Central venous catheter insertion system and central venous catheter insertion assembly

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 Art

[0002] Central venous catheters ("CVCs") are generally introduced into patients by the Seldinger technique and advanced through the patient's vasculature. The Seldinger technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). The Seldinger technique is effective, but both the many steps and the handling of many medical devices are time-consuming and cumbersome, which can both lead to patient trauma. Additionally, due to the large number of medical devices that need to be exchanged during many steps of the Seldinger technique, the potential for contact contamination is relatively high. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vasculature.

Summary of the Invention

[0003] This specification discloses rapid insertion central venous catheters ("RICCs"), introducers, and insertion devices, as well as combinations and methods thereof, that address the foregoing.

[0004] This specification discloses an RICC insertion system, including an RICC assembly, an RICC insertion device, and an introducer. The RICC assembly includes an RICC, an access guidewire, and a keeper. The RICC includes a catheter tube, a catheter hub connected to the proximal portion of the catheter tube, and one or more extension legs. Each of the one or more extension legs is connected to the catheter hub by its distal portion. The access guidewire is positioned within the primary lumen of the RICC. The keeper includes a divisible casing, which covers both the catheter tube and the distal portion of the access guidewire extending from the distal end of the RICC, forming a longitudinal composite of the divisible 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 covering the nose of the frame. The frame includes a longitudinal handle, a nose, and a curved cradle. The handle includes a wheel well. The nose extends from the distal portion of the handle located distal to the wheel well. The nose includes a through channel, which is configured to advance the RICC catheter tube through the channel. The cradle extends from the proximal portion of the handle. One or more roller wheels are located within the wheel well. The nose cover and nose form a split channel, which is configured to divide and pass a divisible casing through the 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 achieved by repeatedly pushing the longitudinal complex into one or more roller wheels and advancing the longitudinal complex across one or more roller wheels.

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

[0006] In some embodiments, the catheter hub holder includes a peripheral wall on at least a portion of its outer circumference. The peripheral wall defines a recess into which the catheter hub is fitted by engineering fit.

[0007] In some embodiments, the cradle includes a curved extension that covers the distal portion of the cradle. The extension substantially follows the same curve as the cradle. In some embodiments, the cradle includes an enclosure covering the distal portion of the cradle, with an extension extending from the enclosure. The enclosure is configured to contain the proximal portions of the otherwise exposed access guidewires within the enclosure in the initial position of the RICC assembly within the frame.

[0008] In some embodiments, the RICC insertion device further includes a retaining clip. The retaining clip is clipped to the proximal portion of the RICC and is configured to hold the RICC assembly within the RICC insertion device. The retaining clip is also configured to prevent the catheter tube from advancing prematurely on the access guidewire. The retaining clip includes a post configured to engage with a slot in the extension facing the open surface of the cradle.

[0009] In some embodiments, the retaining clip is configured to disengage from the extension slot once any remaining slack in the longitudinal composite is removed as the RICC assembly is advanced from its initial position to its final position within the frame.

[0010] In some embodiments, the frame further includes a retaining arch that covers the cradle in close proximity to the proximal portion of the handle from which the cradle extends. The retaining arch is configured to hold the RICC assembly within the RICC insertion device. The retaining arch is also configured to hold the longitudinal complex on the handle as the RICC assembly moves over the proximal portion of the handle from which the cradle extends as the RICC assembly is advanced within the frame from its initial position to its final position.

[0011] In some embodiments, the nose cover and nose further form a retaining clamp, which is configured to slidably clamp the longitudinal complex within the retaining clamp. The nose cover is rotatable on the nose. The nose cover includes a longitudinal gap configured to rotatably align with a through channel of the nose for removing the longitudinal complex, a divisible casing, or a catheter tube from the nose.

[0012] In some embodiments, the RICC insertion device further includes a retractable cutting edge. The retractable cutting edge is located in a cutting edge carriage that is slidably integrated with the nose. The cutting edge carriage has a cutting position in which the retractable cutting edge extends beyond the distal end of the nose. The cutting edge carriage also has a safety position in which the retractable cutting edge is located in front of the distal end of the nose.

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

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

[0015] In some embodiments, the sheath hub includes a pair of longitudinal defects comprising a primary defect and a secondary defect. The primary defect extends along the primary side of the sheath hub opposite the vertex of the interior angle formed by the wing. The secondary defect extends along the secondary side of the sheath hub opposite the primary defect. The sheath hub is configured to split along the primary defect so that it propagates along the primary side of the sheath body when the wings are pinched together. The sheath hub is also configured to split along the secondary defect so that it propagates along the secondary side of the sheath body when the wings are pulled apart.

[0016] In some embodiments, the sheath hub further includes a valved cap located at the proximal portion of the sheath hub. The valved cap includes a tapered female valved cap connector and a partition wall located distal to the 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 the distal portion of the needle hub into the female valved cap connector. The partition wall is configured to receive the needle shaft through the partition wall.

[0017] In some embodiments, the valved cap is partially or completely separated so that when the wings are pinched together, the valved cap separates with the sheath hub. In some embodiments, the sheath hub further includes an overmolded cutting edge and a hinged cutting edge cover. The overmolded cutting edge extends distally from the sheath hub. The cutting edge cover has an open state that opens away from the overmolded cutting edge. The cutting edge cover also has a closed state that closes to cover the overmolded cutting edge.

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

[0019] This specification also discloses RICC insertion assemblies, including an RICC assembly and an RICC insertion device, in some embodiments. The RICC assembly includes an RICC, an access guidewire, and a keeper. The RICC includes a catheter tube, a catheter hub connected to the proximal portion of the catheter tube, and one or more extension legs. Each of the one or more extension legs is connected to the catheter hub by its distal portion. The access guidewire is located within the primary lumen of the RICC. The keeper includes a divisible casing, which covers both the catheter tube and the distal portion of the access guidewire extending from the distal end of the RICC, forming a longitudinal composite of the divisible 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 covering the nose of the frame. The frame includes a longitudinal handle, a nose, and a curved cradle. The handle includes a wheel well. The nose extends from the distal portion of the handle located distal to the wheel well. The nose includes a through channel, which is configured to advance the RICC catheter tube through the channel. The cradle extends from the proximal portion of the handle. One or more roller wheels are located within the wheel well. The nose cover and nose form a split channel, which is configured to divide and pass a divisible casing through the 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 achieved by repeatedly pushing the longitudinal complex into one or more roller wheels and advancing the longitudinal complex across one or more roller wheels.

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

[0021] In some embodiments, the 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 substantially divided at the final position of the RICC assembly within the frame. In some embodiments, the proximal end of an extension leg or a Luer connector connected to one or more extension legs of the RICC substantially corresponds to the proximal end of the cradle in the initial position of the RICC assembly within the frame.

[0023] In some embodiments, the proximal end of the access guide wire is connected to the proximal end of the cradle in the initial position of the RICC assembly within the frame. In some embodiments, one or more extension legs of the RICC are substantially located on the handle at the final position of the RICC assembly within the frame.

[0024] In some embodiments, the catheter hub of the RICC is located on the wheel well at the final position of the RICC assembly within the frame. This specification also discloses a method for inserting an RICC into a patient's vascular lumen. In some embodiments, the method includes an acquisition step, a needle route establishment step, an introducer needle removal step, an access guidewire advance step, an introducer sheath removal step, and a catheter tube advance step. The acquisition step includes acquiring the RICC insertion system. The RICC insertion system includes an introducer, an RICC insertion device, and an RICC assembly containing an RICC. The RICC assembly is optionally already positioned within the RICC insertion device in a substantially operable state of the RICC insertion assembly. The needle route establishment step includes establishing a needle route from a skin area to the patient's vascular lumen using the introducer needle of the introducer. The introducer needle is positioned within the introducer's divisible introducer sheath to establish the needle route. The introducer needle removal step includes removing the introducer needle from the introducer sheath, leaving the introducer sheath in the vascular lumen. The access guidewire advancement step includes advancing the access guidewire into the vascular lumen through the nose and nose cover of the RICC insertion device, through the detachable sheath hub of the introducer, and through the introducer sheath. The access guidewire advancement step is partially achieved by separating the detachable casing from the longitudinal complex of the RICC assembly. The distal portion of the access guidewire extending from the primary lumen opening of the catheter tube of the RICC is released from the longitudinal complex by separating the detachable casing in order to advance the access guidewire. The introducer sheath removal step includes removing the introducer sheath, leaving the access guidewire in the vascular lumen. The catheter tube advancement step includes advancing the catheter tube into the vascular lumen on the access guidewire. The catheter tube advancement step is partially achieved by further separating the detachable casing from the longitudinal complex of the RICC assembly.The catheter tube can be advanced on the access guide wire when the longitudinal composite body in the RICC insertion assembly is freed by dividing the splitable casing, removing the remaining slack of the longitudinal composite body.

[0025] In some embodiments, the needle path establishment step includes ensuring that blood backflows 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 blood aspiration step. The blood aspiration step includes aspirating blood using a syringe connected to the introducer needle to confirm that the needle path extends into the blood vessel lumen. The blood aspiration step is performed before the introducer needle removal step.

[0027] In some embodiments, the method further includes an introducer sheath advancement step. The introducer sheath advancement step includes further advancing the introducer sheath into the blood vessel lumen over the introducer needle. The introducer sheath advancement step is performed before the introducer needle removal step.

[0028] In some embodiments, the method further includes a connector connection step. The connector connection step includes inserting the male nose connector of the nose of the RICC insertion device into the female cap connector with a valve of the sheath hub of the introducer sheath. The connector connection step is performed before the access guide wire advancement step.

[0029] In some embodiments, the method further includes a skin incision step. The skin incision step includes making an incision in the skin area around the needle path using an incision blade extending from the sheath hub. The skin incision step is performed when the catheter tube is 7Fr or more. The skin incision step is also performed before the access guide wire 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 is performed before the skin cutting step. The cover closing step includes closing the cutting blade cover so as to cover the cutting blade to a safe position that covers the cutting blade. The cover closing step is performed after the skin cutting step.

[0031] In some embodiments, the method further includes an alternative skin incision step. The alternative skin incision step involves making an incision in the skin area around the needle path using a retractable incision blade integrated into the nose of the RICC insertion device. The alternative skin incision step is performed when the catheter tube is 7Fr 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, comprising a first carriage sliding step and a second carriage sliding step. The first carriage sliding step includes sliding the cutting edge carriage, which is overmolded with the cutting edge, distally to the cutting position so that the cutting edge extends beyond the distal end of the nose of the RICC insertion device. The second carriage sliding step includes sliding the cutting edge carriage proximal to the safety position so that the cutting edge is in front of the distal end of the nose of the RICC insertion device.

[0033] In some embodiments, the introducer sheath removal step includes splitting the introducer sheath by pinching together a pair of wings extending outward from the sheath hub to form a tear along one side of the introducer sheath. The introducer sheath removal step also includes propagating the tear along the same side of the introducer sheath body toward the sheath hub.

[0034] In some embodiments, the access guidewire advancement step or catheter tube advancement step includes repeatedly pushing the longitudinal complex with one hand onto one or more roller wheels located in the wheel well of the longitudinal handle of the RICC insertion device, advancing the longitudinal complex across one or more roller wheels to separate the separable casing from the longitudinal complex.

[0035] In some embodiments, the access guidewire advancement step or catheter tube advancement step includes pulling out the separable casing of the longitudinal complex from a dividing channel formed between the nose of the RICC insertion device and the nose cover that covers the nose, thereby separating the separable casing from the longitudinal complex.

[0036] In some embodiments, a retaining clip clipped to the proximal portion of the RICC allows the catheter tube to advance on the access guidewire by disengaging from the curved extension covering the cradle of the RICC insertion device when any remaining slack in the longitudinal complex within the RICC insertion assembly is removed.

[0037] In some embodiments, the method further includes an access guidewire removal step. The access guidewire removal step includes removing the access guidewire while leaving the catheter tube in the vascular lumen.

[0038] In some embodiments, the method further includes a keeper removal step. The keeper removal step includes removing a keeper from the RICC assembly, which includes the proximal end of a divisible casing attached to the catheter hub holder. The keeper removal step is achieved in part by removing the catheter hub of the RICC from the catheter hub holder and separating the remaining divisible casing of the longitudinal complex from the catheter tube.

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

[0040] This specification also describes, in some embodiments, a catheter insertion system for an RICC assembly, comprising an insertion assembly having a housing including a blood flush nozzle and a catheter nozzle, the system comprising: a blood flush indicator in fluid communication with the blood flush nozzle; an RICC disposed within an internal cavity of the housing and slidably engaged with the catheter nozzle; and an introducer comprising an introducer needle and an introducer sheath, the introducer being releasably engaged with either the blood flush nozzle or the catheter nozzle. A catheter insertion system including this is also disclosed.

[0041] In some embodiments, the catheter insertion system further includes a needle storage system connected to an introducer needle. The needle storage system is configured to retract the introducer needle proximal to the introducer sheath through a 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, the sheath hub of the introducer sheath is configured to releasably engage with the catheter nozzle and to longitudinally align the sheath's sheath membrane 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 connected to a guidewire advancement assembly. The guidewire advancement assembly is configured to slidably engage the access guidewire with the catheter nozzle.

[0044] This specification also discloses a method for placing a catheter in a patient's vascular system, which in some embodiments includes: accessing the vascular system using an introducer needle of an introducer; retracting the introducer needle from the sheath membrane of the introducer's introducer sheath through a blood flush nozzle of an insertion assembly; removing the sheath hub of the introducer sheath from the blood flush nozzle and engaging the sheath hub with the catheter nozzle of an insertion assembly; advancing an access guidewire through the catheter nozzle and the sheath membrane; splitting the introducer sheath longitudinally to disengage the introducer sheath from the access guidewire; and advancing the catheter on the access guidewire through the catheter nozzle.

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

[0046] In some embodiments, the method further includes the step of activating a needle storage assembly located within the insertion assembly to retract the introducer needle into the internal cavity of the insertion assembly through a blood flush nozzle.

[0047] In some embodiments, the catheter includes one of a rapid insertion central venous catheter, a central venous catheter, a peripheral insertion central catheter, or a dialysis catheter. These and other features of the concepts provided herein will become more apparent to those skilled in the art by considering the accompanying drawings and the following description, which illustrate in more detail specific embodiments of such concepts. [Brief explanation of the drawing]

[0048] [Figure 1] We present an RICC insertion system, including an RICC insertion assembly and introducer, according to several embodiments. [Figure 2] Several embodiments of RICC are presented. [Figure 3] The distal portion of the RICC according to several embodiments is presented. [Figure 4] A first cross-section of RICC according to several embodiments is presented. [Figure 5] A second or third cross-section of the RICC according to several embodiments is presented. [Figure 6] Several embodiments of RICC assemblies are presented. [Figure 7] A first cross-section of an RICC assembly according to several embodiments is presented. [Figure 8] A second cross-section of an RICC assembly according to several embodiments is presented. [Figure 9] We present a first alternative RICC assembly according to several embodiments. [Figure 10] Cross-sections of a first alternative RICC assembly according to several embodiments are presented. [Figure 11] We present a second alternative RICC assembly according to several embodiments. [Figure 12] A first cross-section of a second alternative RICC assembly according to several embodiments is presented. [Figure 13]We present a second cross-section of a second alternative RICC assembly according to several embodiments. [Figure 14] A third alternative RICC assembly is presented according to several embodiments. [Figure 15A] A top view of a fourth alternative RICC assembly according to several embodiments is presented. [Figure 15B] A side view of a fourth alternative RICC assembly according to several embodiments is presented. [Figure 16] We present RICC insertion assemblies, including RICC assemblies positioned within a RICC insertion device in an operable state, according to several embodiments. [Figure 17] We present nose covers that cover the nose of an RICC insertion device, according to several embodiments. [Figure 18A] We present, in several embodiments, a retaining clamp formed between the nose cover and the nose of an RICC insertion device when it is in a closed state. [Figure 18B] We present a retaining clamp in the open position according to several embodiments. [Figure 19] We present a curved extension of a curved cradle of an RICC insertion device, including a slot configured to engage with a retaining clip, according to several embodiments. [Figure 20] We present several embodiments of retaining clips for RICC insertion devices. [Figure 21A] Several embodiments present a retractable cutting blade integrated into the nose of an RICC insertion device, which is retractable when in a safe position. [Figure 21B] Several embodiments present a retractable cutting blade in the cutting position. [Figure 22] We present an RICC insertion assembly in which the RICC assembly is located in a leading intermediate position within the frame of the RICC insertion device, according to several embodiments. [Figure 23A]We present RICC insertion assemblies in which, according to several embodiments, the RICC assembly is located at the same or different preceding intermediate positions within the frame of the RICC insertion device, with a slack loop of the longitudinal composite remaining within the RICC insertion assembly. [Figure 23B] We present RICC insertion assemblies in which, according to several embodiments, the RICC assembly is located at a subsequent intermediate position within the frame of the RICC insertion device, and no loose loops of the longitudinal composite remain within the RICC insertion assembly. [Figure 24] We present an RICC insertion assembly in which the RICC assembly is located at the final position within the frame of the RICC insertion device assembly, according to several embodiments. [Figure 25] Several embodiments of the introducer are presented. [Figure 26] We present a pair of wings, in several embodiments, that extend outward along the length of the sheath hub of the introducer. [Figure 27] Longitudinal cross-sections of sheath hubs according to several embodiments are presented. [Figure 28A] We present, in several embodiments, an overmolded cutting blade integrated into a sheath hub, with the cutting blade cover in a safe position. [Figure 28B] We present, in several embodiments, an overmolded cutting blade integrated into a sheath hub, with the cutting blade cover located in the cutting position. [Figure 29] We present another RICC insertion system, including a different RICC insertion assembly, according to several embodiments. [Figure 30] Detailed diagrams of the introducer of the RICC insertion assembly shown in Figure 29, according to several embodiments, are presented. [Figure 31] Detailed views of the nose portion of the RICC insertion device in the RICC insertion assembly shown in Figure 29, according to several embodiments, are presented. [Figure 32A]Figure 29 shows a first state of the RICC insertion assembly in a method of using the RICC insertion system according to several embodiments. [Figure 32B] Figure 29 presents a second state of the RICC insertion assembly in a method of using the RICC insertion system according to several embodiments. [Figure 32C] A third state of the RICC insertion assembly in Figure 29 is presented in a method of using the RICC insertion system according to several embodiments. [Figure 32D] A fourth state of the RICC insertion assembly in Figure 29 is presented in a method of using the RICC insertion system according to several embodiments. [Figure 32E] A fifth state of the RICC insertion assembly in Figure 29 is presented in a method of using the RICC insertion system according to several embodiments. [Figure 32F] A sixth state of the RICC insertion assembly in Figure 29 is presented in a method of using the RICC insertion system according to several embodiments. [Figure 32G] Figure 29 presents a seventh state of the RICC insertion assembly in a method of using the RICC insertion system according to several embodiments. [Modes for carrying out the invention]

[0049] Before disclosing some specific embodiments in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein can be easily separated from a particular embodiment and may have features that can be optionally combined with or substituted for features of any of several other embodiments disclosed herein.

[0050] With regard to the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps and do not impose any limitation of continuity or numerical limitation. For example, the “first,” “second,” and “third” features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps is not necessarily limited to three features or steps. In addition, any of the features or steps described herein may further include one or more features or steps unless otherwise specified. Labels such as “left,” “right,” “up,” “down,” “front,” and “back” are used for convenience and are not intended to imply any particular fixed position, orientation, or direction, for example. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a," "an," and "the" include the plural form unless the context explicitly indicates otherwise.

[0051] Regarding "proximal," for example, the "proximal portion" or "proximal end portion" 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, for example, the "proximal length" 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. For example, the "proximal end" 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. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0052] Regarding "distal," for example, the "distal portion" or "distal end portion" of a catheter includes the portion of the catheter that is intended to be near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within the patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. As described above, there is a need to reduce the number of steps and medical devices involved in introducing catheters such as CVCs into patients and advancing them through the patient's vascular system. This specification discloses RICCs, introducers, and insertion devices, as well as combinations and methods thereof, that address the aforementioned. However, it should be understood that the RICC is just one type of catheter in which the concepts provided herein can be embodied or otherwise incorporated. In fact, peripheral insertion center catheters ("PICCs"), dialysis catheters, etc., can also embodied or otherwise incorporated the concepts provided herein regarding RICCs, introducers, and insertion devices, as well as combinations and methods thereof.

[0054] RICC Insertion System Figure 1 presents an RICC insertion system 100, including an RICC insertion assembly 102 and an introducer 104, according to several embodiments.

[0055] As shown in the figure, the RICC insertion system 100 may include a RICC 106 as part of the RICC assembly 108, a RICC insertion device 110, and an introducer 104. The RICC assembly 108 is positioned in its initial position within the frame 172 of the RICC insertion device 110, as described below, thereby forming a substantially operational state of the RICC insertion assembly 102, as further shown in Figure 1.

[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 after the specific components. However, descriptions of the components of the RICC insertion system 100 are not limited to any specific section. In fact, descriptions of any component of the RICC insertion system 100 may span from one section to one or more other sections, taking into account the interrelationships 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 the section about them to the section about the RICC insertion assembly 102. Similarly, a description of the RICC insertion assembly 102 may span from the section about it to the section about the RICC assembly 108 or the RICC insertion device 110. Therefore, please understand that descriptions of the RICC assembly 108, the RICC insertion device 110, the RICC insertion assembly 102, the introducer 104, or any other components of the RICC insertion system 100 can be found anywhere in this patent application.

[0057] RICC insertion kit Although not shown, the RICC insertion kit may include the RICC insertion system 100, instructions for use of the RICC insertion system 100, and packaging. Again, the RICC insertion system 100 may include the RICC assembly 108, the RICC insertion device 110, and the introducer 104. The RICC assembly 108 may be placed inside the RICC insertion device 110 in a substantially operable state for use of the RICC insertion assembly 102 as soon as it is removed from the RICC insertion kit. The RICC insertion system 100 may be packaged in packaging (e.g., polyethylene pouch, polyethylene / Tyvek® pouch, etc.). Instructions for use may be packaged inside the package with the RICC insertion system 100 or printed on the package.

[0058] Despite the aforementioned RICC insertion kit, combinations of fewer components than the entire RICC insertion system 100 (i.e., the RICC assembly 108, the RICC insertion device 110, and the introducer 104) can be packaged together in any package, along with instructions for use of the combination or the entire RICC insertion system 100, either in the package or printed on the package. For example, the RICC assembly 108 and the RICC insertion device 110 can be packaged in a substantially operational state as the RICC insertion assembly 102, along with instructions for use of the RICC insertion assembly 102 or the entire RICC insertion system 100, either in the package or printed on the package. Each component of the RICC insertion system 100 (i.e., the RICC assembly 108, the RICC insertion device 110, and the introducer 104) can also be packaged separately in any package, along with instructions for use of that component, the combination of components including that component, or the entire RICC insertion system 100, either in the package or printed on the package. For example, the introducer 104 can be packaged together with instructions for use, either within the package or printed on the package, for the introducer 104 or the entire RICC insertion system 100.

[0059] RICC Assembly Figure 6 presents an RICC assembly 108 in several embodiments, and Figures 9, 11, 14, 15A, and 15B present several alternative RICC assemblies in several embodiments.

[0060] As shown in the figure, the RICC assembly 108 may include the RICC 106, the access guide wire 112, and the keeper 114. In particular, the RICC assembly 108 does not need to include the keeper 114 in certain embodiments, such as the embodiment in Figure 29.

[0061] Figure 2 shows RICC106 according to several embodiments. Figure 3 shows the distal portion of RICC106, Figure 4 shows a first cross-section of the distal portion of RICC106, and Figure 5 shows a second or third cross-section of the distal portion of RICC106 according to several embodiments.

[0062] As shown in the figure, the RICC106 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 located at the distal end of the catheter tube 116 and one or more catheter tube lumens passing through the catheter tube 116.

[0063] One or more catheter tube lumens may extend throughout the entire catheter tube 116. However, in multi-lumen RICCs (e.g., 2-lumen RICC, 3-lumen RICC, 4-lumen RICC, 5-lumen RICC, 6-lumen RICC, etc.), typically only one catheter tube lumen extends from the proximal end to the distal end of the catheter tube 116. (See Figures 3-5.) In practice, the catheter tip 122 typically includes a single lumen passing through the catheter tip, whether the catheter tip 122 is formed integrally with the catheter tube 116 or formed separately from the catheter tube 116 and connected to the catheter tube.

[0064] The catheter hub 118 can be connected to the proximal portion of the catheter tube 116. The catheter hub 118 may include one or more catheter hub lumens corresponding to one or more catheter tube lumens. One or more catheter hub lumens may extend throughout the entire catheter hub 118 from the proximal end to the distal end.

[0065] Each of the one or more extension legs 120 can be connected to the catheter hub 118 by its distal portion. Each of the one or more extension legs 120 may contain one or more extension leg lumens, and the number of extension leg lumens corresponds to the number of one or more catheter hub lumens. Each of the one or more extension leg lumens may extend throughout the entire extension leg from the proximal end to the distal end.

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

[0067] As shown in the figure, RICC106 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 the fluid-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 RICC106. The secondary lumen 126 may have a secondary lumen opening 132 on the distal end of the catheter tube 116. The tertiary lumen 128 may have a tertiary lumen opening 134 on the distal end of the catheter tube 116 proximal to the secondary lumen opening 132.

[0068] The access guide wire 112 may be positioned within the primary lumen 124 of the RICC 106 in the RICC assembly 108. The access guide wire 112 may include a distal portion extending from the distal end of the RICC 106, as can be seen by comparing at least Figures 7 and 8. The access guide wire 112 may also include a proximal portion extending from the proximal end of the RICC 106, as shown in Figure 6. As described below, the proximal portion of the access guide wire 112 extending from the proximal end of the RICC 106, or a guide wire hub 135 connected thereto, can be mounted at the guide wire mounting position 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 divisible casing 136 and a catheter hub holder 138 to which the proximal end of the divisible casing 136 is attached. Figures 7 and 8 show cross-sections of the RICC assembly 108, which also show a separable casing 136 as part of a longitudinal composite 140 of the RICC assembly 108 according to several embodiments.

[0070] As shown in the figures, the divisible casing 136 can form a longitudinal composite 140 with the catheter tube 116, access guidewire 112, or both the catheter tube 116 and access guidewire 112 of the RICC assembly 108, depending on the embodiment of the RICC assembly 108 and its parts. With respect to the RICC assembly 108 of Figure 6, for example, the divisible casing 136 can cover both the catheter tube 116 and access guidewire 112 in the proximal portion of the RICC assembly 108, as shown in Figure 7. The divisible casing 136 can also cover the distal portion of the access guidewire 112 extending from the distal end of the RICC 106, as shown in Figure 8. The divisible 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 way, the divisible casing 136 is configured to remain sterile until the catheter tube 116 and at least the distal portion of the access guidewire 112 are deployed.

[0071] The catheter hub holder 138 is configured to hold the catheter hub 118 within the catheter hub holder 138 and to cover and hold the detachable casing 136 in place over the catheter tube 116 and the access guidewire 112. The catheter hub holder 138 includes a circumferential wall 142 on at least a portion of its outer circumference (e.g., the proximal portion). The circumferential wall 142 defines recesses into which the catheter hub 118 fits by an engineering fit (e.g., a clearance fit such as a running fit, sliding fit, or location fit, or an intermediate fit such as a similar fit or fixed fit as classified by the International Organization for Standardization ["ISO"]), and one or more gaps 144 for extending through one or more extension legs 120. Additionally or alternatively, the catheter hub holder 138 may include wings corresponding to the suture wings 146 of the catheter hub 118. Such wings may include a post configured to be inserted by engineering fit into the suture wing hole 148 of the suture wing 146 of the catheter hub 118.

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

[0073] As shown in the figure, the RICC assembly 150 may include the RICC 106, the access guidewire 112, and the keeper 114. However, the divisible casing 136 covering the catheter tube 116 and the access guidewire 112 can conform more closely to the contours of the catheter tube 116 and the access guidewire 112 by having a larger diameter to cover the catheter tube 116 and a smaller diameter to cover the access guidewire 112. Advantageously, the divisible casing 136 can prevent the catheter tube 116 from advancing prematurely over the access guidewire 112 while the RICC assembly 150 is advanced from its initial position in the frame 172 to its final position in the frame 172, as described below.

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

[0075] As shown in the figure, the RICC assembly 152 may include the RICC 106 and the access guidewire 112 without the keeper 114 and its detachable casing 136. Optionally, the catheter tube 116 and the access guidewire 112 may be placed in a transparent cover, such as a foldable plastic bag, configured to keep the distal portions of the catheter tube 116 and the access guidewire 112 sterile until they are deployed. Whether the catheter tube 116 and the access guidewire 112 are exposed or placed in a cover, the transition between the distal portion of the access guidewire 112 and the catheter tube 116 can be advantageously visualized while advancing the RICC assembly 152 from its initial position in the frame 172 to its final position in the frame 172, as described below.

[0076] Figure 14 presents a third alternative RICC assembly 154 according to several embodiments. As shown in the figure, the RICC assembly 154 may include the RICC 106 and the access guidewire 112 without the keeper 114 and its detachable casing 136. Instead of an optional cover covering the catheter tube 116 and access guidewire 112 of the RICC assembly 154, the entire RICC assembly 152 may be placed in a transparent cover 156, such as a foldable or zippered plastic bag, configured to keep the distal portions of the catheter tube 116 and access guidewire 112 sterile until deployed. Similar to the RICC assembly 152, the transition between the distal portion of the access guidewire 112 and the catheter tube 116 can be advantageously visualized through the cover 156 while advancing the RICC assembly 154 from its initial position in the frame 172 to its final position in the frame 172, as described below.

[0077] Figures 15A and 15B present different diagrams of a fourth alternative RICC assembly 158 according to several embodiments. As shown in the figure, the RICC assembly 158 may include the RICC 106 and access guidewire 112 without the keeper 114 and its detachable casing 136. However, the RICC assembly 158, including the distal portion of the catheter tube 116 and access guidewire 112, may be housed in a longitudinal housing 160, with the proximal portion of the access guidewire 112 extending from the housing but housed in a transparent cover 162, such as a foldable plastic bag. The housing 160 may include a longitudinal slot 164, which is configured to allow the RICC advance wing 166 to advance or retract within the longitudinal slot 164. The RICC advance wing 166 may be configured such that the catheter hub 118 fits into the RICC advance wing 166 by engineering fit, or its suture wing 146 fits into a post on the RICC advance wing 166, similar to the catheter hub holder 138. In any case, the housing 160 can be configured to keep the distal portions of the catheter tube 116 and access guidewire 112 sterile until they are deployed. Advantageously, the housing 160 can control the relative movement of 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 Figure 16 presents an RICC insertion assembly 102, including an RICC assembly 108 positioned within an RICC insertion device 110, according to several embodiments. Figure 17 presents a nose cover 168, covering the nose 170 of the frame 172 of the RICC insertion device 110, according to several embodiments.

[0079] As shown in the figure, the RICC insertion device 110 may include a frame 172, one or more roller wheels 174, and a nose cover 168 that covers the nose 170 of the frame 172. The RICC insertion device 110 may be configured to advance the RICC assembly 108 from an initial position within the frame 172 (see Figure 16) through one or more intermediate positions within the frame 172 (see Figure 22) to a final position within the frame 172 (see Figure 24) in order to insert the access guidewire 112 and catheter tube 116 of the RICC 106 into the patient's vascular lumen after establishing a needle path into the vascular 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 may include a wheel well 180 located distal to the handle 176. The wheel well 180 may include one or more roller wheels 174 positioned 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 positioned in the RICC insertion device 110, the RICC assembly 108 can be advanced with one hand from an initial position in the frame 172 through one or more intermediate positions in the frame 172 to a final position in the frame 172 by repeatedly pushing the longitudinal complex 140 of the RICC assembly 108 onto one or more roller wheels 174 with the thumb of the same hand while holding the handle 176 of the RICC insertion device 110 with the fingers of the same hand, thereby advancing the longitudinal complex 140 across one or more roller wheels 174.

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

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

[0084] As shown in the figure, the nose 170 and the nose cover 168 covering it may also form a retaining clamp 188. The retaining clamp 188 may be configured to slidably clamp the longitudinal composite 140 of the RICC assembly 108, or a divisible casing 136, catheter tube 116, or access guidewire 112 within the retaining clamp 188. The nose cover 168 may be rotatable on the nose 170. In addition, the nose cover 168 may include a longitudinal gap 190 configured to rotatably align with the through channel 182 of the nose 170 in order to remove the longitudinal composite 140 of the RICC assembly 108, or a divisible casing 136, catheter tube 116, or access guidewire 112 from the nose. In fact, if the longitudinal complex 140 is partially or completely divided, the longitudinal gap 190 of the nose cover 168 can be rotatably aligned with the through channel 182 of the nose 170 in order to remove a divisible casing 136, catheter tube 116, or access guidewire 112 from the nose.

[0085] The cradle 178 may be integrated with the handle 176, extending from the proximal portion of the handle 176 and curving toward the distal portion of the handle 176. The cradle 178 may include an open surface, an enclosure 192 covering the distal portion of the cradle 178, and a retaining arch 194 covering the cradle 178 in proximity to the proximal portion of the handle 176 from which the cradle 178 extends.

[0086] The open surface of the cradle 178 can be configured to accommodate the RICC assembly 108 (e.g., longitudinal complex 140, catheter hub 118, one or more extension legs 120, etc.) within the open surface of the cradle 178, from its initial position within the frame 172, through one or more intermediate positions within the frame 172, to its final position 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 legs of 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 Figures 16, 22, and 23A.) In fact, the aforementioned proximal portion of the access guidewire 112 or the guidewire hub 135 connected thereto can be mounted at the guidewire mounting position 196 at the closed end of the enclosure 192 in the initial position of the RICC assembly 108 within the frame 172. In this way, the enclosure 192 can keep at least the proximal portion of the access guidewire 112 extending from the proximal end of the RICC 106 non-contact and sterile.

[0088] The retaining arch 194, which covers the cradle 178, is configured to hold the RICC assembly 108 within the RICC insertion device 110. The retaining arch 194 is also configured to hold the longitudinal complex 140 on the handle 176 as the RICC assembly 108 moves along the proximal portion of the handle 176 extending from the cradle 178 when advancing the RICC assembly 108 from its initial position to its final position within the frame 172.

[0089] Figure 19 shows a curved extension 198 of a cradle 178 extending from an enclosure 192, according to several embodiments. As shown in the figure, the extension 198 may extend from the open end of the enclosure 192, substantially following the same curve as the cradle 178 and covering the distal portion of the cradle 178. The extension 198 may include a slot 200 facing the open surface of the cradle 178. The slot 200 may be configured to engage with a retaining clip 202, as described below.

[0090] Figure 20 shows a retaining clip 202 of an RICC insertion device 110 according to several embodiments. As shown in the figure, the retaining clip 202 may be a separate component of the RICC insertion device 110, including one or more extension leg clips 204 and posts 206. The retaining clip 202 may be configured to clip onto the proximal portion of the RICC 106 and hold 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, which can help prevent the RICC 106 and its catheter tube 116 from advancing prematurely on the access guidewire 112 when the RICC assembly 108 is advanced within the frame 172.

[0091] One or more extension leg clips 204 can be configured to clip onto one or more extension legs 120. While one or more extension leg clips 204 may include dedicated extension leg clips for each of the one or more extension legs 120, as shown in the figure, they may alternatively include a single extension leg clip configured to clip onto any single extension leg among two or more extension legs 120, a pair of extension leg clips 204 configured to clip onto any two extension legs among three or more extension legs 120, and so on.

[0092] Post 206 can be configured to engage with the slot 200 of the extension 198 of the cradle 178 at the initial position of the RICC assembly 108 within the frame 172, and through several preceding intermediate positions of one or more intermediate positions of the RICC assembly 108 within the frame 172. (See Figures 16, 22, and 23A.) However, 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 insertion assembly 102 as the RICC assembly 108 is advanced through the transition to a subsequent intermediate position of one or more intermediate positions of the RICC assembly 108 within the frame 172. (See Figure 23B.) The retaining clip 202 can be configured to remain clipped to one or more extension legs 120 throughout the transition, and to follow the cradle 178 along the proximal portion of the handle 176 to the middle portion of the handle 176 at the final position of the RICC assembly 108 within the frame 172. (See Figure 24.) Figures 21A and 21B show a retractable cutting blade 208 integrated into the nose 170 of the RICC insertion device 110 according to several embodiments, the cutting blade 208 being in a safety position and a cutting position, respectively.

[0093] As shown in the figure, the cutting edge 208 can be positioned within or overmolded in a cutting edge carriage 210 that is slidably integrated within the nose 170. When the cutting edge carriage 210 is in the safe position, the cutting edge 208 may be located in front of the distal end of the nose 170 to prevent accidental cutting. However, when the cutting edge carriage 210 is in the cutting position, the cutting edge 208 may extend beyond the distal end of the nose 170 to cut into the skin area. In particular, when the catheter tube 116 is 7 Fr or larger, the cutting edge 208 can be configured to cut into the skin area around the needle path for later insertion of the catheter tube 116.

[0094] RICC Insertion Assembly Again, Figure 16 presents a RICC insertion assembly 102, which includes a RICC assembly 108 positioned in an initial position within the frame 172 of the RICC insertion device 110, according to several embodiments, thereby forming an operable state for the RICC insertion assembly 102.

[0095] An RICC insertion assembly 102, including an RICC assembly 108 positioned within an RICC insertion device 110, can be configured to advance 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, following the establishment of a needle path into the vascular lumen, thereby inserting the access guidewire 112 and catheter tube 116 of the RICC 106 into the patient's vascular lumen.

[0096] If the longitudinal composite 140 is not divided in the initial position of the RICC assembly 108 within the frame 172 of the RICC insertion device 110, the distal end of the longitudinal composite 140 can substantially correspond to the distal end of the frame 172 (e.g., the nose 170). If the longitudinal composite 140 is partially divided as shown in Figure 16, the distal end of the divisible casing 136 or the distal end of the access guidewire 112 can substantially correspond to the distal end of the frame 172 in the initial position of the RICC assembly 108 within 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 within the retaining clamp 188 in the initial position of the RICC assembly 108 within the frame 172. Furthermore, in the initial position of the RICC assembly 108 within the frame 172, the proximal end of the extension leg or a Luer connector connected to one or more extension legs 120 can substantially correspond to the proximal end of the cradle 178 of the RICC insertion device 110. In addition, the proximal end of the access guide wire 112 or its guide wire hub 135 can be connected to the proximal end of the cradle 178 (e.g., the guide wire mounting position 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 the distal portion of the longitudinal complex 140 with the retaining clamp 188 and attaching the proximal end of the access guide wire 112 or its guide wire hub 135 to the proximal end of the cradle 178, the slack loop 212 of the longitudinal complex 140 may 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] Figure 22 presents a RICC insertion assembly 102 according to several embodiments, where the RICC assembly 108 is in a leading intermediate position within the frame 172 of the RICC insertion device 110. Figure 23A presents a RICC insertion assembly 102 according to several embodiments, where the RICC assembly 108 is in a leading intermediate position within the frame 172, the same as or different from that in Figure 22, with the slack loop 212 of the longitudinal composite 140 remaining within the RICC insertion assembly 102. Figure 23B presents a RICC insertion assembly 102 according to several embodiments, where the RICC assembly 108 is in a trailing intermediate position within the frame 172, with the slack loop of the longitudinal composite 140 no longer remaining within the RICC insertion assembly 102.

[0098] As shown in the figure, at the preceding intermediate position of the RICC assembly 108 within the frame 172 of the RICC insertion device 110, the slack loop 212 of the longitudinal complex 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 remains engaged with the slot 200 of the extension 198 on the cradle 178, thereby holding the RICC 106 itself in place within the RICC insertion device 110 and preventing the catheter tube 116 from advancing prematurely on the access guidewire 112 when 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 complex 140 is removed within the RICC insertion assembly 102 as the RICC assembly 108 is advanced through the subsequent transition to the intermediate position. In fact, when the remaining slack of 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 by being pulled out of the slot 200, thereby allowing the RICC 106 to advance along the access guide wire 112 as the longitudinal composite 140 advances. At the subsequent intermediate position of the RICC assembly 108 within the frame 172, the slack loop of the longitudinal composite 140 does not remain in the RICC insertion assembly 102, allowing the RICC 106 to continue advancing along the access guide wire 112 as the longitudinal composite 140 advances.

[0099] Figure 24 shows an RICC insertion assembly 102 according to several embodiments, with the RICC assembly 108 in its final position within the frame 172 of the RICC insertion device 110 assembly.

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

[0101] Introducer Figure 25 shows an introducer 104 in several embodiments. As shown in the figure, the introducer 104 may include an introducer needle 214 and a detachable introducer sheath 216. The introducer sheath 216 may be configured to receive the introducer needle 214 into the introducer sheath 216. In fact, the introducer sheath 216 may be positioned to cover the introducer needle 214 in the operable state of the introducer 104, as shown in Figure 25. Advantageously, the introducer 104 combined with the RICC insertion assembly 102 can save clinicians time by eliminating the need to pull the introducer needle 214 over the access guidewire 112 and eliminating the need to pass the catheter tube 116 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 configured to establish a needle pathway from the skin region into the vascular lumen at its distal portion. The needle hub 220 may be connected to the proximal portion of the needle shaft 218. Advantageously, the introducer needle 214 can be smaller in size than needles typically used to place CVCs, which makes access to the vessel easier. As a result, the introducer sheath 216 may be configured not to accept the catheter tube 116 of the RICC 106 into the introducer sheath 216.

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

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

[0105] Figure 26 presents a pair of wings 328 extending outward along the length of the sheath hub 226, according to several embodiments. As shown in the figure, the sheath hub 226 may include wings 328 along the length of the sheath hub 226. The wings 328 may have an interior angle of about 90° or less between them, and the sheath hub 226 may be separated by pinching the wings 328 together with one hand.

[0106] The sheath hub 226 may include a single longitudinal defect along one side of the sheath hub 226, or a pair of longitudinal defects including a primary 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 run along the side of the sheath hub 226 opposite the vertex of the interior angle formed by the wing 328, allowing the vertex of the interior angle to function as a molded hinge. The sheath hub 226 may be configured to split along the defect so that when the wings 328 are pinched together, the split propagates 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 the primary side of the sheath hub 226 opposite the vertex of the interior angle formed by the wing 328, and the secondary defect may extend along the secondary side of the sheath hub 226 opposite the primary defect. The sheath hub 226 may be configured to split along a primary defect so that it propagates along the primary side of the sheath body 224 when the wing 328 is pinched together. The sheath hub 226 may also be configured to split along a secondary defect so that it propagates along the secondary side of the sheath body 224 when the wing 328 is pulled away.

[0107] Figure 27 shows longitudinal cross-sections of a sheath hub 226 including a valved cap 230 according to several embodiments. As shown in the figure, the sheath hub 226 may include a valved cap 230 located on the proximal portion of the sheath hub 226. The valved cap 230 may include a tapered female valved cap connector 232 and a partition wall 234 distal to the proximal opening of the female valved cap connector 232. The female valved cap connector 232 may be configured to receive a tapered male needle hub connector extending from the distal portion of the needle hub 220 into the female valved cap connector 232. The partition wall 234 may be configured to receive the needle shaft 218 through the partition wall 234. In fact, the male needle hub connector may be located inside the female valved cap connector 232 in the operable state of the introducer 104. In addition, the needle shaft 218 may pass through the partition wall 234 such that the needle tip 222 extends beyond the distal end of the sheath body 224 in the operable state of the introducer 104. In particular, the valved cap 230 may be partially or completely separated so that the valved cap 230 separates with the sheath hub 226 when the wing 328 is pinched together.

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

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

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

[0111] method The method for inserting the RICC insertion system 100 includes a method for inserting the RICC 106 into the lumen of a patient's blood vessel. Such a method, in some embodiments, includes one or more steps selected from the following: acquisition step, needle route establishment step, blood aspiration step, introducer sheath advance step, introducer needle removal step, connector connection step, skin incision step, access guidewire advance step, introducer sheath removal step, catheter tube advance step, access guidewire removal step, keeper removal step, catheter tube release step, maneuver guidewire insertion step, catheter tube placement step, and maneuver guidewire retraction step.

[0112] The acquisition step may include acquiring the RICC insertion system 100. As described above, the RICC insertion system 100 may include an introducer 104, a RICC insertion device 110, and a RICC assembly 108 containing a RICC 106. The RICC assembly 108 may already be positioned within the RICC insertion device 110 in a substantially operational state of the RICC insertion assembly 102.

[0113] The needle route establishment step may include establishing a needle route from a skin area to the patient's vascular lumen using the introducer needle 214 of the introducer 104. In addition, the needle route establishment step may include ensuring that blood flows back into the needle hub 220 of the introducer needle 214 to confirm that the needle route extends into the vascular lumen. The introducer needle 214 may be placed inside the introducer sheath 216 of the introducer 104 for the needle route establishment step.

[0114] The blood aspiration step may include aspirating blood using a syringe 240 connected to the introducer needle 214 to confirm that the needle pathway extends into the lumen of the blood vessel. The blood aspiration step may be performed before the introducer needle removal step.

[0115] The introducer sheath advancement step may include further advancing the introducer sheath 216 into the vascular lumen on the introducer needle 214. The introducer sheath advancement step can be performed before the introducer needle removal step.

[0116] The introducer needle removal step may include removing the introducer needle 214 from the introducer sheath 216 while leaving the introducer sheath 216 in the vascular lumen, thereby making the access guidewire 112 insertable into the introducer sheath 216.

[0117] The connector connection step may 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 be performed before the access guide wire advancement step.

[0118] The skin incision step may include making an incision in the skin area around the needle path using an incision blade 236 extending from the sheath hub 226. The skin incision step can be performed when the catheter tube 116 is 7 Fr or larger. The skin incision step may be accompanied by a cover opening step prior to the skin incision step and a cover closing step after the skin incision step. The cover opening step may include opening the incision blade cover 238 away from the incision blade 236 to an incision position away from the incision blade 236. The cover closing step may include closing the incision blade cover 238 to a safe position covering the incision blade 236. The skin incision step may be performed before the access guidewire advancement step.

[0119] The access guidewire advancement step may include advancing the access guidewire 112 into the vascular lumen through the nose 170 and nose cover 168 of the RICC insertion device 110, through the sheath hub 226 of the introducer 104, and through the introducer sheath 216. The access guidewire advancement step can be achieved in part by separating the detachable casing 136 from the longitudinal complex 140 of the RICC assembly 108. The distal portion of the access guidewire 112 extending from the primary lumen opening 130 of the catheter tube 116 of the RICC 106 can be freed from the longitudinal complex 140 by separating the detachable casing 136 for the access guidewire advancement step.

[0120] The introducer sheath removal step may include splitting the introducer sheath 216 by grasping together the wings 328 extending outward from the sheath hub 226, thereby forming a tear along one side of the introducer sheath 216. The introducer sheath removal step may also include propagating the tear along the same side of the sheath body 224 of the introducer 104 towards the sheath hub 226. Finally, the introducer sheath removal step may include removing the split introducer sheath, leaving the access guidewire 112 in the vascular lumen.

[0121] The skin incision step may alternatively include making an incision in the skin area around the needle path using a retractable incision blade 208 integrated into the nose 170 of the RICC insertion device 110. Such a skin incision step is also performed when the catheter tube 116 is 7 Fr or larger. The skin incision step may be accompanied by a pair of carriage sliding steps, including a first carriage sliding step prior to the skin incision step and a second carriage sliding step after the skin incision step. The first carriage sliding step may include sliding the incision blade carriage 210, which is overmolded internally, distally to the incision position so that the incision 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 incision blade carriage proximal to a safe position so that the incision blade 208 is in front of the distal end of the nose 170 of the RICC insertion device 110. The skin incision step is also performed before the catheter tube advancement step.

[0122] The catheter tube advancement step may include advancing the catheter tube 116 into the vascular lumen on the access guidewire 112. The catheter tube advancement step can be achieved in part by further separating the detachable casing 136 from the longitudinal complex 140 of the RICC assembly 108. By separating the detachable casing 136, the catheter tube 116 can be freed from the longitudinal complex 140, thereby allowing the catheter tube 116 to be advanced on the access guidewire 112 once the remaining slack in the longitudinal complex 140 within the RICC insertion assembly 102 is removed.

[0123] The access guidewire advancement step or catheter tube advancement step described above may include repeatedly pushing the longitudinal complex 140 with one hand onto one or more roller wheels 174 located in the wheel well 180 of the handle 176 of the RICC insertion device 110, advancing the longitudinal complex 140 across one or more roller wheels 174 to separate the divisible casing from the longitudinal complex 140. The access guidewire advancement step or catheter tube advancement step may also include, additionally or alternatively, pulling out the divisible casing 136 of the longitudinal complex 140 from the nose 170 of the RICC insertion device 110 and the nose cover 168 covering the nose, thereby separating the divisible casing from the longitudinal complex 140.

[0124] The access guidewire removal step may include removing the access guidewire 112 while leaving the catheter tube 116 in the vascular lumen. The keeper removal step may include removing the keeper 114, which includes the proximal end of the divisible casing 136 attached to the catheter hub holder 138, from the RICC assembly 108. The keeper removal step can be achieved in part by removing the catheter hub 118 of the RICC 106 from the catheter hub holder 138 and separating the remaining divisible casing 136 of the longitudinal complex 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 can be achieved in part by rotating the nose cover 168 on the nose 170 to align the longitudinal gap 190 of the nose cover 168 with the through channel 182 in the nose 170, thereby 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, leaving only the RICC 106 with the catheter tube 116 positioned in the vascular lumen.

[0126] The maneuvering guidewire insertion step may include inserting the maneuvering guidewire into the vascular lumen via the distal lumen of the RICC 106. The maneuvering guidewire in the maneuvering guidewire advancement step may be long enough to advance the catheter tube 116 of the RICC 106 to the lower third of the SVC of the patient's heart. The maneuvering guidewire may be part of a guidewire management device configured to maintain the sterility of the maneuvering guidewire and facilitate the maneuvering guidewire advancement step. Alternatively, the maneuvering guidewire may be a standalone maneuvering guidewire packaged within a sterile barrier (e.g., a bag, casing, etc.) configured to maintain the sterility of the maneuvering guidewire. Such a maneuvering guidewire can eliminate the loss of the maneuvering guidewire in the patient by including a stopping means to stop the advancement of the maneuvering guidewire during the maneuvering guidewire advancement step. The stopping means may be, for example, a ball, slug, etc. coupled to the proximal portion of the maneuvering guidewire, configured to prevent it from passing through the Luer connector of the extension leg where at least the proximal portion of the maneuvering guidewire is located during the maneuvering guidewire advancement step.

[0127] The catheter tube placement step may include further advancing the distal portion of the catheter tube 116 into the vascular lumen to the lower one-third of the SVC of the patient's heart on a maneuvering guidewire.

[0128] The maneuvering guidewire retraction step may include retracting the maneuvering guidewire from the patient's vascular lumen and from the RICC106. Further Embodiments Figures 29–31 and 32A–32G present further embodiments of RICC insertion systems, RICC insertion kits, their components, and related methods. As stated above, for convenience, descriptions of specific components of RICC insertion systems 100 and 300 are provided in sections herein, but such sections are not intended to limit the descriptions of specific components of RICC insertion systems 100 and 300. In fact, descriptions of any component of RICC insertion system 100 or 300 may span from one section to one or more other sections provided herein, taking into account the interrelationships of the components of RICC insertion systems 100 and 300.

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

[0130] The outer surface of the housing 310 may define one or more handles configured to facilitate gripping or manipulating 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 internal cavity 312 of the housing 310 can provide a protective environment for receiving the RICC assembly 108, allowing the user to manipulate the RICC assembly 108 without the need for direct contact with the RICC assembly 108 or the RICC 106 or its access guide wire 112. In one embodiment, the RICC insertion device 309 may include one or more flexible barriers. The housing 310 and one or both of the flexible barriers can work together 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, which is analogous to the barrel of a syringe located within a housing 310 and in fluid communication with the needle lumen of the introducer needle 314 of the introducer 304, as will be described in more detail herein.

[0131] In one embodiment, one or more of the needle storage assembly 330, catheter advancement assembly 340, or guidewire advancement assembly 350 may be located within the internal cavity 312 of the housing 310. As shown, the needle storage assembly 330 and the catheter advancement assembly 340 may be located within the longitudinal handle 315. The guidewire advancement assembly 350 may be located within the curved portion 317 of the housing 310. However, other configurations of the needle storage assembly 330, catheter advancement assembly 340, and guidewire advancement assembly 350 are also conceivable.

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

[0133] In one embodiment, the catheter advancement assembly 340 may be configured to move 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 may include a catheter slider 342 that extends through a slot in the housing 310 and is slidably engaged with the slot. The catheter slider 342 may be configured to be operated by a user to move the catheter advancement assembly 340 between the extended position and the retracted position. In one embodiment, the catheter advancement assembly 340 may engage with a portion of the catheter hub 118 of the RICC 106. However, it will be understood that the catheter advancement assembly 340 may engage with other portions of the RICC 106 without being restricted in its movement between the retracted and extended positions.

[0134] In one embodiment, the RICC insertion system 300 may further include a guidewire advance assembly 350, which includes a guidewire slider 352. The guidewire advance assembly 350 may be configured to move the access guidewire 112 between an extended position and a retracted position relative to the housing 310. The guidewire slider 352 may extend through a slot in the housing 310 for user operation to move the guidewire advance assembly 350 between the retracted position and the extended position.

[0135] Figure 30 shows a detail view of an 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 divisible introducer sheath 316, which is positioned around the needle shaft of the introducer needle 314 and supported at its proximal end by a divisible sheath hub 326, as described herein. The introducer 304 may further include an incision blade 308 for cutting into the skin adjacent to the access site to widen the access site and advance the RICC 106 into the vascular system.

[0136] Figure 31 shows a detailed view of the nose portion 318 of the RICC insertion device 309, including a blood flush nozzle 324 and a catheter nozzle 344. The proximal end of the introducer 304 can be configured to engage with one or both of the blood flush nozzle 324 and the catheter nozzle 344 in a releasable manner by crimp-fit, press-fit, or snap-fit. In one embodiment, either the needle hub 320 or the sheath hub 326 can be connected 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 connected to the blood flush nozzle 324, the needle lumen can provide fluid communication with the blood flush indicator 321. Fluid flow can be drawn proximal through the needle lumen to the blood flush indicator 321 to observe the color and pulsatile flow to confirm correct vascular access. In one embodiment, the blood flush indicator 321 may include a vacuum located inside the blood flush indicator 321 to facilitate the drawing of a proximal fluid flow, or may be configured to generate a vacuum inside the blood flush indicator 321.

[0137] In an embodiment where the introducer 304 is connected to the blood flush nozzle 324, the distal portion of the needle storage assembly 330 can be connected to the needle hub 320. By using the needle slider 332 to actuate the needle retraction assembly 330, the introducer needle 314 can be retracted into the housing 310 of the RICC insertion device 309. The sheath hub 326 is then detached from the blood flush nozzle 324 and connected 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 is retracted into the housing 310 after the vascular system has been accessed, thereby retracting and retracting into the housing 310, reducing the risk of accidental needle stick injuries and exposure of the user to bodily fluids.

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

[0139] The user can access the patient's vascular system by grasping either the longitudinal handle 315 or the curved portion 317 of the housing 310 and manipulating the RICC insertion assembly 302, thereby biasing the introducer needle 314 distally into the vascular system. Thus, the introducer needle 314 and introducer sheath 316 assembly can access the vascular system simultaneously. The blood flush indicator 321 can draw fluid flow proximal into the blood flush indicator 321 through the needle lumen to confirm correct vascular access.

[0140] As shown in Figures 32A and 32B, once correct vascular access is confirmed, the user can operate the needle slider 332 to move the needle storage assembly 330 to the storage position (Figure 32B), retract the introducer needle 314 from the introducer sheath 316, and secure the introducer needle 314 within the housing 310 of the RICC insertion device 309. In one 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 vascular system, thereby maintaining the patency of the access site. In one embodiment, the user can grasp the sheath hub 326 and advance the introducer sheath 316 further into the access site. A cutting blade 308 positioned close to the sheath hub 326 can cut into the skin adjacent to the access site, widening the access site and advancing the RICC 106 into the vascular system.

[0141] Advantageously, by removing the RICC insertion device 309 from the sheath hub 326, the user can maintain access site patency without needing to stabilize the RICC insertion assembly 302 (without introducer 104) and any associated components adjacent to the access site. For example, the user can pause the catheter placement process to prepare for subsequent steps, etc., without having to restart the entire placement process. Furthermore, the blood flush indicator 321, introducer needle 314, and needle storage assembly 330 can be offset from the axis of the catheter advancement assembly 340, the guidewire advancement assembly 350, or both, so as described herein, the advancement of the RICC 106 and access guidewire 112 is not obstructed.

[0142] As shown in Figure 32C, the user can continue the catheter placement process by connecting the catheter nozzle 344 to the sheath hub 326. Connecting 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 Figure 32D, the user can then operate the guidewire advance assembly 350 by manipulating the guidewire slider 352 to move the access guidewire 112 from the retracted position (Figure 32C) to the extended position (Figure 32D). In the extended position, the distal end of the access guidewire 112 may extend into the patient's vascular system through the primary lumen 124 of the RICC 106, through the catheter nozzle 344 of the housing 310, and through the lumen of the introducer sheath 316 until the distal end of the access guidewire 112 is positioned at the target site.

[0143] As shown in Figure 32E, the user can then longitudinally separate the introducer sheath 316 into a first portion 316A and a second portion 316B. The user can then grasp the wings 328 of the sheath hub 326 and separate them laterally to separate the sheath hub 326 and the introducer sheath 316. The sheath portions 316A and 316B can then be retracted proximal to the access site while the access guidewire 112 maintains the patency of the access site. Advantageously, since the inner diameter of the lumen of the introducer sheath 316 is smaller than the outer diameter of the catheter tube 116 or RICC 106, the introducer sheath 316 can be separated and withdrawn in order to advance the RICC 106 into the vascular system on the access guidewire 112.

[0144] As shown in Figure 32F, the user can then operate the catheter slider 342 to move the catheter advancement assembly 340 from the retracted position to the extended position. In the extended position, the RICC 106 can be advanced into the vascular system on the access guidewire 112. In one embodiment, the housing 310 may include a first lateral slot 360A and a second lateral slot 360B located opposite the first lateral slot across the central longitudinal axis of the catheter nozzle 344 (Figure 31). The first and second lateral slots 360A and 360B may extend longitudinally proximal from the distal tip of the catheter nozzle 344 and communicate with the internal cavity 312 of the housing 310. Thus, the first and second lateral slots 360A and 360B pass through the catheter hub 118 and one or more extension legs 120, and when positioned, can disengage the RICC 106 from the housing 310. As shown in Figure 32G, the guidewire slider 352 is then retracted to move the guidewire advance assembly 350 and the access guidewire 112 to the retracted position, storing the access guidewire 112 within the housing 310 and reducing the exposure of the user to bodily fluids.

[0145] While several specific embodiments are disclosed herein, and these specific embodiments are disclosed in some degree of detail, they are not intended to limit the scope of the concept provided herein. Further adaptations or modifications may be apparent to those skilled in the art, and these adaptations or modifications are also encompassed in broader embodiments. Thus, it is possible to deviate from specific embodiments disclosed herein without departing from the scope of the concept provided herein. The technical concepts included in this disclosure are described below. (Note 1) A rapid insertion central venous catheter ("RICC") insertion system, An insertion assembly including a housing having a blood flush nozzle and a catheter nozzle, A blood flush indicator that is in fluid communication with the aforementioned blood flush nozzle, A RICC is disposed within the internal cavity of the housing and slidably engaged with the catheter nozzle, An introducer comprising an introducer needle and an introducer sheath, wherein the introducer is releasably engaged with either the blood flush nozzle or the catheter nozzle, An RICC insertion system equipped with the following features. (Note 2) The RICC insertion system according to Note 1, further comprising a needle storage system connected to the introducer needle, configured to retract the introducer needle proximal through the blood flush nozzle from the introducer sheath. (Note 3) The RICC insertion system according to Note 1, wherein the blood flush indicator is in fluid communication with the needle lumen of the needle. (Note 4) The RICC insertion system according to Note 1, wherein the sheath hub of the introducer sheath is configured to releasably engage with the catheter nozzle and to longitudinally align the sheath membrane of the introducer sheath with the RICC. (Appendix 5) The RICC insertion system according to Appendix 1, further comprising a catheter advancement assembly configured to slidably engage the RICC and the catheter nozzle. (Appendix 6) The RICC insertion system according to any one of Appendices 1 to 5, further comprising an access guide wire connected to a guide wire advancement assembly, wherein the guide wire advancement assembly is configured to slidably engage the access guide wire with the catheter nozzle.

Claims

1. A central venous catheter insertion system, Central venous catheter assembly, Central venous catheter insertion device, Introducer, The central venous catheter assembly is equipped with, A central venous catheter, Catheter tube and A catheter hub connected to the proximal portion of the catheter tube, One or more extension legs, each of which is connected to the catheter hub by its distal portion, Including a central venous catheter, An access guidewire positioned within the primary lumen of the central venous catheter, A keeper comprising a divisible casing, wherein the divisible casing covers both the catheter tube and the distal portion of the access guidewire extending from the distal end of the central venous catheter, thereby forming a longitudinal composite of the divisible casing, the catheter tube, and the distal portion of the access guidewire; Includes, The aforementioned central venous catheter insertion device It is a frame, A longitudinal handle including a wheel well, A nose extending from the distal portion of the handle located distal to the wheel well, comprising a through channel, wherein the through channel is configured to advance the catheter tube of the central venous catheter through the through channel, A curved cradle extending from the proximal portion of the aforementioned handle, Frames, including One or more roller wheels disposed within the wheel well, A nose cover that covers the nose, wherein the nose cover and the nose form a divided channel, and the divided channel is configured to divide and allow the divisible casing to pass through the divided channel, The configuration includes, and is configured to advance the central venous catheter assembly from an initial position within the frame to a final position within the frame by repeatedly pushing the longitudinal complex onto one or more roller wheels and advancing the longitudinal complex across the one or more roller wheels, Central venous catheter insertion system.

2. The central venous catheter insertion system according to claim 1, wherein the keeper further includes a catheter hub holder to which the proximal end of the divisible casing is attached, and the catheter hub holder is configured to hold the catheter hub within the catheter hub holder and to cover the divisible casing and keep it in place over the catheter tube and the access guidewire.

3. The central venous catheter insertion system according to claim 2, wherein the catheter hub holder includes a peripheral wall on at least a portion of the outer circumference of the catheter hub holder, and the peripheral wall defines a recess into which the catheter hub is fitted by engineering fit.

4. The central venous catheter insertion system according to claim 1, wherein the cradle includes a curved extension that covers the distal portion of the cradle, and the extension substantially follows the same curve as the cradle.

5. The central venous catheter insertion system according to claim 4, wherein the cradle includes an enclosure covering the distal portion of the cradle, the extension extends from the enclosure, and the enclosure is configured to enclose the proximal portion of the access guidewire within the enclosure in the initial position of the central venous catheter assembly within the frame.

6. The central venous catheter insertion system according to claim 4, further comprising a retaining clip clipped to the proximal portion of the central venous catheter, which is configured to hold the central venous catheter assembly within the central venous catheter insertion device and to prevent the catheter tube from advancing prematurely on the access guidewire, wherein the retaining clip includes a post configured to engage with a slot in the extension facing the open surface of the cradle.

7. The central venous catheter insertion system according to claim 6, wherein the retaining clip is configured to disengage from the slot of the extension when the remaining slack of the longitudinal complex is removed as the central venous catheter assembly is advanced from the initial position to the final position within the frame.

8. The frame further includes a retaining arch that covers the cradle in proximity to the proximal portion of the handle from which the cradle extends, The central venous catheter insertion system according to claim 1, wherein the retaining arch is configured to hold the central venous catheter assembly within the central venous catheter insertion device, and is configured to hold the longitudinal complex on the handle when the central venous catheter assembly moves over the proximal portion of the handle extending from the cradle as the central venous catheter assembly is advanced 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 clamp the longitudinal composite so that it can slide within the retaining clamp. The nose cover is rotatable on the nose, The central venous catheter insertion system according to claim 1, wherein the nose cover includes a longitudinal gap configured to be rotatably aligned with the through-channel of the nose in order to remove the longitudinal composite, the divisible casing, or the catheter tube from the nose.

10. The nose is further equipped with a retractable cutting blade positioned within a cutting blade carriage that is slidably integrated with the nose, The central venous catheter insertion system according to 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 in front of the distal end of the nose.

11. The aforementioned introducer, It is an introducer needle, A needle shaft, wherein the distal portion of the needle shaft includes the needle tip, A needle hub connected to the proximal portion of the needle shaft, Includes an introducer needle, A divisible introducer sheath, configured to receive the introducer needle within the divisible introducer sheath, The detachable sheath body, A divisible sheath hub connected to the proximal portion of the sheath body, comprising a pair of wings extending outward along the length of the sheath hub, wherein the wings have an internal angle of 90° or less between them, and the sheath hub is configured to be separated by pinching the wings together with one hand; The introducer series, A central venous catheter insertion system according to any one of claims 1 to 10, including the above.

12. The central venous catheter insertion system according to claim 11, wherein the sheath hub includes a single longitudinal defect along the side of the sheath hub opposite to the apex of the interior angle formed by the wing, and is configured to split along the defect so that it propagates along the same side of the sheath body when the wing is pinched together.

13. The sheath hub includes a pair of longitudinal defects, the primary defect being a primary defect along the primary side of the sheath hub opposite to the vertex of the interior angle formed by the wing, and the secondary defect being a secondary defect being a secondary defect being opposite to the primary defect being. The central venous catheter insertion system according to claim 11, wherein the sheath hub is configured to be divided along the primary defect so that the division propagates along the primary side of the sheath body when the wings are grasped together, and is configured to be divided along the secondary defect so that the division propagates along the secondary side of the sheath body when the wings are pulled apart.

14. The sheath hub further includes a valved cap positioned on the proximal portion of the sheath hub, The valved cap includes a tapered female valved cap connector and a partition wall distal to the proximal opening of the female valved cap connector. The female valve-equipped cap connector is configured to receive a tapered male needle hub connector, which extends from the distal portion of the needle hub, into the female valve-equipped cap connector. The central venous catheter insertion system according to claim 11, wherein the partition wall is configured to receive the needle shaft through the partition wall.

15. The central venous catheter insertion system according to claim 14, wherein the valved cap is partially or completely separated so that when the wings are grasped together, the valved cap separates with the sheath hub.

16. The aforementioned sheath hub, An overmolded cutting edge extending distally from the sheath hub, A hinged cutting blade cover having an open state that opens away from the overmolded cutting blade and a closed state that closes to cover the cutting blade, The central venous catheter insertion system according to claim 11, further comprising:

17. The central venous catheter insertion system according to claim 11, further comprising a syringe, wherein the syringe includes a tapered male syringe tip extending from the distal portion of the syringe, and the tapered male syringe tip is configured to be inserted into a tapered female needle hub connector located at the proximal portion of the needle hub.

18. A central venous catheter insertion assembly, Central venous catheter assembly, Central venous catheter insertion device, The central venous catheter assembly is equipped with, A central venous catheter, Catheter tube and A catheter hub connected to the proximal portion of the catheter tube, One or more extension legs, each of which is connected to the catheter hub by its distal portion, Including a central venous catheter, An access guidewire positioned within the primary lumen of the central venous catheter, A keeper comprising a divisible casing, wherein the divisible casing covers both the catheter tube and the distal portion of the access guidewire extending from the distal end of the central venous catheter, thereby forming a longitudinal composite of the divisible casing, the catheter tube, and the distal portion of the access guidewire; Includes, The aforementioned central venous catheter insertion device It is a frame, A longitudinal handle including a wheel well, A nose extending from the distal portion of the handle located distal to the wheel well, the nose including a through channel, the through channel configured to advance through the catheter tube of the central venous catheter, A curved cradle extending from the proximal portion of the aforementioned handle, Frames, including One or more roller wheels disposed within the wheel well, A nose cover that covers the nose, wherein the nose cover and the nose form a divided channel, and the divided channel is configured to divide and allow the divisible casing to pass through the divided channel, The configuration includes, and is configured to advance the central venous catheter assembly from an initial position within the frame to a final position within the frame by repeatedly pushing the longitudinal complex onto one or more roller wheels and advancing the longitudinal complex across the one or more roller wheels, Central venous catheter insertion assembly.

19. The central venous catheter insertion assembly according to claim 18, wherein the distal end of the longitudinal composite, the divisible casing, or the access guidewire substantially corresponds to the distal end of the frame in the initial position of the central venous catheter assembly within the frame.

20. The central venous catheter insertion assembly according to claim 18, wherein the slack loop of the longitudinal complex extends away from both the handle and the cradle in the initial position of the central venous catheter assembly within the frame.

21. The central venous catheter insertion assembly according to claim 18, wherein the longitudinal composite is substantially divided at the final position of the central venous catheter assembly within the frame.

22. The central venous catheter insertion assembly according to claim 18, wherein the proximal end of an extension leg or a Luer connector connected to one of the extension legs of the central venous catheter substantially corresponds to the proximal end of the cradle in the initial position of the central venous catheter assembly within the frame.

23. The central venous catheter insertion assembly according to claim 22, wherein the proximal end of the access guidewire is connected to the proximal end of the cradle in the initial position of the central venous catheter assembly within the frame.

24. The central venous catheter insertion assembly according to claim 22, wherein one or more extension legs of the central venous catheter are substantially located on the handle at the final position of the central venous catheter assembly within the frame.

25. The central venous catheter insertion assembly according to any one of claims 18 to 24, wherein the catheter hub of the central venous catheter is located on the wheel well at the final position of the central venous catheter assembly within the frame.

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