106. In particular, the proximal end of the access guidewire 106 can be coupled to the pivot arm 182 of the coupler 108, while the distal end of the access guidewire 106 is disposed within the introducer needle 104 via the valve module 180 of the coupler 108, thereby forcing the access guidewire 106 into a loop. The RICC 102 can be disposed over the loop of the access guidewire 106 in the ready-to-deploy state of the RICC insertion assembly 100, thereby maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0101] The puncture path establishing step may include establishing a puncture path from the region of skin to the lumen of the blood vessel using the introducer needle 104. Such a puncture path establishing step may include a pivot arm flip step before puncturing the region of skin with the introducer needle 104. The puncture path establishing step may also include a blood backflow ensuring step while establishing the puncture path.

[0102] The pivot arm flipping step can include flipping the pivot arm 182, and thus the loop between the two sides of the RICC insert assembly 100. The pivot arm flipping step can include flipping the loop between the left side of the RICC insert assembly 100 for left-handed venipuncture using the RICC insert assembly 100 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 can accommodate 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 can accommodate right-handed venipuncture using the RICC insert assembly 100.

[0103] The blood backflow ensuring step may include ensuring blood backflow while establishing the puncture path. Ensuring blood backflow may include visually observing blood backflow into the needle hub 144 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 may be applied using the syringe 110 while establishing the puncture path so that blood backflows into at least the needle hub 144 of the introducer needle 104 upon establishment of the puncture path. Ensuring blood backflow as described above may confirm that the puncture path extends into the lumen of the blood vessel.

[0104] The blood aspiration step may include aspirating blood using a syringe 110 fluidly connected to the introducer needle 104 to confirm that the puncture path extends into the blood vessel lumen before performing the introducer needle withdrawal step. The sheath 142 covering the needle shaft 140 may seal the needle slot 148 below it except for a portion of the needle slot 148 below a sheath opening 162 of the sheath 142, which portion of the needle slot 148 may be sealed by a substantially airtight space within a gasket 198 for aspirating blood using the syringe 110.

[0105] The access guidewire advancement step can include advancing the distal end of the access guidewire 106 from its initial position within the needle shaft 140 proximally just before the needle tip 146 of the needle shaft 140 into the vascular lumen, thereby ensuring vascular access for the RICC 102 during the RICC advancement step. To accomplish this, the access guidewire 106 can be first advanced through the proximal end portion of the gasket 198 and into the access guidewire channel 206, for example, by using the thumb and index finger to grasp the access guidewire 106 and push it into the access guidewire channel 206 with an acceptable level of force. As described above, the access guidewire channel 206 can form an acute angle with the proximal needle through-hole 202, thereby directing the distal portion of the access guidewire 106 into the side opening of the introducer needle 104, specifically the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140.

[0106] The introducer needle withdrawal step can include withdrawing the introducer needle 104 from the coupler 108, thereby leaving the access guidewire 106 in place within the blood vessel lumen. The introducer needle 104 is withdrawn from the gasket 198 before the introducer needle 104 is completely withdrawn from the coupler 108. Specifically, the introducer needle 104 can be withdrawn from the proximal needle through-hole 202 through the proximal end portion of the gasket 198 and from the distal needle through-hole 204 through the distal end portion of the gasket 198. As the introducer needle 104 is withdrawn from the proximal needle through-hole 202 and the distal needle through-hole 204 of the gasket 198, the sheath 142 can be simultaneously severed from the needle shaft 140 using either the access guidewire 106 itself or a blade 192 extending through the gasket 198 and into the valve module 180. Detaching the sheath 142 from the needle shaft 140 allows the access guidewire 106 to exit the needle shaft 140 via the needle slot 148 in the needle shaft 140. Again, a single-piece embodiment of the gasket 198 may include a slit 200 in the top of the gasket 198, which further allows the access guidewire 106 to exit through the top of the gasket 198 when the introducer needle 104 is withdrawn from the coupler 108. Notably, the slit 200 in the top of the single-piece embodiment of the gasket 198 may continue to the bottom of the gasket 198, which is formed from two complementary, substantially mirror-image parts mated together. In fact, the symmetry plane described above for the two-piece embodiment of the gasket 198 coincides with the slit 200 in the upper part of the single-piece embodiment of the gasket 198, and the slit 200 can be continued to the lower part of the two-piece embodiment of the gasket 198, thereby further allowing the access guidewire 106 to exit through the lower part of the gasket 198 when the introducer needle 104 is withdrawn from the coupler 108.Finally, the coupler housing 178 may include a coupler housing slot 186 further configured to allow the access guidewire 106 to exit the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108.

[0107] The RICC advancing step may include inserting the RICC 102 into the vessel lumen by advancing the catheter tube 112 of the RICC 102 over the access guidewire 106 and into the vessel lumen.

[0108] The access guidewire withdrawal step can include withdrawing the access guidewire 106, thereby leaving the catheter tube 112 in place within the vessel lumen.

[0109] The steering guidewire advancing step may include advancing the steering guidewire through the primary lumen 128 of the RICC 102 into the lumen of the blood vessel and into the lower third of the SVC of the patient's heart.

[0110] Another RICC advancement step may include further advancing the distal portion of the catheter tube 112 over the steering guidewire and into the vessel lumen up to the lower third of the superior vena cava of the patient's heart.

[0111] The steering guidewire withdrawal step can include withdrawing the steering guidewire, thereby leaving the catheter tube 112 in place in the lower third of the SVC.

[0112] The introducer assembly 208 method can include a method for establishing access to a vascular lumen of a patient, such a method can include one or more steps selected from an introducer assembly obtaining step, a puncture path establishing step, a blood aspiration step, an access guidewire advancing step, an introducer needle withdrawal step, a dilation step, a catheter threading step, and a catheter advancing step.

[0113] The introducer assembly obtaining step can include obtaining an introducer assembly 208. As described above, the introducer assembly 208 can include the introducer needle 104, the access guidewire 106, and the coupler 108 that couples the introducer needle 104 and the access guidewire 106 together. Optionally, the introducer assembly 208 can further include a syringe 110 fluidly connected to the introducer needle 104. The coupler 108 can include a coupler housing 178 having a valve module compartment 185 and a valve module 180 disposed within the valve module compartment 185. The valve module 180 can include a gasket 198 that surrounds at least a portion of the valve module compartment 185 of the coupler housing 178 along the length of the valve module compartment 185. The gasket 198 within the valve module section 185 of the coupler housing 178 can be compressed around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 when the introducer assembly 208 is in a ready-to-deploy state, thereby creating a substantially airtight space within the gasket 198 around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106.

[0114] The step of establishing a puncture path may include establishing a puncture path from the region of skin to the lumen of the blood vessel using the introducer needle 104. As described above, the step of establishing a puncture path may also include ensuring backflow of blood while establishing the puncture path. Again, ensuring that blood flows back into the needle hub 144 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 may confirm that the puncture path extends into the lumen of the blood vessel.

[0115] The blood aspiration step may include aspirating blood using a syringe 110 fluidly connected to the introducer needle 104 to confirm that the puncture path extends into the blood vessel lumen before performing the introducer needle withdrawal step. The sheath 142 covering the needle shaft 140 may seal the needle slot 148 below it except for a portion of the needle slot 148 below a sheath opening 162 of the sheath 142, which portion of the needle slot 148 may be sealed by a substantially airtight space within a gasket 198 for aspirating blood using the syringe 110.

[0116] The access guidewire advancement step can include advancing the distal end of the access guidewire 106 into the vascular lumen from its initial position within the needle shaft 140 proximally just before the needle tip 146 of the needle shaft 140, thereby ensuring vascular access for the dilator if a dilation step is performed, and for the CVC during the catheter advancement step. As mentioned above, the access guidewire 106 can be initially advanced through the proximal end portion of the gasket 198 and into the access guidewire channel 206, for example, by using the thumb and index finger to grasp the access guidewire 106 and push it into the access guidewire channel 206 with an acceptable level of force. Again, the access guidewire channel 206 can form an acute angle with the proximal needle through-hole 202, thereby directing the distal portion of the access guidewire 106 into the side opening of the introducer needle 104, specifically the sheath opening 162 of the sheath 142 and the needle slot 148 of the needle shaft 140.

[0117] The introducer needle withdrawal step may include withdrawing the introducer needle 104 from the coupler 108, thereby leaving the access guidewire 106 in place within the blood vessel lumen. As described above, the introducer needle 104 is withdrawn from the gasket 198 before the introducer needle 104 is fully withdrawn from the coupler 108. Specifically, the introducer needle 104 may be withdrawn from a proximal needle through-hole 202 through a proximal end portion of the gasket 198 and from a distal needle through-hole 204 through a distal end portion of the gasket 198. When the introducer needle 104 is withdrawn from the proximal and distal needle through-holes 202, 204 of the gasket 198, the sheath 142 can be simultaneously disconnected from the needle shaft 140 using either the access guidewire 106 itself or the blade 192 extending through the gasket 198 and into the valve module 180. Disconnecting the sheath 142 from the needle shaft 140 allows the access guidewire 106 to exit the needle shaft 140 via the needle slot 148 in the needle shaft 140. Again, a single-piece embodiment of the gasket 198 can include a slit 200 in the top of the gasket 198, which further allows the access guidewire 106 to exit out the top of the gasket 198 when the introducer needle 104 is withdrawn from the coupler 108. In particular, the slit 200 in the top of a single-piece embodiment of the gasket 198 can be continued to the bottom of the gasket 198, which is formed from two complementary, substantially mirror-image parts mated together. Indeed, the plane of symmetry described above for the two-piece embodiment of the gasket 198 coincides with the slit 200 in the top of the single-piece embodiment of the gasket 198, allowing the slit 200 to be continued to the bottom of the two-piece embodiment of the gasket 198, thereby further allowing the access guidewire 106 to exit through the bottom of the gasket 198 when the introducer needle 104 is withdrawn from the coupler 108.Finally, the coupler housing 178 may include a coupler housing slot 186 further configured to allow the access guidewire 106 to exit the coupler housing 178 when the introducer needle 104 is withdrawn from the coupler 108.

[0118] The dilating step can include dilating the tissue around the puncture path with a dilator before passing the catheter tube of the CVC over the proximal portion of the access guidewire 106 in the catheter passing step. Similar to the catheter passing step and catheter advancing step described below, the dilating step can include a dilator passing step in which a dilator is passed over the proximal portion of the access guidewire 106, and a dilator advancing step in which the dilator is advanced into the blood vessel lumen over the access guidewire 106.

[0119] The catheter threading step may include threading a catheter tube of the CVC over a proximal portion of the access guidewire 106. The CVC may be a RICC 102 as described herein, although it should be understood that any CVC may be used in the present method. Furthermore, if a RICC 102 is used as the CVC, it is not necessary to perform the dilation step, as the RICC 102 is configured to make this unnecessary.

[0120] The catheter advancing step may include advancing the catheter tube of the CVC over the access guidewire 106 and into the vessel lumen. Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter (RICC) insertion assembly comprising: RICC and an introducer needle, a needle shaft including a needle slot extending longitudinally from a proximal portion of the needle shaft to a distal tip; a sheath covering the needle shaft and sealing the needle slot below the sheath except for a portion of the needle slot below a sheath opening in a proximal portion of the sheath; an introducer needle including a coupler for connecting the RICC and the introducer needle to each other, a coupler housing containing a valve module compartment; a valve module disposed within the valve module compartment of the coupler housing, an elastomeric gasket surrounding at least a portion of the valve module section of the coupler housing along a length of the valve module section, the gasket within the valve module section being compressed around a proximal portion of the introducer needle in a ready-to-deploy state of the RICC insertion assembly to create a substantially airtight space within the gasket around a proximal portion of the introducer needle; Valve module and a coupler including:

1. An access guidewire, a distal portion that passes through both the sheath opening of the sheath and the needle slot of the needle shaft and enters the introducer needle, wherein the gasket within the valve module compartment also compresses around the distal portion of the access guidewire to create a substantially airtight space within the gasket around the distal portion of the access guidewire in the ready-to-deploy state of the RICC insertion assembly; a distal end disposed within the introducer needle proximally just before a needle tip at the distal end of the introducer needle; an access guidewire including 1. A RICC insertion assembly comprising:

2. The RICC insertion assembly of claim 1 , wherein the gasket is formed from a single piece.

3. 3. The RICC insertion assembly of claim 2, wherein the gasket includes a proximal needle through-hole through a proximal end portion thereof and a distal needle through-hole aligned with the proximal needle through-hole through a distal end portion thereof, and the proximal portion of the introducer needle passes through both the proximal and distal needle through-holes in a ready-to-deploy state of the RICC insertion assembly.

4. 4. The RICC insertion assembly of claim 3, wherein the gasket includes an access guidewire channel passing through the proximal end portion thereof, the access guidewire channel forming an acute angle with the proximal needle through-hole to direct a distal portion of the access guidewire through both the sheath opening of the sheath and the needle slot of the needle shaft into the proximal portion of the introducer needle.

5. The RICC insertion assembly of claim 4 , wherein the access guidewire channel coincides with an end portion of a longitudinal slit through the top of the gasket.

6. The RICC insertion assembly of claim 5 , wherein the access guidewire channel has an inner diameter equivalent to an outer diameter of the access guidewire.

7. 7. The RICC insertion assembly of claim 5 or 6, wherein the distal needle through-hole coincides with another terminal portion of a slit through the top portion of the gasket.

8. The RICC insertion assembly of claim 7 , wherein the distal needle through-bore has an inner diameter equivalent to an outer diameter of the introducer needle.

9. 9. The RICC insertion assembly of claim 5, wherein the slit is configured to separate the access guidewire and allow the access guidewire to exit through the top of the gasket when compression on the gasket is released and the introducer needle is withdrawn from the coupler.

10. The RICC insertion assembly of claim 1 , wherein the gasket is formed from two complementary parts of the gasket that fit together.

11. 11. The RICC insert assembly of claim 10, wherein the gasket is substantially symmetrical along a longitudinal plane of symmetry passing through a majority of the gasket, and the two complementary parts of the gasket are substantially mirror images of each other.

12. 11. The RICC insert assembly of claim 10, wherein the gasket is symmetrical and the two complementary parts of the gasket are not related to each other by any symmetry operation.

13. 12. The RICC insertion assembly according to claim 10 or 11, wherein the gasket includes a proximal needle through-hole through a proximal end portion thereof and a distal needle through-hole aligned with the proximal needle through-hole through a distal end portion thereof, the proximal needle through-hole and the distal needle through-hole being formed between the two complementary parts of the gasket that are mated with each other, and the proximal portion of the introducer needle passes through both the proximal needle through-hole and the distal needle through-hole in the ready-to-deploy state of the RICC insertion assembly.

14. 14. The RICC insertion assembly of claim 13, wherein the gasket includes an access guidewire channel passing through the proximal end portion thereof, the access guidewire channel being formed between the two complementary parts of the gasket that are mated together, and the access guidewire channel forming an acute angle with the proximal needle through-hole to direct the distal portion of the access guidewire through both the sheath opening of the sheath and the needle slot of the needle shaft and into the introducer needle.

15. 15. The RICC insertion assembly of claim 10, wherein the two complementary parts of the gasket are configured to separate the access guidewire and allow the access guidewire to exit the gasket when compression on the gasket is released and the introducer needle is withdrawn from the coupler.

16. 16. The RICC insertion assembly of claim 1, wherein the gasket approximates a rectangle in a side view of the gasket.

17. 16. The RICC insertion assembly of claim 1, wherein the gasket approximates a right-angled trapezoid in a side view of the gasket.

18. 18. The RICC insertion assembly of claim 1, wherein the coupler further includes a blade coupled to the coupler housing, the blade extending through the gasket and into the valve module such that when the introducer needle is withdrawn from the coupler, a distally facing blade edge for separating the sheath from the needle shaft is positioned within the needle slot of the needle shaft below the distal end of the sheath opening of the sheath, thereby separating the sheath from the needle shaft and allowing the access guidewire to exit the needle shaft through the needle slot.

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

20. 20. The RICC insertion assembly of claim 1, wherein the coupler further includes a compression clip that covers a complementary mating part of the coupler housing, the compression clip configured to compress a gasket within the valve module compartment.

21. 21. The RICC insertion assembly of claim 1, wherein the coupler further comprises one or more lubricant wells containing a lubricant, one or more lubricant receptacles configured to receive or redistribute a lubricant, or a combination thereof.

22. 22. A RICC insertion assembly according to any one of claims 1 to 21, comprising: The RICC insertion assembly further comprising a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the RICC insertion assembly.

23. 1. A valve module for a rapid insertion central venous catheter (RICC) insertion assembly, comprising: An elastomeric gasket, configured to surround at least a portion of a valve module section of a coupler housing of a coupler along a length of the valve module section; a gasket configured to compress within the valve module compartment around the proximal portion of the introducer needle and the distal portion of the access guidewire to create a substantially airtight space within the gasket around the proximal portion of the introducer needle and the distal portion of the access guidewire. A valve module comprising an elastomeric gasket.

24. 24. The valve module of claim 23, wherein the gasket is formed from a single piece.

25. 25. The valve module of claim 24, wherein the gasket includes a proximal needle through-hole through a proximal end portion thereof and a distal needle through-hole aligned with the proximal needle through-hole through a distal end portion thereof, both the proximal needle through-hole and the distal needle through-hole receiving the proximal portion of the introducer needle therethrough.

26. 26. The valve module of claim 25, wherein the gasket includes an access guidewire channel passing through a proximal end portion thereof, the access guidewire channel forming an acute angle with the proximal needle through-hole to direct the distal portion of the access guidewire through an opening in the side of the introducer needle and into the proximal portion of the introducer needle.

27. 27. The valve module of claim 26, wherein the access guidewire channel coincides with an end portion of a longitudinal slit through the top of the gasket.

28. 28. The valve module of claim 27, wherein the distal needle through-hole coincides with another terminal portion of a slit through the top of the gasket.

29. 24. The valve module of claim 23, wherein the gasket is formed from two complementary parts of the gasket that fit together.

30. 30. The valve module of claim 29, wherein the gasket is substantially symmetrical along a longitudinal plane of symmetry passing through a majority of the gasket, and the two complementary parts of the gasket are substantially mirror images of each other.

31. 30. The valve module of claim 29, wherein the gasket is symmetrical and the two complementary parts of the gasket are not related to each other by any symmetry operation.

32. 31. The valve module of claim 30, wherein the gasket includes a proximal needle through-hole through a proximal end portion thereof and a distal needle through-hole aligned with the proximal needle through-hole through a distal end portion thereof, the proximal needle through-hole and the distal needle through-hole being formed between the two complementary parts of the gasket that are mated to each other, and both the proximal needle through-hole and the distal needle through-hole receive the proximal portion of the introducer needle therethrough.

33. 33. The valve module of claim 32, wherein the gasket includes an access guidewire channel passing through the proximal end portion thereof, the access guidewire channel being formed between the two complementary parts of the gasket that are mated together, and the access guidewire channel forming an acute angle with the proximal needle through-hole to direct the distal portion of the access guidewire into the introducer needle through an opening in the side of the introducer needle.

34. 34. The valve module of any one of claims 23 to 33, wherein the gasket approximates a rectangle when viewed from the side of the gasket.

35. 34. The valve module of any one of claims 23 to 33, wherein the gasket approximates a right-angled trapezoid in a side view of the gasket.

36. 36. The valve module of claim 23, wherein the gasket is further configured to receive a blade therethrough such that the blade extends into the valve module to separate a sheath from a needle shaft of the introducer needle when the introducer needle is withdrawn from the coupler.

37. 1. An introducer assembly comprising: an introducer needle, a needle shaft including a needle slot extending longitudinally from a proximal portion of the needle shaft to a distal tip; a sheath covering the needle shaft and sealing the needle slot below the sheath except for a portion of the needle slot below a sheath opening in a proximal portion of the sheath; an introducer needle including A coupler, a coupler housing containing a valve module compartment; a valve module disposed within the valve module compartment of the coupler housing, a valve module including an elastomeric gasket surrounding at least a portion of the valve module section of the coupler housing along a length of the valve module section, the gasket within the valve module section being compressed around a proximal portion of the introducer needle in a ready-to-deploy state of the introducer assembly to create a substantially airtight space within the gasket around a proximal portion of the introducer needle; a coupler including:

1. An access guidewire, a distal portion that passes through both the sheath opening of the sheath and the needle slot of the needle shaft and enters the introducer needle, wherein the gasket within the valve module compartment also compresses around the distal portion of the access guidewire to create a substantially airtight space within the gasket around the distal portion of the access guidewire in the ready-to-deploy state of the introducer assembly; a distal end disposed within the introducer needle proximally just before the tip of the distal end of the introducer needle; an access guidewire including An introducer assembly comprising:

38. 38. The introducer assembly of claim 37, The introducer assembly further comprising a syringe fluidly connected to the introducer needle in the ready-to-deploy state of the introducer assembly.

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