Quickly insertable central catheter insertion assembly and introducer needle subassembly

Abstract

The utility model relates to a quick insertable central catheter insertion assembly and introducer needle subassembly. A quick insertable central catheter ("RICC") insertion assembly may include an RICC, an introducer needle, and a coupler that couples the RICC and introducer needle together. The introducer needle may include a needle bushing positioned over a proximal portion of a composite shaft that includes a sheath positioned over the needle shaft that seals a needle pocket of the needle shaft thereunder. The coupler may include a coupler housing and a valve module disposed within the coupler housing. The composite shaft may pass through an introducer needle passage defined by a valve module housing of the valve module such that in a ready deployed state of the RICC insertion assembly, the valve module forms a seal over a sheath opening of the sheath. The valve module may include a needle stick injury protection mechanism configured to capture a distal needle tip of the needle shaft within the valve module when the introducer needle is withdrawn from the coupler in a proximal direction.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 438,474, filed on January 11, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present application relates to the field of medical devices, and more particularly to a rapidly insertable central catheter insertion assembly and an introducer needle subassembly. Background Art

[0004] A central venous catheter ("CVC") is typically introduced into a patient and advanced through the patient's vascular system to achieve placement using the Seldinger technique. The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, the multiple steps are time consuming, handling multiple medical devices is difficult, and both of the aforementioned can cause patient injury. In addition, since multiple medical devices need to be replaced during the Seldinger technique, there is a relatively high likelihood of contact contamination. Therefore, there is a need to reduce the multiple steps and medical devices involved in introducing a catheter (such as a CVC) into a patient and advancing the catheter through the patient's vascular system.

[0005] Disclosed herein are rapidly insertable central catheter ("RICC") insertion assemblies, introducer needle assemblies, and methods that address the aforementioned problems. Notably, such RICC insertion assemblies, introducer needle assemblies, and methods include needle stick protection, as described below. Utility Model Content

[0006] A RICC insertion assembly is disclosed herein, in some embodiments, comprising a RICC, an introducer needle, and a coupler for coupling the RICC to the introducer needle. The introducer needle comprises a needle bushing located on the proximal portion of a composite shaft. The composite shaft comprises a needle shaft having a longitudinal needle groove and a sheath located on the needle shaft, the sheath sealing the needle groove below it, but not sealing the sheath opening leading to the needle groove in the sheath. The coupler comprises a coupler housing and a valve module arranged in the coupler housing. The composite shaft passes through the introducer needle channel defined by the valve module housing of the valve module, so that in the ready-to-deploy state of the RICC insertion assembly, the valve module forms a seal above the sheath opening. The valve module comprises a needle puncture ("NSI") protection mechanism, and the NSI protection mechanism is configured to capture the distal needle tip of the needle shaft in the valve module when the introducer needle is withdrawn from the coupler in the proximal direction.

[0007] In some embodiments, the NSI shielding mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

[0008] In some embodiments, the tether has a fixed tether length configured to prevent the needle tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn in a proximal direction from the coupler.

[0009] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes passing through the pleats. The composite shaft is disposed in the pleat through-holes such that when the introducer needle is withdrawn from the coupler in a proximal direction, the pleats are deployed over the composite shaft.

[0010] In some embodiments, the NSI protection mechanism includes a spring loaded in a spring cavity along a portion of the introducer needle channel. The spring is configured to unload into the introducer needle channel when the introducer needle is withdrawn from the coupler in a proximal direction and the needle tip of the needle shaft passes through the spring.

[0011] In some embodiments, the spring is a flat spring including an end tab configured to extend across the introducer needle channel into a tab receiver of the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring. This prevents the needle tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced into the coupler in the distal direction.

[0012] In some embodiments, the end tab of the spring provides a first end guard and the fulcrum of the spring provides a second end guard where the needle tip of the needle shaft is forcibly advanced in a distal direction past the end tab into the coupler.

[0013] In some embodiments, the fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve module housing in the spring cavity.

[0014] In some embodiments, the RICC insertion assembly further comprises an entry guidewire. The entry guidewire comprises a distal portion having a distal end. The distal portion of the entry guidewire passes through a guidewire channel defined by a valve module housing of the valve module, a continuation of the guidewire channel defined by an elastomeric gasket of the valve module, a sheath opening in the sheath, and an introducer needle lumen of the introducer needle, such that in the ready-to-deploy state of the RICC insertion assembly, the distal end of the entry guidewire is arranged just proximal to the needle tip of the needle shaft.

[0015] In some embodiments, the valve module includes a blade extending from the valve module housing into the sheath opening of the sheath, the blade being fixed to the valve module housing. The blade is configured to cut the sheath along the needle groove when the introducer needle is withdrawn from the coupler in a proximal direction. This allows the entry guide wire to be disengaged from the introducer needle lumen of the introducer needle.

[0016] In some embodiments, the RICC includes a catheter tip, a catheter tube, a catheter hub, and one or more extension legs. The catheter tip is coupled to a distal portion of the catheter tube. The catheter tube includes a catheter tube portion of a first lumen of the RICC. The catheter hub is coupled to a proximal portion of the catheter tube. Each of the one or more extension legs is coupled to the catheter hub via its distal portion.

[0017] In some embodiments, the catheter tip is made of a first polymer material and the catheter tubing is made of a second, softer polymer material.

[0018] In some embodiments, the first polymer material is hard enough to prevent the catheter tip from collapsing, buckling, or otherwise significantly deforming when the distal portion of the RICC is advanced into the patient's vascular lumen. The first polymer material is also flexible enough to prevent damage to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

[0019] In some embodiments, the RICC comprises a set of three lumens, the set of three lumens comprising a first lumen, a second lumen and a third lumen, the set of three lumens being formed by fluidly connecting portions of at least three catheter tubing lumens, three catheter hub lumens and three extension leg lumens. The second lumen and the third lumen terminate at a distal portion of the catheter tubing through at least some filler made of molten polymer material of the first polymer material.

[0020] In some embodiments, the first lumen has a first lumen hole in the distal end of the catheter tip, the second lumen has a second lumen hole in a side of the distal portion of the catheter tubing, and the third lumen has a third lumen hole in the side of the distal portion of the catheter tubing but proximal to the second lumen hole.

[0021] In some embodiments, the RICC insertion assembly further comprises a syringe. The syringe is fluidly coupled to the needle hub of the introducer needle in at least a ready-to-deploy state of the RICC insertion assembly.

[0022] Also disclosed herein is an introducer needle subassembly, which, in some embodiments, includes an introducer needle and a coupler connected to the introducer needle. The introducer needle includes a needle hub located above the proximal portion of the composite shaft. The composite shaft includes a needle shaft having a longitudinal needle groove and a sheath located above the needle shaft, the sheath sealing the needle groove below it, but not sealing the sheath opening leading to the needle groove in the sheath. The coupler includes a coupler housing and a valve module arranged in the coupler housing. The composite shaft passes through the introducer needle channel defined by the valve module housing of the valve module, so that in the ready-to-deploy state of the introducer needle subassembly, the valve module forms a seal above the sheath opening. The valve module includes an NSI protection mechanism, which is configured to capture the distal needle tip of the needle shaft in the valve module when the introducer needle is withdrawn from the coupler in the proximal direction.

[0023] In some embodiments, the NSI shielding mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

[0024] In some embodiments, the tether has a fixed tether length configured to prevent the needle tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn in a proximal direction from the coupler.

[0025] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats. The composite shaft is disposed in the pleat through-holes such that when the introducer needle is withdrawn from the coupler in a proximal direction, the pleats deploy over the composite shaft.

[0026] In some embodiments, the NSI protection mechanism includes a spring loaded in a spring cavity along a portion of the introducer needle channel. The spring is configured to unload into the introducer needle channel when the introducer needle is withdrawn from the coupler in a proximal direction and the needle tip of the needle shaft passes through the spring.

[0027] In some embodiments, the spring is a flat spring including an end tab configured to extend across the introducer needle channel into a tab receiver of the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring. This prevents the needle tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced into the coupler in the distal direction.

[0028] In some embodiments, the end tab of the spring provides a first end guard and the fulcrum of the spring provides a second end guard where the needle tip of the needle shaft is forcibly advanced in a distal direction past the end tab into the coupler.

[0029] In some embodiments, the fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve module housing in the spring cavity.

[0030] A method for an introducer needle subassembly is also disclosed herein. In some embodiments, the method includes a needle tract establishment step, an entry guide wire advancement step, an introducer needle withdrawal step, and a needle end capture step. The needle tract establishment step includes establishing a needle tract from the skin surface to the patient's blood vessel using an introducer needle of the introducer needle subassembly. The introducer needle includes a needle hub located on the proximal portion of the composite shaft. The composite shaft includes a needle shaft having a longitudinal needle groove and a sheath located on the needle shaft, the sheath sealing the needle groove below it, but not sealing the sheath opening leading to the needle groove in the sheath. The entry guide wire advancement step includes advancing the distal end of the entry guide wire into the blood vessel just proximal to the distal needle end of the needle shaft. The introducer needle withdrawal step includes withdrawing the introducer needle from the needle tract in the proximal direction, thereby leaving the entry guide wire in place. The introducer needle withdrawal step also includes further withdrawing the introducer needle from the connector that couples the introducer needle with the entry guide wire in the proximal direction. The coupler includes a coupler housing and a valve module having a valve module housing disposed in the coupler housing. The needle tip capturing step includes capturing the needle tip of the needle shaft within the valve module by the NSI guard mechanism.

[0031] In some embodiments, the NSI shielding mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

[0032] In some embodiments, the tether has a fixed tether length configured to prevent the needle tip of the needle shaft from disengaging from the valve module during or after further withdrawal of the introducer needle from the coupler during an introducer needle withdrawal step.

[0033] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats. The composite shaft is disposed in the pleat through-holes such that the pleats expand over the composite shaft during further withdrawal of the introducer needle from the coupler during the introducer needle withdrawal step.

[0034] In some embodiments, the NSI protection mechanism includes a spring loaded in a spring chamber along a portion of an introducer needle channel defined by a valve module housing of the valve module. During the introducer needle withdrawal step, when the needle tip of the needle shaft passes the spring, the spring is unloaded into the introducer needle channel as the introducer needle is further withdrawn from the coupler.

[0035] In some embodiments, the spring is a flat spring including an end tab configured to extend across the introducer needle channel into a tab receiver of the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring. This prevents the needle tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced into the coupler in the distal direction.

[0036] In some embodiments, the end tab of the spring provides a first end guard and the fulcrum of the spring provides a second end guard where the needle tip of the needle shaft is forcibly advanced in a distal direction past the end tab into the coupler.

[0037] In some embodiments, the fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve module housing in the spring cavity.

[0038] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A RICC insert assembly according to some embodiments is shown.

[0040] Figure 2 An introducer needle subassembly of a RICC insertion assembly according to some embodiments is shown.

[0041] Figure 3 A longitudinal cross-section of an introducer needle subassembly is shown with the spring of the NSI guard mechanism loaded in the spring cavity according to some embodiments.

[0042] Figure 4 A longitudinal cross-section of an introducer needle subassembly is shown with the spring of the NSI guard mechanism unloaded from the spring chamber, according to some embodiments.

[0043] Figure 5 According to some embodiments, Figure 4 Detailed view of a longitudinal section of an introducer needle subassembly.

[0044] Figure 6 A detailed isometric view of an introducer needle subassembly is shown with the spring of the NSI guard mechanism unloaded from the spring chamber, according to some embodiments.

[0045] Figure 7 A composite shaft of an introducer needle including a needle shaft and a sheath positioned over the needle shaft is shown according to some embodiments.

[0046] Figure 8 A sheath according to some embodiments is shown.

[0047] Fig. 9 A needle shaft is shown according to some embodiments.

[0048] Fig.10 RICC according to some embodiments is shown.

[0049] Fig.11 A distal portion of a catheter tube of a RICC is shown according to some embodiments.

[0050] Fig.12 A longitudinal cross-section of a distal portion of a catheter tube is shown according to some embodiments.

[0051] Fig.13 A transverse cross-section of a catheter tip coupled to a catheter tube is shown according to some embodiments.

[0052] Fig.14 Another transverse cross-section of a catheter tip is shown according to some embodiments.

[0053] Fig.15 A transverse cross-section of a distal portion of a catheter tube is shown according to some embodiments. DETAILED DESCRIPTION

[0054] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0055] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and 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 sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. In addition, unless otherwise specified, any feature or step in the aforementioned features or steps and then can also include one or more features or steps. For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly specifies otherwise.

[0056] "Proximal" is used to indicate a portion, segment, component, element, etc. of a medical device that is intended to be placed near or relatively close to a clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal segment" of a medical device includes a portion or segment of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes a length of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The "proximal end" of a medical device includes an end of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The proximal portion, proximal segment, or proximal length of a medical device need not include the proximal end of the medical device. In fact, the proximal portion, proximal segment, or proximal length of a medical device may be shorter than the proximal end of the medical device. However, the proximal portion, proximal segment, or proximal length of a medical device may include the proximal end of the medical device. If the context does not indicate that the proximal portion, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if deemed advantageous in the following description, the "proximal portion," "proximal segment," or "proximal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length, respectively, of the medical device to refer to the "proximal portion," "proximal segment," or "proximal length" of the medical device.

[0057] "Distal" is used to indicate that the part, segment, component, element, etc. of the medical device is intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. For example, the "distal part" or "distal segment" of the medical device includes the part or segment of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. Similarly, the "distal length" of the medical device includes the length of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The "distal end" of the medical device is the end of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The distal part, distal segment, or distal length of the medical device does not need to include the distal end of the medical device. In fact, the distal part, distal segment, or distal length of the medical device can be shorter than the distal end of the medical device. However, the distal part, distal segment, or distal length of the medical device can include the distal end of the medical device. If the context does not indicate that the distal portion, distal segment, or distal length of a medical device includes the distal end of the medical device, or if deemed advantageous in the following description, the "distal portion," "distal segment," or "distal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length, respectively, of the medical device to refer to the "distal portion," "distal segment," or "distal length" of the medical device.

[0058] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0059] Likewise, RICC insertion assemblies, introducer needle assemblies and methods are disclosed herein, particularly those including needle stick protection, as described below. Such RICC insertion assemblies, introducer needle assemblies and methods will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe specific embodiments of the foregoing primarily in the context of RICC insertion assemblies. However, the RICC insertion assembly includes only one type of catheter, which can be incorporated into a catheter insertion assembly similar to the RICC insertion assembly provided herein. In fact, peripherally inserted central catheters ("PICCs"), dialysis catheters, etc. can also be incorporated into the catheter insertion assembly for rapid insertion or other purposes.

[0060] RICC Insert Components

[0061] Figure 1 A RICC insert assembly 100 is shown according to some embodiments. Figure 2 An introducer needle subassembly 102 of the RICC insertion assembly 100 is shown according to some embodiments.

[0062] As shown, the RICC insertion assembly 100 may include a RICC 104, an introducer needle 106, and a coupler 108 that couples the RICC 104 to the introducer needle 106. It is noteworthy that the introducer needle subassembly 102 may include an introducer needle 106 and a coupler 108 that is coupled to the introducer needle 106. As described below for the RICC insertion assembly 100, according to some embodiments, the introducer needle subassembly 102 may also include an entry guide wire 204. In at least the ready-to-deploy state of the RICC insertion assembly 100, the proximal end of the entry guide wire 204 may be attached to the extension arm 110 of the coupler 108, or may be held in place by some other retaining devices (including by hand) for holding the entry guide wire 204, and the distal end of the entry guide wire 204 may be arranged in the needle lumen 164 of the introducer needle 106, as described below. This may force a loop 112 to be formed in the entry guide wire 204. The RICC 104 may be arranged on the ring 112 in the ready-to-deploy state of the RICC insert assembly 100, thereby maintaining the RICC insert assembly 100 in a relatively compact form.

[0063] As shown, the coupler 108 may include a coupler housing 114 and a valve module 116 having a valve module housing 118 disposed in the coupler housing 114. Although shown as such, it should be understood that in some embodiments, the valve module housing 118 may be integrated with the coupler housing 114 in an integrated housing.

[0064] The coupler housing 114 may include two molded pieces that are coupled together (e.g., coupled together using compression pins or heat-seal pins, fastened or tightened together using screws or bolts, welded together using ultrasonic welding or hot plate welding, etc.) to form a body that, as shown, can be configured to be comfortably held under the hand (e.g., held) during left-handed venipuncture or right-handed venipuncture using the introducer needle 106 of the RICC insertion assembly 100. Although not shown, the interior of each of the two molded pieces may include a distal recess that forms a valve module compartment for the valve module 116 when the two molded pieces are coupled together. Alternatively, in the embodiment of the integrated housing described above, the distal recess in each of the two molded pieces may similarly form a gasket compartment that may be configured for the elastomeric gasket 120 described below. In either case, the interior of each of the two molded parts may also include a proximal recess that forms a needle hub receptacle for the needle hub 156 of the introducer needle 106 when the two molded parts are coupled together. As shown in the clamp arm 119 of the needle hub 156, the coupler housing 114 may also include a tab located outside the needle hub receptacle for clamping the clamp arm 119 thereon. Finally, when the two molded parts are coupled together, the coupler housing 114 may include a longitudinal coupler housing slot between the two molded parts. The coupler housing slot may be open in the same or different direction as the needle slot 160 of the needle shaft 152, thereby configuring the coupler housing slot to allow the entry guide wire 204 to disengage from the coupler housing 114 after the introducer needle 106 is withdrawn from the coupler 108 in the proximal direction according to the introducer needle withdrawal step of the method described below.

[0065] Similar to the coupling housing 114, the valve module housing 118 can include two molded pieces coupled together in a valve module compartment to form a gasket compartment for the elastomeric gasket 120. The valve module compartment of the coupling housing 114 can be configured to have sufficient space to allow the valve module housing 118 and the elastomeric gasket 120 disposed therein to separate for the entry guidewire 204 to be disengaged from the valve module 116 after the introducer needle 106 is withdrawn from the coupling 108 in the proximal direction according to the introducer needle withdrawal step of the method set forth below. Notably, the introducer needle 106 is withdrawn in the proximal direction through the introducer needle channel 122, and the composite shaft 150 of the introducer needle 106 is disposed in the introducer needle channel in the at least ready-to-deploy state of the RICC insertion assembly 100. The introducer needle channel 122 can be defined by a combination of coupling components selected from the coupling housing 114, the valve module housing 118, and the elastomeric gasket 120. Likewise, the guidewire channel 124 connected to the introducer needle channel 122 in the valve module 116 can be defined by a combination of connector components selected from the connector housing 114, the valve module housing 118, and the elastomeric gasket 120. The entry guidewire 204 can be disposed in the composite shaft 150 of the introducer needle 106 while the composite shaft 150 of the introducer needle 106 is disposed in the introducer needle channel 122 through the connection of the guidewire channel 124 with the introducer needle channel 122 in the valve module 116, and the sheath opening 168 of the sheath 154 described below to the needle slot 160 of the needle shaft 152.

[0066] The coupler 108 may also include a blade 126 for cutting the sheath 154 along the needle slot 160 of the needle shaft 152. For example, the valve module 116 may include a blade 126 distal to the spring 128, the blade extending from the valve module housing 118 to which the blade 126 is secured into a sheath opening 168 of the sheath 154. The blade 126 may be configured to cut the sheath 154 along the needle slot 160 when the introducer needle 106 is withdrawn from the coupler 108 in a proximal direction according to the introducer needle withdrawal step of the method set forth below, which allows the access guidewire 204 to disengage from the needle lumen 164 of the introducer needle 106.

[0067] Figure 3 A longitudinal cross-section of the introducer needle subassembly 102 is shown with the spring 128 of the NSI guard mechanism 130 loaded in the spring cavity 132 according to some embodiments. Figure 4 to

[0068] Figure 6 Various views of the introducer needle subassembly 102 are shown with the spring 128 of the NSI guard mechanism 130 unloaded from the spring cavity 132 according to some embodiments.

[0069] As shown, the coupler 108 may also include an NSI guard mechanism 130 configured to capture the needle tip 158 of the needle shaft 152 after the needle track is established according to the needle track establishment step of the method set forth below. For example, the valve module 116 may include an NSI guard mechanism 130 configured to capture the needle tip 158 of the needle shaft 152 within the valve module 116 when the introducer needle 106 is withdrawn from the coupler 108 in the proximal direction according to the introducer needle withdrawal step of the method set forth below.

[0070] In some embodiments, the NSI protection mechanism 130 can include a tether 134 having a proximal portion coupled to the needle hub 156 and a distal portion coupled to the valve module housing 118 or the coupler housing 114. The tether 134 can have a fixed tether length configured to prevent the needle tip 158 of the needle shaft 152 from disengaging from the valve module 116 when or after the introducer needle 106 is withdrawn from the coupler 108 in the proximal direction according to the introducer needle withdrawal step of the method set forth below. Notably, the tether 134 can include a plurality of pleats 136 and a plurality of pleat through-holes 138 passing through the pleats 136. The composite shaft 150 of the introducer needle 106 can be disposed in the pleat through-holes 138 such that the pleats 136 deploy over the composite shaft 150 when the introducer needle 106 is withdrawn from the coupler 108 in the proximal direction according to the introducer needle withdrawal step of the method set forth below.

[0071] The NSI guard mechanism 130 may also include a spring 128 loaded in a spring cavity 132 along a portion of the introducer needle channel 122. Such a spring cavity 132 may be defined by the valve module housing 118; however, the NSI guard mechanism 130 may extend outside of the valve module 116 such that the spring cavity 132 is defined by the coupler housing 114. Regardless, the spring 128 may be configured to unload into the introducer needle channel 122 when the introducer needle 106 is withdrawn from the coupler 108 in a proximal direction according to the introducer needle withdrawal step of the method set forth below and the needle tip 158 of the needle shaft 152 passes over the spring 128.

[0072] The spring 128 of the NSI guard mechanism 130 may be a flat spring including an end tab 140 that is sized or otherwise configured to extend across the introducer needle passage 122 into a tab receiver 142 of the valve module housing 118 or the coupler housing 114 opposite the spring cavity 132 when the needle tip 158 of the needle shaft 152 passes through the spring 128. Such a tab receiver 142 may be another smaller cavity opposite the spring cavity 132 along the aforementioned portion of the introducer needle passage 122. Once seated in the tab receiver 142, the end tab 140 may prevent the needle tip 158 of the needle shaft 152 from disengaging from the coupler 108 or its valve module 116 when the introducer needle 106 is advanced in the distal direction into the coupler 108. It is worth noting that the end tab 140 of the spring 128 can provide a first end protection and the fulcrum 144 of the spring 128 can provide a second end protection when the needle tip 158 of the needle shaft 152 is forced into the coupler 108 in the distal direction past the end tab 140. As shown, the fulcrum 144 of the spring 128 is between a free arm 146 of the spring 128 including the end tab 140 and a fixed arm 148 of the spring 128 fixed to the valve module housing 118 or the coupler housing 114 in the spring cavity 132.

[0073] Figure 7 A composite shaft 150 of the introducer needle 106 is shown including a needle shaft 152 and a sheath 154 over the needle shaft 152 according to some embodiments. Figure 8 A sheath 154 is shown according to some embodiments, while Fig. 9 A needle shaft 152 is shown according to some embodiments.

[0074] The introducer needle 106 can include a needle hub 156 on a proximal portion of the composite shaft 150. In at least the ready-to-deploy state of the RICC insertion assembly 100, the composite shaft 150 can pass through the introducer needle channel 122, including the portion of the introducer needle channel 122 passing through the valve module 116, which in turn includes the valve module housing 118 and its gasket, so that the valve module 116 forms a seal on the sheath opening 168.

[0075] The composite shaft 150 may include a needle shaft 152 and a sheath 154 over the needle shaft 152 that seals the needle slot 160 thereunder but does not seal a sheath opening 168 in the sheath 154 that leads to the needle slot 160 , as described below.

[0076] The needle shaft 152 can include a distal needle tip 158 in the distal portion of the needle shaft 152 and a longitudinal needle slot 160 extending from the proximal portion of the needle shaft 152 through the needle tip 158. The needle slot 160 forms a needle passage 162 along most of the length of the needle shaft 152, opposite a needle lumen 164 extending therethrough, as described below. The needle slot 160 can have a width sized according to the outer diameter of the entry guidewire 204, which allows the entry guidewire 204 to pass from the proximal portion of the needle shaft 152 through the needle tip 158 according to the introducer needle withdrawal step of the method set forth below.

[0077] Although the needle shaft 152 may include a needle slot 160, it should be understood that the introducer needle 106 or its composite shaft 150 may include a needle lumen 164. In practice, the needle lumen 164 is created by the combination of the needle shaft 152 and the sheath 154 on the needle shaft 152. That is, the sheath 154 on the needle shaft 152 may seal the needle slot 160 thereunder, thereby forming the needle lumen 164 of the introducer needle 106 or its composite shaft 150, thereby enabling the syringe 208 to aspirate blood, for example, to confirm vascular access after the needle track is established according to the needle track establishment step of the method set forth below.

[0078] The sheath 154 may include a sheath tip 166 in a distal portion of the sheath 154 and a sheath opening 168 in a side of a proximal portion of the sheath 154 .

[0079] The sheath tip 166 may include a relatively short taper from the outer diameter of the distal portion of the sheath 154 to the outer diameter of the distal end of the sheath 154 , where the latter may be commensurate with the outer diameter of the distal portion of the needle shaft 152 .

[0080] The sheath opening 168 can be open to the needle slot 160 of the needle shaft 152, thereby allowing the entry guide wire 204 to pass through the sheath opening 168 and enter the needle channel 162 or the needle lumen 164 in at least the ready-to-deploy state of the RICC insertion assembly 100. Therefore, the sheath opening 168 can have a width that is approximately commensurate with the width of the needle slot 160, which in turn can be designed according to the diameter of the entry guide wire 204. The sheath opening 168 can also have a sufficient length to allow the entry guide wire 204 to pass through the sheath opening 168 and enter the needle slot 160 or the needle lumen 164, while also accommodating the blade 126 of the valve module 116 under the distal end of the sheath opening 168. It is worth noting that the sheath 154 on the needle shaft 152 can seal the needle slot 160 below it, but does not seal the portion of the needle slot 160 under the sheath opening 168. However, the valve module 116 can seal on the needle slot 160 exposed by the sheath opening 168 by sealing the proximal portion of the needle shaft 152 and the sheath 154 therein, thereby enabling the syringe 208 to draw blood, for example, to confirm vascular access after the needle track is established according to the needle track establishment step of the method described below.

[0081] The sheath 154 or its sheath body can be formed of a polymer material that is configured to facilitate smooth, consistent insertion of the introducer needle 106 from a skin area into a patient's vascular lumen according to the needle tract establishment step of the method set forth below. In addition, the polymer material can have sufficient mechanical properties at the thickness of the sheath 154 to prevent the sheath 154 from collapsing into the needle groove 160 of the needle shaft 152 when blood is aspirated, and it is worth noting that it also facilitates the sheath 154 from being cut off from the needle shaft 152 according to the introducer needle withdrawal step of the method set forth below. Such polymer materials can include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0082] Fig.10 A RICC 104 is shown according to some embodiments.

[0083] As shown, the RICC 104 may include a catheter tube 170, a catheter hub 174, and one or more extension legs 176, the catheter tube having a single-piece catheter tip 172 coupled thereto. The catheter tip 172 may be coupled to the distal portion of the catheter tube 170, and the catheter hub 174 may be coupled to the proximal portion of the catheter tube 170. Each of the one or more extension legs 176 may be coupled to the catheter hub 174 via its distal portion. In addition, one or more extension leg connectors 177 (e.g., Luer connectors) may be coupled to the one or more extension legs 176 for connection to one or more other medical devices, respectively.

[0084] RICC 104 may be a single-cavity RICC or a multi-cavity RICC (e.g., a double-cavity RICC, a triple-cavity RICC, a quad-cavity RICC, a penta-cavity RICC, a hexa-cavity RICC, etc.). Figure 1 and Fig.10 The illustrated triple lumen RICC includes three lumens grouped together. (See also Fig.15). The three lumens in a group may include a first lumen 178, a second lumen 180, and a third lumen 182. Each of the first lumen 178, the second lumen 180, and the third lumen 182 may be formed by at least three fluidically connected lumen portions (i.e., those fluidically connected lumen portions of the three catheter tubing lumens, the three catheter sleeve lumens, and the three extension leg lumens in the three-lumen RICC). For example, the first lumen 178 of the RICC 104 may be formed by the first catheter tubing lumen 184, the first catheter sleeve lumen, and the first extension leg lumen; however, the first lumen 178 of the RICC 104 may also include the fluidically connected catheter end lumen 186 of the catheter end 172. In addition, the second lumen 180 of the RICC 104 may be formed by the second catheter tubing lumen 188, the second catheter sleeve lumen, and the second extension leg lumen. Finally, the third lumen 182 of the RICC 104 can be formed by the third catheter tubing lumen 190, the third catheter hub lumen, and the third extension leg lumen. The first lumen 178 can have a first lumen hole 192 in the distal end of the catheter tip 172 (which corresponds to the distal end of the RICC 104). The second lumen 180 can have a second lumen hole 194 in one side of the distal portion of the catheter tubing 170. The third lumen 182 can have a third lumen hole 196 in the side of the distal portion of the catheter tubing 170, proximal to the second lumen hole 194. Similar to the second lumen 180 and the third lumen 182, each additional lumen of the aforementioned lumens can have a corresponding lumen hole in the side of the distal portion of the catheter tubing 170, proximal to its leading lumen.

[0085] Fig.11 Shown is a distal portion of a catheter tube 170 and a catheter tip 172 coupled thereto, according to some embodiments. Fig.12 A longitudinal cross-section of the distal end portion of the catheter tip 172 and the catheter tube 170 is shown according to some embodiments, and Figures 13 to 15 Various transverse cross-sections of the catheter tip 172 and the distal portion of the catheter tube 170 are shown according to some embodiments.

[0086] As shown, the catheter tube 170 may include one or more catheter tube lumens, such as the three catheter tube lumens described above. In fact, when the RICC 104 is a three-lumen RICC, the catheter tube 170 may include a catheter tube portion of a first lumen 178 of the RICC 104, a catheter tube portion of a second lumen 180 of the RICC 104, and a catheter tube portion of a third lumen 182 of the RICC 104. Before forming a catheter end 172 connected to the catheter tube 170, each of the aforementioned three catheter tube lumens may extend completely through the catheter tube 170. However, after forming the catheter end 172, only the first catheter tube lumen 184 generally extends from the proximal end of the catheter tube 170 to the distal end of the catheter tube 170. In fact, the first catheter tube lumen 184 generally extends through both the proximal end and the distal end of the catheter tube 170, and continues to extend through the catheter end lumen 186 of the catheter end 172. In contrast, the second and third catheter tube lumens 188 , 190 typically terminate at the distal portion of the catheter tube 170 with at least some filler made of molten polymer material of the first polymer material used to form the catheter tip 172 .

[0087] The catheter tube 170 can be formed by a second polymer material softer than the first polymer material of the catheter end 172 described below. In other words, the second polymer material can have a second hardness less than the first hardness of the first polymer material. This second polymer material can include but is not limited to polyvinyl chloride, polyethylene, polyurethane or silicone resin, which has a second hardness less than the first hardness of the first polymer material. For example, if the catheter end 172 is formed by the polyurethane described below, the catheter tube 170 can be formed by different polyurethanes (for example, the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or under different additives, etc.) having a second hardness less than the first hardness of the polyurethane of the catheter end 172. It is worth noting that polyurethane can be advantageous for the catheter tube 170 because polyurethane is relatively hard at room temperature, but becomes more flexible in vivo at body temperature, which reduces the stimulation to the vessel wall and phlebitis. Polyurethane is also advantageous in that it may be less thrombogenic than some other polymers.Whether or not the second polymer material is polyurethane, the second polymer material may be configured to be sufficiently rigid in vitro to impart column strength to the catheter tubing 170 that prevents the catheter tubing 170 from collapsing, buckling, or otherwise significantly deforming when the RICC 104 is advanced into and placed in the lumen of a blood vessel.

[0088] As shown, the catheter tip 172 may have a first segment 198, a second segment 200, and a third segment 202. The second segment 200 of the catheter tip 172 may have a length greater than the first segment 198 of the catheter tip 172. Long Length The third segment 202 of the catheter tip 172 may have a length greater than that of the second segment 200 of the catheter tip 172. Long Length

[0089] The first segment 198 of the catheter tip 172 can have a uniform taper on its outer diameter, the uniform taper having a constant first taper angle, which is configured to expand the tissue around the needle track formed by the introducer needle 106 immediately when the RICC 104 is advanced into the patient's vascular lumen. Similar to what is described below with respect to the second segment 200 of the catheter tip 172, the uniform taper can be visualized by continuous transverse cross-sections of the first segment 198 of the catheter tip 172, which approximate larger concentric rings in the proximal direction of the first segment 198 of the catheter tip 172 and smaller concentric rings in the distal direction of the first segment 198 of the catheter tip 172. The uniform taper of the first segment 198 of the catheter tip 172 can expand the tissue around the needle track from a size commensurate with the outer diameter of the needle shaft 152 of the introducer needle 106 to a size commensurate with the minimum value of the outer diameter of the second segment 200 of the catheter tip 172. Because the uniform taper of the first section 198 of the catheter tip 172 is not as blunt as the catheter tip of a typical CVC, the first section 198 of the catheter tip 172 can reduce the force required to insert the RICC 104 into the needle track relative to a typical CVC.

[0090] The second section 200 of the catheter tip 172 can have a uniform taper on its outer diameter having a constant second taper angle. Alternatively, the outer diameter of the second section 200 of the catheter tip 172 can be consistent along the second section 200 without a uniform taper. When present, the uniform taper of the second section 200 of the catheter tip 172 can be visualized by successive transverse cross-sections of the second section 200 of the catheter tip 172 that approximate larger concentric rings in a proximal direction along the second section 200 of the catheter tip 172 and smaller concentric rings in a distal direction along that section of the catheter tip 172. Fig.131 shows one such transverse cross section. The uniform taper can be configured to further expand the tissue surrounding the needle track immediately when the RICC 104 is advanced into the patient's vascular lumen. The uniform taper of the second segment 200 of the catheter tip 172 can expand the tissue surrounding the needle track from a size commensurate with the maximum outer diameter of the first segment 198 of the catheter tip 172 to a size commensurate with the minimum outer diameter of the third segment 202 of the catheter tip 172. In addition, since the uniform taper of the second segment 200 of the catheter tip 172 is not as blunt as the catheter tip of a typical CVC, the second segment 200 of the catheter tip 172 can further reduce the force required to insert the RICC 104 into the needle track relative to a typical CVC.

[0091] The third segment 202 can have a non-uniform taper on its outer diameter, the non-uniform taper having a variable third taper angle, the non-uniform taper being configured to further dilate the tissue surrounding the needle track immediately when the RICC 104 is advanced into the patient's vascular lumen. The uniform taper of the third segment 202 of the catheter tip 172 can be visualized by continuous transverse cross-sections of the third segment 202 of the catheter tip 172 that approximate a larger eccentric ring in the proximal direction of the third segment 202 of the catheter tip 172 and a smaller eccentric ring in the distal direction of the third segment 202 of the catheter tip 172. Fig.14 1 shows one such transverse cross section. The non-uniform taper of the third segment 202 of the catheter tip 172 can expand the tissue around the needle track from a size commensurate with the maximum outer diameter of the second segment 200 of the catheter tip 172 to a size commensurate with the outer diameter of the catheter tube 170. In addition, because the non-uniform taper of the third segment 202 of the catheter tip 172 is not as blunt as the catheter tip of a typical CVC, the third segment 202 of the catheter tip 172 can further reduce the force required to insert the RICC 104 into the needle track relative to a typical CVC. In fact, the third segment 202 of the catheter tip 172 is configured to integrate the expansion that is usually performed by the dilator in the Seldinger technique into the catheter tip 172, thereby reducing the force required to insert the RICC 104 into the needle track and eliminating a separate expansion step.

[0092] The uniform taper of the first segment 198 of the catheter tip 172 may have a constant first taper angle, the uniform taper of the second segment 200 of the catheter tip 172 (when present) may have a constant second taper angle, and the non-uniform taper of the third segment 202 of the catheter tip 172 may have a variable third taper angle. Fig.11As shown, at the maximum taper angle of the third taper angle, the first taper angle can be greater than the third taper angle. Also, at the maximum taper angle of the third taper angle, the third taper angle can be greater than the second taper angle. It is worth noting that the third taper angle associated with the non-uniform taper of the third segment 202 of the catheter tip 172 can be obtained from the following example. Fig.12 The bottom edge of the longitudinal cross section of the third segment 202 shown in FIG. 2 changes from about 0° to about 10° according to Fig.12 The maximum taper angle of the bottom edge of the longitudinal cross section of the third segment 202 is shown in FIG.

[0093] The catheter end 172 can be formed by a first polymer material harder than the second polymer material of the catheter tube 170 described above. In other words, the first polymer material can have a first hardness greater than the second hardness of the second polymer material. The first hardness can be a Shore A hardness of about 70 to 100, including a Shore A hardness of about 80 to 100, such as a Shore A hardness of about 90 to 100, for example, a Shore hardness of 90 to 95. This first polymer material can include but is not limited to polytetrafluoroethylene, polypropylene or polyurethane, which has a first hardness greater than the second hardness of the second polymer material. For example, the catheter end 172 can be formed by a polyurethane with a first hardness. Similar to what is described above with respect to the catheter tube 170, polyurethane can also be advantageous for the catheter end 172. Regardless of whether the first polymer material is polyurethane, the first polymer material can be configured to be sufficiently flexible in vivo at body temperature to prevent damage to the patient's vascular lumen when the RICC 104 is advanced into the vascular lumen according to the method for placing the RICC 104 described below. However, the first polymer material can be configured to soften less in vivo than the second polymer material at body temperature, in the presence of moisture, or both. In fact, the first polymer material can be configured to remain hard enough to prevent the catheter tip 172 from collapsing, buckling, or otherwise significantly deforming when the RICC 104 is advanced into the patient's vascular lumen. Additionally or alternatively, the first polymer material can be configured to remain hard enough to prevent the catheter tip lumen 186 of the catheter tip 172 from collapsing when suction is performed through the catheter tip 172.

[0094] It should be understood that the first hardness of the first polymer material and the second hardness of the second polymer material can have different hardness scales (e.g., Type A or Type D). Based on this understanding, when the second hardness is less than the first hardness, the second hardness of the second polymer material may not be numerically less than the first hardness of the first polymer material. In fact, the hardness of the second polymer material can still be less than the hardness of the first polymer material because different hardness scales (where each hardness scale ranges from 0 to 100) are designed to characterize different materials with similar hardness in a material group.

[0095] The catheter hub 174 may include one or more catheter hub lumens corresponding in number to the one or more catheter tubing lumens, such as the three catheter hub lumens set forth above, which correspond in number to the three catheter tubing lumens also set forth above. When the RICC 104 is a three-lumen RICC, the catheter hub 174 may include a catheter hub portion of a first lumen 178 of the RICC 104, a catheter hub portion of a second lumen 180 of the RICC 104, and a catheter hub portion of a third lumen 182 of the RICC 104. The one or more catheter hub lumens may extend from the proximal end of the catheter hub 174 through the entire catheter hub 174 to the distal end of the catheter hub 174.

[0096] The one or more extension legs 176 may respectively include one or more extension leg lumens, which in turn correspond in number to the one or more catheter hub lumens, such as the three extension leg lumens described above, which correspond in number to the three catheter hub lumens also described above. When the RICC 104 is a three-lumen RICC, the one or more extension legs 176 may include: a first extension leg, which includes an extension leg portion of a first lumen 178 of the RICC 104; a second extension leg, which includes an extension leg portion of a second lumen 180 of the RICC 104; and a third extension leg, which includes an extension leg portion of a third lumen 182 of the RICC 104. Each of the one or more extension leg lumens may extend from the proximal end of its corresponding extension leg through the entire extension leg to the distal end of the extension leg.

[0097] It is noteworthy that any component of the RICC 104 selected from the catheter tip 172, the catheter tubing 170, the catheter hub 174, the one or more extension legs 176, and the one or more extension leg connectors 177 can include an antimicrobial agent thereon or therein. In one example, the catheter tubing 170 and the catheter tip 172 connected thereto can include an antimicrobial coating on their distal luminal surfaces. In another example, the pre-extruded material (such as a second polymer material) of the catheter tubing 170 can include an antimicrobial agent mixed therein, so that when extruded, the antimicrobial agent is incorporated into the catheter tubing 170, and the antimicrobial agent protects both the distal luminal surface of the catheter tubing 170 and the luminal surface of the catheter tubing 170 from microbial contamination. Additionally or alternatively, the polymer plug of the first polymer material tube can include an antimicrobial agent mixed therein such that when the catheter tip 172 is formed by, for example, inserting the polymer plug into the second or third catheter tubing lumen of the cut end of the catheter tubing body and forming the catheter tip 172 from the molten polymer material of the polymer plug on a mandrel in a cavity of a radio frequency ("RF") welding die, the antimicrobial agent is incorporated into the catheter tip 172. The antimicrobial agent in such a catheter tip 172 can protect both the distal lumen surface of the catheter tip 172 and the lumen surface of the catheter tip 172 from microbial contamination.

[0098] As shown, the RICC insertion assembly 100 or its introducer needle subassembly 102 may also include an entry guide wire 204. The entry guide wire 204 may include a proximal portion having a proximal end and a distal portion having a distal end. The distal portion of the entry guide wire 204 may pass through a guide wire channel 124 of a combination of connector components selected from the connector housing 114, the valve module housing 118, and the elastomeric gasket 120, through the sheath opening 168 in the sheath 154, and into the needle lumen 164 of the introducer needle 106, so that in the ready-to-deploy state of the RICC insertion assembly 100 or the introducer needle subassembly 102, the distal end of the entry guide wire 204 is arranged to be just proximal to the needle tip 158 of the needle shaft 152. Likewise, the proximal end of the entry guidewire 204 can be attached to the extension arm 110, and in at least the ready-to-deploy state of the RICC insertion assembly 100, the proximal and distal ends of the entry guidewire 204 can be forced to form a loop 112 in the entry guidewire 204, and the RICC 104 can be arranged on the loop 112, thereby maintaining the RICC insertion assembly 100 in a relatively compact form.

[0099] The entry guidewire 204 may include a guidewire tip 206 in the distal portion of the entry guidewire 204, the guidewire tip being in a "J" shape configured to prevent puncturing the back wall of the blood vessel. Such a guidewire tip 206 may be in a straightened state in at least the ready-to-deploy state of the RICC insertion assembly 100, and may be in a bent state when the guidewire tip 206 is advanced beyond the needle tip 158 (e.g., advanced into the lumen of the blood vessel) in the deployed state of the RICC insertion assembly 100.

[0100] As shown, the RICC insertion assembly 100 or the introducer needle subassembly 102 may also include a syringe 208. The syringe 208 may be fluidically coupled to the needle hub 156 of the introducer needle 106 in at least the ready-to-deploy state of the RICC insertion assembly 100. As described above, the sheath 154 may seal the needle groove 160 of the needle shaft 152 below it. Specifically, the sheath 154 may seal the needle groove 160 on the outside of the valve module 116. The valve module 116 may then seal on the sheath opening 168 of the sheath 154. The valve module 116 may also seal around the entry guide wire 204. This seal enables the syringe 208 to draw blood, for example, to confirm vascular access after the needle track is established according to the needle track establishment step of the method described below.

[0101] method

[0102] The method may include a method of RICC insertion assembly 100 or introducer needle subassembly 102. For example, at least the method of introducer needle subassembly 102 may include one or more steps selected from the following: a needle track establishment step, an entry guidewire advancement step, an introducer needle withdrawal step, and a needle tip capture step.

[0103] The needle track establishment step may include establishing a needle track from the skin surface to the patient's blood vessel using the introducer needle 106 of the RICC insertion assembly 100 or the introducer needle subassembly 102. As described above, the introducer needle 106 may include a needle hub 156 on the proximal portion of the composite shaft 150. And the composite shaft 150 may include a needle shaft 152 and a sheath 154 on the needle shaft 152, the sheath sealing the needle slot 160 below it, but not sealing the sheath opening 168 in the sheath 154 leading to the needle slot 160.

[0104] The access guidewire advancing step may include advancing the distal end of the access guidewire 204 into the blood vessel from just proximal to the needle tip 158 of the needle shaft 152 .

[0105] The introducer needle retraction step may include retracting the introducer needle 106 from the needle track in a proximal direction, thereby leaving the access guidewire 204 in place in the blood vessel. The introducer needle retraction step may also include further retracting the introducer needle 106 in a proximal direction from the coupler 108 that couples the introducer needle 106 with the access guidewire 204. As described above, the coupler 108 may include a coupler housing 114 and a valve module 116 disposed in the coupler housing 114.

[0106] The needle tip capture step may include capturing the needle tip 158 of the needle shaft 152 within the valve module 116 via the NSI guard mechanism 130 .

[0107] As described above, the NSI protection mechanism 130 may include a tether 134 having a proximal portion coupled to the needle hub 156 and a distal portion coupled to the valve module housing 118. The tether 134 may have a fixed tether length configured to prevent the needle tip 158 of the needle shaft 152 from disengaging from the valve module 116 during or after further withdrawal of the introducer needle 106 from the coupler 108 in the introducer needle withdrawal step. In addition, the tether 134 may include pleats 136 and pleat through-holes 138 passing through the pleats 136. The composite shaft 150 may be disposed in the pleat through-holes 138 such that the pleats 136 are deployed over the composite shaft 150 during further withdrawal of the introducer needle 106 from the coupler 108 in the introducer needle withdrawal step.

[0108] As further explained above, the NSI protection mechanism 130 can include a spring 128 loaded in a spring cavity 132 along a portion of the introducer needle channel 122 defined by the valve module housing 118 of the valve module 116. During the introducer needle withdrawal step as the introducer needle 106 is further withdrawn from the coupler 108, the spring 128 can be unloaded into the introducer needle channel 122 as the needle tip 158 of the needle shaft 152 passes the spring 128. Likewise, the spring 128 can be a flat spring including an end tab 140 configured to extend across the introducer needle channel 122 into a tab receiver 142 of the valve module housing 118 opposite the spring cavity 132 as the needle tip 158 of the needle shaft 152 passes the spring 128. This prevents the needle tip 158 of the needle shaft 152 from disengaging from the valve module 116 in the event that the introducer needle 106 is advanced into the coupler 108 in the distal direction. It is noteworthy that the end tab 140 of the spring 128 can provide a first end protection and the fulcrum 144 of the spring 128 can provide a second end protection when the needle tip 158 of the needle shaft 152 is forced into the coupler 108 in the distal direction past the end tab 140. The fulcrum 144 of the spring 128 can be between a free arm 146 of the spring 128 including the end tab 140 and a fixed arm 148 of the spring 128 fixed to the valve module housing 118 in the spring cavity 132.

[0109] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A rapidly insertable central catheter insertion assembly, characterized in that: include: Rapidly insertable central catheter; an introducer needle comprising a needle hub positioned over a proximal portion of a composite shaft, the composite shaft comprising a needle shaft having a longitudinal needle slot and a sheath positioned over the needle shaft, the sheath sealing the needle slot therebelow but not sealing a sheath opening in the sheath leading to the needle slot; A connector, which connects the rapidly insertable central catheter and the introducer needle together, the connector comprising: Connector housing; and a valve module disposed in the connector housing, the composite shaft passing through an introducer needle channel defined by the valve module housing of the valve module, such that in a ready-to-deploy state of the rapidly insertable central catheter insertion assembly, the valve module forms a seal over the sheath opening, the valve module including a needle stick protection mechanism configured to capture a distal needle tip of the needle shaft within the valve module when the introducer needle is withdrawn from the connector in a proximal direction.

2. The rapidly insertable central catheter insertion assembly according to claim 1, characterized in that: The needle stick protection mechanism includes a tie having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

3. The rapidly insertable central catheter insertion assembly according to claim 2, characterized in that: The tether has a fixed tether length configured to prevent the needle tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn from the coupler in the proximal direction.

4. The rapidly insertable central catheter insertion assembly according to claim 2, characterized in that: The tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, the composite shaft being disposed in the pleat through-holes such that the pleats deploy over the composite shaft when the introducer needle is withdrawn from the coupler in a proximal direction.

5. The rapidly insertable central catheter insertion assembly according to claim 1, characterized in that: The needle stick protection mechanism includes a spring loaded in a spring cavity along a portion of the introducer needle channel, the spring being configured to unload into the introducer needle channel when the introducer needle is withdrawn from the coupler in the proximal direction and the needle tip of the needle shaft passes the spring.

6. The rapidly insertable central catheter insertion assembly according to claim 5, characterized in that: The spring is a flat spring including an end tab, and the end tab is configured to extend across the introducer needle channel into a tab receiver of the valve module housing opposite to the spring chamber when the needle tip of the needle shaft passes through the spring, thereby preventing the needle tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced into the connector in the distal direction.

7. The rapidly insertable central catheter insertion assembly according to claim 6, characterized in that: The end tab of the spring provides a first end guard and the fulcrum of the spring provides a second end guard when the needle tip of the needle shaft is forcibly advanced in the distal direction past the end tab into the coupler.

8. The rapidly insertable central catheter insertion assembly according to claim 7, characterized in that: The fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve module housing in the spring cavity.

9. The rapidly insertable central catheter insertion assembly according to claim 7, characterized in that: Also includes: An entry guidewire includes a distal portion having a distal end, wherein the distal portion of the entry guidewire passes through a guidewire channel defined by the valve module housing of the valve module, a continuation of the guidewire channel defined by an elastomeric gasket of the valve module, the sheath opening in the sheath, and an introducer needle lumen of the introducer needle, so that in the ready-to-deploy state of the rapidly-insertable central catheter insertion assembly, the distal end of the entry guidewire is arranged just proximal to the needle tip of the needle shaft.

10. The rapidly insertable central catheter insertion assembly according to claim 9, characterized in that: The valve module includes a blade extending from the valve module housing into the sheath opening of the sheath, the blade being fixed to the valve module housing, the blade being configured to cut the sheath along the needle groove when the introducer needle is withdrawn from the connector in a proximal direction, thereby allowing the entry guide wire to disengage from the introducer needle lumen of the introducer needle.

11. The rapidly insertable central catheter insertion assembly according to claim 1, characterized in that: The rapidly insertable central catheter comprises: a catheter tube, comprising a catheter tube portion of the first inner lumen of the rapidly insertable central catheter; a one-piece catheter tip coupled to the distal portion of the catheter tube; a catheter hub coupled to the proximal portion of the catheter tube; and One or more extension legs, each of the one or more extension legs coupled to the catheter hub via a distal portion thereof.

12. The rapidly insertable central catheter insertion assembly according to claim 11, characterized in that: The catheter tip is made of a first polymer material and the catheter tube is made of a second, softer polymer material.

13. The rapidly insertable central catheter insertion assembly according to claim 12, characterized in that: The first polymer material is sufficiently hard to prevent the catheter tip from being significantly deformed in a collapsed or buckled manner when the distal portion of the rapidly insertable central catheter is advanced into the patient's vascular lumen, and the first polymer material is also sufficiently flexible to prevent damage to the vascular lumen when the distal portion of the rapidly insertable central catheter is advanced further into the vascular lumen.

14. The rapidly insertable central catheter insertion assembly according to claim 11, characterized in that: The rapidly insertable central catheter comprises a group of three lumens, the group of three lumens comprising the first lumen, the second lumen and the third lumen, the group of three lumens being formed by fluid connection portions of at least three catheter tube lumens, three catheter sleeve lumens and three extension leg lumens, the second lumen and the third lumen terminating at the distal end portion of the catheter tube via at least some fillers made of molten polymer material of the first polymer material.

15. The rapidly insertable central catheter insertion assembly according to claim 14, characterized in that: The first lumen has a first lumen hole located in the distal end of the catheter tip, the second lumen has a second lumen hole located in a side of the distal portion of the catheter tube, and the third lumen has a third lumen hole located in the side of the distal portion of the catheter tube but proximal to the second lumen hole.

16. The rapidly insertable central catheter insertion assembly according to claim 1, characterized in that: Also includes: A syringe is fluidly coupled to the needle hub of the introducer needle in at least the ready-to-deploy state of the rapidly-insertable central catheter insertion assembly.

17. An introducer needle subassembly, characterized in that: include: an introducer needle comprising a needle hub positioned over a proximal portion of a composite shaft, the composite shaft comprising a needle shaft having a longitudinal needle slot and a sheath positioned over the needle shaft, the sheath sealing the needle slot therebelow but not sealing a sheath opening in the sheath leading to the needle slot; a coupler coupled to the introducer needle, the coupler comprising: Connector housing; and a valve module disposed in the connector housing, the composite shaft passing through an introducer needle channel defined by the valve module housing of the valve module such that in a ready-to-deploy state of the introducer needle subassembly, the valve module forms a seal over the sheath opening, the valve module including a needle stick protection mechanism configured to capture a distal needle tip of the needle shaft within the valve module when the introducer needle is withdrawn from the connector in a proximal direction.

18. The introducer needle subassembly according to claim 17, characterized in that: The needle stick protection mechanism includes a tie having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

19. The introducer needle subassembly according to claim 18, characterized in that: The tether has a fixed tether length configured to prevent the needle tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn from the coupler in the proximal direction.

20. The introducer needle subassembly according to claim 18, characterized in that The tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, the composite shaft being disposed in the pleat through-holes such that the pleats deploy over the composite shaft when the introducer needle is withdrawn from the coupler in a proximal direction.

21. The introducer needle subassembly according to claim 17, characterized in that: The needle stick protection mechanism includes a spring loaded in a spring cavity along a portion of the introducer needle channel, the spring being configured to unload into the introducer needle channel when the introducer needle is withdrawn from the coupler in the proximal direction and the needle tip of the needle shaft passes the spring.

22. The introducer needle subassembly according to claim 21, characterized in that: The spring is a flat spring including an end tab, and the end tab is configured to extend across the introducer needle channel into a tab receiver of the valve module housing opposite to the spring chamber when the needle tip of the needle shaft passes through the spring, thereby preventing the needle tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced into the connector in the distal direction.

23. The introducer needle subassembly according to claim 22, characterized in that: The end tab of the spring provides a first end guard and the fulcrum of the spring provides a second end guard when the needle tip of the needle shaft is forcibly advanced in the distal direction past the end tab into the coupler.

24. The introducer needle subassembly according to claim 23, characterized in that: The fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve module housing in the spring cavity.

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