Catheter insertion assembly with needlestick protection, introducer needle subassembly and method

Abstract

The rapid insertion central venous catheter (RICC) insertion assembly (100) includes a RICC, an introducer needle (106), and a coupler (108) for coupling them together. The needle (106) includes a composite shaft including a needle hub and a sheath that covers the underlying needle shaft, sealing the needle slot of the needle shaft. The coupler (108) includes a housing and a valve module disposed within the housing. The composite shaft passes through an introducer needle passage defined by the valve module housing such that the valve module forms a seal over the sheath opening when the RICC insertion assembly is ready to be deployed. The valve module includes a needlestick protection mechanism configured to capture the distal tip of the needle shaft within the valve module when the introducer needle is withdrawn proximally from the coupler.

Description

[Background technology]

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

[0002] Disclosed herein are rapidly insertable central catheter (RICC) insertion assemblies, introducer needle assemblies, and methods that address the above. In particular, such RICC insertion assemblies, introducer needle assemblies, and methods include needlestick injury protection, as described below. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is a RICC insertion assembly including a RICC, an introducer needle, and a coupler that couples the RICC and the introducer needle together. The introducer needle includes a needle hub that covers a proximal portion of a composite shaft. The composite shaft includes a needle shaft having a longitudinal needle slot and a sheath that covers the needle shaft, the sheath sealing the underlying needle slot except for a sheath opening in the sheath to the needle slot. The coupler includes a coupler housing and a valve module disposed within the coupler housing. The composite shaft passes through an introducer needle passage defined by a valve module housing of the valve module such that the valve module forms a seal over the sheath opening in a ready-to-deploy state of the RICC insertion assembly. The valve module includes a needlestick injury (NSI) protection mechanism configured to capture a distal tip of the needle shaft within the valve module when the introducer needle is withdrawn proximally from the coupler.

[0004] In some embodiments, the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing. In some embodiments, the tether has a fixed tether length configured to prevent the tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn proximally from the coupler.

[0005] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, and the composite shaft is disposed within the pleat through-holes such that the pleats expand above the composite shaft when the introducer needle is withdrawn proximally from the coupler.

[0006] In some embodiments, the NSI protection mechanism includes a spring loaded into a spring cavity along a portion of the introducer needle passageway, the spring configured to unload into the introducer needle passageway when the introducer needle is withdrawn proximally from the coupler and the tip of the needle shaft passes through the spring.

[0007] In some embodiments, the spring is a leaf spring including an end tab configured to extend across the introducer needle passageway into a tab receiver in the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring, preventing the needle tip from disengaging from the valve module when the introducer needle is advanced distally into the coupler.

[0008] In some embodiments, the end tab of the spring provides a primary tip shield and the fulcrum of the spring provides a secondary tip shield when the tip of the needle shaft is forced forward distally beyond the end tab and into the coupler.

[0009] In some embodiments, the fulcrum of the spring is between the free arm of the spring, which includes the end tab, and the fixed arm of the spring, which is fixed to the valve module housing within the spring cavity. In some embodiments, the RICC insertion assembly further includes an access guidewire. The access guidewire includes a distal portion having a distal end. The distal portion of the access guidewire passes through a guidewire passage defined by the valve module housing of the valve module, an extension of the guidewire passage defined by the elastomeric gasket of the valve module, a sheath opening of the sheath, and an introducer needle lumen of the introducer needle so as to position the distal end of the access guidewire just proximal to the tip of the needle shaft in a ready-to-deploy state of the RICC insertion assembly.

[0010] In some embodiments, the valve module includes a blade extending from a valve module housing to which the blade is secured and into a sheath opening of the sheath, the blade configured to cut the sheath along the needle slot when the introducer needle is withdrawn proximally from the coupler, thereby allowing the access guidewire to be disengaged from the introducer needle lumen of the introducer needle.

[0011] 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 proximal end portion of the catheter tube. The catheter tube includes a catheter tube portion of the primary lumen of the RICC. The catheter hub is coupled to the proximal portion of the catheter tube. Each extension leg of the one or more extension legs is coupled by its distal portion to the catheter hub.

[0012] In some embodiments, the catheter tip is made of a first polymeric material and the catheter tube is made of a second, softer polymeric material. In some embodiments, the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when the distal portion of the RICC is advanced into the patient's vascular lumen, and the first polymeric material is also sufficiently flexible to prevent trauma to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

[0013] In some embodiments, the RICC includes a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen formed by fluidly connected portions of at least three catheter tube lumens, three catheter hub lumens, and three extension leg lumens, the secondary and tertiary lumens terminating at a distal end portion of the catheter tube with at least a partial fill of molten polymeric material of a first polymeric material.

[0014] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on a side of the distal end portion of the catheter tube proximal to the secondary lumen opening.

[0015] In some embodiments, the RICC insertion assembly further includes a syringe that is fluidly connected to the needle hub of the introducer needle in at least the ready-to-deploy state of the RICC insertion assembly.

[0016] Also disclosed herein, in some embodiments, is an introducer needle subassembly including an introducer needle and a coupler coupled to the introducer needle. The introducer needle includes a needle hub covering a proximal portion of a composite shaft. The composite shaft includes a needle shaft having a longitudinal needle slot and a sheath covering the needle shaft, the sheath sealing the underlying needle slot except for a sheath opening in the sheath to the needle slot. The coupler includes a coupler housing and a valve module disposed within the coupler housing. The composite shaft passes through an introducer needle passage defined by a valve module housing of the valve module such that the valve module forms a seal over the sheath opening in a ready-to-deploy state of the introducer needle subassembly. The valve module includes an NSI protection mechanism configured to capture a distal tip of the needle shaft within the valve module when the introducer needle is withdrawn proximally from the coupler.

[0017] In some embodiments, the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing. In some embodiments, the tether has a fixed tether length configured to prevent the tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn proximally from the coupler.

[0018] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, and the composite shaft is disposed within the pleat through-holes such that the pleats expand above the composite shaft when the introducer needle is withdrawn proximally from the coupler.

[0019] In some embodiments, the NSI protection mechanism includes a spring loaded into a spring cavity along a portion of the introducer needle passageway, the spring configured to unload into the introducer needle passageway when the introducer needle is withdrawn proximally from the coupler and the tip of the needle shaft passes through the spring.

[0020] In some embodiments, the spring is a leaf spring including an end tab configured to extend across the introducer needle passageway into a tab receiver in the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring, preventing the needle tip from disengaging from the valve module when the introducer needle is advanced distally into the coupler.

[0021] In some embodiments, the end tab of the spring provides a primary tip shield and the fulcrum of the spring provides a secondary tip shield when the tip of the needle shaft is forced forward distally beyond the end tab and into the coupler.

[0022] In some embodiments, the fulcrum of the spring is between the free arm of the spring, which includes the end tab, and the fixed arm of the spring, which is fixed to the valve module housing within the spring cavity. Also disclosed herein are methods of an introducer needle subassembly. In some embodiments, the method includes establishing a puncture path, advancing an access guidewire, withdrawing an introducer needle, and capturing a needle tip. The establishing a puncture path step includes establishing a puncture path from a patient's skin surface to a blood vessel using an introducer needle of the introducer needle subassembly. The introducer needle includes a needle hub covering a proximal portion of a composite shaft. The composite shaft includes a needle shaft having a longitudinal needle slot and a sheath covering the needle shaft, the sheath sealing the underlying needle slot except for a sheath opening in the sheath to the needle slot. The advancing an access guidewire step includes advancing a distal end of the access guidewire into the blood vessel from just proximal to the needle tip of the needle shaft. The withdrawing an introducer needle step includes withdrawing the introducer needle proximally from the puncture path, leaving the access guidewire in place. The introducer needle withdrawing step also includes further withdrawing the introducer needle proximally from a coupler coupling the introducer needle and the access guidewire together, the coupler including a coupler housing and a valve module having a valve module housing disposed within the coupler housing, and the needle tip capturing step includes capturing the needle tip of the needle shaft within the valve module by the NSI protection mechanism.

[0023] In some embodiments, the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing. In some embodiments, the tether has a fixed tether length configured to prevent the tip of the needle shaft from disengaging from the valve module during or after further withdrawal of the introducer needle from the coupler during the introducer needle withdrawal step.

[0024] In some embodiments, the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, and the composite shaft is positioned within the pleat through-holes such that the pleats expand over the composite shaft during further withdrawal of the introducer needle from the coupler in the introducer needle withdrawal step.

[0025] In some embodiments, the NSI protection mechanism includes a spring loaded into a spring cavity along a portion of the introducer needle passage defined by the valve module housing of the valve module, the spring unloading into the introducer needle passage as the tip of the needle shaft passes through the spring during further withdrawal of the introducer needle from the coupler in an introducer needle withdrawal step.

[0026] In some embodiments, the spring is a leaf spring including an end tab configured to extend across the introducer needle passageway into a tab receiver in the valve module housing opposite the spring cavity when the needle tip of the needle shaft passes through the spring, preventing the needle tip from disengaging from the valve module when the introducer needle is advanced distally into the coupler.

[0027] In some embodiments, the end tab of the spring provides a primary tip shield and the fulcrum of the spring provides a secondary tip shield when the tip of the needle shaft is forced forward distally beyond the end tab and into the coupler.

[0028] In some embodiments, the fulcrum of the spring is between the free arm of the spring, which includes the end tab, and the fixed arm of the spring, which is fixed to the valve module housing within the spring cavity. These and other features of the concepts provided herein will become more apparent to those skilled in the art upon review of the following description and accompanying figures that describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0029] [Figure 1] 1 illustrates a RICC insertion assembly, according to some embodiments. [Figure 2] 10A-10C illustrate an introducer needle subassembly of the RICC insertion assembly, according to some embodiments. [Figure 3] FIG. 10 is a longitudinal cross-sectional view of an introducer needle sub-assembly with a spring of an NSI protection mechanism loaded into the spring cavity, according to some embodiments. [Figure 4] FIG. 10 is a longitudinal cross-sectional view of the introducer needle sub-assembly with the spring of the NSI protection mechanism unloaded from the spring cavity, according to some embodiments. [Figure 5] FIG. 5 is a detailed longitudinal cross-sectional view of the introducer needle subassembly of FIG. 4, according to some embodiments. [Figure 6] FIG. 10 is a detailed isometric view of the introducer needle subassembly with the NSI protection mechanism spring unloaded from the spring cavity, according to some embodiments. [Figure 7] 1A-1C illustrate a composite shaft of an introducer needle including a needle shaft and a sheath covering the needle shaft, according to some embodiments. [Figure 8] 1 illustrates a sheath according to some embodiments. [Figure 9] 1 illustrates a needle shaft according to some embodiments. [Figure 10] FIG. 1 illustrates a RICC according to some embodiments. [Figure 11] 1A-1C illustrate a distal end portion of a catheter tube of a RICC, according to some embodiments. [Figure 12] FIG. 1 is a longitudinal cross-sectional view of a distal end portion of a catheter tube, according to some embodiments. [Figure 13] 1 is a cross-sectional view of a catheter tip coupled to a catheter tube, according to some embodiments. [Figure 14]10A-10C are cross-sectional views of a catheter tip according to some embodiments. [Figure 15] 1 is a cross-sectional view of a distal end portion of a catheter tube, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0030] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0031] Regarding the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, unless otherwise indicated, any of the aforementioned features or steps can include one or more additional features or steps. Labels such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "said" also include plural references unless the context clearly dictates otherwise.

[0032] "Proximal" is used to refer to a portion, section, piece, element, etc. of a medical device that is intended to be near or relatively near a clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal section" of a medical device includes a portion or section of the medical device that is intended to be near a clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes the length of the medical device that is intended to be near a clinician when the medical device is used on a patient. A "proximal end" of a medical device includes the end of the medical device that is intended to be near a clinician when the medical device is used on a patient. The proximal portion, section, or length of a medical device need not include the proximal end of the medical device. In fact, the proximal portion, section, or length of a medical device may be shorter than the proximal end of the medical device. However, the proximal portion, section, or length of a medical device may include the proximal end of the medical device. Where the context does not suggest, or where deemed convenient in the detailed description below, that the proximal portion, proximal section, or proximal length of a medical device includes the proximal end of the medical device, the terms "proximal portion," "proximal section," or "proximal length" may be modified to refer to such portion, section, or length including the end portion, end section, or end length of the medical device, as opposed to the "proximal end portion," "proximal end section," or "proximal end length," respectively.

[0033] "Distal" is used to refer to a portion, section, piece, element, etc. of a medical device that is intended to be near, relatively near, or within a patient when the medical device is used on a patient. For example, a "distal portion" or "distal section" of a medical device includes a portion or section of the medical device that is intended to be near, relatively near, or within a patient when the medical device is used on a patient. Similarly, a "distal length" of a medical device includes a length of the medical device that is intended to be near, relatively near, or within a patient when the medical device is used on a patient. A "distal end" of a medical device includes an end of the medical device that is intended to be near, relatively near, or within a patient when the medical device is used on a patient. A distal portion, section, or length of a medical device need not include the distal end of the medical device. In fact, a distal portion, section, or length of a medical device may be shorter than the distal end of the medical device. However, a distal portion, section, or length of a medical device may include the distal end of the medical device. Where the context does not suggest, or where deemed convenient in the following detailed description, that the distal portion, distal section, or distal length of a medical device includes the distal end of the medical instrument, the terms "distal portion," "distal section," or "distal length" may be modified to indicate such a portion, section, or length, including the end portion, end section, or end length of the medical instrument, as opposed to the "distal end portion," "distal end section," or "distal end length," respectively, of the medical instrument.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Also disclosed herein are RICC insertion assemblies, introducer needle assemblies, and methods, particularly those including needlestick 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 most of the specific embodiments discussed above in the context of a RICC insertion assembly. However, a RICC insertion assembly includes only one type of catheter that may be incorporated into a catheter insertion assembly such as the RICC insertion assemblies provided herein. Indeed, peripherally inserted central catheters (PICCs), dialysis catheters, and the like, may also be incorporated into catheter insertion assemblies for rapid insertion or otherwise.

[0035] RICC Insertion Assembly Figure 1 illustrates a RICC insertion assembly 100 according to some embodiments. Figure 2 illustrates an introducer needle subassembly 102 of the RICC insertion assembly 100 according to some embodiments.

[0036] 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 and the introducer needle 106 together. In particular, the introducer needle subassembly 102 may include the introducer needle 106 and the coupler 108 coupled to the introducer needle 106. As described below with respect to the RICC insertion assembly 100, the introducer needle subassembly 102 may also further include an access guidewire 204 according to some embodiments. At least in the ready-to-deploy state of the RICC insertion assembly 100, the proximal end of the access guidewire 204 can be held in place by being attached to the extension arm 110 of the coupler 108 or by some other holding means for holding the access guidewire 204, including manually, and the distal end of the access guidewire 204 can be placed within the needle lumen 164 of the introducer needle 106, as described below. This allows for a loop 112 of the access guidewire 204 to be achieved. The RICC 104 can be placed over the loop 112 in the ready-to-deploy state of the RICC insertion assembly 100, thereby maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0037] As shown, the coupler 108 may include a coupler housing 114 and a valve module 116 having a valve module housing 118 disposed within the coupler housing 114. While so illustrated, it should be understood that in some embodiments, the valve module housing 118 may be integrated with the coupler housing 114 in a one-piece housing.

[0038] The coupler housing 114, as shown, can include two molded parts that are coupled together (e.g., coupled together with compression or heat staked pins, fastened or screwed together with screws or bolts, welded together with ultrasonic or hot plate welding, etc.) to form a body that can be configured to be comfortably held (e.g., tucked) under the hand with the introducer needle 106 of the RICC insertion assembly 100 in the left hand for a left-handed venipuncture or in the right hand for a right-handed venipuncture. Although not shown, the interior of each of the two molded parts can include a distal recess that forms a valve module compartment for the valve module 116 when the two molded parts are coupled together. Alternatively, the distal recess of each of the two molded parts can similarly form a gasket compartment, which can be configured for the elastomeric gasket 120 described below in the one-piece housing embodiment described above. In either case, the interior of each of the two molded parts may further include a proximal recess that forms a needle hub receiver for the needle hub 156 of the introducer needle 106 when the two molded parts are coupled together. As seen by the clip arms 119 on the needle hub 156, the coupler housing 114 may further include tabs on the exterior of the needle hub receiver for clipping the clip arms 119 to them. Finally, the coupler housing 114 may include a longitudinal coupler housing slot between the two molded parts when the two molded parts are coupled together. The coupler housing slot may be configured to open in the same direction as the needle slot 160 in the needle shaft 152 or in a different direction, thereby allowing the access guidewire 204 to disengage from the coupler housing 114 after the introducer needle 106 is proximally withdrawn from the coupler 108 in accordance with the introducer needle withdrawal step of the method described below.

[0039] Similar to the coupler housing 114, the valve module housing 118 may include two molded parts that are joined together within the valve module compartment to form a gasket compartment for the elastomeric gasket 120. The valve module compartment of the coupler housing 114 may be configured with sufficient space to allow the valve module housing 118 and the elastomeric gasket 120 disposed therein to separate for disengaging the access guidewire 204 from the valve module 116 after the introducer needle 106 is withdrawn proximally from the coupler 108 in accordance with the introducer needle withdrawal step of the method described below. In particular, the introducer needle 106 is withdrawn proximally through an introducer needle passage 122 in which the composite shaft 150 of the introducer needle 106 is disposed in at least the ready-to-deploy state of the RICC insertion assembly 100. The introducer needle passage 122 may be defined by a combination of coupler components selected from the coupler housing 114, the valve module housing 118, and the elastomeric gasket 120. Similarly, the guidewire passage 124 connected to the introducer needle passage 122 in the valve module 116 may be defined by a combination of coupler components selected from the coupler housing 114, the valve module housing 118, and the elastomeric gasket 120. The guidewire passage 124 connecting with the introducer needle passage 122 in the valve module 116 and the sheath opening 168 of the sheath 154 to the needle slot 160 of the needle shaft 152, described below, allows the access guidewire 204 to be positioned within the composite shaft 150 of the introducer needle 106, which is positioned within the introducer needle passage 122.

[0040] The coupler 108 can further 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 can include the blade 126 distal to a spring 128 that extends from the valve module housing 118 to which the blade 126 is secured and into a sheath opening 168 of the sheath 154. The blade 126 can be configured to cut the sheath 154 along the needle slot 160 when the introducer needle 106 is withdrawn proximally from the coupler 108 in accordance with the introducer needle withdrawal step of the method described below, allowing the access guidewire 204 to disengage from the needle lumen 164 of the introducer needle 106.

[0041] Figure 3 shows a longitudinal cross section of the introducer needle subassembly 102 with the spring 128 of the NSI protection mechanism 130 loaded into the spring cavity 132, according to some embodiments. Figures 4-6 show various views of the introducer needle subassembly 102 with the spring 128 of the NSI protection mechanism 130 unloaded from the spring cavity 132, according to some embodiments.

[0042] As shown, the coupler 108 can further include an NSI protection mechanism 130 configured to capture the tip 158 of the needle shaft 152 after establishing a puncture path according to the establish puncture path step of the method described below. For example, the valve module 116 can include an NSI protection mechanism 130 configured to capture the tip 158 of the needle shaft 152 within the valve module 116 when the introducer needle 106 is withdrawn proximally from the coupler 108 according to the introducer needle withdrawal step of the method described below.

[0043] The NSI protection mechanism 130, in some embodiments, 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 proximally from the coupler 108 in accordance with the introducer needle withdrawal step of the method described below. In particular, the tether 134 can include a plurality of pleats 136 and a plurality of pleat through-holes 138 extending through the pleats 136. The composite shaft 150 of the introducer needle 106 can be positioned within the pleat through-hole 138 so that the pleats 136 spread out above the composite shaft 150 when the introducer needle 106 is withdrawn proximally from the coupler 108 in accordance with the introducer needle withdrawal step of the method described below.

[0044] The NSI protection mechanism 130 may further include a spring 128 loaded into a spring cavity 132 along a portion of the introducer needle passageway 122. Such spring cavity 132 may be defined by the valve module housing 118. However, the NSI protection mechanism 130 may extend outside the valve module 116 such that the spring cavity 132 is defined by the coupler housing 114. In either case, the spring 128 may be configured to unload into the introducer needle passageway 122 when the introducer needle 106 is withdrawn proximally from the coupler 108 in accordance with an introducer needle withdrawal step of the method described below and the needle tip 158 of the needle shaft 152 passes through the spring 128.

[0045] The spring 128 of the NSI protection mechanism 130 can be a leaf spring including an end tab 140 sized or otherwise configured to extend across the introducer needle passageway 122 into a tab receiver 142 in the valve module housing 118 or coupler housing 114 opposite the spring cavity 132 when the needle tip 158 of the needle shaft 152 passes through the spring 128. Such tab receiver 142 can be another smaller cavity along the aforementioned portion of the introducer needle passageway 122 opposite the spring cavity 132. When in place within the tab receiver 142, the end tab 140 can 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 distally into the coupler 108. In particular, the end tab 140 of the spring 128 can provide a primary tip shield, and the fulcrum 144 of the spring 128 can provide a secondary tip shield, if the needle tip 158 of the needle shaft 152 is forced to advance distally beyond the end tab 140 into the coupler 108. As shown, the fulcrum 144 of the spring 128 is between a free arm 146 of the spring 128, which includes the end tab 140, and a fixed arm 148 of the spring 128, which is fixed within the spring cavity 132 to the valve module housing 118 or the coupler housing 114.

[0046] Figure 7 shows a composite shaft 150 of the introducer needle 106, according to some embodiments, including a needle shaft 152 and a sheath 154 that covers the needle shaft 152. Figure 8 shows the sheath 154 according to some embodiments, and Figure 9 shows the needle shaft 152 according to some embodiments.

[0047] The introducer needle 106 can include a needle hub 156 that covers 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 passageway 122, including that portion of the introducer needle passageway 122 that passes through the valve module 116, which includes the valve module housing 118 and its gasket, such that the valve module 116 forms a seal over the sheath opening 168.

[0048] The composite shaft 150 may include a needle shaft 152 and a sheath 154 that covers the needle shaft 152 and seals the underlying needle slot 160 except for a sheath opening 168 in the sheath 154 to the needle slot 160, as described below.

[0049] The needle shaft 152 may include a distal needle tip 158 at a distal portion of the needle shaft 152 and a longitudinal needle slot 160 extending from a proximal portion of the needle shaft 152 through the needle tip 158. The needle slot 160 forms a needle channel 162 along a majority of the length of the needle shaft 152 opposite a needle lumen 164 therethrough, as described below. The needle slot 160 may have a width sized according to the outer diameter of the access guidewire 204 to allow passage of the access guidewire 204 from the proximal portion of the needle shaft 152 through the needle tip 158 in accordance with the introducer needle withdrawal step of the method described below.

[0050] It should be understood that the needle shaft 152 can include a needle slot 160, and the introducer needle 106 or its composite shaft 150 can include a needle lumen 164. In fact, the needle lumen 164 results from the combination of the needle shaft 152 and the sheath 154 covering the needle shaft 152. That is, the sheath 154 covering the needle shaft 152 can seal the underlying needle slot 160 to form the needle lumen 164 of the introducer needle 106 or its composite shaft 150, thereby allowing the syringe 208 to aspirate blood, for example, to confirm vascular access after establishing a puncture path in accordance with the puncture path establishment step of the method described below.

[0051] The sheath 154 may include a sheath tip 166 at a distal portion of the sheath 154 and a sheath opening 168 at a side of a proximal portion of the sheath 154 . The sheath tip 166 can 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, which can be equal to the outer diameter of the distal portion of the needle shaft 152.

[0052] The sheath opening 168 opens to the needle slot 160 of the needle shaft 152 and can allow the access guidewire 204 to pass through the sheath opening 168 and enter the needle channel 162 or needle lumen 164, at least in the ready-to-deploy state of the RICC insertion assembly 100. Accordingly, the sheath opening 168 can have a width approximately equal to the width of the needle slot 160, which can be sized according to the diameter of the access guidewire 204. The sheath opening 168 can also have a length sufficient to allow the access guidewire 204 to pass through the sheath opening 168 and enter the needle slot 160 or needle lumen 164, and to accommodate the blade 126 of the valve module 116 below the distal end of the sheath opening 168. Notably, the sheath 154 covering the needle shaft 152 can seal the underlying needle slot 160, except for the portion of the needle slot 160 below the sheath opening 168. However, the valve module 116 can cover and seal the needle slot 160 exposed by the sheath opening 168 by sealing the needle shaft 152 and the proximal portion of the sheath 154 therein, thereby allowing the syringe 208 to aspirate blood, for example, to confirm vascular access after establishing a puncture path in accordance with the puncture path establishment step of the method described below.

[0053] The sheath 154, or sheath body thereof, may be formed of a polymeric material configured to facilitate smooth and consistent insertion of the introducer needle 106 from an area of ​​skin into the patient's vascular lumen in accordance with the puncture path establishment step of the method described below. Additionally, the polymeric material may have sufficient mechanical properties to resist collapse of the sheath 154 into the needle slot 160 of the needle shaft 152 when blood is aspirated, particularly to facilitate detachment of the sheath 154 from the needle shaft 152 in accordance with the introducer needle withdrawal step of the method described below. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, or polytetrafluoroethylene.

[0054] FIG. 10 illustrates the RICC 104 according to some embodiments. As shown, the RICC 104 may include a catheter tube 170 having a single-piece catheter tip 172 coupled thereto, a catheter hub 174, and one or more extension legs 176. The catheter tip 172 may be coupled to a distal end portion of the catheter tube 170, and the catheter hub 174 may be coupled to a proximal end portion of the catheter tube 170. Each extension leg of the one or more extension legs 176 may be coupled by its distal end portion to the catheter hub 174. Additionally, one or more extension leg connectors 177 (e.g., Luer connectors) may be coupled to the one or more extension legs 176 for connecting one or more other medical devices, respectively.

[0055] The RICC 104 can be a single-lumen RICC or a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.). For example, the RICC 104 can be a three-lumen RICC including three sets of lumens, as shown in FIGS. 1 and 10 (see also FIG. 15 ). The set of three lumens can include a primary lumen 178, a secondary lumen 180, and a tertiary lumen 182. Each lumen of the primary lumen 178, the secondary lumen 180, and the tertiary lumen 182 can be formed by at least three fluidly connected lumen portions, i.e., the lumen portions of the catheter tube lumen, the catheter hub lumen, and the extension leg lumen, of the three catheter tube lumens, the three catheter hub lumens, and the three extension leg lumens within the three-lumen RICC. For example, the primary lumen 178 of the RICC 104 may be formed of a primary catheter tube lumen 184, a primary catheter hub lumen, and a primary extension leg lumen. However, the primary lumen 178 of the RICC 104 may also include a fluidly connected catheter tip lumen 186 of the catheter tip section 172. Furthermore, the secondary lumen 180 of the RICC 104 may be formed of a secondary catheter tube lumen 188, a secondary catheter hub lumen, and a secondary extension leg lumen. Finally, the tertiary lumen 182 of the RICC 104 may be formed of a tertiary catheter tube lumen 190, a tertiary catheter hub lumen, and a tertiary extension leg lumen. The primary lumen 178 may have a primary lumen opening 192 at the distal end of the catheter tip section 172 corresponding to the distal end of the RICC 104. The secondary lumen 180 may have a secondary lumen opening 194 on the side of the distal portion of the catheter tube 170. The tertiary lumen 182 can have a tertiary lumen opening 196 on a side of the distal portion of the catheter tube 170, proximal to the secondary lumen opening 194. Similar to the secondary lumen 180 and the tertiary lumen 182, each additional lumen to those previously described can have a corresponding lumen opening on a side of the distal portion of the catheter tube 170, proximal to its preceding lumen.

[0056] Figure 11 shows a distal end portion of a catheter tube 170 and a catheter tip 172 coupled thereto, according to some embodiments. Figure 12 shows a longitudinal cross section of the catheter tip 172 and the distal end portion of the catheter tube 170, according to some embodiments, and Figures 13-15 show various cross sections of the catheter tip 172 and the distal end portion of the catheter tube 170, according to some embodiments.

[0057] As shown, the catheter tube 170 can include one or more catheter tube lumens, such as the three catheter tube lumens described above. Indeed, when the RICC 104 is a three-lumen RICC, the catheter tube 170 can include a catheter tube portion for a primary lumen 178 of the RICC 104, a catheter tube portion for a secondary lumen 180 of the RICC 104, and a catheter tube portion for a tertiary lumen 182 of the RICC 104. Prior to forming the catheter tip 172 coupled to the catheter tube 170, each of the three catheter tube lumens described above can extend completely through the catheter tube 170. However, after forming the catheter tip 172, only the primary catheter tube lumen 184 typically extends from the proximal end of the catheter tube 170 to the distal end of the catheter tube 170. Indeed, the primary catheter tube lumen 184 typically extends through both the proximal and distal ends of the catheter tube 170, and subsequently through a catheter tip lumen 186 at the catheter tip 172. In contrast, the secondary catheter tube lumen 188 and the tertiary catheter tube lumen 190 typically terminate at the distal end portion of the catheter tube 170 with at least a partial fill of molten polymer material of the first polymer material used to form the catheter tip 172.

[0058] The catheter tube 170 can be formed of a second polymeric material that is softer than the first polymeric material of the catheter tip 172, which will be described below. In other words, the second polymeric material can have a second durometer that is less than the first durometer of the first polymeric material. Such second polymeric materials can include, but are not limited to, polyvinyl chloride, polyethylene, polyurethane, or silicone, each having a second durometer that is less than the first durometer of the first polymeric material. For example, if the catheter tip 172 is formed of polyurethane, as described below, the catheter tube 170 can be formed of a different polyurethane (e.g., the same or a different diisocyanate or triisocyanate reacted with a different diol or triol, a different diisocyanate or triisocyanate reacted with the same or a different diol or triol, the same diisocyanate or triisocyanate reacted with the same diol or triol under different conditions or with different additives, etc.) having a second durometer that is less than the first durometer of the polyurethane of the catheter tip 172. In particular, polyurethane can be advantageous for the catheter tube 170 in that it is relatively stiff at room temperature but becomes more flexible in vivo at body temperature, reducing irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous in that it can be less thrombogenic than some other polymers. Whether the second polymeric material is polyurethane or not, the second polymeric material can be configured to be sufficiently stiff in vitro to provide the catheter tube 170 with column strength that prevents the catheter tube 170 from collapsing, buckling, or otherwise appreciably deforming when the RICC 104 is advanced into and positioned within a blood vessel lumen.

[0059] As shown, the catheter tip 172 can have a first section 198, a second section 200, and a third section 202. The second section 200 of the catheter tip 172 can have a length l2 that is greater than the length l1 of the first section 198 of the catheter tip 172, and the third section 202 of the catheter tip 172 can have a length l3 that is greater than the length l2 of the second section 200 of the catheter tip 172.

[0060] The first section 198 of the catheter tip 172 may have a uniform taper with a constant first taper angle across its outer diameter configured to immediately dilate tissue around a puncture path formed with the introducer needle 106 when the RICC 104 is advanced into a patient's vascular lumen. Similar to what is described below with respect to the second section 200 of the catheter tip 172, the uniform taper may be visualized by successive cross-sections of the first section 198 of the catheter tip 172, which approach larger concentric rings proximally along the first section 198 of the catheter tip 172 and smaller concentric rings distally along the first section 198 of the catheter tip 172. The uniform taper of the first section 198 of the catheter tip 172 allows the tissue around the puncture tract to expand from a size equivalent to the outer diameter of the needle shaft 152 of the introducer needle 106 to a size equivalent to the smallest outer diameter of the second section 200 of the catheter tip 172. Because the uniform taper of the first section 198 of the catheter tip 172 is not blunt like the catheter tip of a typical CVC, the first section 198 of the catheter tip 172 allows the force required to insert the RICC 104 into the puncture tract to be reduced compared to a typical CVC.

[0061] The second section 200 of the catheter tip 172 can have a uniform taper, with a constant second taper angle across its outer diameter. Alternatively, the outer diameter of the second section 200 of the catheter tip 172 can be constant along the second section 200 without a uniform taper. If present, the uniform taper of the second section 200 of the catheter tip 172 can be visualized by successive cross-sections of the second section 200 of the catheter tip 172, which approach a larger concentric ring proximally along the second section 200 of the catheter tip 172 and a smaller concentric ring distally along the section of the catheter tip 172. One such cross-section is shown in FIG. 13. The uniform taper can be configured to immediately further dilate tissue around the puncture path when the RICC 104 is advanced into the patient's vascular lumen. The uniform taper of the second section 200 of the catheter tip 172 allows the tissue around the puncture tract to expand from a size equivalent to the maximum outer diameter of the first section 198 of the catheter tip 172 to a size equivalent to the minimum outer diameter of the third section 202 of the catheter tip 172. One such cross-section is shown in FIG. 14. Furthermore, because the uniform taper of the second section 200 of the catheter tip 172 is not blunt like the catheter tip of a typical CVC, the second section 200 of the catheter tip 172 may further reduce the force required to insert the RICC 104 into the puncture tract compared to a typical CVC.

[0062] The third section 202 can have a non-uniform taper with a third taper angle that varies across its outer diameter, configured to immediately further dilate the tissue around the puncture path when the RICC 104 is advanced into the patient's vascular lumen. The uniform taper of the third section 202 of the catheter tip 172 can be visualized by successive cross-sections of the third section 202 of the catheter tip 172, which approach a larger eccentric annulus proximally along the third section 202 of the catheter tip 172 and a smaller eccentric annulus distally along the third section 202 of the catheter tip 172. One such cross-section is shown in FIG. 14. The non-uniform taper of the third section 202 of the catheter tip 172 can dilate the tissue around the puncture path from a size equivalent to the maximum outer diameter of the second section 200 of the catheter tip 172 to a size equivalent to the outer diameter of the catheter tube 170. Furthermore, because the non-uniform taper of the third section 202 of the catheter tip 172 is not blunt like the catheter tip of a typical CVC, the third section 202 of the catheter tip 172 can further reduce the force required to insert the RICC 104 into the puncture tract than is the case with a typical CVC. In fact, the third section 202 of the catheter tip 172 is configured to incorporate the dilation normally performed by a dilator in the Seldinger technique into the catheter tip 172, thereby reducing the force required to insert the RICC 104 into the puncture tract and eliminating a separate dilation step.

[0063] The uniform taper of the first section 198 of the catheter tip 172 can have a constant first taper angle, the uniform taper of the second section 200 of the catheter tip 172, if present, can have a constant second taper angle, and the non-uniform taper of the third section 202 of the catheter tip 172 can have a varying third taper angle. As shown in FIG. 11 , the first taper angle can be greater than the third taper angle at the maximum taper angle of the third taper angle. That is, the third taper angle can be greater than the second taper angle at the maximum taper angle of the third taper angle. In particular, the third taper angle associated with the non-uniform taper of the third section 202 of the catheter tip 172 can vary from approximately 0° according to the bottom edge of the longitudinal cross-section of the third section 202 shown in FIG. 12 to the maximum taper angle according to the bottom edge of the longitudinal cross-section of the third section 202 shown in FIG. 12.

[0064] The catheter tip 172 can be formed of a first polymeric material that is harder than the second polymeric material of the catheter tube 170 described above. In other words, the first polymeric material can have a first durometer that is greater than the second durometer of the second polymeric material. The first durometer can be approximately 70-100 Shore A, including approximately 80-100 Shore A, approximately 90-100 Shore A, and the like, such as approximately 90-95 Shore A. Such first polymeric materials can include, but are not limited to, polytetrafluoroethylene, polypropylene, or polyurethane, each having a first durometer greater than the second durometer of the second polymeric material. For example, the catheter tip 172 can be formed of polyurethane having a first durometer. Similar to that described above with respect to the catheter tube 170, polyurethane can be advantageous for the catheter tip 172. Whether the first polymeric material is polyurethane or not, the first polymeric material can be configured to be sufficiently flexible at body temperature in the body to prevent trauma to the patient's vascular lumen when the RICC 104 is advanced into the vascular lumen in accordance with the method of deploying the RICC 104 described below. However, the first polymeric material can be configured to soften less than the second polymeric material in the body at body temperature, in the presence of moisture, or both. Indeed, the first polymeric material can be configured to remain sufficiently stiff to prevent the catheter tip 172 from collapsing, buckling, or otherwise appreciably deforming when the RICC 104 is advanced into the patient's vascular lumen. Additionally or alternatively, the first polymeric material can be configured to remain sufficiently stiff to prevent the catheter tip lumen 186 of the catheter tip 172 from collapsing when suction is applied through the catheter tip 172.

[0065] It should be understood that the first durometer of the first polymeric material and the second durometer of the second polymeric material may be on different hardness scales (e.g., Type A or Type D). With this understanding, when the second durometer is lower than the first durometer, the second durometer of the second polymeric material may not be numerically lower than the first durometer of the first polymeric material. In fact, the hardness of the second polymeric material may still be lower than the hardness of the first polymeric material, since each different hardness scale ranging from 0 to 100 is designed to characterize a different material in a group of materials having similar hardness.

[0066] The catheter hub 174 can include one or more catheter hub lumens corresponding in number to one or more catheter tube lumens, such as three catheter hub lumens also described above, corresponding in number to the three catheter tubing lumens described above. When the RICC 104 is a three-lumen RICC, the catheter hub 174 can include a catheter hub portion of a primary lumen 178 of the RICC 104, a catheter hub portion of a secondary lumen 180 of the RICC 104, and a catheter hub portion of a tertiary lumen 182 of the RICC 104. The one or more catheter hub lumens can extend entirely through the catheter hub 174 from the proximal end of the catheter hub 174 to the distal end of the catheter hub 174.

[0067] The one or more extension legs 176 can each include one or more extension leg lumens corresponding in number to one or more catheter hub lumens, such as the three extension leg lumens also described above, which correspond in number to the three catheter hub lumens described above. When the RICC 104 is a three-lumen RICC, the one or more extension legs 176 can include a primary extension leg including an extension leg portion of the primary lumen 178 of the RICC 104, a secondary extension leg including an extension leg portion of the secondary lumen 180 of the RICC 104, and a tertiary extension leg including an extension leg portion of the tertiary lumen 182 of the RICC 104. Each extension leg lumen of the one or more extension leg lumens can extend entirely through the corresponding extension leg, from the proximal end of the extension leg to the distal end of the extension leg.

[0068] In particular, any component of the RICC 104 selected from the catheter tip 172, the catheter tube 170, the catheter hub 174, the one or more extension legs 176, and the one or more extension leg connectors 177 may include an antimicrobial agent thereon or therein. In one example, the catheter tube 170 and the catheter tip 172 coupled thereto may include an antimicrobial agent coating on their abluminal surfaces. In another example, the pre-extrusion material of the catheter tube 170, such as a second polymeric material, may include an antimicrobial agent incorporated therein such that the antimicrobial agent is incorporated into the catheter tube 170 upon extrusion, and the antimicrobial agent protects both the abluminal surface of the catheter tube 170 and the luminal surface of the catheter tube 170 from microbial contamination. Additionally or alternatively, the polymer plug of the first polymeric material tube can include an antimicrobial agent entrained therein such that the antimicrobial agent is incorporated into the catheter tip section 172 as it is formed, for example, by inserting the polymer plug into either the secondary or tertiary catheter tube lumen at the cut end of the catheter tube and using the molten polymer material of the polymer plug to form the catheter tip section 172 over a mandrel in a cavity of a radio frequency (RF) welding die. Such an antimicrobial agent in the catheter tip section 172 can protect both the abluminal surface of the catheter tip section 172 and the luminal surface of the catheter tip section 172 from microbial contamination.

[0069] As shown, the RICC insertion assembly 100 or its introducer needle subassembly 102 can further include an access guidewire 204. The access guidewire 204 can include a proximal portion having a proximal end and a distal portion having a distal end. The distal portion of the access guidewire 204 can pass through the guidewire passageway 124 of a combination of coupler components selected from the coupler housing 114, the valve module housing 118, and the elastomer gasket 120, pass through the sheath opening 168 of the sheath 154, and enter the needle lumen 164 of the introducer needle 106 so as to position the distal end of the access guidewire 204 just proximal to the needle tip 158 of the needle shaft 152 in a ready-to-deploy state of the RICC insertion assembly 100 or introducer needle subassembly 102. Again, the proximal end of the access guidewire 204 can be attached to the extension arm 110, and at least in the ready-to-deploy state of the RICC insertion assembly 100, the proximal and distal ends of the access guidewire 204 can form a loop 112 of the access guidewire 204, with the RICC 104 positioned over the loop 112, thereby maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0070] The access guidewire 204 can include a guidewire tip 206 at a distal portion thereof, the guidewire tip 206 having a "J" shape configured to prevent puncturing the posterior wall of a blood vessel. Such guidewire tip 206 can be straight in at least the ready-to-deploy state of the RICC insertion assembly 100 and curved when the guidewire tip 206 is advanced beyond the needle tip 158 (e.g., advanced into the lumen of a blood vessel) in the deployed state of the RICC insertion assembly 100.

[0071] As shown, the RICC insertion assembly 100 or the introducer needle subassembly 102 can further include a syringe 208. The syringe 208 can be fluidly connected to the needle hub 156 of the introducer needle 106 when the RICC insertion assembly 100 is in at least a ready-to-deploy state. As described above, the sheath 154 can seal the needle slot 160 of the underlying needle shaft 152. In particular, the sheath 154 can seal the needle slot 160 outside of the valve module 116. The valve module 116 can seal over the sheath opening 168 of the sheath 154. The valve module 116 can also seal around the access guidewire 204. Such a seal allows the syringe 208 to aspirate blood, for example, to confirm vascular access after establishing a puncture path according to the puncture path establishment step of the method described below.

[0072] method The method can include a method for the RICC insertion assembly 100 or the introducer needle subassembly 102. For example, the method for at least the introducer needle subassembly 102 can include one or more steps selected from a puncture path establishment step, an access guidewire advancement step, an introducer needle withdrawal step, and a needle tip capture step.

[0073] The puncture path establishing step may include establishing a puncture path from the patient's skin surface to a blood vessel using the introducer needle 106 or introducer needle subassembly 102 of the RICC insertion assembly 100. As described above, the introducer needle 106 may include a needle hub 156 that covers a proximal portion of the composite shaft 150. The composite shaft 150 may also include a needle shaft 152 and a sheath 154 that covers the needle shaft 152 and seals the underlying needle slot 160 except for a sheath opening 168 in the sheath 154 to the needle slot 160.

[0074] The access guidewire advancing step can include advancing the distal end of the access guidewire 204 into the blood vessel just proximal to the needle tip 158 of the needle shaft 152 .

[0075] The introducer needle withdrawal step may include withdrawing the introducer needle 106 proximally from the puncture tract, leaving the access guidewire 204 in place within the blood vessel. The introducer needle withdrawal step may also include further withdrawing the introducer needle 106 proximally from the coupler 108, which couples the introducer needle 106 and the access guidewire 204 together. As described above, the coupler 108 may include a coupler housing 114 and a valve module 116 disposed within the coupler housing 114.

[0076] The needle tip capturing step may include capturing the needle tip 158 of the needle shaft 152 within the valve module 116 by the NSI protection mechanism 130 . 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 during the introducer needle withdrawal step. Additionally, the tether 134 may include pleats 136 and pleat through-holes 138 extending through the pleats 136. The composite shaft 150 may be positioned within the pleat through-holes 138 such that the pleats 136 expand above the composite shaft 150 during further withdrawal of the introducer needle 106 from the coupler 108 during the introducer needle withdrawal step.

[0077] As further described above, the NSI protection mechanism 130 may include a spring 128 loaded into a spring cavity 132 along a portion of the introducer needle passageway 122 defined by the valve module housing 118 of the valve module 116. The spring 128 may unload into the introducer needle passageway 122 when the tip 158 of the needle shaft 152 passes through the spring 128 during further withdrawal of the introducer needle 106 from the coupler 108 during an introducer needle withdrawal step. Again, the spring 128 may be a leaf spring including an end tab 140 configured to extend across the introducer needle passageway 122 into a tab receiver 142 of the valve module housing 118 opposite the spring cavity 132 when the tip 158 of the needle shaft 152 passes through the spring 128. This prevents the tip 158 of the needle shaft 152 from disengaging from the valve module 116 when the introducer needle 106 is advanced distally into the coupler 108. In particular, if the tip 158 of the needle shaft 152 is forced to advance distally beyond the end tab 140 into the coupler 108, the end tab 140 of the spring 128 can provide a primary tip shield, and the fulcrum 144 of the spring 128 can provide a secondary tip shield. 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 that is fixed to the valve module housing 118 within the spring cavity 132.

[0078] Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter (RICC) insertion assembly comprising: RICC and an introducer needle including a needle hub covering a proximal portion of a compound shaft, the compound shaft including a needle shaft having a longitudinal needle slot and a sheath covering the needle shaft, the sheath sealing the underlying needle slot except for a sheath opening in the sheath to the needle slot; a coupler that couples the RICC and the introducer needle together; Equipped with The coupler comprises: A coupler housing; a valve module disposed within the coupler housing; Including, the composite shaft passes through an introducer needle passage defined by a valve module housing of the valve module such that the valve module forms a seal over the sheath opening when the RICC insertion assembly is in a ready-to-deploy state, and the valve module includes a needlestick injury (NSI) protection mechanism configured to capture a distal tip of the needle shaft within the valve module when the introducer needle is withdrawn proximally from the coupler.

2. The RICC insertion assembly of claim 1 , wherein the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

3. 3. The RICC insertion assembly of claim 2, wherein the tether has a fixed tether length configured to prevent the tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn proximally from the coupler.

4. 4. The RICC insertion assembly of claim 2 or 3, wherein the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, and the composite shaft is positioned within the pleat through-holes such that the pleats expand above the composite shaft when the introducer needle is withdrawn proximally from the coupler.

5. 5. The RICC insertion assembly of claim 1, wherein the NSI protection mechanism includes a spring loaded into a spring cavity along a portion of the introducer needle passageway, the spring configured to unload into the introducer needle passageway when the introducer needle is withdrawn proximally from the coupler and the tip of the needle shaft passes through the spring.

6. 6. The RICC insertion assembly of claim 5, wherein the spring is a leaf spring including an end tab configured to extend across the introducer needle passage into a tab receiver of the valve module housing opposite the spring cavity when the tip of the needle shaft passes through the spring, thereby preventing the tip of the needle shaft from disengaging the valve module when the introducer needle is advanced distally into the coupler.

7. 7. The RICC insertion assembly of claim 6, wherein the end tab of the spring provides a primary tip shield and the fulcrum of the spring provides a secondary tip shield when the tip of the needle shaft is forced to advance distally beyond the end tab into the coupler.

8. 8. The RICC insertion assembly of claim 7, wherein the spring fulcrum is between a free arm of the spring including the end tab and a fixed arm of the spring secured to the valve module housing within the spring cavity.

9. The RICC insertion assembly according to claim 7 comprises: an access guidewire including a distal portion having a distal end, the distal portion of the access guidewire passing through a guidewire passage defined by the valve module housing of the valve module, an extension of the guidewire passage defined by an elastomer gasket of the valve module, the sheath opening of the sheath, and an introducer needle lumen of the introducer needle so as to position the distal end of the access guidewire just proximal to the needle tip of the needle shaft when the RICC insertion assembly is in a ready-to-deploy state.

10. 10. The RICC insertion assembly of claim 9, wherein the valve module includes a blade extending from the valve module housing to which it is secured into the sheath opening of the sheath, the blade configured to cut the sheath along the needle slot when the introducer needle is withdrawn proximally from the coupler, thereby allowing the access guidewire to be released from the introducer needle lumen of the introducer needle.

11. 11. A RICC insertion assembly according to any one of claims 1 to 10, wherein the RICC comprises: a catheter tube comprising a catheter tube portion of the primary lumen of the RICC; a single-piece catheter tip coupled to a distal end portion of the catheter tube; a catheter hub coupled to a proximal portion of the catheter tube; one or more extension legs, each extension leg of the one or more extension legs being coupled to the catheter hub by a distal portion of the extension leg; RICC insertion assembly, comprising:

12. 12. The RICC insertion assembly of claim 11, wherein the catheter tip is made of a first polymeric material and the catheter tube is made of a second, softer polymeric material.

13. 13. The RICC insertion assembly of claim 12, wherein the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or appreciably deforming when a distal portion of the RICC is advanced into a patient's vascular lumen, and the first polymeric material is sufficiently flexible to prevent trauma to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

14. 13. The RICC insertion assembly according to claim 11 or 12, wherein the RICC comprises a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen, formed in fluidly connected portions of at least three catheter tube lumens, three catheter hub lumens, and three extension leg lumens, and the secondary lumens and the tertiary lumens terminate at a distal end portion of the catheter tube with at least a partial fill of molten polymer material of the first polymer material.

15. 15. The RICC insertion assembly of claim 14, wherein the primary lumen has a primary lumen opening at a distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on the side of the distal end portion of the catheter tube proximal to the secondary lumen opening.

16. 16. The RICC insertion assembly of claim 1, further comprising a syringe fluidly connected to the needle hub of the introducer needle in at least the ready-to-deploy state of the RICC insertion assembly.

17. 1. An introducer needle subassembly comprising: an introducer needle including a needle hub covering a proximal portion of a compound shaft, the compound shaft including a needle shaft having a longitudinal needle slot and a sheath covering the needle shaft, the sheath sealing the underlying needle slot except for a sheath opening in the sheath to the needle slot; a coupler coupled to the introducer needle; Equipped with The coupler comprises: A coupler housing; a valve module disposed within the coupler housing; Including, an introducer needle subassembly, the composite shaft passing through an introducer needle passage defined by a valve module housing of the valve module such that the valve module forms a seal over the sheath opening when the introducer needle subassembly is in a ready-to-deploy state, the valve module including a needlestick injury (NSI) protection mechanism configured to capture a distal tip of the needle shaft within the valve module when the introducer needle is withdrawn proximally from the coupler.

18. The introducer needle subassembly of claim 17 , wherein the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve module housing.

19. 20. The introducer needle subassembly of claim 18, wherein the tether has a fixed tether length configured to prevent the tip of the needle shaft from disengaging from the valve module when or after the introducer needle is withdrawn proximally from the coupler.

20. 20. The introducer needle subassembly of claim 18 or 19, wherein the tether includes a plurality of pleats and a plurality of pleat through-holes extending through the pleats, and the composite shaft is positioned within the pleat through-holes such that the pleats expand above the composite shaft when the introducer needle is withdrawn proximally from the coupler.

21. 21. The introducer needle subassembly of claim 17, wherein the NSI protection mechanism includes a spring loaded into a spring cavity along a portion of the introducer needle passageway, the spring configured to unload into the introducer needle passageway when the introducer needle is withdrawn proximally from the coupler and the tip of the needle shaft passes through the spring.

22. 22. The introducer needle subassembly of claim 21, wherein the spring is a leaf spring including an end tab configured to extend across the introducer needle passage into a tab receiver of the valve module housing opposite the spring cavity when the tip of the needle shaft passes through the spring, thereby preventing the tip of the needle shaft from disengaging from the valve module when the introducer needle is advanced distally into the coupler.

23. 23. The introducer needle subassembly of claim 22, wherein the end tab of the spring provides a primary tip shield and the fulcrum of the spring provides a secondary tip shield when the tip of the needle shaft is forced to advance distally beyond the end tab into the coupler.

24. 24. The introducer needle subassembly of claim 23, wherein the fulcrum of the spring is between a free arm of the spring that includes the end tab and a fixed arm of the spring that is fixed to the valve module housing within the spring cavity.

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