Splittable catheter docking station system

Abstract

A two-stage rapid insertion central catheter (“RICC”) system is disclosed, which may include an insertion system, a docking station, and a catheter placement system. The insertion system may place an insertion device within a vascular structure, and the insertion system is supported by a docking station that is detachable from the distal end of the insertion system. The catheter placement system is configured to be coupled with the docking station, and the catheter may be advanced into the vascular structure through the insertion device. Subsequently, before the catheter placement system separates from the docking station, the insertion device may be split and retracted. The docking station may be configured to be split and detachable from the catheter. The RICC system may include a guide wire hub to prevent guide wire embolism, a crushable sterile barrier to prevent contamination, and a locking feature to prevent premature advancement of the guide wire, dilator, and others.

Description

Technology Field

[0001] The present disclosure relates to an invention concerning a catheter, and more specifically, to an invention concerning a docking station system for a divisible catheter and a method thereof. Background Technology

[0002] Prior art documents for the present disclosure include U.S. Patent Publication No. 2019-0321590.

[0003] In summary, the embodiments disclosed herein relate to a two-stage rapid insertion central catheter ("RICC") system. In one embodiment, the two-stage RICC system comprises an insertion system, a docking station, and a catheter placement system. The insertion system can place the insertion within a vascular structure, and the insertion system can be supported by a docking station that is detachable from the distal end of the insertion system. The docking station can provide a primary access route to the vascular structure and allows a clinician to handle the insertion while it is maintained in place within the vascular structure. In an embodiment, the catheter placement system is coupled to the docking station, and the catheter can be advanced into the vascular structure through the insertion. Subsequently, before the catheter placement system separates from the docking station, the insertion can be split and retracted. Finally, the docking station can be split and separated from the catheter. Some embodiments include a guide wire hub to prevent guide wire embolism, a crushable sterile barrier to prevent contamination, and a locking feature to prevent premature advancement of the guide wire, dilator, and others.

[0004] The embodiments described herein provide a simplification of the insertion process for a CVC catheter or similar device. This requires fewer components, fewer steps for the procedure, and housing the components to be inserted within a sterile barrier, or other factors. The embodiments may include a guide wire hub and a locking device to prevent guide wire embolism, and a docking station that supports the inserter. The docking station allows the clinician to release the inserter during the procedure, which is not possible with current methods where the clinician must maintain a grip on the inserter while performing additional steps in a single-handling manner.

[0005] A rapid insertion central catheter system comprising an insertion placement system is disclosed herein, wherein the insertion placement system is configured to place an insertion within a patient's vasculature and comprises a needle defining a needle lumen, an introducer guidewire placed within the needle lumen, a dilator forming a dilator lumen, an introducer forming an insertion lumen supported by an insertion hub and configured to receive a dilator placed inside, a guidewire housing comprising a guidewire advancement assembly coupled to the proximal end of the introducer guidewire and a needle retraction assembly coupled to the proximal end of the needle, a dilator housing comprising a dilator advancement assembly coupled to the distal end of the guidewire housing and coupled to the proximal end of the dilator, and a blood flush indicator fluidically coupled to the needle lumen. It includes a blood flash indicator tube.A rapid insertion central catheter system also comprises a docking station forming a lumen configured to be releasably coupled to the distal end of an extender housing and to hold an inserter hub, and a catheter placement system coupled to the proximal end of the docking station and configured to place the catheter within the patient's vascular structure, wherein the catheter placement system comprises a docking portion configured to be coupled to the docking station to axially align the catheter with the inserter lumen, a rail extending proximally from the docking portion, a locking hub positioned at the proximal end of the rail and forming a locking hub lumen, a catheter guide wire comprising a guide wire hub permanently attached to the distal end, wherein a portion of the guide wire is placed within the locking hub lumen, and a catheter frame slidably coupled to the rail, wherein the catheter is supported by the catheter frame.

[0006] In some embodiments, the insertion system further comprises a blood flush actuator, which is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow through the needle lumen and into the blood flush indicator tube. The blood flow placed within the blood flush indicator tube can be observed through the blood flush indicator tube and through the guide wire housing. One of the rail and the catheter guide wire is placed within a collapsible sterile barrier to prevent contact between them. The catheter is placed within a collapsible sterile barrier in which the rail is placed, and the catheter frame is configured to extend through an opening in the sidewall of the sterile barrier and be grasped by a clinician.

[0007] In some embodiments, one of the guide wire advance assembly, the needle retrieval assembly, and the dilator advance assembly includes a release mechanism, and this release mechanism requires a pair of finger tabs to be moved laterally inward prior to allowing any longitudinal movement. The guide wire of the dilator placement system is configured to blunt the tip of the needle when the guide wire is advanced distally through the needle lumen. Distally advance of the dilator assembly advances the dilator and the inserter distally over the needle and the guide wire. Proximal withdrawal of the needle retrieval assembly causes proximal withdrawal of the needle and the inserter guide wire. Distally advance of the dilator advance assembly transfers the inserter from the dilator housing to the docking station. Proximal withdrawal of the dilator advance assembly causes proximal withdrawal of the dilator from the lumen of the inserter.

[0008] In some embodiments, the docking station forms a distal surface comprising an adhesive layer configured to adhere the docking station to the surface of the patient's skin. The width of the guide wire hub of the catheter guide wire is wider than the width of the locking hub lumen, thereby preventing the proximal end of the catheter guide wire from passing through the locking hub lumen. The docking portion of the catheter placement system includes an insertion retrieval assembly configured to divide the insertion into a first half and a second half along a longitudinal axis, the first half being wound around a first reel and the second half being wound around a second reel. The locking hub further includes a guide wire lock configured to lock the catheter guide wire and prevent its longitudinal movement relative to the locking hub. The docking station includes a longitudinally extending leak line and is configured to separate along the leak line when the first body portion and the second body portion of the docking station are compressed laterally outward.

[0009] Additionally, a two-step method for placing a catheter within a patient's vascular structure is disclosed, wherein the two-step method comprises a first step of placing an insertion device using an insertion device placement system, wherein the insertion device placement system comprises a body, a docking station distally coupled to the distal end of the body, a needle, an insertion device guide wire, a dilator, and an insertion device; and a second step of placing a catheter using a catheter placement system, wherein the catheter placement system comprises a docking portion, a rail to which a catheter frame is slidably coupled, a catheter distally coupled to the catheter frame, and a locking hub disposed at the proximal end of the rail, wherein the method comprises the steps of approaching a vascular structure using a needle, advancing an insertion device guide wire through the lumen of the needle, advancing a dilator on which the insertion device is placed over the needle to transfer the insertion device from the body to the docking station, retracting the needle and guide wire from the dilator, retracting the dilator from the insertion device, detaching the body of the insertion device placement system from the docking station, and the catheter The method includes the steps of: coupling the docking portion of the placement system to the proximal end of the docking station; advancing the catheter guide wire distally through the lumen of the catheter and through the lumen of the inserter until the distal portion is positioned distally to the distal tip of the inserter; advancing the catheter frame distally to advance the catheter through the lumen of the inserter; operating the inserter retrieval assembly to divide the inserter into a first half and a second half along the longitudinal axis; winding the first half of the inserter around a first reel and winding the second half of the inserter around a second reel; retracting the catheter guide wire distally from the catheter; removing the catheter placement system from the docking station; and removing the docking station from the catheter.

[0010] In some embodiments, the step of accessing a vascular structure using a needle further comprises the step of operating a blood flush actuator, wherein the blood flush actuator is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow through the needle lumen and into the blood flush indicator tube, thereby confirming the access of the needle to the vascular structure. The step of accessing a vascular structure using a needle further comprises the step of observing blood flow through the blood flush indicator tube and through the body of the insertion system. One of the steps of advancing the insertion guide wire, advancing the dilator, and retracting the needle includes the step of releasing the locking mechanism by tightening the pair of finger tabs together prior to the longitudinal movement of the pair of finger tabs relative to the insertion system. The step of advancing the catheter guide wire distally includes the step of crushing the guide wire sterile barrier between the locking hub of the catheter placement system and the guide wire hub, wherein the guide wire sterile barrier surrounds the catheter guide wire and prevents the clinician from contacting the catheter guide wire.

[0011] In some embodiments, the step of advancing the catheter frame distally includes the step of crushing a portion of the rail sterile barrier between the catheter frame and the docking portion of the catheter placement system, wherein the rail sterile barrier surrounds the rail and a portion of the catheter to prevent the clinician from contacting the portion of the catheter. A portion of the catheter frame extends through an opening positioned within the sidewall of the rail sterile barrier and is configured so that the clinician can grasp the portion of the catheter frame to distally compress the catheter frame. The step of advancing the catheter frame distally includes the step of expanding the extension leg sterile barrier between the locking hub and the extension leg of the catheter, wherein the extension leg sterile barrier surrounds the catheter guide wire to prevent the clinician from contacting the catheter guide wire. The step of advancing the inserter guide wire through the lumen of the needle further includes the step of blunting the tip of the needle.

[0012] In some embodiments, the step of transferring the inserter from the body to the docking station further includes the step of holding the inserter hub within the lumen of the docking station. The step of detaching the docking station from the body further includes the step of adhering the distal surface of the docking station to the skin surface of the patient. The catheter guide wire further includes a guide wire hub permanently attached to its proximal end, and the guide wire hub is configured to prevent the proximal end of the catheter guide wire from entering the lumen of the catheter. The step of coupling the catheter placement system to the proximal end of the docking station further includes the step of coupling a clamp of the inserter retrieval assembly to the inserter hub, and the clamp opens a valve disposed within the inserter hub. The step of proximally advancing the catheter guide wire further includes the step of unlocking the guide wire lock to allow longitudinal movement of the catheter guide wire relative to the catheter placement system, and then the step of locking the guide wire lock to prevent longitudinal movement of the catheter guide wire relative to the catheter placement system when the distal tip of the catheter guide wire is placed close to the target position.

[0013] In some embodiments, the step of operating the inserter retrieval assembly further includes the step of rotating the twist knob of the inserter retrieval assembly. The step of removing the catheter placement system from the docking station further includes the step of removing the cap portion of the catheter placement system to allow lateral movement of the catheter placement system relative to the catheter. The step of removing the docking station from the catheter further includes the step of splitting the docking station longitudinally along the breach line by compressing the first portion and the second portion laterally outward.

[0014] A rapid insertion central catheter system is also disclosed, and the system comprises an insertion device placement system configured to place an insertion device within a patient's vascular structure, a docking station distally coupled to the distal end of the insertion device placement system, and a catheter placement system coupled to the proximal end of the docking station and configured to place a catheter within a patient's vascular structure.

[0015] In some embodiments, the inserter placement system comprises one of a needle, an inserter guide wire, a dilator, an inserter, an inserter hub, and a blood flush indicator tube. The inserter placement system further comprises a blood flush actuator, which is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow through the lumen of the needle and into the blood flush indicator tube. The catheter placement system comprises one of a docking part, a rail, a locking hub, a catheter guide wire, and a catheter frame. One of the rail, the catheter, and the catheter guide wire is placed within a crushable sterile barrier to prevent contact between them. The inserter placement system comprises one of a guide wire advance assembly, a needle retrieval assembly, and a dilator advance assembly. One of the guide wire advance assembly, the needle retrieval assembly, and the dilator advance assembly comprises a release mechanism.

[0016] Additionally, a method for placing a catheter within a patient's vascular structure is disclosed, and the method comprises the steps of: placing an insertion device within a patient's vascular structure using an insertion device placement system comprising a body and a docking station; detaching the body of the insertion device placement system from the docking station; coupling the catheter placement system with the docking station; advancing the catheter into the patient's vascular structure; removing the insertion device using an insertion device retrieval assembly; and removing the catheter placement system and the docking station.

[0017] In some embodiments, the step of placing the insertion device further includes the step of transferring the insertion device from the body of the insertion device placement system to a docking station. The method further includes the step of holding the insertion device hub of the insertion device within the lumen of the docking station. The method further includes the step of operating a blood flush actuator, wherein the blood flush actuator is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow through the needle lumen and into the blood flush indicator tube, thereby confirming the needle's access to the blood vessel.

[0018] In some embodiments, the step of placing the inserter within the patient's vascular structure further comprises the step of advancing the inserter guide wire through the needle lumen and the step of blunting the tip of the needle. The step of advancing the catheter into the patient's vascular structure further comprises a guide wire hub permanently attached to the proximal end of the catheter guide wire, and the guide wire hub is configured to prevent the proximal end of the catheter guide wire from entering the lumen of the catheter. The step of removing the inserter further comprises the step of splitting the inserter along the longitudinal axis. Brief explanation of the drawing

[0019] The present disclosure will be described more specifically with reference to specific embodiments illustrated in the accompanying drawings. It will be understood that these drawings illustrate only typical embodiments of the invention and are not to be construed as limiting the scope thereof. Embodiments of the invention will be described and explained with additional specificity and detail using the following accompanying drawings: FIGS. 1a to 1c illustrate perspective views of a two-stage rapid insertion catheter system comprising an insertion device placement system, a docking station, and a catheter placement system according to an embodiment disclosed herein. FIGS. 2a to 2e illustrate various detailed views of the inserter placement system of FIGS. 1a and FIG. 1b according to an embodiment disclosed herein. FIGS. 3a to 2c illustrate various detailed views of the catheter placement system of FIG. 1c according to an embodiment disclosed herein. FIGS. 4a to 4g illustrate several stages for placing an inserter using the inserter placement system of FIGS. 1a and 1b according to an embodiment disclosed herein. FIGS. 4h to 4n illustrate several stages of placing a catheter using the catheter placement system of FIG. 1c according to an embodiment disclosed herein. Specific details for implementing the invention

[0020] The present application claims the benefit of priority to U.S. Patent Application No. 62 / 965,064 filed on January 23, 2020, the entirety of which is incorporated herein by reference.

[0021] Before specifically disclosing some particular embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It will also be understood that the specific embodiments disclosed herein can be easily separated from the specific embodiments and can optionally be combined with or replaced with features of any many other embodiments disclosed herein.

[0022] With respect to the terms used herein, it should be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not imply a sequential or numerical limitation. For example, "first," "second," and "third" features or steps do not necessarily need to appear in such an order, and a specific embodiment containing such features or steps is not necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "rear," and others are used for convenience and are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. Unless otherwise clearly stated in the context, the singular forms (“a,” “an,” and “the”) include plural objects.

[0023] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein comprises the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter comprises the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter comprises the end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may comprise the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily have to comprise the proximal end of the catheter. That is, unless otherwise indicated in the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of a catheter.

[0024] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. Likewise, for example, the “distal length” of a catheter comprises a length of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. For example, the “distal end” of a catheter comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. The distal portion, distal end portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter does not need to comprise the distal end of the catheter. That is, unless otherwise indicated in the context, the distal part, distal end portion, or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0025] To assist in the description of the embodiments described herein, as shown in FIG. 1a, the longitudinal axis extends substantially parallel to the axial length of the needle (130). The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0026] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as generally understood by those skilled in the art.

[0027] FIGS. 1a through 1c illustrate various detailed views of a two-stage rapid insertion central catheter ("RICC") system (10) comprising an insertion placement system (100), a docking station (200), and a catheter placement system (300), according to an embodiment disclosed herein. FIGS. 2a through 2e illustrate additional detailed views of the insertion placement system (100) and the docking station (200). FIGS. 3a and 3b illustrate additional detailed views of the catheter placement system (300) and the docking station (200). Although the embodiment disclosed herein relates to the placement of a central venous catheter (CVC), it will be understood that this is exemplary and that the system and method disclosed herein may be used, without limitation, to place various slender medical devices, including peripheral insertion central catheters (PICC), dialysis catheters, midline catheters, peripheral catheters, or others.

[0028] The insertion system (100) comprises a substantially cylindrical body (110) that extends from a proximal end to a distal end and forms a substantially circular cross section. However, it will be understood that other cross section shapes are also considered. In an embodiment, the body (110) is formed of a translucent material that, as described more specifically herein, advantageously allows a clinician to observe the components placed inside. The proximal portion of the body (110) comprises a guide wire housing (112), and the distal portion of the body (110) comprises an expander housing (114).

[0029] The guide wire housing (112) includes an elongated slot (122) disposed on the upper surface of the guide wire housing (112). The slot (122) extends longitudinally and communicates with the inner portion of the guide wire housing (112). The guide wire housing (112) includes a guide wire advance assembly (124) comprising a guide wire carriage (126) disposed within the inner portion of the guide wire housing (112), and a guide wire finger tab (128) extending to the outer portion of the guide wire housing (112) through the slot (122). In an embodiment, the guide wire finger tab (128) includes a release mechanism that a clinician needs to operate to allow the guide wire advance assembly (124) to slide longitudinally. For example, as illustrated in FIG. 2b, the guide wire advance assembly (124) may include a first finger tab (128A) and a second finger tab (128B), which requires the clinician to tighten the finger tabs (128A, 128B) before the guide wire advance assembly (124) can be slid longitudinally. In an embodiment, the finger tab (128) includes an actuator button that must be pressed before the guide wire advance assembly (124) can be slid longitudinally.

[0030] The guide wire carriage (126) is configured to be slidably coupled to the inner portion of the guide wire housing (112). For example, the carriage (126) forms a substantially cylindrical shape that forms a longitudinally extended and substantially circular cross-sectional shape that is slidably coupled to the cylindrical inner portion of the guide wire housing (112). In an embodiment, the carriage (126) may additionally include several openings and notches to accommodate various additional structures disposed within the guide wire housing (112), such as a blood flush tube or others, as described more specifically herein. The guide wire carriage (126) is coupled to the proximal end of an inserter guide wire (120) disposed axially within the guide wire housing (112). The inserter guide wire (120) extends distally from the carriage (126) to the distal end of the body (110).

[0031] The guide wire housing (112) further comprises a needle advance assembly (134) including a needle carriage (136) disposed within the inner portion of the guide wire housing (112), and a needle finger tab (138) extending to the outer portion of the guide wire housing (112) through a slot (122). In an embodiment, the needle finger tab (138) includes a release mechanism, e.g., finger tab (138A, 138B), which a clinician needs to operate to allow the needle advance assembly (134) to slide longitudinally as described herein. The needle carriage (136) is configured to slideably engage with the inner portion of the guide wire housing (112). For example, the needle carriage (136) forms a substantially cylindrical shape that forms a longitudinally extending and substantially circular cross-sectional shape that slideably engages with the cylindrical inner portion of the guide wire housing (112). In an embodiment, the needle carriage (136) additionally includes several openings and notches to accommodate various additional structures disposed within the guide wire housing (112), such as a blood flush tube or others, as described more specifically herein. The needle carriage (136) is coupled to the proximal end of a needle (130) disposed axially within the body (110). The needle (130) forms a needle lumen (132) and extends distally from the carriage (126) to a distal point of the distal end of the body (110).

[0032] The guide wire housing (112) further comprises a blood flush tube (160) coupled to the needle carriage (136) and fluidly communicating with the needle lumen (132). The blood flush tube (160) extends along the inner surface of the guide wire housing (112) between the needle carriage (136) and the proximal end of the guide wire housing (112). The blood flush tube (160) is made of a translucent material, which, together with the translucent material of the guide wire housing (112), allows a clinician to observe the blood flow within the blood flush tube (160) and confirm that the distal tip of the needle has approached the patient's vascular structure.

[0033] In an embodiment, the blood flush tube (160) is coupled to an actuator (162), for example, a blood flush button. The blood flush tube (160) is evacuated to provide a vacuum within it. When the needle is inserted into the patient, the clinician may press the actuator (162), and the actuator subsequently provides fluid communication between the blood flush tube (160) and the needle lumen (132). The vacuum within the blood flush tube (160) draws blood flow proximally through the needle lumen (132) and into the blood flush tube (160), thereby helping to observe the blood flow within the blood flush tube (160) and helping to confirm that the needle tip has approached the vascular structure. Advantageously, the vacuum draws blood flow faster than other methods, thereby providing faster venous access and preventing the needle from advancing further into an incorrect vessel, such as an artery, or preventing over-insertion of the needle (130), thereby preventing leakage from the distal wall of the vessel. All of these can be fatal to the patient.

[0034] The expander housing (114) includes an elongated slot (142) disposed on the upper surface of the expander housing (114). The slot (142) extends longitudinally and communicates with the inner portion of the expander housing (114). The expander housing (114) includes an expander advance assembly (144) comprising an expander carriage (146) disposed within the inner portion of the expander housing (114), and an expander finger tab (148) extending to the outer portion of the expander housing (114) through the expander housing slot (142). In an embodiment, the expander finger tab (148) includes a release mechanism, e.g., finger tabs (148A, 148B), which a clinician needs to operate to allow the expander advance assembly (144) to slide longitudinally as described herein.

[0035] The expander carriage (146) is configured to be slidably coupled to the inner portion of the expander housing (114). For example, the expander carriage (146) forms a substantially cylindrical shape that forms a longitudinally extended and substantially circular cross-sectional shape that is slidably coupled to the cylindrical inner portion of the expander housing (114). In an embodiment, the expander carriage (146) further includes several openings and notches to accommodate several additional structures disposed within the expander housing (114), as described herein.

[0036] An expander carriage (146) is coupled to the proximal end of an expander (140), which is axially positioned within an expander housing (114) and forms an expander lumen (158), as shown in FIG. 2c. The expander (140) extends distally from the expander carriage (146) to the distal end of the body (110). A splittable inserter shell ("inserter") (150) is axially positioned on the outer surface of the expander (140) and supported by an inserter hub (152). The inserter (150) forms an inserter lumen (154). As described more specifically herein, the expander (140) supports the inserter (150) and facilitates the insertion of the inserter before it is retracted.

[0037] The docking station (200) is disengagedly coupled to the distal end of the body (110), for example, to the distal end of the expander housing (114). In an embodiment, a spin nut (202) disengagesly secures the docking station to the distal end of the body (110), but other suitable attachment mechanisms, such as lugs, interference fits, Luer locks, clips, protrusions and stoppers, combinations thereof, or others, are considered.

[0038] As illustrated in FIGS. 2d and 2e, the docking station (200) comprises a body (210) formed by a first body part (212) and a second body part (214) joined along a longitudinal axis to form a docking station body (210). In an embodiment, the first body part (212) and the second body part (214) are joined along a plane perpendicular to the longitudinal direction, but it will be understood that within the scope of the invention, the first body part (212) and the second body part (212) may be joined along a plane horizontal to the longitudinal direction or a plane of other orientation. In an embodiment, the first body part (212) and the second body part (214) may be separated perpendicular to the longitudinal axis by pressing the body parts (212, 214) apart. This helps to remove the docking station from the insertion site after the catheter is placed, as described more specifically herein.

[0039] The docking station body (210) forms a longitudinally extending lumen (218) and is configured to accommodate one or a combination of the distal end of the dilator housing (114), a needle (130), a dilator (140), an inserter (150), or an inserter hub (152). In an embodiment, the lumen (218) is configured to hold the inserter hub (152) internally. Advantageously, this allows the clinician to release the inserter (150) during the procedure and thereby still maintain access to the blood vessel. As described herein, the docking station (200) can hold the inserter (150) at an accessible angle and align the inserter lumen (154) for the introduction of additional structures into the blood vessel structure.

[0040] The docking station body (210) includes a distal surface (216) configured to bond with the surface of the patient's skin, and, in the embodiment, includes an adhesive layer placed thereon. The distal surface (216) provides an increased surface area to provide increased stability by improving the adhesion between the docking station (200) and the surface of the patient's skin. Additionally, the distal surface (216) may be angled with respect to the longitudinal axis to stabilize the lumen of the docking station (200) at a preferred insertion angle. In the embodiment, the distal surface (216) may additionally include various other layers including various antibacterial, antibacterial, hemostatic properties, combinations thereof, or others. The docking station (200) further includes a concave side surface configured to provide a comfortable gripping surface for the clinician. The concave shape allows the clinician's fingers to grip the midpoint of the side surface of the docking station (200).

[0041] As illustrated in FIGS. 3a to 3c, a catheter placement system (300) comprises a docking portion (310) positioned at a distal end, a rail (312) extending proximally from a proximal side of the docking portion (310), and a locking hub (314) positioned at a distal end of the rail (312), wherein the locking hub (314) forms a locking hub lumen (342) extending along a longitudinal axis. The rail (312) extends from a lower edge of the docking portion (310) along a longitudinal axis to axially align the catheter (330) with the central lumen (352) of the docking portion (310). The distal end of the docking portion (310) includes a connecting portion (354) configured to be coupled to the proximal end of the docking station (200) and to axially align the central lumen (352) of the docking portion (310) with the central lumen (218) of the docking station (200). In an embodiment, the connecting portion (354) may be a male lure lock coupled to a female lure lock positioned at the proximal end of the docking station. It will be understood that other coupling structures, including mechanical pits, interference pits, snap pits, press-fits, spin nuts, clips, protrusions and stoppers, combinations thereof, and others, are also considered.

[0042] A catheter frame (316) is slidably coupled to the upper surface of a rail (312) and extends laterally upward and proximally to form a handle (318). The distal portion of the catheter frame (316) is configured to hold a portion of the catheter (330), for example, a catheter hub (332) is held by the catheter frame (316) in an interference pit. The proximal portion of the catheter frame (316) includes one or more clips, each clip being configured to hold the proximal end of an extension leg extending from the proximal end of the hub (332). For example, as shown in FIG. 3a, the catheter hub (332) includes a first extension leg (334), a second extension leg (336), and a third extension leg (338). The catheter frame (316) includes a first clip (324), a second clip (326), and a third clip (328) configured to hold a first extension leg (334), a second extension leg (336), and a third extension leg (338), respectively. The clips (324, 326, 328) may hold an angle convenient for accessing the extension legs (334, 336, 338) and, for example, to flush the lumen of the catheter with saline prior to placement.

[0043] In an embodiment, the first clip (324) is configured to align the first extension leg (334) with the locking hub lumen (342) and to receive the catheter guide wire (320). The first extension leg (334) further includes a flushing manifold (382) comprising one or more valves and a guide wire port (384), which allows the lumen of the catheter to be flushed prior to placement but prevents proximal flow. The catheter guide wire (320) extends through the locking hub lumen (342) and is aligned with the lumen of the first extension leg (334). In an embodiment, the first extension leg (334) further includes a spin nut (388) or a similar connection that couples the catheter (330) and the catheter frame (316) coupled thereto to the distal side of the locking hub (314) and prevents the catheter frame (316) from sliding longitudinally with respect to the rail (312). In an embodiment, as described more specifically herein, the spin nut (388) further includes a sterile barrier, for example, an extension leg sterile barrier (348) positioned between the spin nut (388) and the locking hub (314).

[0044] The locking hub (314) further includes a guide wire lock (378), such as a collet lock, which can be twisted against the locking hub (314) to secure the catheter guide wire (320) in place and twisted in the opposite direction to allow the catheter guide wire (320) to slide against the locking hub (314). The catheter guide wire (320) includes a guide wire hub (322) that is permanently attached to its proximal end. The guide wire hub (322) is configured to prevent the proximal end of the catheter guide wire (320) from advancing through the locking hub lumen (342). Advantageously, the guide wire lock (378) allows the clinician to lock the guide wire (320) in place and allow the guide wire (320) to be moved for the execution of other procedures. This contrasts with current systems in which a clinician must maintain a grip on the guide wire to prevent the guide wire from being pulled into the patient's vascular structure, thereby causing embolism and various associated complications. Additionally, the guide wire hub (322) is configured to prevent the proximal end of the guide wire (320) from advancing through the locking hub lumen (342) and into the lumen of the catheter (330), so that when the clinician releases the guide wire (320) while the guide wire lock (378) is unsecured, the guide wire (320) cannot still be pulled into the patient's vascular structure. This contrasts with current systems and methods that require the device to be retrieved over the proximal end of the guide wire.

[0045] The catheter guide wire (320) further comprises a sterile barrier (344) that surrounds the catheter guide wire (320) and extends from the guide wire hub (322) to the locking hub (314). The sterile barrier may comprise a gas-impermeable film, e.g., polyethylene, polypropylene, or others, to maintain the catheter guide wire (320) in a sterile environment and prevents the clinician from coming into contact with the portion of the guide wire (320) advancing into the patient's vascular structure. Additionally, the barrier (344) prevents the clinician from being exposed to body fluids when the guide wire (320) is withdrawn from the vascular structure. In an embodiment, the barrier (344) can be crushed, thereby allowing the catheter guide wire (320) to advance distally.

[0046] The catheter placement system (300) also includes a sterile barrier (346) extending between the locking hub (314) and the first extension leg (334) to maintain the guide wire (320) in a sterile environment when the guide wire is extended between the locking hub (314) and the first extension leg (334). The catheter placement system (300) also includes a rail sterile barrier (348) extending between the locking hub (314) and the proximal end of the docking portion (310). The rail sterile barrier (348) surrounds the rail (312) and a portion of the catheter (330). Advantageously, the rail sterile barrier (348) maintains the catheter (330) in a sterile environment and prevents a clinician from coming into contact with the portion of the catheter (330) advancing into the patient's vascular structure. Additionally, the barrier (348) prevents the clinician from being exposed to fluid when the catheter (330) is withdrawn from the vascular structure. In an embodiment, the rail barrier (348) includes an opening, through which a catheter frame (316), one or more extension legs (334, 336, 338), a catheter hub (332), or a combination thereof may be extended. In an embodiment, the proximal end of the rail barrier (348) is coupled to a sliding ring (356) that is slidably coupled to the rail (312) and allows the proximal end of the rail barrier (348) to slide longitudinally. In an embodiment, the distal end of the rail barrier (348) is coupled to a collar (358) that is coupled to the proximal end of the docking portion (310).

[0047] The docking portion (310) includes a housing (350) that forms a through-extended central lumen (352). As illustrated in FIG. 3c, the housing (350) includes a cap (380) that extends over a portion of the central lumen (352) of the housing. As described more specifically herein, the cap (380) can be separated from the housing (350), thereby allowing the catheter (330) to be released from the docking portion (310) after the catheter is placed in the vein.

[0048] The docking portion (310) further comprises an insertion retrieval assembly (360) comprising a clamp (362) configured to be coupled with an insertion hub (152). The clamp (362) forms a clamp lumen (366) that allows the clamp (362) to be coupled to an extender and allows various slender medical devices to pass through. For example, a catheter (330) may extend through the clamp (362) and into the lumen of the insertion (150). In an embodiment, the clamp (362) opens a valve located within the insertion hub (152). The valve is configured to prevent proximal blood flow when the docking station (200) is detached from the insertion placement system (100). The clamp (362) opens the valve when the catheter placement system (300) is connected to provide a path through which the catheter can pass. The clamp (362) further includes a leak line (364) that extends longitudinally and is configured to facilitate separating the clamp (362) into a first half (362A) and a second half (362B). The leak line (364) may include a scoreline, a perforation, a laser cutting line, or a similar weak line to facilitate separating the clamp (362) into a first half (362A) and a second half (362B).

[0049] The inserter retrieval assembly (360) further comprises a first reel (370) and a second reel (372) disposed within the housing (350) and laterally spaced so as to be disposed on opposite sides of the central axis of the housing (350). In an embodiment, the first reel (370) and the second reel (372) are coupled by a gear mechanism such that when the first reel (370) is rotated, the gear mechanism also rotates the second reel (372). Similarly, it will be understood that when the second reel (372) is rotated, the gear mechanism also rotates the first reel (370). In an embodiment, when the first reel (370) is rotated, for example, clockwise, the gear mechanism rotates the second reel (372) in the opposite direction, i.e., counter-clockwise.

[0050] The first reel (370) includes a first pull tab (374) extending between the first reel (370) and the first half (362A) of the clamp. The second reel (372) includes a second pull tab (376) extending between the second reel (372) and the second half (362B) of the clamp. A twist knob (368) is coupled to a first reel (370) to allow a clinician to rotate the first reel (370) and the second reel (372), which in turn retracts the first pull tab (374) around the first reel (370) and the second pull tab (376) around the second reel (372), which separates the clamp (362), the inserter hub (152), and the inserter (150) coupled thereto into two separate halves along the longitudinal axis and winds each half around the respective first and second reels (370, 372). In an embodiment, the second reel (372) is coupled to a second twist knob (not shown), and the first reel (370) and the second reel (372) are configured to rotate independently of each other. Other mechanisms and methods for rotating the reel (370, 372) included within the scope of the present invention may also be understood.

[0051] Method of use

[0052] In an exemplary method of use, a rapid insertion central catheter (RICC) system (10) is provided, comprising an insertion placement system (100), a docking station (200), and a catheter placement system (300). Generally, this method comprises a two-step process of using the insertion placement system (100) to place the docking station (200) and the insertion (150) within the patient's vascular structure, and then removing the insertion placement system (100) from the docking station (200) and coupling the catheter placement system (300) to the docking station (200) for the placement of the catheter (330).

[0053] As illustrated in FIG. 4a and as described herein, an inserter placement system (100) is provided, wherein a docking station (200) is disposably coupled to a distal end. The inserter placement system (100) comprises a needle (130), which is coupled to a needle advance assembly (134) and extends distally through a lumen (218) of the docking station (200) to a point distally relative to the distal surface (216) of the docking station. The inserter placement system (100) and the docking station (200) assembly further comprise a cap (102) which is positioned over the distal end of the needle (130) and coupled to the distal surface (216) of the docking station (200), the distal end of the docking station lumen (218), or a combination thereof. The cap (102) is formed of an elastic material and is configured to provide a sterile barrier to prevent damage to the needle during transport, to prevent accidental needle stick injury, and to prevent contamination of the needle (130) before use. Thus, the cap (102) is removed, and the inserter placement system (100) and docking station (200) assembly are ready for use.

[0054] The insertion device placement system (100) and docking station (200) assembly is advanced distally until the distal tip of the needle (130) penetrates the surface of the patient's skin. Subsequently, the clinician operates a blood flush button (162) to release the vacuum within the blood flush tube (160). As illustrated in FIG. 4b, the needle (130) is advanced until the tip approaches the patient's vascular structure (20). The vacuum released by the blood flush button (162) induces proximal flow through the needle lumen (132) and into the blood flush tube (160) that is fluidly connected to the needle lumen (132). The clinician can observe the presence or absence of blood color and pulsating blood flow through the blood flush tube (160) and, accordingly, determine whether the needle (130) has approached a venous or arterial vascular structure.

[0055] As illustrated in FIG. 4c, once access to the correct vascular structure is confirmed, the guide wire advance assembly (124) can be actuated to advance the distal end of the inserter guide wire (120) through the needle lumen (132) and into the patient's vascular structure (20). To actuate the guide wire advance assembly (124), the clinician may press the finger tab of the guide wire assembly, which is coupled to the guide wire carriage (126), distally. In an embodiment, the finger tab (128) includes a locking mechanism as described herein, and this locking mechanism requires the clinician to tighten a pair of finger tabs (128A, 128B) laterally inward to advance the guide wire advance assembly (124) distally. As the distal end of the insertion guide wire (120) advances past the tip of the needle (130), the guide wire abrades the soft end of the needle (130), causing the needle to become dull. Advantageously, this prevents accidental needle puncture injury when the needle is removed from the vascular structure (20).

[0056] As illustrated in FIG. 4d, the expander advance assembly (144) is subsequently advanced distally to advance the expander (140) and the inserter (150) placed thereon. The expander advance assembly (144) is advanced by distally operating the finger tab (148). In an embodiment, the finger tab (148) may include a locking mechanism, and such locking mechanism requires that a pair of tabs be pinched laterally inward before the expander advance assembly (144) can be advanced distally as described herein. The expander advance assembly (144) is advanced until the inserter hub (152) supporting the inserter (150) is placed within the lumen (218) of the docking station (200). In an embodiment, a portion of the docking station lumen (218) is formed to match the outer surface of the inserter hub (152) so that the inserter hub (152) is held by the docking station by a friction fitting connection. It will be understood that, in order to further hold the inserter hub (152) within the lumen (218), the docking station lumen (218) may additionally include various clips, stoppers, protrusions, barbs, combinations thereof, and others.

[0057] As illustrated in FIG. 2c, the dilator (140) includes a tapered tip that fits snugly around the outer surface of the needle (130). Additionally, the inserter (150) also includes a tapered tip that fits snugly around the outer surface of the dilator (140). Thus, when the dilator advancing assembly (144) is advanced, the dilator (140) expands the insertion site. Additionally, the inserter (150) further expands the insertion site. This expands the insertion site from the diameter of the needle (130) to a diameter sufficient to accommodate a catheter (330), for example, a triple-lumen central venous catheter.

[0058] As illustrated in FIG. 4e, once the distal end of the inserter is placed within the patient's vascular structure (20), the needle retrieval assembly (134) is actuated to proximally retract the needle (130) so that the dilator (140) and the inserter (150) can be left in place. It should be noted that both the needle retrieval assembly (134) and the guide wire advancement assembly (124) are slidably coupled with the guide wire housing slot (122). Thus, when the needle retrieval assembly (134) is actuated proximally, the needle finger tab (138), the needle carriage (136), or a combination thereof is in contact with the guide wire finger tab (128), the guide wire carriage (126), or a combination thereof, and the inserter guide wire (120) is simultaneously proximally retracted. Thus, the needle (130) and the inserter guide wire (120) are retracted into the body (110) of the inserter placement system (100). Advantageously, the needle and guide wire are housed within the body (110) to prevent exposure to the clinician and to prevent accidental puncture injury. Additionally, as shown in FIG. 4e, a blood flush tube (160) extending along the inner surface of the guide wire housing (112) is bent to accommodate the movement of the needle carriage coupled thereto.

[0059] As illustrated in FIGS. 4f and 4g, when the distal end of the inserter (150) is positioned within the vascular structure (20) and the inserter hub (152) is positioned within the docking station lumen (218), the dilator advancing assembly (144) can be proximally retracted and, accordingly, the dilator (140) can be retracted into the dilator housing (114). Advantageously, this accommodates the dilator (140) within the dilator housing (114), thereby preventing exposure to the clinician.

[0060] The distal surface (216) of the docking station (200) comprises an adhesive layer as described herein. The adhesive layer (222) further comprises a cover placed thereon to protect the adhesive layer (222) during manufacturing and transport. The cover (224) can be removed to expose the adhesive layer (222), and the docking station (200) can be advanced distally until the distal surface (216) comes into contact with the surface of the patient's skin and the docking station (200) is secured thereto. Subsequently, the inserter placement system (100) can be detached from the docking station (200), for example, by twisting and releasing the spin nut (202), thereby leaving the inserter (150) placed within the vascular structure (20) supported by the docking station (200). Advantageously, the docking station (200) supports the inserter without the clinician needing to hold the inserter's gripping portion.

[0061] As illustrated in FIG. 4h and as described herein, a catheter placement system (300) comprising a catheter (330), for example a triple-lumen CVC catheter, is provided. The lumen of the catheter (330) can be flushed by attaching a syringe or other saline fluid to a port located at the proximal end of an extension leg (336, 338) or to a side port (386) of a manifold (382). Subsequently, the catheter placement system (300) is coupled to a docking station (200). As described herein, a connection (354) is coupled to the proximal portion of the docking station lumen (218) with a Luer lock or an interference fitting connection. As the connection part (354) is coupled with the docking station (200), the clamp (362) is also coupled with the inserter hub (152) and optionally opens a valve placed within the inserter hub (152).

[0062] As illustrated in FIG. 4i, when the catheter placement system (300) is coupled to the docking station (200), the catheter guide wire (320) can be advanced through the locking hub (314), through the lumen of the catheter (330), and through the inserter (150) until the distal end of the catheter guide wire (320) extends beyond the distal tip of the inserter (150) into the patient's vascular structure (20). In an embodiment, the catheter guide wire (320) includes a measurement demarcation positioned along the shaft of the catheter guide wire (320) to indicate to the clinician the length of the catheter guide wire (320) placed within the patient's vascular structure. Accordingly, the clinician can advance the catheter guide wire (320) until the distal tip of the catheter guide wire is positioned at a desired distance within the patient's vascular structure near the target location. Subsequently, the clinician can lock the catheter guide wire (320) in place using the guide wire lock (378).

[0063] As illustrated in FIG. 4j, the first extension leg (334) is released from the locking hub (314) by rotating the spin nut (388). This allows the catheter frame (316) and the catheter (330) coupled thereto to slide distally along the rail (312). A clinician may, for example, grasp the catheter frame (316) at the handle (318) and push the catheter (330) distally to advance the distal tip through the docking station lumen (218), through the clamp lumen (366), through the inserter (150) lumen, and to a point distally at the distal tip of the inserter (150) on the catheter guide wire (320).

[0064] It should be noted that when the catheter frame (316) advances, the crushing extension leg sterile barrier (346) deploys to maintain the sterile barrier between the extension leg (338) and the locking hub (314). Similarly, the rail sterile barrier (348) allows the catheter (330) and the catheter frame (316) to slide along the rail (312) while maintaining the catheter (330) in a sterile environment.

[0065] As illustrated in FIG. 4k, when the distal tip of the catheter (330) is placed within the vascular structure (20), the inserter (150) can be retracted by twisting the knob (368). As described herein, the operating knob (368) rotates the first reel (370) and the second reel (372) to retract and split the clamp (362) into two halves, and then splits and retracts the inserter hub (152) into two halves, and then splits and retracts the inserter (150) into two separate halves. Each clamp half, hub half, and inserter sheath half is wound around each reel (370, 372) and stored within the housing (350). This removes the inserter from the insertion site while the catheter (330) is placed and maintained within the vascular structure (20).

[0066] As illustrated in FIG. 4L, when the inserter (150) is removed from the lumen (352) of the housing (350), the catheter frame (316) can be further advanced to advance the distal tip of the catheter (330) further into the patient's vascular structure. As illustrated in FIG. 4M, when the catheter (330) is further positioned within the vascular structure (20), the guide wire lock (378) can be released and the guide wire can be proximally retracted until the distal tip of the catheter guide wire (320) is retracted from the catheter (330). Optionally, the catheter guide wire (320) can then be re-locked in place using the guide wire lock (378).

[0067] As illustrated in FIG. 4n, the catheter placement system (300) and the docking station (200) can be subsequently removed. A collar (358) supporting the distal end of the rail sterile barrier (348) is detached from the proximal end of the housing (350). A connecting part (354) is detached from the docking station (200). A housing cap (380) is detached from the housing (350) to expose a portion of the catheter (330) placed within the central lumen (352) of the housing (350). A catheter hub (332) is detached from the catheter frame (316), and extension legs (334, 336, 338) are detached from their respective clips (324, 326, 328) so that the extension legs can be pulled through the collar (358). Next, the catheter placement system (300) can be removed from the catheter (330).

[0068] Subsequently, the docking station (200) is removed from the insertion site by laterally pressing the first body part (212) and the second body part (214). The two body parts can be separated along the leak-line, thereby allowing the docking station (200) to be removed. Subsequently, the catheter (330) can be stabilized again against the surface of the patient's skin.

[0069] While some specific embodiments have been disclosed herein and some specific embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concept provided herein. Additional configurations and / or modifications may be apparent to those skilled in the art and are included in a broader sense. Accordingly, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

Claim 1 As a rapid insertion central catheter system, an introducer placement system configured to place an introducer within a patient's vasculature, wherein the introducer placement system comprises: a needle defining a needle lumen; an introducer guidewire placed within the needle lumen; a dilator forming a dilator lumen; an introducer forming an introducer lumen supported by an introducer hub and configured to receive the dilator placed therein; a guidewire housing comprising a guidewire advancement assembly coupled to the proximal end of the introducer guidewire and a needle retraction assembly coupled to the proximal end of the needle; and a dilator housing comprising a dilator advancement assembly coupled to the proximal end of the dilator and coupled to the distal end of the guidewire housing. and a blood flash indicator tube fluidically coupled to the needle lumen; comprising - a docking station forming a lumen that is releasably coupled to the distal end of the dilator housing and configured to hold the inserter hub; and a catheter placement system coupled to the proximal end of the docking station and configured to place the catheter within the patient's vascular structure - the catheter placement system comprises: a docking portion configured to be coupled to the docking station to axially align the catheter with the inserter lumen; a rail extending proximally from the docking portion; and a locking hub disposed at the proximal end of the rail and forming a locking hub lumen;A rapid insertion central catheter system comprising: a catheter guide wire including a guide wire hub permanently attached to the proximal end of the catheter guide wire, wherein a portion of the guide wire is disposed within the locking hub lumen; and a catheter frame slidably coupled to the rail; and wherein the catheter is supported by the catheter frame. Claim 2 A rapid insertion central catheter system according to claim 1, wherein the insertion placement system further comprises a blood flush actuator, and the blood flush actuator is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow through the needle lumen into the blood flush indicator tube. Claim 3 In paragraph 2, the blood flow disposed within the blood flush indicator tube is observable through the blood flush indicator tube and the guide wire housing, in a rapid insertion central catheter system. Claim 4 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein one of the rail and the catheter guide wire is disposed within a collapsible sterile barrier to prevent contact between them. Claim 5 A rapid insertion central catheter system according to claim 4, wherein the catheter is disposed within the crushable sterile barrier in which the rail is disposed, and the catheter frame is configured to extend through an opening disposed within the side wall of the sterile barrier and to be grasped by a clinician. Claim 6 A rapid insertion central catheter system comprising, in any one of claims 1 to 3, a release mechanism requiring one of the guide wire advance assembly, the needle retrieval assembly, and the dilator advance assembly to move a pair of finger tabs laterally inward before allowing any longitudinal movement. Claim 7 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the guide wire of the insertion device placement system is configured such that when the guide wire advances distally through the needle lumen, the guide wire abrades the edge of the needle and blunts the tip of the needle. Claim 8 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the distal advancement of the dilator advancement assembly causes the dilator and the inserter to advance distally over the guide wire and the needle. Claim 9 A rapid insertion central catheter system, wherein, in any one of claims 1 to 3, the proximal withdrawal of the needle withdrawal assembly causes the proximal withdrawal of the needle and the insertion guide wire. Claim 10 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the distal advancement of the dilator advancement assembly transfers the inserter from the dilator housing to the docking station. Claim 11 In claim 10, the proximal retrieval of the dilator advancing assembly causes the proximal retrieval of the dilator from the lumen of the inserter, a rapid insertion central catheter system. Claim 12 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the docking station forms a distal surface comprising an adhesive layer configured to adhere the docking station to the skin surface of a patient. Claim 13 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the width of the guide wire hub of the catheter guide wire is wider than the width of the locking hub lumen to prevent the proximal end of the catheter guide wire from passing through the locking hub lumen. Claim 14 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the docking portion of the catheter placement system comprises an insertion retrieval assembly configured to divide the insertion into a first half and a second half along a longitudinal axis, and wherein the first half is wound around a first reel and the second half is wound around a second reel. Claim 15 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the locking hub further comprises a guide wire lock configured to lock the catheter guide wire and prevent longitudinal movement relative to the locking hub. Claim 16 A rapid insertion central catheter system according to any one of claims 1 to 3, wherein the docking station comprises a breach line extending longitudinally, and is configured to separate along the breach line when the first body portion and the second body portion of the docking station are compressed laterally outward. Claim 17 A rapid insertion central catheter system comprising: an insertion device placement system configured to place an insertion device within a patient's vascular structure; a docking station distally coupled to the distal end of the insertion device placement system, wherein the docking station forms a lumen configured to hold an insertion device hub; and a catheter placement system coupled to the proximal end of the docking station and configured to place a catheter within a patient's vascular structure, wherein the catheter placement system is configured to axially align the catheter with the lumen of the insertion device when coupled with the docking station. Claim 18 In paragraph 17, the insertion placement system comprises one of a needle, an insertion guide wire, an expander, an insertion device, an insertion hub, and a blood flush indicator tube, a rapid insertion central catheter system. Claim 19 In paragraph 18, the insertion placement system comprises a blood flush actuator, and the blood flush actuator is configured to release a vacuum placed within the blood flush indicator tube to draw proximal blood flow into the blood flush indicator tube through the lumen of the needle, a rapid insertion central catheter system. Claim 20 In any one of claims 17 to 19, the catheter placement system comprises one of a docking portion, a rail, a locking hub, a catheter guide wire, and a catheter frame, a rapid insertion central catheter system. Claim 21 In claim 20, a rapid insertion central catheter system wherein one of the rail, the catheter, and the catheter guide wire is placed within a crushable sterile barrier to prevent contact between them. Claim 22 A rapid insertion central catheter system according to any one of claims 17 to 19, wherein the insertion placement system comprises one of a guide wire advance assembly, a needle retrieval assembly, and an expander advance assembly. Claim 23 A rapid insertion central catheter system according to claim 22, comprising a release mechanism to allow one of the guide wire advance assembly, the needle retrieval assembly, and the dilator advance assembly to slide longitudinally.

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