CN220193778U

CN220193778U - Quick-insertion type central catheter insertion assembly

Info

Publication number: CN220193778U
Application number: CN202222569315.0U
Authority: CN
Inventors: G·H·豪厄尔; D·B·布兰查德; J·R·斯塔斯; K·G·索恩利; J·斯帕塔罗; E·W·林德库格尔
Original assignee: Bard Access Systems Inc
Current assignee: Bard Access Systems Inc
Priority date: 2021-09-27
Filing date: 2022-09-27
Publication date: 2023-12-19
Anticipated expiration: 2032-09-27

Abstract

The present application relates to a quick insertable central catheterization assembly. A quick-insertion center catheter ("rich") insertion assembly may include a rich, an introducer needle, an access guidewire, and a coupler coupling the rich and introducer needle together. The introducer needle may include a proximal portion of the seal module insert coupled to a distal portion of the needle hub. The coupler may include a coupler housing including a seal module chamber and a distal portion of a seal module insert disposed in the seal module chamber. The seal module chamber and the proximal and distal portions of the seal module insert form a detachable seal module of the RICC insert assembly. When the proximal and distal portions of the seal module insert are compressed in the seal module chamber, the detachable seal module may be configured to seal around the introducer needle and the access guidewire disposed therein, respectively.

Description

Quick-insertion type central catheter insertion assembly

Priority

The present application claims priority benefits from U.S. provisional application Ser. No. 63/249,009, U.S. provisional application Ser. No. 63/271,043, and U.S. provisional application Ser. No. 63/290,056, both filed on month 27, 9, 2021, and 22, 10, 2021, and U.S. provisional application Ser. No. 63/290,056, both of which are incorporated herein by reference in their entirety.

Technical Field

The present application relates to the field of medical devices, and more particularly to a quick-insertable central catheterization assembly.

Background

A central venous catheter ("CVC") is typically introduced into a patient by femoral artery puncture techniques and advanced through its vasculature. Femoral artery puncture techniques employ multiple steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). While the femoral artery puncture technique is effective, several steps can be time consuming, handling several medical devices can be cumbersome, and both of the foregoing can result in patient trauma. Furthermore, there is a relatively high likelihood of contact contamination due to the several medical devices that need to be interchanged in the femoral artery puncture technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through its vasculature.

Disclosed herein are insertion assemblies and methods of a quick insertable central catheter ("RICC") that address the above-described problems. Notably, the RICC insert assemblies disclosed herein include a detachable sealing module for sealing different components of the RICC insert assembly therein.

Disclosure of Invention

Disclosed herein is a rich insertion assembly, in some embodiments, comprising a rich, an introducer needle, an access guidewire, and a coupler coupling the rich and introducer needle together. The RICC comprises a catheter tube and a main lumen passing through the catheter tube. The introducer needle includes a needle shaft, a needle hub surrounding a proximal portion of the needle shaft, and a proximal portion of the seal module insert coupled to a distal portion of the needle hub. The access guidewire includes a proximal portion disposed in the main lumen of the RICC and a distal portion disposed in the needle shaft through the longitudinal needle slot of the needle shaft. The coupler includes a coupler housing including a seal module chamber and a distal portion of a seal module insert disposed in the seal module chamber. The seal module chamber and the proximal and distal portions of the seal module insert form a detachable seal module of the RICC insert assembly. The detachable sealing module is configured to seal around the proximal portion of the introducer needle and the distal portion of the access guidewire, respectively, when the proximal and distal portions of the sealing module insert are compressed in the sealing module chamber.

In some embodiments, each of the proximal and distal portions of the seal module insert are formed of an elastomer.

In some embodiments, the proximal and distal portions of the seal module insert complete the introducer needle channel and the access guidewire channel when combined in the seal module chamber.

In some embodiments, the proximal portion of the introducer needle channel is present in the proximal portion of the seal module insert. Further, the distal portion of the introducer needle channel is completed by the proximal and distal portions of the seal module insert incorporated in the seal module chamber.

In some embodiments, the entire access guidewire channel is completed by the proximal and distal portions of the seal module insert incorporated into the seal module chamber.

In some embodiments, the distal end of the access guidewire channel is connected to the middle portion of the introducer needle channel. Such connection allows the distal portion of the access guidewire to be disposed through the needle slot in the needle shaft.

In some embodiments, the introducer needle channel is configured to seal around the proximal portion of the introducer needle when the proximal and distal portions of the seal module insert are compressed in the seal module chamber. Further, the access guidewire channel is configured to seal around the distal portion of the access guidewire when the proximal and distal portions of the seal module insert are in compression in the seal module chamber.

In some embodiments, the introducer needle channel includes an internal relief (relief) between the proximal and distal portions of the introducer needle channel such that when the proximal and distal portions of the seal module insert are compressed in the seal module chamber, only the proximal and distal portions of the introducer needle channel are configured to seal around the proximal portion of the introducer needle.

In some embodiments, the access guidewire channel includes an internal relief in at least a proximal portion of the access guidewire channel such that when the proximal and distal portions of the seal module insert are compressed in the seal module chamber, only the proximal portion of the access guidewire channel is configured to seal around the distal portion of the access guidewire.

In some embodiments, the seal module insert is radially compressed in the seal module chamber by the coupler housing.

In some embodiments, the seal module insert is axially compressed in the seal module chamber by the distal portion of the needle hub. Axial compression of the seal module insert in the seal module chamber in turn radially compresses the seal module insert in the seal module chamber.

In some embodiments, the coupler housing includes a longitudinal coupler housing slot configured to: the access guidewire is allowed to disengage from the coupler housing after withdrawing the introducer needle from the coupler and withdrawing the proximal portion of the seal module insert from the seal module chamber.

In some embodiments, the introducer needle further comprises a sheath on the needle shaft that seals the needle slot therebelow. A needle slot extends from the proximal portion of the needle shaft through the distal needle tip.

In some embodiments, the coupler includes a blade that extends into the detachable sealing module such that the blade is disposed within the needle slot below the distal end of the sheath opening. The blade includes a distally facing blade edge configured to cut the sheath from the needle shaft when the introducer needle is withdrawn from the coupler. Cutting the sheath away from the needle shaft allows the access guidewire to be detached from the needle shaft through the needle slot.

In some embodiments, the blade is overmolded into the coupler housing, thereby integrating the blade in the coupler housing.

In some embodiments, the sheath is detachable.

In some embodiments, a pattern of holes, slits, or a combination thereof extending longitudinally on the sheath is perforated on the sheath, the pattern configured for splitting the sheath. The pattern is offset from the needle groove to maintain the seal of the needle groove by the sheath.

In some embodiments, the sheath includes one or more grooves extending longitudinally on the sheath, the one or more grooves configured to split the sheath.

In some embodiments, the sheath includes an embedded drawstring extending longitudinally within the sheath, the embedded drawstring configured to detach the sheath when pulled away from the sheath.

In some embodiments, the sheath is formed from a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane, and polytetrafluoroethylene.

In some embodiments, the coupler further comprises an access guidewire connecting side arm. The access guidewire attachment side arm includes a connector configured to attach to an access guidewire hub surrounding a proximal portion of the access guidewire. The distal portion of the access guidewire is arranged in the needle shaft and the access guidewire hub is connected to a connector of the access guidewire connection side arm, thereby realizing a ring in the access guidewire on which the RICC is arranged at least in a ready-to-operate state of the RICC insertion assembly.

In some embodiments, the RICC insert assembly further comprises a retainer. The retainer includes a detachable housing over the catheter tube of the RICC and an outer catheter portion of the access guidewire extending from the distal end of the RICC. The detachable housing is configured to maintain sterility of the catheter tubing and the outer catheter portion of the access guidewire until deployment.

In some embodiments, the holder further comprises a catheter hub holder to which the proximal end of the detachable housing is attached. The catheter hub holder is configured to retain a catheter hub of a RICC therein and to hold the detachable housing in place over the catheter tube and the outer catheter portion of the access guidewire.

In some embodiments, the catheter hub holder includes a peripheral wall surrounding at least a portion of the periphery of the catheter hub holder. The peripheral wall defines a recess into which the conduit liner fits by an engineering fit.

In some embodiments, the coupler further comprises a detachable housing holding sidearm comprising a primary channel and a secondary channel. The main channel is configured to slidably retain the detachable housing therein. The secondary channel is configured for guiding an access guidewire detached from the detachable housing into the coupler and through the needle slot into the needle shaft.

In some embodiments, the coupler further comprises an access guidewire connecting side arm. The access guidewire attachment side arm includes a connector configured to attach to an access guidewire hub surrounding a proximal portion of the access guidewire. The distal portion of the access guidewire is arranged in the needle shaft, the distal portion of the detachable housing is held in the main channel of the detachable housing holding side arm, and the access guidewire hub is connected to the connector of the access guidewire connecting side arm, thereby realizing a ring in the access guidewire on which the RICC is arranged at least in the ready-to-operate state of the RICC insertion assembly.

In some embodiments, the RICC comprises a set of three lumens, including a primary lumen, a secondary lumen, and a third lumen. The set of three lumens is formed by fluid connections of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

In some embodiments, the main lumen has a main lumen orifice in the distal end of the catheter tube, the secondary lumen has a secondary lumen orifice in a side of the distal portion of the catheter tube, and the third lumen has a third lumen orifice in a side of the distal portion of the catheter tube proximal to the secondary lumen orifice.

Also disclosed herein is a method for inserting a RICC into a vascular lumen of a patient. In some embodiments, the method comprises an insertion assembly obtaining step, a needle tract establishing step, an entry guidewire advancing step, and a RICC advancing step. The step of obtaining the insert assembly includes: a RICC insert assembly is obtained, optionally already in its ready-to-operate state. The RICC insertion assembly includes a RICC, an introducer needle, an access guidewire, and a coupler that couples the RICC and introducer needle together. Further, the RICC insert assembly includes a detachable seal module formed between at least the seal module chambers of the coupler housing of the coupler, a proximal portion of the seal module insert coupled to the distal portion of the needle hub of the introducer needle, and a distal portion of the seal module insert disposed in the seal module chambers. The detachable sealing module seals around the proximal portion of the introducer needle and the distal portion of the access guidewire, respectively. The needle track establishment step comprises the following steps: an introducer needle is used to create a needle path from the skin area to the lumen of the blood vessel. The step of advancing the guide wire comprises the following steps: the distal portion of the access guidewire is advanced through the detachable sealing module and the longitudinal needle slot of the needle shaft of the introducer needle such that the distal end of the access guidewire is advanced from the introducer needle into the lumen of the blood vessel at a location just proximal of the needle tip of the needle shaft. The RICC advancing step includes: the RICC catheter is advanced over the access guidewire and into the vessel lumen, thereby inserting the RICC into the vessel lumen.

In some embodiments, the distal end of the access guidewire channel is connected to the middle portion of the introducer needle channel. Such connection allows the distal portion of the access guidewire to be disposed in the needle shaft through the longitudinal needle slot of the needle shaft.

In some embodiments, the introducer needle channel is configured to seal around the proximal portion of the introducer needle when the proximal and distal portions of the seal module insert are compressed in the seal module chamber. Further, the access guidewire channel is configured to seal around the distal portion of the access guidewire when the proximal and distal portions of the seal module insert are compressed in the seal module chamber.

In some embodiments, the method further comprises: and a state confirmation step. The state confirmation step includes confirming that the RICC insert assembly is in its ready-to-operate state prior to the track establishment step. Such confirmation ensures that the proximal and distal portions of the seal module insert are compressed in the seal module chamber, sealing the introducer needle channel and the access guidewire channel, respectively, around the introducer needle and the access guidewire.

In some embodiments, the step of advancing the entry guidewire comprises: an outer catheter portion of the access guidewire extending from the distal end of the rich is clamped and the access guidewire is pushed into the needle shaft via the detachable sealing module of the coupler. Advancing the access guidewire in this manner reduces the loop of access guidewire over which the RICC is disposed. This is achieved by an access guidewire bushing of an access guidewire arranged in the distal portion of the access guidewire in the needle shaft and a connector connected to the access guidewire connection side arm of the coupler.

In some embodiments, the step of advancing the entry guidewire comprises: the detachable housing is clamped over the catheter tube of the RICC and the outer catheter portion of the access guidewire extending from the distal end of the RICC. The step of advancing the entry guidewire further comprises: the detachable housing is pushed into the main channel of the detachable housing retention sidearm of the coupler while clamping the detachable housing. By clamping and pushing the detachable housing into the main channel of the detachable housing holding side arm, the access guidewire detached from the detachable housing enters into the secondary channel of the detachable housing holding side arm and then into the needle shaft via the detachable sealing module of the coupling.

In some embodiments, the step of advancing the entry guidewire comprises: the loop into the guidewire is reduced, and the RICC is disposed on the loop. The ring is implemented by a detachable housing held in a main channel of a detachable housing holding side arm and an access guidewire bushing of an access guidewire connected to a connector of an access guidewire connection side arm of the coupler.

In some embodiments, the method further comprises an introducer needle extraction step. The introducer needle withdrawing step includes: prior to the RICC advancing step, the introducer needle is withdrawn from the coupler, leaving the access guidewire in place in the vessel lumen. Withdrawing the introducer needle from the coupler removes the needle hub of the introducer needle from the needle hub receptacle and removes the proximal portion of the seal module insert from the seal module cavity with the needle hub, thereby separating the proximal and distal portions of the seal module insert from each other and unsealing the proximal portion of the introducer needle and the distal portion of the access guidewire to allow the access guidewire to disengage the detachable seal module.

In some embodiments, the introducer needle withdrawing step includes: the needle slot seal sheath of the introducer needle resects the needle shaft. The coupler includes a blade extending into the split seal module such that the blade is disposed in the needle slot below the distal end of the sheath opening of the sheath, the blade having a distally facing blade edge for resecting the sheath from the needle shaft.

In some embodiments, cutting the sheath away from the needle shaft allows the access guidewire to be detached from the needle shaft through the needle slot.

In some embodiments, the longitudinal coupler housing slot of the coupler housing allows the access guidewire to be disengaged from the coupler housing after the introducer needle extraction step.

In some embodiments, the needle track establishing step comprises: ensuring that blood flows back into the introducer needle or a syringe fluidly coupled to the introducer needle, thereby confirming that the needle track extends into the lumen of the blood vessel.

In some embodiments, the method further comprises a blood drawing step. The blood drawing step comprises the following steps: blood was drawn with a syringe to confirm that the needle tract extended into the lumen of the blood vessel.

In some embodiments, the method further comprises entering a guidewire extraction step. The step of drawing out the guide wire comprises the following steps: the access guidewire is withdrawn, leaving the catheter tubing in place within the vessel lumen.

In some embodiments, the method further comprises a steering guidewire advancing step, another RICC advancing step, and a steering guidewire withdrawing step. The steering guidewire advancing step includes: a steering guidewire is advanced into the vessel lumen through the main lumen of the RICC. Another RICC advancing step comprises: the catheter tubing is advanced further into the vessel lumen over the steering guidewire to the lower 1/2 of the superior vena cava ("SVC") of the patient's heart. The manipulating guidewire extraction step includes: the steering guidewire is withdrawn, leaving the catheter tubing in place in the lower 1/2 of the SVC.

These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the drawings and the following description, which describe in more detail certain embodiments of the concepts.

Drawings

FIG. 1 illustrates a RICC insert assembly according to some embodiments.

FIG. 2 illustrates a perspective view of a coupler of a RICC insert assembly according to some embodiments.

Fig. 3 illustrates a side view of a coupler according to some embodiments.

Fig. 4 illustrates a longitudinal section of a coupler and its detachable sealing module according to some embodiments.

Fig. 5 illustrates a perspective view of a needle hub of an introducer needle and proximal and distal portions of a seal module insert of a detachable seal module, according to some embodiments.

Fig. 6 illustrates a longitudinal cross-section of a proximal portion and a distal portion of a needle hub and a seal module insert according to some embodiments.

Fig. 7 illustrates a longitudinal section of a detachable sealing module in two different states according to some embodiments.

Fig. 8 illustrates a transverse cross-section of a proximal portion of a detachable sealing module in two different states, according to some embodiments.

Fig. 9 illustrates radial compression of a seal module insert in a seal module chamber of a detachable seal module defined by a coupler housing of the coupler, according to some embodiments.

Fig. 10 illustrates radial compression of a seal module insert in the seal module chamber by axial compression of the seal module insert in the seal module chamber by the needle hub, according to some embodiments.

Fig. 11 illustrates a longitudinal section of another seal module insert of a seal module insert having internal reliefs in the introducer needle channel and the access guidewire channel of the seal module insert, in accordance with some embodiments.

Fig. 12 illustrates a top view of an introducer needle in accordance with some embodiments.

Fig. 13A illustrates a cuttable sheath of an introducer needle according to some embodiments.

Fig. 13B illustrates a detachable sheath of an introducer needle according to some embodiments.

Fig. 13C illustrates another detachable sheath of an introducer needle according to some embodiments.

Fig. 13D illustrates yet another detachable sheath of an introducer needle in accordance with some embodiments.

Fig. 14 illustrates a needle shaft of an introducer needle in accordance with some embodiments.

FIG. 15 illustrates a RICC of a RICC insert assembly according to some embodiments.

FIG. 16 illustrates a detailed view of a distal portion of a catheter of a RICC according to some embodiments.

Fig. 17 illustrates a transverse cross-section of a distal portion of a catheter according to some embodiments.

Fig. 18 illustrates another transverse cross-section of a distal portion of a catheter according to some embodiments.

Fig. 19 illustrates a longitudinal section of a distal portion of a catheter according to some embodiments.

Detailed Description

Before some embodiments are disclosed in more detail, it is to be understood that the embodiments disclosed herein are not limiting the scope of the concepts provided herein. It should also be understood that features that may be possessed by particular embodiments disclosed herein may be readily separated from the particular embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

With respect to the terms used herein, it is also to be understood that these terms are for the purpose of describing some particular embodiments and that these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide a sequential or numerical limitation. For example, the "first," "second," and "third" features or steps do not necessarily appear in this order, and particular implementations including such features or steps are not necessarily limited to three features or steps. Furthermore, any of the foregoing features or steps may in turn comprise one or more features or steps, unless otherwise indicated. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used and are not intended to imply any particular fixed position, orientation or direction, for example. Rather, such indicia are used to reflect, for example, relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

For example, a "proximal" or "proximal portion" of a catheter as disclosed herein includes a portion of the catheter intended to be proximal to a clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be close to the clinician when the catheter is used on a patient. The proximal portion, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the tip portion or tip length of the catheter.

With respect to "distal", for example, a "distal portion" or "distal portion" of a catheter includes that portion of the catheter that is intended to be near or in a patient when the catheter is used with the patient. Likewise, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within the patient when the catheter is in use on the patient. The distal portion, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context implies otherwise, the distal portion, or distal length of the catheter is not the tip portion or tip length of the catheter.

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

While effective, as described above with respect to the femoral artery puncture technique (Seldinger technique), several steps can be time consuming, handling several medical devices can be cumbersome, and both of the foregoing can result in patient trauma. Furthermore, there is a relatively high likelihood of contact contamination due to the several medical devices that need to be interchanged in the femoral artery puncture technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through its vasculature.

Disclosed herein are insert assemblies and methods of a RICC that address the above-described problems. Notably, the RICC insert assemblies disclosed herein include a detachable sealing module for sealing different components of the RICC insert assembly therein. For example, a RICC insertion assembly may include a RICC, an introducer needle, an access guidewire, and a coupler that couples the RICC and introducer needle together. The introducer needle can include a proximal portion of the seal module insert coupled to a distal portion of the needle hub. The coupler may include a coupler housing including a seal module chamber and a distal portion of a seal module insert disposed in the seal module chamber. The seal module chamber and the proximal and distal portions of the seal module insert form a detachable seal module of the RICC insert assembly. When the proximal and distal portions of the seal module insert are compressed in the seal module chamber, the detachable seal module may be configured to seal around the introducer needle and the access guidewire disposed therein, respectively.

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

RICC insert assembly

FIG. 1 illustrates a RICC insert assembly 100 according to some embodiments.

As shown, RICC insert assembly 100 includes RICC102, introducer needle 104, access guidewire 106, and coupler 108 coupling RICC102, introducer needle 104, and access guidewire 106 together in a ready-to-operate state of RICC insert assembly 100. As set forth in more detail below, in the ready-to-operate state of the rich insertion assembly 100, the proximal end of the access guidewire 106 is coupled to the coupler 108, and the distal end of the access guidewire 106 is disposed within the needle lumen 158 of the introducer needle 104. This achieves a ring 110 in the access guidewire 106, and the rich 102 is disposed on this ring 110 in the ready-to-operate state of the rich insert assembly 100, maintaining the rich insert assembly 100 in a relatively compact form.

RiCC insert assembly 100 may also include a syringe 112 that is fluidly coupled to introducer needle 104 in a ready-to-operate state of RICC insert assembly 100. As described below, when the seal module insert 198 is compressed in the seal module chamber 178 in one or more states of the RICC insert assembly 100, the detachable seal module 196 seals around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106. In particular, the detachable sealing module 196 seals over the sheath opening 162 of the sheath 142, which sheath opening 162 leads to the needle slot 150 of the needle shaft 144. Outside of the detachable sealing module 196, the sheath 142 seals the needle slot 150 of the needle shaft 144. Such seals enable the syringe 112 to draw blood according to the drawing step of the method described below.

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

RiCC 102 of RICC insert assembly 100 is illustrated in FIG. 15, according to some embodiments.

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

Fig. 16-19 illustrate various views of catheter tube 114 of rich 102, according to some embodiments.

The catheter tube 114 includes a first section 122 in a distal portion of the catheter tube 114, a second section 124 in the distal portion of the catheter tube 114 (proximal to the first section 122), and a tapered joint 126 between the first section 122 and the second section 124 of the catheter tube 114.

The first section 122 of the catheter tube 114 includes a catheter tip 128 having a relatively short taper from an outer diameter of a distal portion of the first section 122 distal of the hub 126 to an outer diameter of a distal end of the first section 122. The taper of the catheter tip 128 is configured to immediately dilate tissue around a needle tract formed with the introducer needle 104 until the outer diameter of the distal portion of the first section 122 of the catheter tube 114. As best shown in fig. 19, the first section 122 of the catheter tube 114 also includes a proximal portion that is disposed in the bore of the distal portion of the fitting 126 and fixedly coupled thereto, such as by solvent bonding, adhesive bonding, or thermal welding.

The second section 124 of the catheter tube 114 has a uniform outer diameter over its length from the distal end of the second section 124 to the proximal end of the second section 124. The uniform diameter of the second section 124 of the catheter tubing 114 is configured for smooth insertion into the needle tract and target vasculature following any expansion of the first section 122 of the catheter tubing 114 and the joint 126. The distal end of the second section 124 of the catheter tube 114 has a planar surface that is flush with the planar surface proximal end of the fitting 126 and fixedly coupled thereto, such as by solvent bonding, adhesive bonding, or thermal welding.

The fitting 126 includes a taper over its length from the proximal end of the fitting 126 to the distal end of the fitting 126. The taper of the joint 126 is configured to immediately dilate tissue around the needle tract from the outer diameter of the proximal portion of the first section 122 of the catheter tube 114 to the outer diameter of the second section 124 of the catheter tube 114. The outer luminal surface of the joint 126 smoothly transitions from the outer luminal surface of the first section 122 of the catheter tube 114 to the outer luminal surface of the second section 124 of the catheter tube 114 without edges that would catch on the skin when the catheter tube 114 is inserted into the needle tract. In addition to the minimum to negligible edges, the edges may include a polymeric material that forms solvent interdiffusion in the polymeric material of the conduit tube 114, which smoothes the transition from the first section 122 of the conduit tube 114 to the junction 126 and from the junction 126 to the second section 124 of the conduit tube 114. Notably, the length of the joint 126 is approximately comparable to the length of the exposed portion of the first section 122 of the conduit fitting 114, or between the lengths of the exposed portions of the first and second sections 122, 124 of the conduit fitting 114. As such, the length of the exposed portion of the first section 122 of the conduit fitting 114 is less than the length of the fitting 126 until approximately equivalent to the length of the fitting 126.

The first section 122 of the catheter tube 114 is formed of a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first hardness. The second section 124 of the catheter tube 114 is formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second hardness, wherein the second hardness is less than the first hardness. For example, the first section 122 of the conduit tube 114 may be formed from a first polyurethane having a first hardness, while the second section 124 of the conduit tube 114 may be formed from a second, different polyurethane having less than the first hardness (e.g., the same or different di-or triisocyanates reacted with different diols or triols, different di-or triisocyanates reacted with the same or different diols or triols, the same di-or triisocyanates reacted under different conditions or with different additives, etc.). In fact, polyurethane is advantageous for catheter tubing 114 because polyurethane can be relatively rigid at room temperature, but becomes more flexible in vivo at body temperature, which reduces irritation of the vessel wall and phlebitis. Polyurethanes are also advantageous in that they can form fewer thrombi than some other polymers. The joint 126 is formed from a second polymeric material or a third polymeric material (e.g., a further polyurethane) having a third hardness, wherein the third hardness is less than the first hardness and greater than, substantially equal to, or less than the second hardness.

It should be appreciated that the first hardness of the first polymeric material, the second hardness of the second polymeric material, and the third hardness of the third polymeric material may have different grades (e.g., type a or type D). Based on this understanding, when the second hardness or the third hardness is smaller than the first hardness, the second hardness of the second polymer material or the third hardness of the third polymer material may be not smaller in value than the first hardness of the first polymer material. In practice, the hardness of the second or third polymeric material may still be less than the hardness of the first polymeric material, as different scales, each ranging from 0 to 100, are designed to characterize different materials in a group of materials having similar hardness.

According to the first section 122 of the catheter tube 114, the second section 124 of the catheter tube 114, and the joint 126 between the first section 122 and the second section 124 of the catheter tube 114 described above, the catheter tube 114 has sufficient column strength to prevent bending of the catheter tube 114 when inserted into a needle tract established by the introducer needle 104. The column strength of the catheter tubing 114 is also sufficient to prevent the catheter tubing 114 from bending as it is advanced through the vasculature of the patient without prior distention of any blood vessels of the tissue or vasculature surrounding the needle tract with a separate dilator.

Catheter tube 114 includes one or more catheter tube lumens extending through catheter tube 114; however, in multi-lumen RICCs (e.g., dual-lumen RICC, triple-lumen RICC, quad-lumen RICC, five-lumen RICC, six-lumen RICC, etc.), typically only one catheter tube lumen extends from the proximal end of catheter tube 114 to the distal end of catheter tube 114. (see fig. 16-19) in practice, the first section 122 of the catheter tube 114 generally includes a single lumen therethrough, as shown in fig. 17 and 19.

The catheter hub 116 is coupled to a proximal portion of the catheter tube 114. Catheter hub 116 includes one or more catheter hub lumens corresponding in number to the one or more catheter tube lumens. One or more catheter hub lumens extend through the entire catheter hub 116 from the proximal end of the catheter hub 116 to the distal end of the catheter hub 116.

Each of the one or more extension legs 118 is coupled by its distal portion to the catheter hub 116. The one or more extension legs 118 each include one or more extension leg lumens, which in turn correspond in number to the one or more catheter hub lumens. Each of the one or more extension leg lumens extends from the proximal end of the extension leg through the entire extension leg to the distal end of the extension leg.

Each of the one or more extension leg connectors 120 is on a proximal portion of an extension leg of the one or more extension legs 118. For example, each of the one or more extension leg connectors 120 may be a luer connector on a proximal portion of the extension leg of the one or more extension legs 118. By means of such an extension leg connector, the respective extension leg and its extension leg lumen may be connected to another medical device and its lumen. However, in the ready-to-operate state of the rich insertion assembly 100, at least one extension leg connector (e.g., an extension leg connector comprising a portion of the main lumen 130 of the rich 102) is indirectly connected to the access guidewire connection side arm 174 of the coupler 108 via an intermediate access guidewire hub 218 to implement the loop 110 in the access guidewire 106 and the rich 102 thereon.

As shown, RICC 102 is a three-lumen RICC comprising a set of three lumens; however, RICC 102 is not limited to the set of three lumens described above. The set of three lumens includes a main lumen 130, a secondary lumen 132, and a third lumen 134, which are formed by fluid coupling portions of three catheter tube lumens, and three extension leg lumens. Main lumen 130 has a main lumen orifice 136 at the distal end of first section 122 of catheter tube 114 that corresponds to the distal end of catheter tube 114 and the distal end of RICC 102. The secondary lumen 132 has a secondary lumen orifice 138 on one side of the distal portion of the catheter tube 114. The third lumen 134 has a third lumen orifice 140 on a side proximal to the secondary lumen orifice 138 of the distal portion of the catheter tube 114.

FIG. 12 illustrates a top view of introducer needle 104 of RICC insert assembly 100 according to some embodiments. Fig. 13A-13D illustrate a sheath 142 of the introducer needle 104 in accordance with some embodiments. Fig. 14 illustrates a needle shaft 144 of the introducer needle 104 in accordance with some embodiments.

As shown, the introducer needle 104 includes a needle shaft 144, a sheath 142 over the needle shaft 144, and a needle hub 146 in a proximal portion of the introducer needle 104, the needle hub 146 being over a proximal portion of the needle shaft 144 and a proximal portion of the sheath 142. Additionally, the introducer needle 104 can be considered to include a proximal portion 200 of the seal module insert 198 coupled to a distal portion of the needle hub 146, particularly when the proximal portion 200 of the seal module insert 198 is fixedly connected to the needle hub 146 rather than removably connected to the needle hub 146. At least in the ready-to-operate state of the RICC insert assembly 100, the needle shaft 144 and sheath 142 extend from the needle hub 146, through the detachable sealing module 196, and out the distal end of the coupler housing 172.

The needle shaft 144 includes a needle tip 148 in a distal portion of the needle shaft 144 and a longitudinal needle slot 150 extending from a proximal portion of the needle shaft 144 through the needle tip 148.

The needle tip 148 includes a bevel having a needle tip bevel 152 and a primary bevel 154 proximal to the needle tip bevel 152. The tip bevel angle of the tip bevel 152 is greater than the primary bevel angle of the primary bevel 154 such that the bevel provides a smooth transition on the tip 148. Such needle tips are thus configured for establishing a needle tract from the skin area into the lumen of a patient's blood vessel according to the needle tract establishing step of the method described below.

The needle slot 150 extends from at least a proximal portion of the needle shaft 144 through the needle tip 148 such that a needle channel 156 is formed along at least a majority of the length of the needle shaft 144, rather than through the needle lumen. That is, the needle slot 150 may extend from the proximal end of the needle shaft 144 through the needle tip 148, thereby forming a needle channel 156 along the entire length of the needle shaft 144. The needle slot 150 has a width sized according to the outer diameter of the access guidewire 106 that allows the access guidewire 106 to pass from the proximal portion of the needle shaft 144 through the needle tip 148 when performing the introducer needle extraction step of the method described below.

Notably, the needle shaft 144 includes the aforementioned needle channel 156, while the introducer needle 104 includes a needle lumen 158. This is because the needle lumen 158 is created by the combination of the needle shaft 144 and the sheath 142 over the needle shaft 144. In effect, the sheath 142 over the needle shaft 144 seals the needle channel 156 forming the needle lumen 158 of the introducer needle 104 and enables the syringe 112 to draw blood according to the drawing step of the method described below.

The sheath 142 includes a sheath tip 160 in a distal portion of the sheath 142 and a sheath opening 162 in a side of a proximal portion of the sheath 142.

Sheath tip 160 includes a relatively short taper from the outer diameter of the distal portion of sheath 142 to the outer diameter of the distal end of sheath 142, which is comparable to the outer diameter of the distal portion of needle shaft 144. The taper angle of the taper is less than the major bevel angle of the major bevel 154 of the needle tip 148, which in turn is less than the bevel angle of the needle tip 152 of the needle tip 148. The shield tip 160, including such a taper, is configured to provide a smooth transition from the needle tip 148 to the shield body for the track establishment step of the method described below.

In the ready-to-operate state of the RICC insert assembly 100, the sheath opening 162 opens into the needle slot 150 of the needle shaft 144, allowing the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 150. Thus, the sheath opening 162 has a width approximately corresponding to the width of the needle slot 150, which in turn is sized according to the diameter of the access guidewire 106. Sheath opening 162 also has a length sufficient to allow access guidewire 106 to pass through sheath opening 162 and into needle slot 150, while also receiving blade 212 of detachable sealing module 196 below the distal end of sheath opening 162. Notably, the sheath 142 above the needle shaft 144 seals the needle slot 150 therebelow, except below the sheath opening 162. However, the detachable sealing module 196 seals therein by sealing the proximal portion of the needle shaft 144 and the sheath 142 over the needle slot 150 exposed by the sheath opening 162, thereby enabling the syringe 112 to draw blood according to the blood drawing step of the method described below.

The sheath 142 may be a cuttable or detachable sheath configured to cut or detach the sheath 142 from the needle shaft 144, respectively, to allow the access guidewire 106 to be detached from the needle shaft 144 via the needle slot 150. When configured to be excised from the needle shaft 144, the sheath 142 may be formed of a polymeric material such as polyurethane, which aids in excision of the sheath 142 from the needle shaft 144. When configured to be detached from the needle shaft 144, the sheath 142 may include a detachment device for detaching the sheath 142, which facilitates detachment of the sheath 142 from the needle shaft 144.

The splitting means for splitting the sheath 142 may include one or more weakened portions of the sheath 142 that facilitate splitting the sheath 142 from the needle shaft 144. In fact, as shown in fig. 13B, a pattern 228 of holes, slits, or a combination thereof extending longitudinally on the sheath 142 may be punched through the sheath 142 for detaching the sheath 142 from the needle shaft 144. Notably, the pattern 228 is offset from the needle slot 150, thereby maintaining the seal provided by the sheath 142 over the needle shaft 144 and the needle slot 150, regardless of the pattern 228 of apertures, slits, or a combination thereof. Alternatively, as shown in fig. 13C, the sheath 142 may include one or more grooves 230 extending longitudinally on the sheath 142. Sheath 142 is thinnest along one or more grooves 230, allowing sheath 142 to be detached from needle shaft 144 along one or more grooves.

The detachment means for detaching the sheath 142 may include an embedded drawstring 232 extending longitudinally within the sheath 142 that facilitates detachment of the sheath 142 from the needle shaft 144. In effect, the pull cord 232 is configured to disengage the sheath 142 when the pull cord 232 is pulled away from the sheath 142. Optionally, the pull cord 232 includes a pull tab 234 on a proximal portion of the pull cord 232 for pulling the pull cord 232 away from the sheath 142. Whether or not pull-cord 232 includes pull-tab 234, a proximal portion of pull-cord 232 may extend from coupler 108 at least in a ready-to-operate state of ric insertion assembly 100 for pulling pull-cord 232 away from sheath 142 and along coupler housing slot 182 when sheath 142 needs to be detached from needle shaft 144.

The sheath 142, or sheath body thereof, is formed of a polymeric material configured to facilitate smooth, consistent insertion of the introducer needle 104 from the skin area into the vascular lumen of a patient in accordance with the track establishment procedure of the method described below. Furthermore, the polymeric material has mechanical properties at the thickness of the sheath 142 that are sufficient to withstand collapse of the sheath 142 into the needle slot 150 of the needle shaft 144 when performing the blood drawing step of the method set forth below, while also facilitating cutting or splitting of the sheath 142 from the needle shaft 144, particularly in accordance with at least the introducer needle extraction step of the method for cutting the sheath 142 from the needle shaft 144 set forth below. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, polyurethane, or polytetrafluoroethylene ("PTFE"). In one example, in an embodiment of the RICC insertion assembly 100, the sheath 142 may be polyurethane, wherein the sheath 142 is cut away from the needle shaft 144 by the blade 212. In another example, in an embodiment of the RICC insert assembly 100, the sheath 142 may be PTFE or even expanded PTFE ("ePTFE"), wherein the sheath 142 is detached from the needle shaft 144. When the sheath 142 is, for example, ePTFE, the sheath 142 need not include one or more weakened portions of the sheath 142 for detaching the sheath 142 from the needle shaft 144, as the ePTFE itself is a detaching device for detaching the sheath 142 due to the longitudinal arrangement of the polymer chains in the ePTFE.

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

The access guidewire channel 164 of the needle hub 146 is configured to allow the access guidewire 106 to pass over the needle hub 146 and guide the access guidewire 106 into the access guidewire channel 206 of the detachable seal module 196. The access guidewire channel 164 is open such that the access guidewire 106 is positioned within the access guidewire channel 164 at least in a ready-to-operate state of the RICC insertion assembly 100. Advantageously, the open access guidewire channel 164 allows the access guidewire 106 to remain in place as the introducer needle 104 is withdrawn from the RICC insertion assembly 100 according to the introducer needle withdrawal step of the method described below.

Notably, the access guidewire channel 164 of the needle hub 146 transitions into the access guidewire channel 168 coupled to the proximal portion 200 of the seal module insert 198 of the distal portion of the needle hub 146. When the proximal portion 200 of the seal module insert 198 is coupled with the distal portion 202 of the seal module insert 198, the access guidewire channel 168 of the proximal portion 200 of the seal module insert 198 is coupled with the access guidewire channel 168 of the distal portion 202 of the seal module insert 198 to form the access guidewire channel 206 of the detachable seal module 196. The needle hub 146, including the proximal portion 200 of the seal module insert 198 coupled thereto, is configured to be detachably disposed in the needle hub receptacle 180 and the seal module chamber 178 of the coupler housing 172, respectively. As described below, when the needle hub 146 is disposed in the needle hub receptacle 180 and the proximal portion 200 of the seal module insert 198 is disposed in the seal module chamber 178, the distal portion of the needle hub 146 axially compresses the proximal portion 200 of the seal module insert 198 in the seal module chamber 178. Axial compression of the proximal portion 200 of the seal module insert 198 in the seal module chamber 178 in turn radially compresses both the proximal portion 200 and the distal portion 202 of the seal module insert 198 in the seal module chamber 178.

The needle hub connector 166 includes a needle hub aperture 170 and an optional needle hub flange (not shown) surrounding the needle hub connector 166.

The needle hub aperture 170 of the needle hub connector 166 is configured to receive a syringe tip of the syringe 112 therein for fluidly coupling the introducer needle 104 to the syringe 112. Indeed, the needle hub bore 170 may have a luer taper (e.g., 6% taper) configured to receive a syringe tip therein, which may be configured complementarily to the luer taper.

The needle hub flange of the needle hub connector 166 is configured to screw together with the internal threads of the threaded ring surrounding the syringe tip of the syringe 112. While the threaded collar of the syringe 112 is optional, the needle hub flange advantageously provides a so-called luer lock type connection with the internal threads of the threaded collar when both are present. This provides additional security against accidental disconnection of the introducer needle 104 and the syringe 112, rather than that provided by other luer slip connections.

Fig. 2-11 illustrate various views of the coupler 108 of the RICC insert assembly 100 according to some embodiments.

As shown, when the RICC insertion assembly 100 further comprises a retainer 220, the coupler 108 comprises a coupler housing 172, an access guidewire attachment side arm 174, and an optional detachable housing retention side arm 176.

The coupler housing 172 includes a seal module chamber 178, a needle hub receptacle 180 proximal to the seal module chamber 178, and a longitudinal coupler housing slot 182 formed along the length of the coupler housing 172. (see FIG. 4, which includes a proximal portion 200 and a distal portion 202 of a seal module insert 198 disposed in seal module chamber 178. FIG. 4 also includes a needle hub 146 of an introducer needle 104 disposed in a needle hub receptacle 180. Notably, the coupler housing 172 may be formed as a bullet shaped body configured to be comfortably held under hand (e.g., held) in the left hand or in the right hand for left hand venipuncture, or in the right hand for right hand venipuncture, with the RICC insert assembly 100, the exterior of the coupler housing 172 may be configured with grip enhancing ridges (e.g., lateral or circumferential ridges), protrusions, etc. to further facilitate such venipuncture.

The seal module cavity 178 is configured to retain a proximal portion 200 and a distal portion 202 of the seal module insert 198 therein. In fact, in each of the one or more states of the RICC insert assembly 100, the seal module chamber 178 includes at least a distal portion 202 of the seal module insert 198 captively disposed therein. For example, the seal module chamber 178 may include a grip 184 in a distal portion thereof, wherein the grip 184 is configured to receive the protrusion 186 of the distal portion 202 of the seal module insert 198 therein for captively disposing the distal portion 202 of the seal module insert 198 in the seal module chamber. Seal module cavity 178 also includes a proximal portion 200 of seal module insert 198 disposed therein in at least some of the one or more states of rich insert assembly 100, such as a ready-to-operate state or one or more operating states of rich insert assembly 100.

The needle hub receptacle 180 is configured to retain the needle hub 146 of the introducer needle 104 therein. In effect, needle hub receptacle 180 includes needle hub 146 inserted therein in a ready-to-operate state of ric insertion assembly 100. Although not shown, the coupler 108 may include a needle hub lock surrounding the needle hub receptacle 180 configured to lock the needle hub 146 in the needle hub receptacle 180. In effect, a pair of locking buttons (e.g., spring loaded locking buttons) of the needle hub lock may be distributed between opposite sides of the coupler housing 172 such that each locking button of the locking buttons extends through the coupler housing 172 on its respective side of the coupler 108. Such locking buttons may be configured to unlock the needle hub 146 when the locking buttons are pressed into the coupler housing 172 to withdraw the introducer needle 104 from the coupler 108. Unlocking the locking button may immediately release axial compression from the distal portion of the needle hub 146, thereby compressing the proximal portion 200 of the seal module insert 198 in the seal module chamber 178. This allows the proximal and distal portions 200, 202 of the seal module insert 198 to relax to withdraw the introducer needle 104 from the coupler 108. This also allows the proximal and distal portions of the seal module insert 198 to be disassembled in order to enter the guidewire 106 to disengage when the introducer needle 104 is withdrawn from the coupler 108 during the introducer needle withdrawal step of the method set forth below.

The coupler housing slot 182 formed along the length of the coupler housing 172 is configured to allow the entry guide wire 106 to disengage from the coupler housing 172 after the introducer needle 104 is withdrawn from the coupler 108 in the introducer needle withdrawal step of the method set forth below. In effect, as the introducer needle 104 is withdrawn from the coupler 108 during the introducer needle withdrawal step, the proximal portion 200 of the seal module insert 198 is also withdrawn from the seal module chamber 178, allowing the access guidewire 106 to be disengaged from the coupler housing 172 once the proximal portion 200 of the seal module insert 198 is withdrawn from the seal module chamber 178.

An access guidewire attachment side arm 174 extends from the coupler 108 or coupler housing 172. Access guidewire attachment side arm 174 includes a connector 188 configured to connect to an access guidewire hub 218 surrounding a proximal portion of access guidewire 106 extending from a proximal end of rich 102 at least in a ready-to-operate state of rich insertion assembly 100. When in the ready-to-operate state of the ric insertion assembly 100, the distal portion of the access guidewire 106 is disposed in the needle shaft 144 and the access guidewire hub 218 is connected to the connector 188 of the access guidewire connection side arm 174, thereby implementing a loop 110 in the access guidewire 106 with the ric 102 disposed on the loop 110. When both retainer 220 and detachable housing retention side arms 176 are present in the RICC insertion assembly 100, the distal portion of detachable housing 222 is also retained in the main channel 190 of detachable housing retention side arms 176, thereby further effecting a loop 110 in the access guidewire 106 with the RICC 102 disposed on the loop 110.

When present, the detachable housing retention side arm 176 extends from the coupler 108 or coupler housing 172 thereof opposite the access guidewire attachment side arm 174. The detachable housing retention sidearm 176 includes a primary channel 190 and a secondary channel 192. The main channel 190 is configured to slidably retain the detachable housing 222 or a longitudinal composite of the detachable housing 222 and at least into the guidewire 106. The secondary channel 192 is configured to guide the access guidewire 106 split from the split housing 222 into the coupler 108, its split seal module 196, and the needle shaft 144 sealed therein by the needle groove 150. The bifurcation 194 of the detachable housing retention sidearm 176 between the primary channel 190 and the secondary channel 192 is configured to detach the access guidewire 106 from the detachable housing 222 as the detachable housing 222 and at least the longitudinal composite of the access guidewire 106 therein are pushed therein.

Fig. 4-11 illustrate different views of a detachable seal module 196 according to some embodiments.

The detachable seal module 196 of the RICC insert assembly 100 includes a seal module cavity 178 of the coupler housing 172 and a resilient seal module insert 198 disposed therein, the seal module insert 198 being detached between a captured proximal portion 200 and a removable distal portion 202, the removable distal portion 202 being referred to herein as a proximal portion 200 of the seal module insert 198 and a distal portion 202 of the seal module insert 198, respectively. (notably, the proximal and distal portions 200, 202 of the seal module insert 198 may be formed of the same elastomer [ e.g., silicone ] or different elastomers.) the proximal portion 200 of the seal module insert 198 is configured to be disposed in or otherwise inserted into the seal module cavity 178 of the coupler housing 172, with the proximal portion 200 of the seal module insert 198 in combination with the distal portion 202 of the seal module insert 198 to complete a pair of passages through the detachable seal module 196. Through the aforementioned channels, the detachable sealing module 196 is configured to detachably seal around the introducer needle 104 and the access guidewire 106 when the proximal portion 200 and the distal portion 202 of the sealing module insert 198 are compressed in the sealing module chamber 178 in one or more states of the rich insertion assembly 100 (e.g., a ready-to-operate state or one or more operating states of the rich insertion assembly 100), which allows the syringe 112 to draw blood according to the blood drawing steps of the methods described below.

The pair of channels that are completed when the proximal and distal portions 200, 202 of the seal module insert 198 are incorporated in the seal module chamber 178 of the coupler housing 172 includes an introducer needle channel 204 and an access guidewire channel 206. As shown in fig. 7, a proximal portion of the introducer needle channel 204 may be present in a proximal portion 200 of the seal module insert 198, but when incorporated in the seal module chamber 178 of the coupler housing 172, a distal portion of the introducer needle channel 204 is completed by the proximal portion 200 and distal portion 202 of the seal module insert 198. As further shown in fig. 7, when the proximal and distal portions 200, 202 of the seal module insert 198 are incorporated in the seal module chamber 178 of the coupler housing 172, the entire access guidewire channel 206 may be completed by the proximal and distal portions 200, 202 of the seal module insert 198. While other configurations of the seal module insert 198 are possible to provide the aforementioned access, these configurations range from alternative configurations of the proximal and distal portions 200, 202 of the seal module insert 198 to one or more additional portions (e.g., intermediate portions) that include the seal module insert 198. When the proximal and distal portions 200, 202 of the seal module insert 198 are compressed in the seal module chamber 178 in one or more states of the rich insertion assembly 100, the detachable seal module 196 is configured to be detachably sealed around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106, respectively, through the introducer needle channel 204 and the access guidewire channel 206. In particular, as opposed to the introducer needle channel 204 passing through the proximal and distal ends of the seal module insert 198, the distal end of the access guidewire channel 206 is connected to a middle portion of the introducer needle channel 204, thereby allowing the distal portion of the access guidewire 106 to be disposed in the needle shaft 144 and the distal portion of the access guidewire 106 to be disposed in the detachable seal module 196. In effect, the access guidewire channel 206 is configured to guide the access guidewire 106 from the access guidewire channel 164 of the needle hub 146 into the sheath opening 162 of the sheath 142 and the needle slot 150 of the needle shaft 144 therebelow, such that in the ready-to-operate state of the RICC insertion assembly 100, the access guidewire 106 may be disposed in the needle shaft 144 with the distal end of the access guidewire 106 just proximal to the needle tip 148.

Fig. 11 illustrates a longitudinal section of the seal module insert 198 with internal reliefs 208 and 210 in the introducer needle channel 204 and the access guidewire channel 206 of the seal module insert 198, according to some embodiments.

As shown, the introducer needle channel 204 formed between the proximal portion 200 and the distal portion 202 of the seal module insert 198 may include an internal relief 208 between the proximal portion and the distal portion of the introducer needle channel 204 to reduce friction on the introducer needle 104 as the introducer needle 104 is withdrawn from the coupler 108 and its detachable seal module 196 during the introducer needle withdrawal step of the method described below. Additionally or alternatively, the access guidewire channel 206 may include an internal relief 210 in at least a proximal portion of the access guidewire channel 206 to reduce friction on the access guidewire 106 as the access guidewire 106 is advanced into the coupler 108 and its detachable sealing module 196 during an access guidewire advancement step of the method set forth below. Because of the internal relief 208 between the proximal and distal portions of the introducer needle channel 204, only the proximal and distal portions of the introducer needle channel 204, including the proximal and distal ends of the introducer needle channel 204, are configured to seal around the proximal portion of the introducer needle 104 when the proximal and distal portions 200, 202 of the seal module insert 198 are compressed in the seal module chamber 178 of the coupler housing 172. When the proximal and distal portions 200, 202 of the seal module insert 198 are compressed in the seal module chamber 178 of the coupler housing 172, only the proximal portion of the access guidewire channel 206, including the proximal end of the access guidewire channel 206, is configured to seal around the distal portion of the access guidewire 106 due to the internal relief 210 in the proximal portion of the access guidewire channel 206. Notably, while the internal reliefs 208 and 210 are configured to reduce friction of the introducer needle 104 and the introducer needle channel 204 and the access guidewire channel 206, respectively, on the access guidewire 106, a lubricant may additionally or alternatively be used in the seal module insert 198 to reduce friction.

The detachable sealing module 196 is configured to detachably seal around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 when the sealing module insert 198 is compressed in the sealing module chamber 178. In practice, the proximal and distal portions 200, 202 of the seal module insert 198 may be radially compressed within the seal module chamber 178 or both axially and radially compressed within the seal module chamber 178 to seal around the introducer needle 104 and the access guidewire 106. By sealing around the introducer needle 104 and the access guidewire 106 in accordance with the foregoing, the syringe 112 can be used to draw blood in accordance with the blood drawing steps of the method described below.

In an example of radial compression of the seal module insert 198 in the seal module chamber 178, the proximal and distal portions 200, 202 of the seal module insert 198 may be radially compressed in the seal module chamber 178 by the coupler housing 172 itself, as shown in fig. 9. Without limiting these embodiments, the two halves of the coupler housing 172 may be coupled together like a clamshell by a hinge opposite the coupler housing slot 182 formed between the two halves of the coupler housing 172. One or more clamps may be clamped through the coupler housing slot 182 in at least a ready-to-operate state of the RICC insert assembly 100 to hold the two halves of the coupler housing 172 together, apply sufficient pressure to radially compress the proximal and distal portions 200, 202 of the seal module insert 198 in the seal module chamber 178, and seal the seal module insert 198 around the introducer needle 104 and the access guidewire 106. In one or more operational states of the RICC insertion assembly 100, one or more clamps may be released to release the radial compression and allow the introducer needle 104 to be withdrawn from the coupler 108 for subsequent exit through the coupler housing slot 182 into the guidewire 106.

In examples where the seal module insert 198 is radially and axially compressed in the seal module chamber 178, the proximal and distal portions 200, 202 of the seal module insert 198 may be axially and radially compressed in the seal module chamber 178 by the distal portion of the needle hub 146. When needle hub 146 is disposed in needle hub receptacle 180, such as in a ready-to-operate state of rich insertion assembly 100, a distal portion of needle hub 146 axially compresses proximal portion 200 and distal portion 202 of seal module insert 198 in seal module chamber 178. Axial compression of the proximal and distal portions 200, 202 of the seal module insert 198 within the seal module chamber 178 in turn radially compresses the proximal and distal portions 200, 202 of the seal module insert 198 within the seal module chamber 178, thereby sealing the seal module insert 198 around the introducer needle 104 and the access guidewire 106. In one or more operational states of the RICC insertion assembly 100, the needle hub 146 may be removed from the needle hub receptacle to release axial compression and radial compression and allow the introducer needle 104 to be withdrawn from the coupler 108 to thereafter disengage the access guidewire 106 through the coupler housing slot 182.

The coupler housing 172 of the coupler 108 may also include a blade 212 that extends into the introducer needle channel 204 of the detachable sealing module 196. Blade 212 may be overmolded into distal portion 202 of seal module insert 198, integrating blade 212 therein. Blade 212 or blade tip 214 thereof may be disposed in needle slot 150 below the distal end of sheath opening 162 at least in the ready-to-operate state of RICC insertion assembly 100. Blade 212 includes a distally facing blade edge 216 configured to cut sheath 142 from needle shaft 144 as introducer needle 104 is withdrawn from coupler 108 through introducer needle channel 204 in an introducer needle withdrawal step of the method described below. When the introducer needle 104 is withdrawn from the coupler 108, the sheath 142 is cut away from the needle shaft 144, allowing the access guidewire 106 to be disengaged from the needle shaft 144 through the needle slot 150.

FIGS. 1, 4, 9, and 10 illustrate various views of an access guidewire 106 of a RICC insert assembly 100 according to some embodiments.

The access guidewire 106 includes a proximal portion and a distal portion, wherein the proximal portion includes a proximal end and the distal portion includes a distal end. In the ready-to-operate state of the RICC insert assembly 100, the proximal end of the access guidewire 106 is coupled to the access guidewire attachment side arm 174 by an access guidewire hub 218 surrounding the proximal portion of the access guidewire 106 including the distal end. In addition, a proximal portion of access guidewire 106 extends along main lumen 130 of rich 102. The distal portion of access guidewire 106 also extends along main lumen 130 of ric 102, but the distal portion of access guidewire 106 further extends out of the distal end of ric 102 as the outer catheter portion of access guidewire 106, through access guidewire channel 164 into detachable sealing module 196 over needle hub 146, through sheath opening 162 of sheath 142 and needle slot 150 of needle shaft 144 and along needle lumen 158 of introducer needle 104 into needle shaft 144 in the ready-to-operate state of ric insertion assembly 100. As shown in FIG. 1, in the ready-to-operate state of RICC insert assembly 100, the distal end of access guidewire 106 is disposed within needle lumen 158, just proximal of needle tip 148. Also, in the ready-to-operate state of the rich insert assembly 100, the proximal and distal ends of the access guidewire 106 implement a loop 110 in the access guidewire 106, with the rich 102 disposed over the loop 110, thereby maintaining the rich insert assembly 100 in a relatively compact form.

The access guidewire 106 may include a guidewire tip in a distal portion of the access guidewire 106 that adopts a J-shape configured to prevent puncture of the posterior wall of the vessel. Such a guidewire tip assumes a straightened state in a ready operational state of the rich insertion assembly 100, and a curved state when the guidewire tip is advanced beyond the needle tip 148 (e.g., into a lumen of a blood vessel) in one or more operational states of the rich insertion assembly 100 in which the access guidewire 106 is deployed.

The access guidewire 106 may also include a bare wire portion and a wrapped wire portion distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, the bare wire portion (when present) extends distally through the access guidewire channel 206 of the detachable sealing module 196 at least in the ready-to-operate state of the RICC insert assembly 100 such that the detachable sealing module 196 forms a fluid-tight seal around the bare wire portion of the access guidewire 106. Notably, the aforementioned bare wire portion may alternatively be a flat wound or grounded wound portion into the guidewire 106, wherein the flat wound portion comprises a winding of tape instead of wire, and wherein the grounded wound portion comprises a winding of wire that is grounded down to flatten the winding.

FIG. 1 illustrates a retainer 220 of a RICC insert assembly 100 according to some embodiments.

As shown, the retainer 220 may include a detachable housing 222 and a catheter hub holder 224, with the proximal end of the detachable housing 222 attached to the catheter hub holder 224.

The detachable housing 222 may form a longitudinal composite with the catheter tubing 114, the access guidewire 106, or both the catheter tubing 114 and the access guidewire 106 in the RICC insertion assembly 100. With respect to the ric insertion assembly 100 of fig. 1, for example, the detachable housing 222 is over and thus forms a longitudinal composite with the catheter tube 114 and the access guidewire 106 in the portion of the ric insertion assembly 100 closest to the catheter hub holder 224 where the access guidewire 106 is disposed in the main lumen 130 of the ric 102. With further reference to the ric insertion assembly 100 of fig. 1, the detachable housing 222 is in the portion of the ric insertion assembly 100 closest to the coupler 108 or detachable housing support side arm 176 thereof, and thus forms a longitudinal complex only with the access guidewire 106, in which portion the outer catheter portion of the access guidewire 106 extends from the distal end of the ric 102. For example, when the detachable housing 222 slides over the bifurcation 194 of the detachable housing retention side arm 176 of the coupler 108, the detachable housing 222 is configured to be detached along its length such that the outer catheter portion of the access guidewire 106 is initially exposed and the distal portion of the catheter tube 114 is subsequently exposed. In such a manner, the detachable housing 222 is configured to maintain sterility of the catheter tubing 114 and at least the distal portion of the access guidewire 106 until deployment.

The catheter hub holder 224 is configured to retain the catheter hub 116 therein and to hold the detachable housing 222 in place on the catheter tube 114 and the access guidewire 106, particularly the outer catheter portion of the access guidewire 106. The catheter hub holder 224 includes a peripheral wall 226 surrounding at least a portion (e.g., a proximal portion) of the periphery of the catheter hub holder 224. The peripheral wall 226 defines a recess into which the conduit sleeve 116 is inserted with an engineering fit (e.g., a clearance fit, such as a running fit, a slip fit, or a position fit, or a transition fit, such as a similar fit or a fixed fit classified by international organization of standardization [ "ISO" ]) and one or more clearance fits for one or more extension legs 118 to extend therethrough. Additionally or alternatively, the catheter hub holder 224 may include wings corresponding to the suture wings of the catheter hub 116. Such wings may include posts configured to be inserted into suture wing holes of suture wings of catheter hub 116 with an engineering fit.

Method

Methods of ric insertion assembly 100 include methods for inserting ric 102 into a vascular lumen of a patient. Such methods include one or more steps selected from an insertion assembly acquisition step, a status confirmation step, a needle track establishment step, a blood drawing step, an entry guidewire advancement step, a sheath detachment step, an introducer needle extraction step, a RICC advancement step, an entry guidewire extraction step, a manipulation guidewire advancement step, another RICC advancement step, and a manipulation guidewire extraction step.

The insert component obtaining step comprises obtaining a RICC insert component 100, optionally the RICC insert component 100 already being in its ready-to-operate state. As described above, RICC insert assembly 100 includes RICC 102, introducer needle 104, access guidewire 106, and coupler 108 connecting RICC 102 and introducer needle 104 together. In addition, the RICC insert assembly 100 includes a separable sealing module 196 formed at least between a distal portion 202 of the sealing module insert 198 disposed in the sealing module chamber 178 and a proximal portion 200 of the sealing module insert 198 coupled to the distal portion of the needle hub 146 of the introducer needle 104, of the coupling housing 172 of the coupling 108. The detachable sealing module 196 is detachably sealed around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 at least in the ready-to-operate state of the RICC insertion assembly 100. Within the detachable sealing module 196, the distal portion of the access guidewire 106 is disposed within the needle shaft 144 through the needle slot 150. This is accomplished by a connection between the distal end of the access guidewire channel 206 and the middle portion of the introducer needle channel 204 in the seal module insert 198.

The state confirmation step includes confirming that the RICC insert assembly 100 is in its ready-to-operate state prior to the track establishment step. Such confirmation ensures that the proximal and distal portions 200, 202 of the seal module insert 198 are compressed in the seal module chamber 178, sealing the introducer needle channel 204 and the access guidewire channel 206 around the introducer needle 104 and the access guidewire 106, respectively. Notably, if the rich insert 100 is not in a ready-to-operate state at the time of inserting the component ICC insert 100, the rich insert 100 may be adapted to be placed in a ready-to-operate state for subsequent steps.

The needle track establishing step includes establishing a needle track from the skin area to the lumen of the blood vessel with the introducer needle 104. The needle tract establishing step may also include ensuring that blood flows back into the introducer needle 104 (e.g., the needle hub 146 of the introducer needle 104), the syringe 112 (e.g., the syringe tip, the barrel of the syringe 112, or both) fluidly coupled to the introducer needle 104, or both the introducer needle 104 and the syringe 112, thereby confirming that the needle tract extends into the vascular lumen. To enhance blood flashback, a slight vacuum can be drawn with syringe 112 while the needle track is established.

The drawing step includes drawing blood with the syringe 112 to confirm that the needle tract extends into the lumen of the blood vessel prior to drawing the introducer needle 104 from the coupler 108 in the introducer needle drawing step. Likewise, the sheath 142 above the needle shaft 144 seals the needle slot 150 below the needle shaft 144. In particular, the sheath 142 seals the needle slot 150 outside of the detachable sealing module 196. The detachable seal module 196 in turn seals over the sheath opening 162 of the sheath 142, which sheath opening 162 allows the access guidewire 106 to pass from an access guidewire channel 206 formed between the proximal portion 200 and the distal portion 202 of the seal module insert 198 and into the needle shaft 144 via the needle slot 150. The detachable sealing module 196 also seals around the distal portion of the access guidewire 106. Such seals enable the syringe 112 to draw blood during the blood drawing step.

The access guidewire advancing step includes advancing the distal portion of the access guidewire 106 through the detachable sealing module 196 and the needle slot 150 of the needle shaft 144 such that the distal end of the access guidewire 106 is advanced into the lumen of the blood vessel from its initial position in the introducer needle 104. As described above, when RICC insert assembly 100 is in the ready-to-operate state of RICC insert assembly 100, the initial position of the distal end of access guidewire 106 is just proximal of needle tip 148.

When the rich insertion assembly 100 does not include the retainer 220 and the detachable housing 222 on the catheter tube 114 of the rich 102 and the outer catheter portion of the access guidewire 106, the access guidewire advancing step includes clamping the outer catheter portion of the access guidewire 106 extending from the distal end of the rich 102 and advancing the access guidewire 106 into the needle shaft 144 via the detachable sealing module 196 of the coupler 108. Advancing access guidewire 106 in this manner reduces loop 110 of access guidewire 106 over which rib 102 is disposed. As described above, the loop 110 is implemented by the distal portion of the access guidewire 106 disposed in the needle shaft 144 and the access guidewire bushing 218 of the access guidewire 106 connected to the connector 188 of the access guidewire connection side arm 174 of the coupler 108.

When the rich insertion assembly 100 includes a retainer 220 and a detachable housing 222 on the catheter tube 114 of the rich 102 and the outer catheter portion of the access guidewire 106, the access guidewire advancing step includes clamping the detachable housing 222 over the catheter tube 114 of the rich 102 and the outer catheter portion of the access guidewire 106 extending from the distal end of the rich 102. The entering guidewire advancing step further includes pushing the detachable housing 222 into the main channel 190 of the detachable housing retention side arm 176 of the coupler 108 while clamping the detachable housing 222. By clamping and pushing the split housing 222 into the main channel 190 of the split housing retention sidearm 176 in this manner, the access guidewire 106 splits from the split housing 222 at the bifurcation 194 of the split housing retention sidearm 176 between the main channel 190 and the secondary channel 192, into the secondary channel 192 of the split housing retention sidearm 176, and into the needle shaft 144 via the split seal module 196 of the coupler 108. Advancing access guidewire 106 in this manner reduces ring 110 of access guidewire 106, and RICC 102 and detachable housing 222 are disposed over ring 110. The loop 110 is implemented with at least the detachable housing 222 held in the main channel 190 of the detachable housing holding side arm 176 and the access guidewire bushing 218 of the access guidewire 106 connected to the connector 188 of the access guidewire connecting side arm 174 of the coupler 108.

The introducer needle extraction step includes extracting the introducer needle 104 from the coupler 108 prior to the rich advancement step, thereby leaving the access guidewire 106 in place within the vessel lumen. Withdrawing the introducer needle 104 from the coupler 108 removes the needle hub 146 of the introducer needle 104 from the needle hub receptacle 180 and removes the proximal portion 200 of the seal module insert 198 from the seal module chamber 178 with the needle hub 146, thereby detaching the proximal and distal portions 200, 202 of the seal module insert 198 from each other and opening the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106, allowing the access guidewire 106 to disengage the detachable seal module 196.

The introducer needle extraction step can also include cutting the needle slot seal sheath 142 of the introducer needle 104 from the needle shaft 144. As described above, the coupler housing 172 of the coupler 108 may include a blade 212 extending into the detachable sealing module 196 such that the blade 212 is disposed in the needle slot 150 below the distal end of the sheath opening 162 of the sheath 142, with the distally facing blade edge 216 for resecting the sheath 142 from the needle shaft 144. If the coupling housing 172 does not include the blade 212, the method may further include a sheath splitting step that includes splitting the sheath 142 according to the splitting apparatus described above for splitting the sheath 142. Cutting or splitting of the sheath 142 away from the needle shaft 144 allows the access guidewire 106 to be disengaged from the needle shaft 144 through the needle slot 150. In addition, the coupler housing slot 182 of the coupler housing 172 allows the access guidewire 106 to be disengaged from the coupler housing 172 after the introducer needle 104 is withdrawn from the coupler 108.

The rich advancement step includes advancing catheter tube 114 of rich 102 over access guidewire 106 and into the vessel lumen, thereby inserting rich 102 into the vessel lumen.

The access guidewire extraction step includes extracting the access guidewire 106, leaving the catheter tube 114 in place within the vessel lumen.

The steering guidewire advancing step includes advancing the steering guidewire through main lumen 130 of rich 102 into the vessel lumen and into the lower 1/3 of the SVC of the patient's heart.

Another rich advancement step involves advancing catheter tubing 114 further into the vessel lumen over the steering guidewire to the lower 1/3 of the SVC of the patient's heart.

The steering guidewire extraction step includes extracting the steering guidewire, leaving the catheter tube 114 in place in the lower SVC section 1/3.

Although certain specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications will occur to those skilled in the art and are also contemplated in the broader aspects. Accordingly, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A quick-insertion type center catheter insertion assembly, comprising:

a quick-insertable central catheter comprising a catheter tube and a main lumen passing through the catheter tube;

an introducer needle, the introducer needle comprising:

a needle shaft comprising a longitudinal needle slot;

a needle hub surrounding a proximal portion of the needle shaft; and

a proximal portion of a seal module insert coupled to a distal portion of the needle hub;

an access guidewire comprising a proximal portion disposed in the main lumen of the quick-insertable central catheter and a distal portion disposed in the needle shaft through the needle slot; and

a coupler coupling the quick-insertable central catheter and the introducer needle together, the coupler comprising:

a coupler housing including a sealed module chamber; and

a distal portion of the seal module insert disposed in the seal module chamber, the seal module chamber and proximal and distal portions of the seal module insert forming a detachable seal module of the quick-insert center catheter insertion assembly, the detachable seal module configured to: when the proximal and distal portions of the seal module insert are compressed in the seal module chamber, seals around the proximal portion of the introducer needle and the distal portion of the access guidewire, respectively.

2. The quick connect center catheter insertion assembly of claim 1, wherein each of the proximal and distal portions of the seal module insert is formed of an elastomer.

3. The quick-insertion center catheter insertion assembly of claim 1, wherein the proximal and distal portions of the seal module insert complete both an introducer needle channel and an access guidewire channel when combined in the seal module chamber.

4. The quick insert center catheter insertion assembly of claim 3, wherein a proximal portion of the introducer needle channel is present in a proximal portion of the seal module insert and a distal portion of the introducer needle channel is completed by the proximal and distal portions of the seal module insert incorporated in the seal module chamber.

5. The quick-insertion center catheter insertion assembly of claim 3, wherein the entire access guidewire channel is completed by a proximal portion and a distal portion of the seal module insert incorporated in the seal module chamber.

6. The rapid insertion type central catheter insertion assembly of claim 3, wherein a distal end of the access guidewire channel is connected to a middle portion of the introducer needle channel, thereby allowing a distal portion of the access guidewire to be disposed in the needle shaft through the needle slot.

7. The rapid insertion type central catheter insertion assembly of claim 3, wherein the introducer needle channel is configured to seal around a proximal portion of the introducer needle and the access guidewire channel is configured to seal around a distal portion of the access guidewire when the proximal and distal portions of the seal module insert are compressed in the seal module chamber.

8. The quick-insertion center catheter insertion assembly of claim 3, wherein the introducer needle channel comprises an internal relief between a proximal portion and a distal portion of the introducer needle channel such that when the proximal portion and distal portion of the seal module insert are compressed in the seal module chamber, only the proximal and distal portions of the introducer needle channel are configured to seal around the proximal portion of the introducer needle.

9. The rapid insertion type central catheter insertion assembly of claim 3, wherein the access guidewire channel comprises an internal relief at least in a proximal portion of the access guidewire channel such that when a proximal portion and a distal portion of the seal module insert are compressed in the seal module chamber, only a proximal portion of the access guidewire channel is configured to seal around a distal portion of the access guidewire.

10. The quick connect type center catheter hub assembly of claim 1, wherein said seal module insert is radially compressed in said seal module chamber by said coupler housing.

11. The quick insert center catheter insertion assembly of claim 1, wherein the seal module insert is axially compressed in the seal module chamber by a distal portion of the needle hub, the axial compression of the seal module insert in the seal module chamber and thereby radially compressing the seal module insert in the seal module chamber.

12. The quick-insertion center catheter insertion assembly of claim 1, wherein the coupler housing comprises a longitudinal coupler housing slot configured to: the access guidewire is allowed to disengage from the coupler housing after the introducer needle is withdrawn from the coupler and the proximal portion of the seal module insert is removed from the seal module chamber.

13. The quick-insertion center catheter insertion assembly of claim 1, wherein the introducer needle further comprises a sheath on the needle shaft, the sheath sealing the needle slot therebelow, the needle slot extending from a proximal portion of the needle shaft through a distal needle tip.

14. The quick-insertion center catheter insertion assembly of claim 13, wherein the coupler comprises a blade extending into the detachable sealing module such that the blade is disposed in the needle slot below a distal end of a sheath opening, the blade comprising a distally facing blade edge configured to: the sheath is cut away from the needle shaft as the introducer needle is withdrawn from the coupler, allowing the access guidewire to be disengaged from the needle shaft by means of the needle slot.

15. The quick connect center catheter insertion assembly of claim 14, wherein said blade is overmolded into said coupler housing thereby integrating said blade into said coupler housing.

16. The quick connect type center catheter insertion assembly of claim 13, wherein said sheath is detachable.

17. The quick connect hub catheter insertion assembly of claim 16, wherein a pattern of holes, slits, or combinations thereof extending longitudinally on the sheath is provided through the sheath configured for detaching the sheath, the pattern being offset from the needle groove to maintain a seal of the sheath to the needle groove.

18. The quick connect hub catheter insertion assembly of claim 16, wherein said sheath comprises one or more grooves extending longitudinally on said sheath configured for detachment of said sheath.

19. The quick-insertion center catheter insertion assembly of claim 16, wherein the sheath comprises an embedded pull cord extending longitudinally within the sheath configured to detach the sheath when pulled away from the sheath.

20. The quick connect hub catheter insertion assembly of claim 13, wherein said sheath is formed of one of a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane and polytetrafluoroethylene.

21. The rapid insertion type central catheter insertion assembly of claim 1, wherein the coupler further comprises an access guidewire connection side arm comprising a connector configured to connect to an access guidewire hub surrounding a proximal portion of the access guidewire, a distal portion of the access guidewire being disposed in the needle shaft, and the access guidewire hub being connected to the connector of the access guidewire connection side arm, thereby realizing a loop in the access guidewire over which the rapid insertion type central catheter is disposed at least in a ready-to-operate state of the rapid insertion type central catheter insertion assembly.

22. The rapid insertion center catheter insertion assembly of claim 1, further comprising a retainer comprising a detachable housing on both a catheter tube of the rapid insertion center catheter and an outer catheter portion of the access guidewire extending from a distal end of the rapid insertion center catheter, the detachable housing configured to maintain sterility of the catheter tube and the outer catheter portion of the access guidewire until deployment.

23. The quick-insertable center catheter insertion assembly of claim 22, wherein the retainer further comprises a catheter hub holder to which the proximal end of the detachable housing is attached, the catheter hub holder configured to retain a catheter hub of the quick-insertable center catheter therein and to hold the detachable housing in place on both the catheter and the outer catheter portion of the access guidewire.

24. The quick connect center catheter insertion assembly of claim 23, wherein the catheter hub holder includes a peripheral wall surrounding at least a portion of a periphery of the catheter hub holder, the peripheral wall defining a recess into which the catheter hub is adapted to be engineering fitted.

25. The quick connect hub catheter insertion assembly of claim 22, wherein said coupler further comprises a detachable housing retention sidearm comprising a primary channel configured to slidably retain said detachable housing therein and a secondary channel configured to guide said access guidewire detached from said detachable housing into said coupler and through said needle slot into said needle shaft.

26. The rapid insertion type central catheter insertion assembly of claim 25, wherein the coupler further comprises an access guidewire connection side arm comprising a connector configured to connect to an access guidewire hub surrounding a proximal portion of the access guidewire, a distal portion of the access guidewire being disposed in the needle shaft, a distal portion of the detachable housing being retained in a main channel of the detachable housing retention side arm, and the access guidewire hub connecting to the connector of the access guidewire connection side arm to thereby implement a loop in the access guidewire, the rapid insertion type central catheter being disposed on the loop at least in a ready-to-operate state of the rapid insertion type central catheter insertion assembly.

27. The quick-insertable center catheter insertion assembly of claim 1, wherein the quick-insertable center catheter comprises a set of three lumens including the primary lumen, secondary lumen, and third lumen formed by fluid connections of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

28. The quick connect hub catheter insertion assembly of claim 27, wherein said primary lumen has a primary lumen orifice in a distal end of said catheter tube, said secondary lumen has a secondary lumen orifice on a side of a distal portion of said catheter tube, and said third lumen has a third lumen orifice on a side of a distal portion of said catheter tube proximal to said secondary lumen orifice.