Rapid insertion central venous catheters, introducers, and insertion devices, and combinations and methods thereof

Abstract

Rapid Insertion Central Venous Catheters (RICC), introducers, and insertion devices, as well as combinations and methods thereof, are disclosed. For example, a RICC system may include an introducer and a RICC insertion assembly. The RICC insertion assembly includes a RICC assembly disposed in a RICC insertion device. The RICC assembly may include a RICC, an access guidewire, and a splittable casing that covers the catheter tube and the access guidewire of the RICC and forms a longitudinal composite. The RICC insertion device includes a frame and a nose cover that form a split channel. The split channel splits away from a through channel in a nose of the frame. The RICC insertion device may be configured to advance the longitudinal composite by advancing the RICC assembly over roller wheels disposed on the frame. The through channel may be configured to advance the catheter tube through the through channel, and the split channel may be configured to split and pass the splittable casing through the split channel.

Description

[Technical field]

[0001] The present disclosure relates to rapid insertion central venous catheters, introducers, and insertion devices, as well as combinations and methods thereof. [Background technology]

[0002] Central venous catheters ("CVCs") are typically introduced into a patient and advanced through the patient's vascular system via the Seldinger technique. The Seldinger technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming and many of the medical devices are cumbersome to handle, both of which can lead to trauma to the patient. In addition, there is a relatively high chance of contact contamination due to the large number of medical devices that need to be replaced during the many steps of the Seldinger technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system. Summary of the Invention

[0003] Disclosed herein are rapid insertion central venous catheters ("RICC"), introducers, and insertion devices, as well as combinations and methods thereof, that address the foregoing.

[0004] Disclosed herein is a RICC insertion system, including a RICC assembly, a RICC insertion device, and an introducer. The RICC assembly includes a RICC, an access guidewire, and a keeper. The RICC includes a catheter tube, a catheter hub connected to a proximal portion of the catheter tube, and one or more extension legs. Each extension leg of the one or more extension legs is connected to the catheter hub by a distal portion of each extension leg. The access guidewire is disposed within a primary lumen of the RICC. The keeper includes a splittable casing that covers both the catheter tube and a distal portion of the access guidewire extending from a distal end of the RICC to form a longitudinal composite of the splittable casing, the catheter tube, and the distal portion of the access guidewire. The RICC insertion device includes a frame, one or more roller wheels, and a nose cover that covers a nose of the frame. The frame includes a longitudinal handle, a nose, and a curved cradle. The handle includes a wheel well. A nose extends from a distal portion of the handle distal to the wheel well. The nose includes a through channel configured to advance a catheter tube of the RICC through the through channel. A cradle extends from a proximal portion of the handle. One or more roller wheels are disposed within the wheel well. The nose cover and nose form a split channel configured to split and pass the splittable casing through the split channel. The RICC insertion device is configured to advance the RICC assembly from an initial position within the frame to a final position within the frame. This is accomplished by repeatedly forcing the longitudinal composite into the one or more roller wheels and advancing the longitudinal composite over the one or more roller wheels.

[0005] In some embodiments, the keeper further includes a catheter hub holder to which the proximal end of the splittable casing is attached, the catheter hub holder configured to retain the catheter hub within the catheter hub holder and to hold the splittable casing in place over the catheter tube and access guidewire.

[0006] In some embodiments, the catheter hub holder includes a peripheral wall about at least a portion of the circumference of the catheter hub holder, the peripheral wall defining a recess into which the catheter hub fits with an engineered fit.

[0007] In some embodiments, the cradle includes a curved extension that covers a distal portion of the cradle, the extension substantially following the same curve as the cradle. In some embodiments, the cradle includes an enclosure covering a distal portion of the cradle with an extension extending from the enclosure configured to enclose an otherwise exposed proximal portion of the access guidewire within the enclosure at the initial position of the RICC assembly within the frame.

[0008] In some embodiments, the RICC insertion device further includes a retaining clip configured to clip onto a proximal portion of the RICC to retain the RICC assembly within the RICC insertion device. The retaining clip is also configured to prevent premature advancement of the catheter tube over the access guidewire. The retaining clip includes a post configured to engage a slot in the extension facing the open side of the cradle.

[0009] In some embodiments, the retaining clip is configured to disengage from the slot of the extension when remaining slack in the longitudinal composite is removed upon advancement of the RICC assembly from an initial position to a final position within the frame.

[0010] In some embodiments, the frame further includes a retaining arch that covers the cradle proximate a proximal portion of the handle from which the cradle extends. The retaining arch is configured to retain the RICC assembly within the RICC insertion device. The retaining arch is also configured to retain the longitudinal composite on the handle as the RICC assembly transitions over the proximal portion of the handle from which the cradle extends during advancement of the RICC assembly from an initial position within the frame to a final position.

[0011] In some embodiments, the nose cover and the nose further form a retention clamp configured to slidably clamp the longitudinal composite within the retention clamp. The nose cover is rotatable on the nose. The nose cover includes a longitudinal gap configured to be rotatably aligned with a through channel of the nose for removal of the longitudinal composite, splittable casing, or catheter tube from the nose.

[0012] In some embodiments, the RICC insertion device further includes a retractable cutting blade disposed within a cutting blade carriage slidably integrated into the nose, the cutting blade carriage having a cutting position in which the retractable cutting blade extends beyond the distal end of the nose, and the cutting blade carriage also having a safety position in which the retractable cutting blade is short of the distal end of the nose.

[0013] In some embodiments, the introducer includes an introducer needle and a splittable introducer sheath. The introducer needle includes a needle shaft and a needle hub. The needle shaft includes a needle tip at a distal portion of the needle shaft. The needle hub is coupled to a proximal portion of the needle shaft. The introducer sheath is configured to receive the introducer needle within the introducer sheath. The introducer sheath includes a splittable sheath body and a splittable sheath hub coupled to a proximal portion of the sheath body. The sheath hub includes a pair of wings extending outwardly along a length of the sheath hub. The wings have an included angle between them of about 90° or less. The wings are configured to split the sheath hub by pinching the wings together with one hand.

[0014] In some embodiments, the sheath hub includes a single longitudinal defect along a side of the sheath hub opposite the apex of the interior angle formed by the wings, the sheath hub being configured to split along the defect such that when the wings are pinched together they propagate along the same side of the sheath body.

[0015] In some embodiments, the sheath hub includes a pair of longitudinal defects including a primary defect and a secondary defect. The primary defect extends along a primary side of the sheath hub opposite an apex of an interior angle formed by the wings. The secondary defect extends along a secondary side of the sheath hub opposite the primary defect. The sheath hub is configured to split along the primary defect when the wings are pinched together to propagate along the primary side of the sheath body. The sheath hub is also configured to split along the secondary defect when the wings are pulled apart to propagate along the secondary side of the sheath body.

[0016] In some embodiments, the sheath hub further comprises a valved cap disposed at a proximal portion of the sheath hub. The valved cap comprises a tapered female valved cap connector and a septum distal to a proximal opening of the female valved cap connector. The female valved cap connector is configured to receive within the female valved cap connector a tapered male needle hub connector extending from a distal portion of the needle hub. The septum is configured to receive the needle shaft therethrough.

[0017] In some embodiments, the valved cap is partially or completely split such that when the wings are pinched together, the valved cap splits along with the sheath hub. In some embodiments, the sheath hub further includes an overmolded cutting blade and a hinged cutting blade cover. The overmolded cutting blade extends distally from the sheath hub. The cutting blade cover has an open state that is open away from the overmolded cutting blade. The cutting blade cover also has a closed state that is closed over the overmolded cutting blade.

[0018] In some embodiments, the introducer further comprises a syringe including a tapered male syringe tip extending from a distal portion of the syringe configured to be inserted into a tapered female needle hub connector at a proximal portion of the needle hub.

[0019] Also disclosed herein in some embodiments is a RICC insertion assembly, including a RICC assembly and a RICC insertion device. The RICC assembly includes a RICC, an access guidewire, and a keeper. The RICC includes a catheter tube, a catheter hub connected to a proximal portion of the catheter tube, and one or more extension legs. Each extension leg of the one or more extension legs is connected to the catheter hub by a distal portion of each extension leg. The access guidewire is disposed within the primary lumen of the RICC. The keeper includes a splittable casing that covers both the catheter tube and a distal portion of the access guidewire extending from a distal end of the RICC to form a longitudinal composite of the splittable casing, the catheter tube, and the distal portion of the access guidewire. The RICC insertion device includes a frame, one or more roller wheels, and a nose cover that covers a nose of the frame. The frame includes a longitudinal handle, a nose, and a curved cradle. The handle includes a wheel well. A nose extends from a distal portion of the handle distal to the wheel well. The nose includes a through channel configured to advance a catheter tube of the RICC through the through channel. A cradle extends from a proximal portion of the handle. One or more roller wheels are disposed within the wheel well. The nose cover and nose form a split channel configured to split and pass the splittable casing through the split channel. The RICC insertion device is configured to advance the RICC assembly from an initial position within the frame to a final position within the frame. This is accomplished by repeatedly forcing the longitudinal composite into the one or more roller wheels and advancing the longitudinal composite over the one or more roller wheels.

[0020] In some embodiments, the distal end of the longitudinal composite, splittable casing, or access guidewire substantially corresponds with the distal end of the frame in the initial position of the RICC assembly within the frame.

[0021] In some embodiments, a slack loop of the longitudinal composite extends away from both the handle and the cradle in the initial position of the RICC assembly within the frame.

[0022] In some embodiments, the longitudinal composite is split substantially at the final location of the RICC assembly within the frame. In some embodiments, a luer connector coupled to a proximal end of the extension leg or to an extension leg of one or more extension legs of the RICC substantially corresponds to a proximal end of the cradle in an initial position of the RICC assembly within the frame.

[0023] In some embodiments, the proximal end of the access guidewire is coupled to the proximal end of the cradle at the initial position of the RICC assembly within the frame. In some embodiments, one or more extension legs of the RICC lie substantially over the handle in the final position of the RICC assembly within the frame.

[0024] In some embodiments, the catheter hub of the RICC sits on a wheel well in the final position of the RICC assembly within the frame. Also disclosed herein is a method for inserting a RICC into a blood vessel lumen of a patient. The method, in some embodiments, includes the steps of obtaining, establishing a needle path, removing an introducer needle, advancing an access guidewire, removing an introducer sheath, and advancing a catheter tube. The obtaining step includes obtaining a RICC insertion system. The RICC insertion system includes an introducer, a RICC insertion device, and a RICC assembly including a RICC. The RICC assembly is optionally already disposed within the RICC insertion device in a substantially operable state of the RICC insertion assembly. The needle path establishing step includes establishing a needle path from a skin region into the blood vessel lumen of the patient with an introducer needle of the introducer. The introducer needle is disposed within a splittable introducer sheath of the introducer to establish the needle path. The introducer needle removing step includes removing the introducer needle from the introducer sheath, leaving the introducer sheath within the blood vessel lumen. The access guidewire advancing step includes advancing the access guidewire through the nose and nose cover of the RICC insertion device, through the splittable sheath hub of the introducer, and through the introducer sheath into the vessel lumen. The access guidewire advancing step is accomplished in part by splitting the splittable casing from the longitudinal composite of the RICC assembly. A distal portion of the access guidewire extending from the primary lumen opening of the catheter tube of the RICC is released from the longitudinal composite by splitting the splittable casing to advance the access guidewire. The introducer sheath removal step includes removing the introducer sheath leaving the access guidewire within the vessel lumen. The catheter tube advancing step includes advancing the catheter tube over the access guidewire into the vessel lumen. The catheter tube advancing step is accomplished in part by further splitting the splittable casing from the longitudinal composite of the RICC assembly.The catheter tube is released from the longitudinal composite by splitting the splittable casing, allowing the catheter tube to be advanced over the access guidewire upon removal of remaining slack in the longitudinal composite within the RICC insertion assembly.

[0025] In some embodiments, the needle path establishing step includes ensuring that blood flows back into the needle hub of the introducer needle to confirm that the needle path extends into the blood vessel lumen.

[0026] In some embodiments, the method further includes a step of aspirating blood using a syringe coupled to the introducer needle to aspirate blood to confirm that the needle track extends into the vessel lumen, the step of aspirating blood being performed prior to the step of removing the introducer needle.

[0027] In some embodiments, the method further includes advancing an introducer sheath further over the introducer needle into the vessel lumen, the advancing introducer sheath step being performed prior to removing the introducer needle.

[0028] In some embodiments, the method further includes a connector connecting step, which includes inserting a male nose connector of a nose of the RICC insertion device into a female valved cap connector of a sheath hub of the introducer sheath, which is performed prior to the access guidewire advancing step.

[0029] In some embodiments, the method further includes a skin incision step, which includes incising the skin area around the needle path with a cutting blade extending from the sheath hub. The skin incision step is performed when the catheter tube is 7 Fr or larger. The skin incision step is also performed prior to the access guidewire advancement step.

[0030] In some embodiments, the method further includes a cover opening step and a cover closing step. The cover opening step includes opening the hinged cutting blade cover away from the cutting blade to a cutting position away from the cutting blade. The cover opening step occurs before the skin incising step. The cover closing step includes closing the cutting blade cover over the cutting blade to a safety position covering the cutting blade. The cover closing step occurs after the skin incising step.

[0031] In some embodiments, the method further includes an alternative skin incision step, which includes incising the skin area around the needle path with a retractable cutting blade integrated into the nose of the RICC insertion device. The alternative skin incision step is performed when the catheter tube is 7 Fr or larger. The alternative skin incision step is also performed before the catheter tube advancement step.

[0032] In some embodiments, the method further includes a pair of carriage sliding steps including a first carriage sliding step and a second carriage sliding step, the first carriage sliding step includes sliding a cutting blade carriage having a cutting blade overmolded therein distally to a cutting position such that the cutting blade extends beyond the distal end of the nose of the RICC insertion device, and the second carriage sliding step includes sliding the cutting blade carriage proximally to a safety position such that the cutting blade is short of the distal end of the nose of the RICC insertion device.

[0033] In some embodiments, the step of removing the introducer sheath includes splitting the introducer sheath to form a split along a side of the introducer sheath by pinching together a pair of wings extending outwardly from the sheath hub, and also includes propagating the split along the same side of the introducer sheath body to the side of the sheath hub.

[0034] In some embodiments, the access guidewire advancement step or catheter tube advancement step includes, with one hand, repeatedly pushing the longitudinal composite against one or more roller wheels positioned within a wheel well of the longitudinal handle of the RICC insertion device to advance the longitudinal composite across the one or more roller wheels to split the splittable casing from the longitudinal composite.

[0035] In some embodiments, the access guidewire advancing step or the catheter tube advancing step includes pulling the splittable casing of the longitudinal composite through a splitting channel formed between the nose of the RICC insertion device and a nose cover covering the nose, thereby splitting the splittable casing from the longitudinal composite.

[0036] In some embodiments, a retaining clip clipped onto the proximal portion of the RICC allows the catheter tube to be advanced over the access guidewire by disengaging with a curved extension covering the cradle of the RICC insertion device upon removing any remaining slack in the longitudinal composite within the RICC insertion assembly.

[0037] In some embodiments, the method further comprises the step of removing the access guidewire, the step of removing the access guidewire comprising removing the access guidewire while leaving the catheter tube within the blood vessel lumen.

[0038] In some embodiments, the method further includes a keeper removal step, which includes removing a keeper from the RICC assembly, the keeper including a proximal end of the splittable casing attached to the catheter hub holder, which is accomplished in part by removing the catheter hub of the RICC from the catheter hub holder and splitting the remaining splittable casing of the longitudinal composite from the catheter tube.

[0039] In some embodiments, the method further includes a catheter tube releasing step that includes releasing the catheter tube of the RICC from a retaining clamp formed from the nose and nose cover of the RICC insertion device, the catheter tube releasing step being accomplished in part by rotating the nose cover onto the nose to align a longitudinal gap of the nose cover with a through channel in the nose and pulling the catheter tube away from the RICC insertion device.

[0040] Also provided herein in some embodiments is a catheter insertion system for a RICC assembly, comprising an insertion assembly having a housing including a blood flush nozzle and a catheter nozzle, a blood flush indicator in fluid communication with the blood flush nozzle, a RICC disposed within an internal cavity of the housing and slidably engaged with the catheter nozzle, an introducer including an introducer needle and an introducer sheath, the introducer releasably engaged with one of the blood flush nozzle or the catheter nozzle, A catheter insertion system is also disclosed that includes:

[0041] In some embodiments, the catheter insertion system further includes a needle retraction system coupled to the introducer needle, the needle retraction system configured to retract the introducer needle proximally from the introducer sheath through the blood flush nozzle.

[0042] In some embodiments, the blood flush indicator is in fluid communication with the needle lumen of the needle. In some embodiments, a sheath hub of the introducer sheath is configured to releasably engage the catheter nozzle and longitudinally align the sheath lumen of the sheath with the RICC.

[0043] In some embodiments, the catheter insertion system further includes a catheter advancement assembly configured to slidably engage the RICC and the catheter nozzle. In some embodiments, the catheter insertion system further includes an access guidewire coupled to the guidewire advancement assembly configured to slidably engage the access guidewire with the catheter nozzle.

[0044] Also disclosed herein is a method of placing a catheter within a patient's vasculature, which in some embodiments includes the steps of accessing the vasculature with an introducer needle of an introducer; retracting the introducer needle from a sheath lumen of an introducer sheath of the introducer through a blood flush nozzle of the insertion assembly; removing a sheath hub of the introducer sheath from the blood flush nozzle and engaging the sheath hub with a catheter nozzle of the insertion assembly; advancing an access guidewire through the catheter nozzle and sheath lumen; longitudinally splitting the introducer sheath to disengage the introducer sheath from the access guidewire; and advancing a catheter over the access guidewire through the catheter nozzle.

[0045] In some embodiments, the method further includes activating a blood flush indicator to draw fluid flow proximally through the needle lumen of the introducer needle and through the blood flush nozzle.

[0046] In some embodiments, the method further includes actuating a needle retraction assembly disposed within the insertion assembly to retract the introducer needle through the blood flush nozzle and into the internal cavity of the insertion assembly.

[0047] In some embodiments, the catheter comprises one of a rapid insertion central catheter, a central venous catheter, a peripherally inserted central catheter, or a dialysis catheter. These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0048] [Figure 1] A RICC insertion system is presented, including a RICC insertion assembly and an introducer, according to some embodiments. [Diagram 2] A RICC according to some embodiments is presented. [Diagram 3] 1 presents a distal portion of a RICC according to some embodiments. [Figure 4] 1 presents a first cross-section of a RICC according to some embodiments. [Diagram 5] 13A-13C present a second or third cross-section of a RICC according to some embodiments. [Figure 6] A RICC assembly according to some embodiments is presented. [Figure 7] 1 presents a first cross-section of a RICC assembly according to some embodiments. [Figure 8] 1 presents a second cross-section of a RICC assembly according to some embodiments. [Figure 9] A first alternative RICC assembly according to some embodiments is presented. [Figure 10] 1 presents a cross-section of a first alternative RICC assembly according to some embodiments. [Figure 11] A second alternative RICC assembly according to some embodiments is presented. [Figure 12] 13 presents a first cross-section of a second alternative RICC assembly according to some embodiments. [Figure 13]13 presents a second cross-section of a second alternative RICC assembly according to some embodiments. [Figure 14] A third alternative RICC assembly according to some embodiments is presented. [Figure 15A] 13 presents a top view of a fourth alternative RICC assembly according to some embodiments. [Figure 15B] 13 presents a side view of a fourth alternative RICC assembly according to some embodiments. [Figure 16] 1 presents a RICC insertion assembly including a RICC assembly disposed within a RICC insertion device in an operational state of the RICC insertion assembly, according to some embodiments. [Figure 17] 1 presents a nose cover that covers the nose of a RICC insertion device, according to some embodiments. [Figure 18A] 1 illustrates a retention clamp formed between the nose cover and nose of a RICC insertion device in a closed state, according to some embodiments. [Figure 18B] 1 illustrates a retaining clamp in an open state according to some embodiments. [Figure 19] 13A-13C present a curved extension of a curved cradle of a RICC insertion device that includes a slot configured to engage a retaining clip, according to some embodiments. [Figure 20] 1 presents a retaining clip of a RICC insertion device according to some embodiments. [Figure 21A] 1 illustrates a retractable cutting blade integrated into the nose of a RICC insertion device in a safe position, according to some embodiments. [Figure 21B] 1 illustrates a retractable cutting blade when in a cutting position according to some embodiments. [Figure 22] 1 presents a RICC insertion assembly with the RICC assembly in a leading intermediate position within a frame of a RICC insertion device, according to some embodiments. [Figure 23A]13A-13C illustrate a RICC insertion assembly according to some embodiments, with the RICC assembly in the same or different intermediate preceding position within the frame of the RICC insertion device, with the loose loop of the longitudinal composite remaining within the RICC insertion assembly. [Figure 23B] 13A-13C illustrate a RICC insertion assembly according to some embodiments, with no loose loops of longitudinal composite remaining in the RICC insertion assembly and with the RICC assembly in a subsequent intermediate position within the frame of the RICC insertion device. [Figure 24] 1 presents a RICC insertion assembly with the RICC assembly in a final position within a frame of a RICC insertion device assembly, according to some embodiments. [Diagram 25] An introducer according to some embodiments is presented. [Figure 26] 1 presents a pair of wings extending outwardly along the length of the introducer sheath hub, according to some embodiments. [Figure 27] 1 presents a longitudinal cross-section of a sheath hub according to some embodiments. [Figure 28A] 1 presents an overmolded cutting blade integrated into a sheath hub with a cutting blade cover in a safe position according to some embodiments. [Figure 28B] 1 presents an overmolded cutting blade integrated into a sheath hub with a cutting blade cover in a cutting position according to some embodiments. [Figure 29] Another RICC insertion system including another RICC insertion assembly is presented, according to some embodiments. [Diagram 30] 30 presents a detailed view of the introducer of the RICC insertion assembly of FIG. 29 according to some embodiments. [Diagram 31] 30 presents a detailed view of a nose portion of a RICC insertion device of the RICC insertion assembly of FIG. 29 according to some embodiments. [Figure 32A]30 depicts a first state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Figure 32B] 30 depicts a second state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Figure 32C] 30 presents a third state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Fig. 32D] 30 illustrates a fourth state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Figure 32E] 30 illustrates a fifth state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Fig. 32F] 30 illustrates a sixth state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. [Fig. 32G] 30 illustrates a seventh state of the RICC insertion assembly of FIG. 29 in a method of using the RICC insertion system, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0049] 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 embodiment and, optionally, combined with or substituted for features of any of several other embodiments disclosed herein.

[0050] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain particular embodiments, and that these terms are not intended to 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 group of features or steps, and do not impose 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, any of the aforementioned features or steps may further include one or more features or steps, unless otherwise specified. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a," "an," and "the" include the plural forms unless the context clearly indicates otherwise.

[0051] With respect to "proximal," a "proximal portion" or "proximal end portion," e.g., of a catheter, includes the portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, a "proximal length," e.g., of a catheter, includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. A "proximal end," e.g., of a catheter, includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0052] With respect to "distal," a "distal portion" or "distal end portion," e.g., of a catheter, includes a portion of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, a "distal length," e.g., of a catheter, includes a length of a catheter that is intended to be near or within a patient when the catheter is used with a patient. A "distal end," e.g., of a catheter, includes an end of a catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As discussed above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system. Disclosed herein are RICCs, introducers, and insertion devices, as well as combinations and methods thereof, that address the foregoing. However, it should be understood that RICCs are only one type of catheter that may embody or otherwise incorporate the concepts provided herein. Indeed, peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like, may also embody or otherwise incorporate the concepts provided herein for RICCs, introducers, and insertion devices, as well as combinations and methods thereof.

[0054] RICC Insertion System FIG. 1 illustrates a RICC insertion system 100 including a RICC insertion assembly 102 and an introducer 104, according to some embodiments.

[0055] As shown, the RICC insertion system 100 can include a RICC 106 as part of a RICC assembly 108, a RICC insertion device 110, and an introducer 104. The RICC assembly 108 can be disposed in an initial position within a frame 172 of the RICC insertion device 110, as described below, to form a substantially operable state of the RICC insertion assembly 102, as further shown in FIG.

[0056] For convenience, descriptions of specific components of the RICC insertion system 100, including the RICC assembly 108, the RICC insertion device 110, the RICC insertion assembly 102, and the introducer 104, are provided below in sections named for the specific components. However, the descriptions of the components of the RICC insertion system 100 are not limited to any particular section. Indeed, the description of any component of the RICC insertion system 100 may span from one section to one or more other sections, given the inter-relationship of the components of the RICC insertion system 100. For example, a description of the RICC assembly 108 or the RICC insertion device 110 may span from its section to a section about the RICC insertion assembly 102. Similarly, a description of the RICC insertion assembly 102 may span from its section to a section about the RICC assembly 108 or the RICC insertion device 110. Therefore, it should be understood that a description of the RICC assembly 108, the RICC insertion device 110, the RICC insertion assembly 102, the introducer 104, or any other component of the RICC insertion system 100 may be found anywhere in this patent application.

[0057] RICC Insertion Kit Although not shown, the RICC insertion kit can include the RICC insertion system 100, instructions for using the RICC insertion system 100, and packaging. Again, the RICC insertion system 100 can include a RICC assembly 108, a RICC insertion device 110, and an introducer 104. The RICC assembly 108 can be disposed within the RICC insertion device 110 in a substantially operable state of the RICC insertion assembly 102 for use upon removal of the RICC insertion assembly 102 from the RICC insertion kit. The RICC insertion system 100 can be packaged within a package (e.g., a polyethylene pouch, a polyethylene / Tyvek pouch, etc.). The instructions for use can be either packaged within the package with the RICC insertion system 100 or printed on the package.

[0058] Notwithstanding the above-mentioned RICC insertion kit, a combination of less than the entire RICC insertion system 100 (i.e., the RICC assembly 108, the RICC insertion device 110, and the introducer 104) may be packaged together in some package with instructions for use of the combination of components of the RICC insertion system 100 or the entire RICC insertion system 100 printed in or on the packaging. For example, the RICC assembly 108 and the RICC insertion device 110 may be packaged in a substantially operable state of the RICC insertion assembly 102 with instructions for use of the RICC insertion assembly 102 or the entire RICC insertion system 100 printed in or on the packaging. Each component of the RICC insertion system 100 (i.e., the RICC assembly 108, the RICC insertion device 110, and the introducer 104) may also be packaged separately in some package with instructions for use of that component, the combination of components including that component, or the entire RICC insertion system 100 printed in or on the packaging. For example, the introducer 104 may be packaged with instructions for use within or printed on the packaging of the introducer 104 or the entire RICC insertion system 100.

[0059] RICC Assembly FIG. 6 illustrates a RICC assembly 108 according to some embodiments, and FIGS. 9, 11, 14, 15A, and 15B illustrate some alternative RICC assemblies according to some embodiments.

[0060] As shown, the RICC assembly 108 may include a RICC 106, an access guidewire 112, and a keeper 114. Notably, the RICC assembly 108 need not include the keeper 114 in certain embodiments, such as the embodiment of FIG.

[0061] Figure 2 illustrates a RICC 106 according to some embodiments, Figure 3 illustrates a distal portion of the RICC 106, Figure 4 illustrates a first cross-section of the distal portion of the RICC 106, and Figure 5 illustrates a second or third cross-section of the distal portion of the RICC 106 according to some embodiments.

[0062] As shown, the RICC 106 may include a catheter tube 116 , a catheter hub 118 , and one or more extension legs 120 . The catheter tube 116 may include a catheter tip 122 at a distal portion of the catheter tube 116 and one or more catheter tube lumens passing therethrough.

[0063] One or more catheter tube lumens may extend throughout the entire catheter tube 116. However, in a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), typically only one catheter tube lumen extends from the proximal end of the catheter tube 116 to the distal end of the catheter tube 116. (See FIGS. 3-5.) In fact, the catheter tip 122 typically includes a single lumen therethrough, regardless of whether the catheter tip 122 is integrally formed with the catheter tube 116 or formed separately from and coupled to the catheter tube 116.

[0064] A catheter hub 118 can be coupled to a proximal portion of the catheter tube 116. The catheter hub 118 can include one or more catheter hub lumen corresponding to a number of the one or more catheter tube lumens. The one or more catheter hub lumen can extend entirely through the catheter hub 118 from a proximal end of the catheter hub 118 to a distal end of the catheter hub 118.

[0065] Each of the one or more extension legs 120 can be coupled by its distal portion to the catheter hub 118. Each of the one or more extension legs 120 can include one or more extension leg lumens, the number of which corresponds to the number of the one or more catheter hub lumens. Each of the one or more extension leg lumens can extend entirely through the extension leg, from a proximal end of the extension leg to a distal end of the extension leg.

[0066] Each extension leg of the one or more extension legs 120 can include a luer connector coupled thereto, which allows the extension leg and its extension leg lumen to be connected to another medical device and its lumen.

[0067] As shown, the RICC 106 may be a three-lumen RICC including a set of three lumens. The set of three lumens may include a primary lumen 124, a secondary lumen 126, and a tertiary lumen 128 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 124 may have a primary lumen opening 130 at the distal end of the catheter tip 122, the distal end of the catheter tube 116, or the distal end of the RICC 106. The secondary lumen 126 may have a secondary lumen opening 132 on the side of the distal portion of the catheter tube 116. The tertiary lumen 128 may have a tertiary lumen opening 134 on the side of the distal portion of the catheter tube 116 proximal to the secondary lumen opening 132.

[0068] The access guidewire 112 may be disposed within the primary lumen 124 of the RICC 106 of the RICC assembly 108. The access guidewire 112 may include a distal portion extending from a distal end of the RICC 106, as evidenced by at least a comparison of Figures 7 and 8. The access guidewire 112 may also include a proximal portion extending from a proximal end of the RICC 106, as shown in Figure 6. As described below, the proximal portion of the access guidewire 112 extending from the proximal end of the RICC 106, or the guidewire hub 135 coupled thereto, may be attached to a guidewire attachment location 196 at the closed end of the enclosure 192 in the initial position of the RICC assembly 108 within the frame 172.

[0069] The keeper 114 may include a splittable casing 136 and a catheter hub holder 138 to which the proximal end of the splittable casing 136 is attached. 7 and 8 present a cross-section of the RICC assembly 108, which shows the splittable casing 136 as part of the longitudinal composite 140 of the RICC assembly 108 according to some embodiments.

[0070] As shown, the splittable casing 136 can form a longitudinal composite 140 with the catheter tube 116, the access guidewire 112, or both the catheter tube 116 and the access guidewire 112 of the RICC assembly 108 depending on the embodiment of the RICC assembly 108 and its portions. With respect to the RICC assembly 108 of FIG. 6, for example, the splittable casing 136 can cover both the catheter tube 116 and the access guidewire 112 at the proximal portion of the RICC assembly 108, as shown in FIG. 7. The splittable casing 136 can also cover a distal portion of the access guidewire 112 extending from the distal end of the RICC 106, as shown in FIG. 8. The splittable casing 136 is configured to split along its length such that the distal portion of the access guidewire 112 is exposed first and the distal portion of the catheter tube 116 is exposed later. In this manner, the splittable casing 136 is configured to keep the catheter tube 116 and at least the distal portion of the access guidewire 112 sterile until deployment.

[0071] The catheter hub holder 138 is configured to retain the catheter hub 118 therein and to hold the splittable casing 136 in place over the catheter tube 116 and the access guidewire 112. The catheter hub holder 138 includes a peripheral wall 142 about at least a portion (e.g., a proximal portion) of the circumference of the catheter hub holder 138. The peripheral wall 142 defines a recess into which the catheter hub 118 fits with an engineering fit (e.g., a clearance fit such as a running fit, a sliding fit, or a location fit, or a similar fit or an intermediate fit such as a fixed fit as classified by the International Organization for Standardization ["ISO"]) and one or more gaps 144 for extending through the one or more extension legs 120. Additionally or alternatively, the catheter hub holder 138 can include wings that correspond to the suture wings 146 of the catheter hub 118. Such wings may include posts configured for insertion into suture wing holes 148 of suture wings 146 of the catheter hub 118 with an engineered fit.

[0072] Figure 9 presents a first alternative RICC assembly 150 according to some embodiments. Figure 10 presents a cross-section of a RICC assembly 150 according to some embodiments.

[0073] As shown, the RICC assembly 150 may include the RICC 106, the access guidewire 112, and the keeper 114. However, the splittable casing 136 over the catheter tube 116 and the access guidewire 112 may have a larger diameter over the catheter tube 116 and a smaller diameter over the access guidewire 112 to more closely follow the contours of the catheter tube 116 and the access guidewire 112. Advantageously, the splittable casing 136 may prevent the catheter tube 116 from being prematurely advanced over the access guidewire 112 during advancement of the RICC assembly 150 from an initial position within the frame 172 to a final position within the frame 172, as described below.

[0074] Figure 11 presents a second alternative RICC assembly 152 according to some embodiments. Figure 12 presents a first cross-section of the RICC assembly 152 according to some embodiments. Figure 13 presents a second cross-section of the RICC assembly 152 according to some embodiments.

[0075] As shown, the RICC assembly 152 may include the RICC 106 and the access guidewire 112 without the keeper 114 and its splittable casing 136. Optionally, the catheter tube 116 and the access guidewire 112 may be disposed within a transparent covering, such as a collapsible plastic bag, configured to keep the catheter tube 116 and the distal portion of the access guidewire 112 sterile until deployment. Whether the catheter tube 116 and the access guidewire 112 are bare or disposed within a covering, the transition between the distal portion of the access guidewire 112 and the catheter tube 116 may be advantageously visualized during advancement of the RICC assembly 152 from an initial position within the frame 172 to a final position within the frame 172, as described below.

[0076] FIG. 14 presents a third alternative RICC assembly 154 according to some embodiments. As shown, the RICC assembly 154 may include the RICC 106 and the access guidewire 112 without the keeper 114 and its splittable casing 136. In lieu of the optional cover over the catheter tube 116 and access guidewire 112 of the RICC assembly 154, the entire RICC assembly 152 may be disposed within a transparent cover 156, such as a collapsible or resealable plastic bag, configured to keep the catheter tube 116 and the distal portion of the access guidewire 112 sterile until deployed. As with the RICC assembly 152, the transition between the distal portion of the access guidewire 112 and the catheter tube 116 may be advantageously visualized through the cover 156 during advancement of the RICC assembly 154 from an initial position within the frame 172 to a final position within the frame 172, as described below.

[0077] 15A and 15B present different views of a fourth alternative RICC assembly 158 according to some embodiments. As shown, the RICC assembly 158 can include the RICC 106 and the access guidewire 112 without the keeper 114 and its splittable casing 136. However, the RICC assembly 158, including the catheter tube 116 and the distal portion of the access guidewire 112, can be disposed within a longitudinal housing 160 with the proximal portion of the access guidewire 112 extending from the housing but disposed within a transparent cover 162, such as a collapsible plastic bag. The housing 160 can include a longitudinal slot 164 configured to advance or retract the RICC advancement wing 166 within the longitudinal slot 164. The RICC advancement wing 166 can be configured, similar to the catheter hub holder 138, such that the catheter hub 118 fits into the RICC advancement wing 166 with an engineered fit or its suture wing 146 fits into the post of the RICC advancement wing 166. In any event, the housing 160 can be configured to keep the distal portion of the catheter tube 116 and the access guidewire 112 sterile until deployment. Advantageously, the housing 160 can control relative movement between the catheter tube 116 and the access guidewire 112 by preventing the guidewire hub 135 of the access guidewire 112 from entering the housing 160.

[0078] RICC Insertion Device FIG 16 presents a RICC insertion assembly 102 including a RICC assembly 108 disposed within a RICC insertion device 110, according to some embodiments. FIG 17 presents a nose cover 168 covering a nose 170 of a frame 172 of the RICC insertion device 110, according to some embodiments.

[0079] As shown, the RICC insertion device 110 can include a frame 172, one or more roller wheels 174, and a nose cover 168 that covers a nose 170 of the frame 172. The RICC insertion device 110 can be configured to advance the RICC assembly 108 from an initial position within the frame 172 (see FIG. 16 ), through one or more intermediate positions within the frame 172 (see FIG. 22 ), to a final position within the frame 172 (see FIG. 24 ) for inserting the access guidewire 112 and catheter tube 116 of the RICC 106 into the patient's blood vessel lumen after establishment of a needle pathway into the blood vessel lumen.

[0080] The frame 172 may include a longitudinal handle 176, a nose 170, and a curved cradle 178. However, in some embodiments, the cradle 178 may be a reel.

[0081] The handle 176 can include a wheel well 180 at a distal portion of the handle 176. The wheel well 180 can include one or more roller wheels 174 disposed within the wheel well 180. The handle 176 can be configured to hold and operate the RICC insertion device 110 with one hand (e.g., left or right hand). For example, when the RICC assembly 108 is disposed within the RICC insertion device 110, the RICC assembly 108 can be advanced with one hand from an initial position within the frame 172, through one or more intermediate positions within the frame 172, to a final position within the frame 172, by holding the handle 176 of the RICC insertion device 110 with the fingers of the hand while repeatedly pushing the longitudinal composite 140 of the RICC assembly 108 through the one or more roller wheels 174 with the thumb of the same hand to advance the longitudinal composite 140 across the one or more roller wheels 174.

[0082] The nose 170 may be integral with the handle 176 and extend from a distal portion of the handle 176 distal to the wheel well 180. The nose 170 may include a through channel 182 configured to advance the access guidewire 112 and the catheter tube 116 of the RICC assembly 108 therethrough. The nose 170 and the overlying nose cover 168 together may form a split channel 184 configured to split and pass the splittable casing 136 of the RICC assembly 108 therethrough. Advantageously, the nose 170 may also include a male nose connector 186 configured to be disposed within a female valved cap connector 232 of a sheath hub 226 of an introducer sheath 216 described below, which facilitates advancement of the access guidewire 112 through the introducer sheath.

[0083] 18A and 18B show a retention clamp 188 formed between the nose 170 and the nose cover 168, according to some embodiments, with the retention clamp 188 in a closed and open position, respectively.

[0084] As shown, the nose 170 and the overlying nose cover 168 may also form a retention clamp 188. The retention clamp 188 may be configured to slidably clamp the longitudinal composite 140 of the RICC assembly 108, or the splittable casing 136, the catheter tube 116, or the access guidewire 112 within the retention clamp 188. The nose cover 168 may be rotatable on the nose 170. Additionally, the nose cover 168 may include a longitudinal gap 190 configured to rotatably align with the through channel 182 of the nose 170 for removing the longitudinal composite 140 of the RICC assembly 108, or the splittable casing 136, the catheter tube 116, or the access guidewire 112 from the nose. Indeed, when the longitudinal composite 140 is partially or completely split, the longitudinal gap 190 of the nose cover 168 can be rotatably aligned with the through channel 182 of the nose 170 to remove the splittable casing 136, catheter tube 116, or access guidewire 112 from the nose.

[0085] The cradle 178 may be integral with the handle 176, extending from a proximal portion of the handle 176 and curving back toward a distal portion of the handle 176. The cradle 178 may include an open face, an enclosure 192 that covers the distal portion of the cradle 178, and a retaining arch 194 that covers the cradle 178 adjacent the proximal portion of the handle 176 from which it extends.

[0086] The open surface of the cradle 178 can be configured to accommodate the RICC assembly 108 (e.g., the longitudinal composite 140, the catheter hub 118, one or more extension legs 120, etc.) within the open surface of the cradle 178 from an initial position of the RICC assembly 108 within the frame 172, through one or more intermediate positions of the RICC assembly 108 within the frame 172, to a final position of the RICC assembly 108 within the frame 172.

[0087] The enclosure 192 covering the cradle 178 can be configured to enclose within the enclosure 192 the otherwise exposed proximal portion of the access guidewire 112 and the extension leg of the one or more extension legs 120 from which the proximal portion of the access guidewire 112 extends, in the initial position of the RICC assembly 108 within the frame 172. (See FIGS. 16, 22 and 23A.) In fact, said proximal portion of the access guidewire 112 or the guidewire hub 135 coupled thereto can be attached to a guidewire attachment location 196 at the closed end of the enclosure 192 in the initial position of the RICC assembly 108 within the frame 172. In this manner, the enclosure 192 can keep at least the proximal portion of the access guidewire 112 extending from the proximal end of the RICC 106 contact-free and sterile.

[0088] A retaining arch 194 over the cradle 178 is configured to retain the RICC assembly 108 within the RICC insertion device 110. The retaining arch 194 is also configured to retain the longitudinal composite 140 on the handle 176 as the RICC assembly 108 transitions over a proximal portion of the handle 176 from which the cradle 178 extends during advancement of the RICC assembly 108 from an initial position to a final position within the frame 172.

[0089] FIG. 19 shows a curved extension 198 of the cradle 178 extending from the enclosure 192, according to some embodiments. As shown, the extension 198 may extend from the open end of the enclosure 192 over a distal portion of the cradle 178 substantially along the same curve as the cradle 178. The extension 198 may include a slot 200 in the extension 198 that faces the open side of the cradle 178. The slot 200 may be configured to engage a retaining clip 202, as described below.

[0090] FIG. 20 illustrates a retaining clip 202 of the RICC insertion device 110 according to some embodiments. As shown, the retaining clip 202 may be a separate component of the RICC insertion device 110, including one or more extension leg clips 204 and a post 206. The retaining clip 202 may be configured to clip onto a proximal portion of the RICC 106 and retain the RICC assembly 108 within the RICC insertion device 110. More specifically, the retaining clip 202 may be configured to hold the RICC 106 itself in place within the RICC insertion device 110 and may help prevent the RICC 106 and its catheter tube 116 from prematurely advancing over the access guidewire 112 when the RICC assembly 108 is advanced within the frame 172.

[0091] The one or more extension leg clips 204 can be configured to clip onto one or more extension legs 120. The one or more extension leg clips 204 can include a dedicated extension leg clip for each extension leg of the one or more extension legs 120, as shown, but the one or more extension leg clips 204 can alternatively include a single extension leg clip configured to clip onto any single extension leg of two or more extension legs 120, a pair of extension leg clips 204 configured to clip onto any two extension legs of three or more extension legs 120, etc.

[0092] The post 206 can be configured to engage with the slot 200 of the extension 198 of the cradle 178 at an initial position of the RICC assembly 108 within the frame 172 and through some prior intermediate positions of the one or more intermediate positions of the RICC assembly 108 within the frame 172. (See FIGS. 16, 22, and 23A.) However, the retaining clip 202 can be configured to disengage from the slot 200 of the extension 198 when the remaining slack in the slack loop 212 of the longitudinal composite 140 is removed within the RICC insert assembly 102 upon advancing the RICC assembly 108 through a transition to a subsequent intermediate position of the one or more intermediate positions of the RICC assembly 108 within the frame 172. (See FIG. 23B.) The retaining clip 202 can be configured to follow the cradle 178 over the proximal portion of the handle 176 to the intermediate portion of the handle 176 in the final position of the RICC assembly 108 within the frame 172, while remaining clipped to the one or more extension legs 120 throughout the transition. (See FIG. 24.) 21A and 21B show a retractable cutting blade 208 integrated into the nose 170 of the RICC insertion device 110 in a safe position and a cutting position, respectively, according to some embodiments.

[0093] As shown, the cutting blade 208 may be disposed or overmolded within a cutting blade carriage 210 that is slidably integrated within the nose 170. When the cutting blade carriage 210 is in the safety position, the cutting blade 208 may be proximal to the distal end of the nose 170 to prevent inadvertent cutting. However, when the cutting blade carriage 210 is in the cutting position, the cutting blade 208 may extend beyond the distal end of the nose 170 to cut into the skin area. In particular, the cutting blade 208 may be configured to cut into the skin area around the needle path for later insertion of the catheter tube 116 when the catheter tube 116 is 7 Fr or greater.

[0094] RICC Insertion Assembly Again, FIG. 16 shows the RICC insertion assembly 102 including the RICC assembly 108 disposed in an initial position within the frame 172 of the RICC insertion device 110, according to some embodiments, thereby forming an operable state of the RICC insertion assembly 102.

[0095] The RICC insertion assembly 102, including the RICC assembly 108 disposed within the RICC insertion device 110, can be configured to insert the access guidewire 112 and catheter tube 116 of the RICC 106 into the patient's blood vessel lumen following establishment of a needle pathway into the blood vessel lumen by advancing the RICC assembly 108 from an initial position within the frame 172 of the RICC insertion device 110, through one or more intermediate positions within the frame 172, to a final position within the frame 172.

[0096] In the initial position of the RICC assembly 108 in the frame 172 of the RICC insertion device 110, if the longitudinal composite 140 is not split, the distal end of the longitudinal composite 140 can substantially correspond to the distal end (e.g., nose 170) of the frame 172. In the initial position of the RICC assembly 108 in the frame 172 of the RICC insertion device 110, if the longitudinal composite 140 is partially split as shown in FIG. 16, the distal end of the splittable casing 136 or the distal end of the access guidewire 112 can substantially correspond to the distal end of the frame 172. In either case, the retaining clamp 188 of the RICC insertion device 110 can clamp the distal portion of the longitudinal composite 140 in the retaining clamp 188 in the initial position of the RICC assembly 108 in the frame 172. Further, in the initial position of the RICC assembly 108 within the frame 172, a proximal end of the extension leg or a luer connector coupled to an extension leg of one or more of the extension legs 120 can substantially correspond to a proximal end of the cradle 178 of the RICC insertion device 110. In addition, a proximal end of the access guidewire 112 or its guidewire hub 135 can be coupled to a proximal end of the cradle 178 (e.g., a guidewire attachment location 196 at the closed end of the enclosure 192) in the initial position of the RICC assembly 108 within the frame 172. As a result of clamping a distal portion of the longitudinal composite 140 with the retaining clamp 188 and attaching the proximal end of the access guidewire 112 or its guidewire hub 135 to the proximal end of the cradle 178, a loose loop 212 of the longitudinal composite 140 can extend away from both the handle 176 and the cradle 178 in the initial position of the RICC assembly 108 within the frame 172.

[0097] FIG 22 presents a RICC insert assembly 102 according to some embodiments, with the RICC assembly 108 in a leading intermediate position within the frame 172 of the RICC insertion device 110. FIG 23A presents a RICC insert assembly 102 according to some embodiments, with the RICC assembly 108 in a leading intermediate position within the same or different frame 172 as in FIG 22, with the slack loops 212 of the longitudinal composite 140 remaining within the RICC insert assembly 102. FIG 23B presents a RICC insert assembly 102 according to some embodiments, with the RICC assembly 108 in a trailing intermediate position within the frame 172, with no slack loops of the longitudinal composite 140 remaining within the RICC insert assembly 102.

[0098] As shown, at the previous intermediate position of the RICC assembly 108 within the frame 172 of the RICC insertion device 110, the slack loop 212 of the longitudinal composite 140 may remain within the RICC insertion assembly 102 and extend away from both the handle 176 and the cradle 178 of the RICC insertion device 110. In addition, the post 206 of the retaining clip 202 may remain engaged with the slot 200 of the extension 198 on the cradle 178 to hold the RICC 106 itself in place within the RICC insertion device 110 and prevent the catheter tube 116 from prematurely advancing over the access guidewire 112 as the RICC assembly 108 is advanced within the frame 172. However, the retaining clip 202 may be configured to disengage from the slot 200 of the extension 198 when the remaining slack of the longitudinal composite 140 is removed within the RICC insertion assembly 102 as the RICC assembly 108 is advanced through the transition to the subsequent intermediate position. Indeed, when the remaining slack in the longitudinal composite 140 is removed from the RICC insertion assembly 102, the post 206 of the retaining clip 202 disengages from the slot 200 of the extension 198, such as by being pulled out of the slot 200, thereby allowing the RICC 106 to advance over the access guidewire 112 as the longitudinal composite 140 advances. At a subsequent intermediate position of the RICC assembly 108 within the frame 172, no slack loops of the longitudinal composite 140 remain within the RICC insertion assembly 102, thereby allowing the RICC 106 to continue to advance over the access guidewire 112 as the longitudinal composite 140 advances.

[0099] FIG. 24 shows the RICC insertion assembly 102 according to some embodiments, with the RICC assembly 108 in a final position within the frame 172 of the RICC insertion device 110 assembly.

[0100] As shown, in the final position of the RICC assembly 108 within the frame 172 of the RICC insertion device 110, the longitudinal composite 140 may be substantially split, the catheter hub 118 of the RICC 106 may be positioned on the wheel well 180 of the frame 172, and one or more extension legs 120 of the RICC 106 may be positioned substantially on the handle 176 of the frame 172.

[0101] Introducer FIG. 25 presents an introducer 104 according to some embodiments. As shown, the introducer 104 can include an introducer needle 214 and a splittable introducer sheath 216. The introducer sheath 216 can be configured to receive the introducer needle 214 therein. In fact, the introducer sheath 216 may be positioned over the introducer needle 214 in the operable state of the introducer 104, as shown in FIG. 25. Advantageously, the introducer 104 in combination with the RICC insertion assembly 102 can save the clinician time in that the introducer needle 214 does not need to be withdrawn over the access guidewire 112 and the catheter tube 116 does not need to be threaded over the access guidewire 112.

[0102] The introducer needle 214 may include a needle shaft 218 and a needle hub 220. The needle shaft 218 may include a needle tip 222 at a distal portion of the needle shaft 218 configured to establish a needle pathway from the skin area into the blood vessel lumen. The needle hub 220 may be coupled to a proximal portion of the needle shaft 218. Advantageously, the introducer needle 214 may be sized smaller than needles typically used to place CVCs, which may provide easier access to the blood vessel. As a result, the introducer sheath 216 may be configured to not receive the catheter tube 116 of the RICC 106 therein.

[0103] The introducer sheath 216 can include a splittable sheath body 224 and a splittable sheath hub 226 coupled to a proximal portion of the sheath body 224. Advantageously, the introducer sheath 216 can be configured to be split end-to-end along a side or a pair of opposing sides of the introducer sheath 216.

[0104] The sheath body 224 may be formed of polytetrafluoroethylene, which facilitates a smooth, consistent split without defects on a side or pair of opposing sides of the sheath body 224. The sheath body 224 may be formed of any of a number of other polymers (e.g., polyethylene). However, the sheath body 224 may generally benefit from including a single longitudinal defect (e.g., a cut, perforation, etc.) along the hub side of the sheath body 224, or a pair of longitudinal defects including a primary defect and a secondary defect along a pair of opposing sides of the sheath body 224 when formed of other polymers.

[0105] FIG. 26 shows a pair of wings 328 extending outwardly along the length of the sheath hub 226, according to some embodiments. As shown, the sheath hub 226 can include wings 328 along the length of the sheath hub 226. The wings 328 can have an included angle of about 90° or less between the wings 328 configured to split the sheath hub 226 by pinching the wings 328 together in one hand.

[0106] The sheath hub 226 may include a single longitudinal defect along a side of the sheath hub 226, or a pair of longitudinal defects including a primary defect and a secondary defect along a pair of opposing sides of the sheath hub 226. When the sheath hub 226 includes a single longitudinal defect, the single longitudinal defect may be along a side of the sheath hub 226 opposite the apex of the interior angle formed by the wings 328, allowing the apex of the interior angle to function as a living hinge. The sheath hub 226 may be configured to split along the defect such that when the wings 328 are pinched together, they propagate along the same side of the sheath body 224. When the sheath hub 226 includes a pair of longitudinal defects, the primary defect may extend along a primary side of the sheath hub 226 opposite the apex of the interior angle formed by the wings 328, and the secondary defect may extend along a secondary side of the sheath hub 226 opposite the primary defect. The sheath hub 226 can be configured to split along a primary defect when the wings 328 are pinched together to propagate along a primary side of the sheath body 224. The sheath hub 226 can also be configured to split along a secondary defect when the wings 328 are pulled apart to propagate along a secondary side of the sheath body 224.

[0107] FIG. 27 presents a longitudinal cross-section of a sheath hub 226 including a valved cap 230, according to some embodiments. As shown, the sheath hub 226 can include a valved cap 230 disposed at a proximal portion of the sheath hub 226. The valved cap 230 can include a tapered female valved cap connector 232 and a septum 234 distal to a proximal opening of the female valved cap connector 232. The female valved cap connector 232 can be configured to receive a tapered male needle hub connector extending from a distal portion of the needle hub 220 therein. The septum 234 can be configured to receive the needle shaft 218 therethrough. In fact, the male needle hub connector can be disposed within the female valved cap connector 232 in the operative state of the introducer 104. Additionally, the needle shaft 218 can penetrate the septum 234 such that the needle tip 222 extends beyond the distal end of the sheath body 224 in the operative state of the introducer 104. In particular, the valve cap 230 may be partially or completely split such that when the wings 328 are pinched together, the valve cap 230 splits along with the sheath hub 226 .

[0108] 28A and 28B show an overmolded cutting blade 236 integrated into the sheath hub 226 according to some embodiments, with a hinged cutting blade cover 238 in a closed or safe position and an open or cutting position, respectively.

[0109] As shown, the sheath hub 226 can include an overmolded cutting blade 236 and a cutting blade cover 238. The cutting blade 236 can extend distally from the sheath hub 226. When the cutting blade cover 238 is in a closed or safe position, the cutting blade cover 238 can close over the cutting blade 236 to prevent inadvertent cutting. However, when the cutting blade cover 238 is in an open or cutting position, the cutting blade cover 238 can open away from the cutting blade 236 to cut into the skin area.

[0110] The introducer 104 may further include a syringe 240. The syringe 240 may include a tapered male syringe tip 242 extending from a distal portion of the syringe 240, which may be configured to be inserted into a tapered female needle hub connector at a proximal portion of the needle hub 220. The syringe 240 may be configured to aspirate blood via a barrel 244 and a plunger 246 to confirm vascular access when establishing a needle pathway from the skin area into the vascular lumen.

[0111] method Methods of the RICC insertion system 100 include methods for inserting the RICC 106 into a vascular lumen of a patient, which in some embodiments include one or more steps selected from the following: acquiring, establishing a needle path, aspirating blood, advancing an introducer sheath, removing an introducer needle, connecting a connector, incising the skin, advancing an access guidewire, removing an introducer sheath, advancing a catheter tube, removing an access guidewire, removing a keeper, releasing a catheter tube, inserting a steering guidewire, placing a catheter tube, and retracting a steering guidewire.

[0112] The obtaining step can include obtaining a RICC insertion system 100. As described above, the RICC insertion system 100 can include an introducer 104, a RICC insertion device 110, and a RICC assembly 108 including a RICC 106. The RICC assembly 108 can already be disposed within the RICC insertion device 110 in a substantially operative state of the RICC insertion assembly 102.

[0113] The needle path establishment step may include establishing a needle path from the skin area into the patient's blood vessel lumen with the introducer needle 214 of the introducer 104. Additionally, the needle path establishment step may include ensuring that blood flows back into the needle hub 220 of the introducer needle 214 to confirm that the needle path extends into the blood vessel lumen. The introducer needle 214 may be positioned within the introducer sheath 216 of the introducer 104 for the needle path establishment step.

[0114] The blood aspiration step may include aspirating blood with a syringe 240 coupled to the introducer needle 214 to confirm that the needle track extends into the blood vessel lumen. The blood aspiration step may be performed prior to the introducer needle removal step.

[0115] The introducer sheath advancing step may include advancing the introducer sheath 216 further into the blood vessel lumen over the introducer needle 214. The introducer sheath advancing step may occur before the introducer needle removal step.

[0116] The introducer needle removal step may include removing the introducer needle 214 from the introducer sheath 216, leaving the introducer sheath 216 within the blood vessel lumen, thereby allowing the access guidewire 112 to be inserted into the introducer sheath 216.

[0117] The connector connection step can include inserting the male nose connector 186 of the nose 170 of the RICC insertion device 110 into the female valved cap connector 232 of the sheath hub 226 of the introducer sheath 216. The connector connection step can occur before the access guidewire advancement step.

[0118] The skin incision step may include incising the skin area around the needle path with the cutting blade 236 extending from the sheath hub 226. The skin incision step may be performed when the catheter tube 116 is 7 Fr or larger. The skin incision step may involve a cover opening step prior to the skin incision step and a cover closing step following the skin incision step. The cover opening step may include opening the cutting blade cover 238 away from the cutting blade 236 to a cutting position away from the cutting blade 236. The cover closing step may include closing the cutting blade cover 238 over the cutting blade 236 to a safe position covering the cutting blade 236. The skin incision step may be performed prior to the access guidewire advancement step.

[0119] The access guidewire advancement step may include advancing the access guidewire 112 through the nose 170 and nose cover 168 of the RICC insertion device 110, through the sheath hub 226 of the introducer 104, through the introducer sheath 216, and into the blood vessel lumen. The access guidewire advancement step may be accomplished, in part, by splitting the splittable casing 136 from the longitudinal composite 140 of the RICC assembly 108. A distal portion of the access guidewire 112 extending from the primary lumen opening 130 of the catheter tube 116 of the RICC 106 may be released from the longitudinal composite 140 for the access guidewire advancement step by splitting the splittable casing 136.

[0120] The introducer sheath removal step can include splitting the introducer sheath 216 to form a split along a side of the introducer sheath 216 by pinching together the wings 328 extending outwardly from the sheath hub 226. The introducer sheath removal step can also include propagating the split along the same side of the sheath body 224 of the introducer 104 to the side of the sheath hub 226. Finally, the introducer sheath removal step can include removing the split introducer sheath, leaving the access guidewire 112 within the vessel lumen.

[0121] The skin incision step may alternatively include incising the skin area around the needle path with a retractable cutting blade 208 integrated into the nose 170 of the RICC insertion device 110. Such a skin incision step may also be performed when the catheter tube 116 is 7 Fr or larger. The skin incision step may involve a pair of carriage sliding steps, including a first carriage sliding step before the skin incision step and a second carriage sliding step after the skin incision step. The first carriage sliding step may include sliding the cutting blade carriage 210, with the cutting blade 208 overmolded therein, distally to a cutting position such that the cutting blade 208 extends beyond the distal end of the nose 170 of the RICC insertion device 110. The second carriage sliding step may include sliding the cutting blade carriage proximally to a safe position such that the cutting blade 208 is short of the distal end of the nose 170 of the RICC insertion device 110. The skin incision step also occurs prior to the catheter tube advancement step.

[0122] The catheter tube advancing step may include advancing the catheter tube 116 over the access guidewire 112 and into the blood vessel lumen. The catheter tube advancing step may be accomplished, in part, by further splitting the splittable casing 136 from the longitudinal composite 140 of the RICC assembly 108. The catheter tube 116 may be released from the longitudinal composite 140 by splitting the splittable casing 136, thereby allowing the catheter tube 116 to be advanced over the access guidewire 112 upon removal of remaining slack in the longitudinal composite 140 within the RICC insertion assembly 102.

[0123] The access guidewire advancement step or catheter tube advancement step described above may include, with one hand, repeatedly pushing the longitudinal composite 140 against one or more roller wheels 174 disposed within a wheel well 180 of the handle 176 of the RICC insertion device 110 to advance the longitudinal composite 140 over the one or more roller wheels 174 to split the splittable casing from the longitudinal composite 140. The access guidewire advancement step or catheter tube advancement step may additionally or alternatively include pulling the splittable casing 136 of the longitudinal composite 140 through a splitting channel 184 formed between the nose 170 of the RICC insertion device 110 and the nose cover 168 covering the nose to split the splittable casing from the longitudinal composite 140.

[0124] The access guidewire removal step can include removing the access guidewire 112 leaving the catheter tube 116 within the blood vessel lumen. The keeper removal step can include removing the keeper 114, including the proximal end of the splittable casing 136 attached to the catheter hub holder 138, from the RICC assembly 108. The keeper removal step can be accomplished, in part, by removing the catheter hub 118 of the RICC 106 from the catheter hub holder 138 and splitting the remaining splittable casing 136 of the longitudinal composite 140 from the catheter tube 116.

[0125] The catheter tube release step may include releasing the catheter tube 116 of the RICC 106 from the retaining clamp 188 formed from the nose 170 and nose cover 168 of the RICC insertion device 110. The catheter tube release step may be accomplished, in part, by rotating the nose cover 168 onto the nose 170 to align the longitudinal gap 190 of the nose cover 168 with the through channel 182 in the nose 170 and pulling the catheter tube 116 away from the RICC insertion device 110. The catheter tube release step may be performed in conjunction with a keeper removal step that leaves only the RICC 106 with the catheter tube 116 disposed within the vessel lumen.

[0126] The steering guidewire insertion step may include inserting a steering guidewire into the blood vessel lumen via the distal lumen of the RICC 106. The steering guidewire for the steering guidewire advancement step may have a length sufficient to advance the catheter tube 116 of the RICC 106 to the lower third of the SVC of the patient's heart. The steering guidewire may be part of a guidewire management device configured to maintain sterility of the steering guidewire and facilitate the steering guidewire advancement step. Alternatively, the steering guidewire may be a stand-alone steering guidewire packaged in a sterile barrier (e.g., bag, casing, etc.) configured to maintain sterility of the steering guidewire. Such a steering guidewire may include a stop means for stopping the advancement of the steering guidewire during the steering guidewire advancement step, thereby eliminating loss of the steering guidewire within the patient. The stop means may be, for example, a ball, slug, etc. coupled to a proximal portion of the steering guidewire configured to prevent passage through a luer connector of an extension leg in which at least a proximal portion of the steering guidewire is disposed during the steering guidewire advancement step.

[0127] The catheter tube placement step may include advancing a distal portion of the catheter tube 116 further into the vessel lumen over the steering guidewire to the lower third of the SVC of the patient's heart.

[0128] The retracting steering guidewire step may include retracting the steering guidewire from within the patient's blood vessel lumen and from the RICC 106 . Further embodiments 29-31 and 32A-32G present further embodiments of RICC insertion systems, RICC insertion kits, their components, and related methods. As noted above, for convenience, descriptions of certain components of the RICC insertion systems 100 and 300 are described in sections herein, but such sections are not intended to limit the description of the specific components of the RICC insertion systems 100 and 300. Indeed, descriptions of any components of the RICC insertion systems 100 or 300 may extend from one section to one or more other sections described herein, taking into account the inter-relatedness of the components of the RICC insertion systems 100 and 300.

[0129] 29-31 provide details of a two-stage RICC insertion system 300 including a RICC insertion assembly 302 to which an introducer 304 is releasably coupled. As shown in FIG. 29, the RICC insertion assembly 302 can include a RICC insertion device 309 having a housing 310 defining an internal cavity 312 configured to receive within the internal cavity 312 the RICC 106, the access guidewire 112, and optionally one or more of the introducer 304, needle retraction assembly 330, catheter advancement assembly 340, and guidewire advancement assembly 350, along with the RICC assembly 108, but without the keeper 114, as shown. Various embodiments of the RICC assemblies 108, 150, 152, 154, and 158, as described above, can be used with the RICC insertion system 300. Similarly, various embodiments of needle, catheter, or guidewire advancement assemblies as described herein may be used with the RICC insertion system 300.

[0130] The exterior surface of the housing 310 may define one or more handles configured to facilitate gripping or manipulation of the RICC insertion system 300. For example, the RICC insertion device 309 may include a longitudinal handle 315 and a curved portion 317 defined by the housing 310. Advantageously, the interior cavity 312 of the housing 310 may provide a protective environment for receiving the RICC assembly 108 therein, allowing the user to manipulate the RICC assembly 108 without having to directly contact the RICC assembly 108 or the RICC 106 or its access guidewire 112. In an embodiment, the RICC insertion device 309 may include one or more flexible barriers. One or both of the housing 310 and the one or more flexible barriers may cooperate to maintain the RICC assembly 108 in a sterile environment. In one embodiment, the RICC insertion device 309 may include a blood flush indicator 321, similar to the barrel of a syringe disposed within the housing 310 in fluid communication with the needle lumen of the introducer needle 314 of the introducer 304, as described in more detail herein.

[0131] In certain embodiments, one or more of the needle retraction assembly 330, catheter advancement assembly 340, or guidewire advancement assembly 350 may be disposed within the interior cavity 312 of the housing 310. As shown, the needle retraction assembly 330 and the catheter advancement assembly 340 may be disposed within the longitudinal handle 315. The guidewire advancement assembly 350 may be disposed within the curved portion 317 of the housing 310. However, other configurations of the needle retraction assembly 330, catheter advancement assembly 340, and guidewire advancement assembly 350 are contemplated.

[0132] In an embodiment, the needle storage assembly 330 can be configured to transition the introducer needle 314 between an extended position and a retracted position relative to the housing 310. The needle storage assembly 330 can include a needle slider 332 that extends through and is slidably engaged with a slot disposed in the housing 310. The needle slider 332 can be configured to be manipulated by a user to transition the needle storage assembly 330 between the extended position and the retracted position.

[0133] In an embodiment, the catheter advancement assembly 340 can be configured to transition the RICC 106 of the RICC assembly 108 between a retracted position and an extended position relative to the housing 310. The catheter advancement assembly 340 can include a catheter slider 342 that extends through and is slidably engaged with a slot in the housing 310. The catheter slider 342 can be configured to be manipulated by a user to transition the catheter advancement assembly 340 between the extended position and the retracted position. In an embodiment, the catheter advancement assembly 340 can engage a portion of the catheter hub 118 of the RICC 106. However, it will be appreciated that the catheter advancement assembly 340 can engage other portions of the RICC 106 without being restricted from transitioning between the retracted position and the extended position.

[0134] In one embodiment, the RICC insertion system 300 can further include a guidewire advancement assembly 350 including a guidewire slider 352. The guidewire advancement assembly 350 can be configured to transition the access guidewire 112 between an extended position and a retracted position relative to the housing 310. The guidewire slider 352 can extend through a slot in the housing 310 for manipulation by a user to transition the guidewire advancement assembly 350 between the retracted position and the extended position.

[0135] 30 provides a detailed view of the introducer 304, which may include an introducer needle 314 supported by a needle hub 320 including a needle lumen, as described herein. The introducer 304 may further include a splittable introducer sheath 316 disposed about a needle shaft of the introducer needle 314 and supported at a proximal end by a splittable sheath hub 326, as described herein. The introducer 304 may further include a cutting blade 308 for cutting into the skin adjacent the access site to widen the access site and advance the RICC 106 into the vasculature.

[0136] FIG. 31 provides a detailed view of the nose portion 318 of the RICC insertion device 309, including the blood flush nozzle 324 and the catheter nozzle 344. The proximal end of the introducer 304 can be configured to releasably engage one or both of the blood flush nozzle 324 and the catheter nozzle 344 with an interference fit, press fit, or snap fit. In an embodiment, one of the needle hub 320 or the sheath hub 326 can be coupled to either the blood flush nozzle 324 or the catheter nozzle 344, and the needle hub 320 or the sheath hub 326 can provide fluid communication with one or both of the needle lumen and the sheath lumen. For example, when the introducer 304 is coupled with the blood flush nozzle 324, the needle lumen can be in fluid communication with the blood flush indicator 321. Fluid flow can be drawn proximally through the needle lumen to the blood flush indicator 321 to observe color and pulsatile flow to confirm proper vascular access. In one embodiment, the blood flush indicator 321 can include a vacuum disposed therein or can be configured to generate a vacuum within the blood flush indicator 321 to facilitate drawing fluid flow in the proximal direction.

[0137] In embodiments in which the introducer 304 is coupled to the blood flush nozzle 324, a distal portion of the needle retraction assembly 330 may be coupled to the needle hub 320. The needle slider 332 may be used to actuate the needle retraction assembly 330 to retract the introducer needle 314 into the housing 310 of the RICC insertion device 309. The sheath hub 326 may then be removed from the blood flush nozzle 324 and coupled to the catheter nozzle 344 to align the lumen of the introducer sheath 316 with the RICC 106, the access guidewire 112, or both the RICC 106 and the access guidewire 112 of the RICC assembly 108. Advantageously, the introducer needle 314 may be retracted into the housing 310 after the vasculature has been accessed, thereby storing the introducer needle 314 within the housing 310, reducing accidental needle stick injuries and exposure of bodily fluids to the user.

[0138] 32A-32G present different states of the RICC insertion assembly 302 in a method of using the RICC insertion system 300 according to some embodiments. The RICC insertion system 300 may be provided including an introducer 304 coupled to a blood flush nozzle 324 and a needle retraction assembly 330 coupled to a needle hub 320. The needle retraction assembly 330 may be in an extended position in which the introducer needle 314 is disposed within a lumen of the introducer sheath 316. The distal needle tip of the introducer needle 314 may be disposed distal to the distal tip of the introducer sheath 316. The RICC insertion assembly 302 may further include a RICC 106 coupled to a catheter advancement assembly 340, an access guidewire 112 coupled to a guidewire advancement assembly 350, and a RICC assembly 108 including the RICC 106 and the access guidewire 112 disposed within a housing 310 of a RICC insertion device 309. Both the catheter advancement assembly 340 and the guidewire advancement assembly 350 may be in a stored position in which the distal tip of the RICC 106 and the distal tip of the access guidewire 112 are disposed within the housing 310.

[0139] A user can grasp one of the longitudinal handles 315 or curved portion 317 of the housing 310 to manipulate the RICC insertion assembly 302 and access the patient's vasculature by urging the introducer needle 314 distally into the vasculature. Thus, the introducer needle 314 and introducer sheath 316 assembly can simultaneously access the vasculature. The blood flush indicator 321 can draw fluid flow proximally through the needle lumen and into the blood flush indicator 321 to confirm proper vascular access.

[0140] As shown in FIGS. 32A and 32B, once proper vascular access is confirmed, the user can actuate the needle slider 332 to transition the needle retraction assembly 330 to a retracted position (FIG. 32B), retracting the introducer needle 314 from the introducer sheath 316 and securing the introducer needle 314 within the housing 310 of the RICC insertion device 309. In an embodiment, the RICC insertion device 309 can then be removed from the introducer 304, or more specifically, from the sheath hub 326, leaving the introducer sheath 316 in place within the vasculature to maintain patency of the access site. In an embodiment, the user can grasp the sheath hub 326 and advance the introducer sheath 316 further into the access site. A cutting blade 308 disposed proximate the sheath hub 326 can cut into the skin adjacent the access site to widen the access site and advance the RICC 106 into the vasculature.

[0141] Advantageously, removal of the RICC insertion device 309 from the sheath hub 326 allows a user to maintain access site patency without having to stabilize the RICC insertion assembly 302 (without the introducer 104) and any associated components adjacent the access site. For example, a user can pause the catheter placement process to prepare for a subsequent step, etc., without having to restart the entire placement process. Additionally, the blood flush indicator 321, introducer needle 314, and needle retraction assembly 330 can be offset from the axis of the catheter advancement assembly 340, the guidewire advancement assembly 350, or both, to allow unimpeded progression of the RICC 106 and access guidewire 112, as described herein.

[0142] As shown in FIG. 32C, the user can couple the catheter nozzle 344 to the sheath hub 326 to continue the catheter placement process. Coupling the sheath hub 326 to the catheter nozzle 344 aligns the sheath lumen with the RICC 106, the access guidewire 112, or both. As shown in FIG. 32D, the user can then actuate the guidewire advancement assembly 350 by manipulating the guidewire slider 352 to transition the access guidewire 112 from the stored position (FIG. 32C) to the extended position (FIG. 32D). In the extended position, the distal tip of the access guidewire 112 may extend through the primary lumen 124 of the RICC 106, through the catheter nozzle 344 of the housing 310, through the lumen of the introducer sheath 316, and into the patient's vasculature until the distal tip of the access guidewire 112 is positioned at the target location.

[0143] As shown in FIGURE 32E, the user can then longitudinally split the introducer sheath 316 into a first portion 316A and a second portion 316B. The user can grasp the wings 328 of the sheath hub 326 and separate them laterally to split the sheath hub 326 and the introducer sheath 316. The sheath portions 316A and 316B can then be retracted proximally from the access site while the access guidewire 112 maintains patency of the access site. Advantageously, because the inner diameter of the lumen of the introducer sheath 316 is smaller than the outer diameter of the catheter tube 116 or the RICC 106, the introducer sheath 316 can be split and removed in order to advance the RICC 106 over the access guidewire 112 into the vasculature.

[0144] As shown in FIG. 32F, the user can then actuate the catheter slider 342 to transition the catheter advancement assembly 340 from the retracted position to the extended position. In the extended position, the RICC 106 can be advanced over the access guidewire 112 into the vasculature. In an embodiment, the housing 310 can include a first transverse slot 360A and a second transverse slot 360B disposed opposite the first transverse slot across a central longitudinal axis of the catheter nozzle 344 (FIG. 31). The first transverse slot 360A and the second transverse slot 360B can extend longitudinally proximally from the distal tip of the catheter nozzle 344 and can communicate with the internal cavity 312 of the housing 310. Thus, the first transverse slot 360A and the second transverse slot 360B can pass through the catheter hub 118 and one or more extension legs 120 and disengage the RICC 106 from the housing 310 once positioned. As shown in FIG. 32G, the guidewire slider 352 can then be retracted to transition the guidewire advancement assembly 350 and the access guidewire 112 to a stored position, storing the access guidewire 112 within the housing 310 and reducing exposure of bodily fluids to the user.

[0145] Although some specific embodiments are disclosed herein and those specific embodiments are 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 those adaptations or modifications are likewise encompassed in the broader aspects. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central catheter ("RICC") insertion system comprising: RICC Assembly; a RICC insertion device; The introducer and said RICC assembly comprising: RICC, A catheter tube; a catheter hub coupled to a proximal portion of the catheter tube; one or more extension legs, each extension leg of the one or more extension legs being coupled to the catheter hub by a distal portion of the each extension leg; RICC, including an access guidewire disposed within the primary lumen of the RICC; a keeper including a splittable casing, the splittable casing covering both the catheter tube and a distal portion of the access guidewire extending from a distal end of the RICC to form a longitudinal composite of the splittable casing, the catheter tube, and the distal portion of the access guidewire; Including, RICC insertion device, A frame, A longitudinal handle including a wheel well; a nose extending from a distal portion of the handle distal to the wheel well, the nose including a through channel configured to advance the catheter tube of the RICC therethrough; a curved cradle extending from a proximal portion of the handle; A frame including: one or more roller wheels disposed within the wheel well; a nose cover covering the nose, the nose cover and the nose forming a split channel, the split channel configured to split and pass the splittable casing through the split channel; and configured to advance the RICC assembly from an initial position within the frame to a final position within the frame by repeatedly forcing the longitudinal composite into and advancing the longitudinal composite across the one or more roller wheels. RICC insertion system.

2. 2. The RICC insertion system of claim 1, wherein the keeper further comprises a catheter hub holder to which a proximal end of the splittable casing is attached, the catheter hub holder configured to retain the catheter hub within the catheter hub holder and to hold the splittable casing in place over the catheter tube and the access guidewire.

3. 3. The RICC insertion system of claim 2, wherein the catheter hub holder includes a peripheral wall about at least a portion of an outer periphery of the catheter hub holder, the peripheral wall defining a recess into which the catheter hub fits with an engineered fit.

4. The RICC insertion system of claim 1 , wherein the cradle includes a curved extension that covers a distal portion of the cradle, the extension substantially following the same curve as the cradle.

5. 5. The RICC insertion system of claim 4, wherein the cradle includes an enclosure covering the distal portion of the cradle, the extension extending from the enclosure, and the enclosure configured to enclose an otherwise exposed proximal portion of the access guidewire within the enclosure at the initial position of the RICC assembly within the frame.

6. 5. The RICC insertion system of claim 4, further comprising a retaining clip configured to clip onto a proximal portion of the RICC to retain the RICC assembly within the RICC insertion device and prevent premature advancement of the catheter tube over the access guidewire, the retaining clip including a post configured to engage with a slot in the extension facing an open side of the cradle.

7. 7. The RICC insertion system of claim 6, wherein the retaining clip is configured to disengage from the extension slot when remaining slack in the longitudinal composite is removed upon advancement of the RICC assembly from the initial position to the final position within the frame.

8. the frame further includes a retaining arch overlying the cradle adjacent the proximal portion of the handle from which the cradle extends; 2. The RICC insertion system of claim 1, wherein the retention arch is configured to retain the RICC assembly within the RICC insertion device and to retain the longitudinal composite on the handle as the RICC assembly transitions over the proximal portion of the handle from which the cradle extends during advancement of the RICC assembly from the initial position to the final position within the frame.

9. the nose cover and the nose further form a retaining clamp; the retaining clamp is configured to slidably clamp the longitudinal composite within the retaining clamp; the nose cover is rotatable on the nose; 2. The RICC insertion system of claim 1, wherein the nose cover includes a longitudinal gap configured to be rotatably aligned with the through channel of the nose for removing the longitudinal composite, the splittable casing, or the catheter tube from the nose.

10. a retractable cutting blade disposed within a cutting blade carriage slidably integrated into the nose; 2. The RICC insertion system of claim 1, wherein the cutting blade carriage has a cutting position in which the retractable cutting blade extends beyond the distal end of the nose and a safety position in which the retractable cutting blade is short of the distal end of the nose.

11. The introducer comprises:

1. An introducer needle, comprising: a needle shaft including a needle tip at a distal portion of the needle shaft; a needle hub coupled to a proximal portion of the needle shaft; an introducer needle comprising: a splittable introducer sheath configured to receive the introducer needle therein; A splittable sheath body; a splittable sheath hub coupled to a proximal portion of the sheath body, the splittable sheath hub including a pair of wings extending outwardly along a length of the sheath hub, the wings having an included angle between them of about 90° or less, the sheath hub being configured to be split by pinching the wings together with one hand; an introducer sheath including The RICC insertion system of any one of claims 1 to 10, comprising:

12. 12. The RICC insertion system of claim 11, wherein the sheath hub includes a single longitudinal defect along a side of the sheath hub opposite an apex of the interior angle formed by the wings and is configured to split along the defect to propagate along a same side of the sheath body when the wings are pinched together.

13. the sheath hub includes a pair of longitudinal defects including a primary defect along a primary side of the sheath hub opposite an apex of the interior angle formed by the wings and a secondary defect along a secondary side of the sheath hub opposite the primary defect; 12. The RICC insertion system of claim 11, wherein the sheath hub is configured to split along the primary defect to propagate along the primary side of the sheath body when the wings are pinched together and to split along the secondary defect to propagate along the secondary side of the sheath body when the wings are pulled apart.

14. the sheath hub further comprises a valved cap disposed at a proximal portion of the sheath hub; the valved cap includes a tapered female valved cap connector and a septum distal to a proximal opening of the female valved cap connector; the female valved cap connector is configured to receive a tapered male needle hub connector extending from a distal portion of the needle hub therein; The RICC insertion system of claim 11 , wherein the septum is configured to receive the needle shaft therethrough.

15. The RICC insertion system of claim 14 , wherein the valved cap splits partially or completely such that when the wings are pinched together, the valved cap splits along with the sheath hub.

16. The sheath hub is an overmolded cutting blade extending distally from the sheath hub; a hinged cutting blade cover having an open state in which the cover is open away from the overmolded cutting blade and a closed state in which the cover is closed over the cutting blade; The RICC insertion system of claim 11 further comprising:

17. 12. The RICC insertion system of claim 11, further comprising a syringe including a tapered male syringe tip extending from a distal portion of the syringe, the tapered male syringe tip configured to be inserted into a tapered female needle hub connector at a proximal portion of the needle hub.

18. 1. A rapid insertion central catheter ("RICC") insertion assembly comprising: RICC Assembly; a RICC insertion device; said RICC assembly comprising: RICC, A catheter tube; a catheter hub coupled to a proximal portion of the catheter tube; one or more extension legs, each extension leg of the one or more extension legs being coupled to the catheter hub by a distal portion of the each extension leg; RICC, including an access guidewire disposed within the primary lumen of the RICC; a keeper including a splittable casing, the splittable casing covering both the catheter tube and a distal portion of the access guidewire extending from a distal end of the RICC to form a longitudinal composite of the splittable casing, the catheter tube, and the distal portion of the access guidewire; Including, RICC insertion device, A frame, A longitudinal handle including a wheel well; a nose extending from a distal portion of the handle distal to the wheel well, the nose including a through channel, the through channel configured for advancement through the catheter tube of the RICC; a curved cradle extending from a proximal portion of the handle; A frame including: one or more roller wheels disposed within the wheel well; a nose cover covering the nose, the nose cover and the nose forming a split channel, the split channel configured to split and pass the splittable casing through the split channel; and configured to advance the RICC assembly from an initial position within the frame to a final position within the frame by repeatedly forcing the longitudinal composite into and advancing the longitudinal composite across the one or more roller wheels. RICC Insertion Assembly.

19. 20. The RICC insertion assembly of claim 18, wherein a distal end of the longitudinal composite, the splittable casing, or the access guidewire substantially corresponds to a distal end of the frame in the initial position of the RICC assembly within the frame.

20. 20. The RICC insertion assembly of claim 18, wherein a slack loop of the longitudinal composite extends away from both the handle and the cradle in the initial position of the RICC assembly within the frame.

21. 20. The RICC insertion assembly of claim 18, wherein the longitudinal composite is substantially split at the final position of the RICC assembly within the frame.

22. 20. The RICC insertion assembly of claim 18, wherein a proximal end of an extension leg or a luer connector coupled to the extension leg of the one or more extension legs of the RICC substantially corresponds to a proximal end of the cradle in the initial position of the RICC assembly within the frame.

23. 23. The RICC insertion assembly of claim 22, wherein a proximal end of the access guidewire is coupled to the proximal end of the cradle in the initial position of the RICC assembly within the frame.

24. 23. The RICC insertion assembly of claim 22, wherein the one or more extension legs of the RICC are located substantially on the handle in the final position of the RICC assembly within the frame.

25. 25. The RICC insertion assembly of claim 18, wherein the catheter hub of the RICC sits on the wheel well in the final position of the RICC assembly in the frame.

26. 1. A rapid insertion central catheter ("RICC") insertion system comprising: an insertion assembly including a housing having a blood flush nozzle and a catheter nozzle; a blood flush indicator in fluid communication with the blood flush nozzle; a RICC disposed within the interior cavity of the housing and slidably engaged with the catheter nozzle; an introducer including an introducer needle and an introducer sheath, the introducer being releasably engaged with one of the blood flush nozzle or the catheter nozzle; RICC insertion system comprising:

27. 27. The RICC insertion system of claim 26, further comprising a needle retraction system coupled to the introducer needle, the needle retraction system configured to proximally retract the introducer needle from the introducer sheath and through the blood flush nozzle.

28. 27. The RICC insertion system of claim 26, wherein the blood flush indicator is in fluid communication with a needle lumen of the needle.

29. 27. The RICC insertion system of claim 26, wherein a sheath hub of the introducer sheath is configured to releasably engage the catheter nozzle and longitudinally align a sheath lumen of the introducer sheath with the RICC.

30. 27. The RICC insertion system of claim 26, further comprising a catheter advancement assembly configured to slidably engage the RICC and the catheter nozzle.

31. 31. The RICC insertion system of any one of claims 26 to 30, further comprising an access guidewire coupled to a guidewire advancement assembly, the guidewire advancement assembly configured to slidably engage the access guidewire with the catheter nozzle.

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