Rapid insertion central venous catheter system

The RICC system simplifies CVC insertion by using a two-stage approach with a docking station to support the introducer and guidewire hub, reducing manual handling and complications, and ensuring sterility, thus enhancing procedural efficiency and safety.

JP7611924B2Active Publication Date: 2025-01-10BARD ACCESS SYSTEMS INC
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Patent Information

Application Number
JP2022544783
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-01-23
Filing Date
2021-01-22
Publication Date
2025-01-10
Estimated Expiration
2041-01-22

AI Technical Summary

Technical Problem

Existing central venous catheter (CVC) insertion methods are complex and require multiple steps, often necessitating clinicians to manually hold the introducer, increasing the risk of complications and inefficiency.

Method used

A two-stage rapid insertion central venous catheter (RICC) system comprising an introducer placement system, a docking station, and a catheter placement system, which simplifies the process by allowing the introducer to be released during the procedure, using a guidewire hub to prevent embolism and a collapsible sterile barrier to maintain sterility, and includes a docking station that supports the introducer without manual grip.

Benefits of technology

The RICC system reduces the complexity and risk of complications by enabling fewer parts and steps, maintaining vascular access, and preventing guidewire embolism, while ensuring sterility and ease of use.

✦ Generated by Eureka AI based on patent content.

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Abstract

A two-stage rapid insertion central venous catheter (RICC) is disclosed that may include an introducer placement system, a docking station, and a catheter placement system. The introducer placement system can place an introducer within the vasculature. The introducer is supported by a docking station that is detached from the distal end of the introducer placement system. The catheter placement system can be configured to couple to the docking station, and a catheter can be advanced through the introducer into the vasculature. The introducer is then split and retracted before the docking station is detached from the catheter placement system. The docking station may be configured to split and detach from the catheter. The RICC system may include a guidewire hub to prevent embolism by the guidewire, a collapsible sterile barrier to prevent contamination, and a locking feature to prevent premature advancement of the guidewire, dilator, or the like.
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Description

Summary of the Invention [Means for solving the problem]

[0001] In summary, the embodiments disclosed herein relate to a two-stage rapidly inserted central catheter (RICC) system. In one embodiment, the two-stage RICC system includes an introducer placement system, a docking station, and a catheter placement system. The introducer placement system can place an introducer in the vasculature. The introducer is supported by a docking station that is detached from a distal end of the introducer placement system. The docking station allows access to the vasculature to be maintained and allows the clinician to release the grip of the introducer once it is in place in the vasculature. In one embodiment, the catheter placement system is coupled to the docking station and the catheter can be advanced through the introducer into the vasculature. The introducer is then split and retracted before the docking station is detached from the catheter placement system. Finally, the docking station is split and detached from the catheter. Some embodiments include a guidewire hub to prevent embolism from the guidewire, a collapsible sterile barrier to prevent contamination, and a locking feature to prevent premature advancement of the guidewire, dilators, etc.

[0002] The embodiments described herein allow for a simplified insertion process for a central venous catheter (CVC) catheter or similar device. The process can be performed with fewer parts and steps, and the parts to be inserted are contained within a sterile barrier or the like. Some embodiments include a guidewire hub, a locking device to prevent guidewire embolism, and a docking station to support the introducer. The docking station allows the clinician to release the introducer during the procedure, which is not possible with conventional methods, as the clinician must continue to hold the introducer, requiring other steps to be performed with one hand.

[0003] The rapid insertion central venous catheter system disclosed herein includes an introducer placement system configured to place an introducer within a patient's vasculature, the introducer placement system having a needle defining a needle lumen, an introducer guidewire disposed within the needle lumen, a dilator defining a dilator lumen, an introducer supported by an introducer hub and defining an introducer lumen configured to receive the dilator, a guidewire housing having a guidewire advancement assembly coupled to a proximal end of the introducer guidewire and a needle retraction assembly coupled to a proximal end of the needle, a dilator housing coupled to a distal end of the guidewire housing and having a dilator advancement assembly coupled to a proximal end of the dilator, and a blood flush indicator tube fluidly connected to the needle lumen. The rapid insertion central venous catheter system may further include a docking station releasably coupled to a distal end of the dilator housing, the docking station defining a lumen configured to hold an introducer hub; a catheter placement system configured to engage a proximal end of the docking station to place a catheter within a patient's vasculature, the docking portion configured to engage the docking station to axially align the catheter with the introducer lumen; a rail extending proximally from the docking portion; a locking hub disposed at a proximal end of the rail and defining a locking hub lumen; a catheter guidewire having a guidewire hub permanently attached to a distal end thereof, a portion of the guidewire disposed within the locking hub lumen; a catheter frame in slidable engagement with the rail; and a catheter supported by the catheter frame.

[0004] In some embodiments, the introducer placement system further includes a blood flush actuation mechanism configured to release a vacuum in the blood flush indicator tube to draw proximal blood flow through the needle lumen into the blood flush indicator tube. Blood flow in the blood flush indicator tube is observable through the blood flush indicator tube and the guidewire housing. One of the rail and the catheter guidewire is disposed within a collapsible sterile barrier to prevent contact with one of the rail and the catheter guidewire. The catheter is disposed within the collapsible sterile barrier with the rail disposed therein. The catheter frame is configured to be grasped by a clinician through an opening in a sidewall of the sterile barrier.

[0005] In some embodiments, one of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly has a release mechanism that requires a pair of finger tabs to be moved laterally inward before longitudinal movement of the release mechanism is permitted. The guidewire of the dilator placement system is configured to blunt the tip of the needle as the guidewire advances distally through the needle lumen. Distal advancement of the dilator assembly advances the dilator and introducer distally over the needle and guidewire. Proximal retraction of the needle retracts the needle and introducer guidewire proximally. Distal advancement of the dilator advancement assembly delivers the introducer from the dilator housing to the docking station. Proximal retraction of the dilator advancement assembly retracts the dilator proximally from the introducer lumen.

[0006] In some embodiments, the docking station defines a distal surface having an adhesive layer configured to adhere the docking station to a skin surface of a patient. A width of the guidewire hub of the catheter guidewire is greater than a width of the locking hub lumen, thereby preventing a proximal end of the catheter guidewire from passing through the locking hub lumen. The docking portion of the catheter placement system includes an introducer retraction assembly configured to split the introducer into a first half portion and a second half portion along a longitudinal axis. The first half portion is wound on a first reel and the second half portion is wound on a second reel. The locking hub further includes a guidewire lock configured to lock the catheter guidewire and prevent longitudinal movement of the catheter guidewire relative to the locking hub. The docking station includes a longitudinally extending break line and is configured to separate along the break line when the first and second body portions of the docking station are biased laterally outward.

[0007] Also disclosed is a two-step method of placing a catheter in a patient's vascular system, the method comprising a first step of placing an introducer with an introducer placement system having a body, a docking station releasably coupled to a distal end of the body, a needle, an introducer guidewire, a dilator, and an introducer, and a second step of placing a catheter with the catheter placement system having a docking portion, a rail having a catheter frame slidably engaged to the rail, a catheter releasably coupled to the catheter frame, and a locking hub disposed at a proximal end of the rail. The method includes accessing the vasculature with a needle, advancing an introducer guidewire through the lumen of the needle, advancing a dilator with the introducer disposed thereon over the needle to deliver the introducer from the body to a docking station, retracting the needle and guidewire from the dilator, retracting the dilator from the introducer, removing the body of the introducer placement system from the docking station, coupling a docking portion of the catheter placement system to a proximal end of the docking station, and advancing the catheter guidewire through the lumen of the catheter and the introducer until a distal portion is disposed distal to the distal end of the introducer. advancing the catheter through the lumen of the introducer by advancing the catheter frame distally; splitting the introducer into a first half-portion and a second half-portion along the longitudinal axis by moving the introducer retraction assembly, wherein the first half-portion of the introducer is wound onto the first reel and the second half-portion of the introducer is wound onto the second reel; retracting the catheter guidewire distally from the catheter; removing the catheter placement system from the docking station; and removing the docking station from the catheter.

[0008] In some embodiments, reaching the vasculature with the needle further comprises verifying that the needle has reached the vessel by activating a blood flush actuation mechanism configured to draw proximal blood flow through the needle lumen and into the blood flush indicator tube by releasing a vacuum in the blood flush indicator tube. Reaching the vasculature with the needle further comprises observing blood flow through the blood flush indicator tube and the body of the introducer placement system. One of advancing the introducer guidewire, advancing the dilator, and retracting the needle includes releasing a locking mechanism by pinching the pair of finger tabs together before longitudinally moving the pair of finger tabs relative to the introducer placement system. Advancing the catheter guidewire distally includes collapsing a guidewire sterile barrier between the guidewire hub and the locking hub of the catheter placement system, the guidewire sterile barrier enclosing the catheter guidewire to prevent a clinician from contacting the catheter guidewire.

[0009] In some embodiments, advancing the catheter frame distally includes collapsing a portion of the rail sterile barrier between the catheter frame and a docking portion of the catheter placement system, the rail sterile barrier enclosing a portion of the rail and the catheter to prevent a clinician from contacting a portion of the catheter. The portion of the catheter frame extends through an opening disposed in a sidewall of the rail sterile barrier to allow a clinician to grasp a portion of the catheter frame and urge the catheter frame distally. Advancing the catheter frame distally includes expanding an extension leg sterile barrier between the locking hub and an extension leg of the catheter, the extension leg sterile barrier enclosing a catheter guidewire to prevent a clinician from contacting the catheter guidewire. Advancing the introducer guidewire through the lumen of the needle further includes blunting a tip of the needle.

[0010] In some embodiments, delivering the introducer from the body to the docking station further comprises the introducer hub being held within the lumen of the docking station. Removing the docking station from the body further comprises adhering a distal face of the docking station to a skin surface of the patient. The catheter guidewire further comprises a guidewire hub permanently attached to a proximal end, the guidewire hub configured to prevent a proximal end of the catheter guidewire from entering the lumen of the catheter. Coupling the catheter placement system to the proximal end of the docking station further comprises coupling a clamp of the introducer retraction assembly to the introducer hub, the clamp opening a valve disposed within the introducer hub. Advancing the catheter guidewire proximally comprises unlocking a guidewire lock to allow longitudinal movement of the catheter guidewire relative to the catheter placement system, whereafter the guidewire lock is locked to inhibit longitudinal movement of the catheter guidewire relative to the catheter placement system when the distal end of the catheter guidewire is proximate to the target location.

[0011] In some embodiments, moving the introducer retraction assembly further includes rotating a twist knob of the introducer retraction assembly. Removing the catheter placement system from the docking station further includes removing a cap portion of the catheter placement system to allow transverse movement of the catheter placement system relative to the catheter. Removing the docking station from the catheter further includes splitting the docking station longitudinally along the break line by biasing the first and second portions laterally outward.

[0012] Another rapid insertion central venous catheter system disclosed herein includes an introducer placement system configured to place an introducer within a patient's vasculature, a docking station releasably coupled to a distal end of the introducer placement system, and a catheter placement system configured to engage a proximal end of the docking station to place a catheter within the patient's vasculature.

[0013] In some embodiments, the introducer placement system includes one of a needle, an introducer guidewire, a dilator, an introducer, an introducer hub, and a blood flush indicator tube. The introducer placement system further includes a blood flush actuation mechanism configured to draw proximal blood flow through the needle lumen into the blood flush indicator tube by releasing a vacuum in the blood flush indicator tube. The catheter placement system includes one of a docking section, a rail, a locking hub, a catheter guidewire, and a catheter frame. The rail, catheter, and catheter guidewire are disposed within a foldable sterile barrier to prevent contact with the rail, catheter, and catheter guidewire. The introducer placement system includes one of a guidewire advancement assembly, a needle retraction assembly, and a dilator advancement assembly. The guidewire advancement assembly, needle retraction assembly, and dilator advancement assembly include a release mechanism.

[0014] Another method disclosed is a method of placing a catheter in a patient's vasculature, comprising placing an introducer in the patient's vasculature using an introducer placement system having a body and a docking station, detaching the body of the introducer placement system from the docking station, coupling the catheter placement system to the docking station, advancing a catheter into the patient's vasculature, removing the introducer using an introducer retraction assembly, and removing the catheter placement system and the docking station.

[0015] In some embodiments, placing the introducer further includes delivering the introducer from a body of the introducer placement system to a docking station. The method further includes an introducer hub of the introducer being held within a lumen of the docking station. The method further includes confirming that the needle has reached the vessel by actuating a blood flush actuation mechanism configured to draw proximal blood flow through the needle lumen and into the blood flush indicator tube by releasing a vacuum in the blood flush indicator tube.

[0016] In some embodiments, placing the introducer within the patient's vasculature further comprises advancing an introducer guidewire through the needle lumen and blunting the needle tip. Advancing the catheter into the patient's vasculature further comprises a guidewire hub permanently attached to a proximal end of the catheter guidewire, the guidewire hub configured to prevent the proximal end of the catheter guidewire from entering the lumen of the catheter. Removing the introducer further comprises splitting the introducer along the longitudinal axis.

[0017] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1A] FIG. 1 shows a perspective view of a two-stage rapid insertion catheter system including an introducer placement system, a docking station, and a catheter placement system according to an embodiment disclosed herein. [Figure 1B] FIG. 1 shows a perspective view of a two-stage rapid insertion catheter system including an introducer placement system, a docking station, and a catheter placement system according to an embodiment disclosed herein. [Figure 1C] FIG. 1 shows a perspective view of a two-stage rapid insertion catheter system including an introducer placement system, a docking station, and a catheter placement system according to an embodiment disclosed herein. [Figure 2A] 1A-1B depict various details of the introducer placement system according to embodiments disclosed herein. [Figure 2B] 1A-1B depict various details of the introducer placement system according to embodiments disclosed herein. [Figure 2C] 1A-1B depict various details of the introducer placement system according to embodiments disclosed herein. [Figure 2D] 1A-1B depict various details of the introducer placement system according to embodiments disclosed herein. [Figure 2E] 1A-1B depict various details of the introducer placement system according to embodiments disclosed herein. [Figure 3A]1D illustrates various details of the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 3B] 1D illustrates various details of the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 3C] 1D illustrates various details of the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4A] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4B] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4C] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4D] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4E] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4F] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4G] 1A-1B show various stages of deployment of the introducer deployment system according to embodiments disclosed herein; [Figure 4H] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4I] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4J] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4K] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4L] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4M] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. [Figure 4N] 1D illustrates various stages of catheter placement using the catheter placement system of FIG. 1C according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0020] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0021] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter 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 intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter 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 can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0022] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0023] In the described embodiment, as shown in Figure 1A, the longitudinal axis extends generally parallel to the axial length of the needle 130. The lateral axes extend perpendicular to the longitudinal axis, and the transverse axes extend perpendicular to both the longitudinal and lateral axes.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A-1C show various details of a two-stage rapidly inserted central catheter (RICC) system 10 according to embodiments described herein, including an introducer placement system 100, a docking station 200, and a catheter placement system 300. FIGS. 2A-2E show the introducer placement system 100 and the docking station 200 in further detail. FIGS. 3A and 3B show the catheter placement system 300 and the docking station 200 in further detail. Although the embodiments disclosed herein are applied to the placement of a central venous catheter (CVC), this is by way of example only, and the systems and methods disclosed herein may be used to place a variety of elongated medical devices, such as peripherally inserted central catheters (PICCs), dialysis catheters, midline catheters, peripheral catheters, etc.

[0025] The introducer placement system 100 includes a generally cylindrical body 110 having a generally circular cross-section and extending from a proximal end to a distal end. It is understood that other cross-sectional shapes may be used. In one embodiment, the body 110 is formed from a translucent material to allow a clinician to view components disposed therein, as will be described in more detail below. The proximal portion of the body 110 includes a guidewire housing 112, and the distal portion of the body 110 includes a dilator housing 114.

[0026] Guidewire housing 112 has an elongated slot 122 disposed on a top surface of guidewire housing 112. Slot 122 extends longitudinally and communicates with the interior of guidewire housing 112. Guidewire housing 112 includes a guidewire advancement assembly 124 having a guidewire carriage 126 disposed inside guidewire housing 112 and a guidewire finger tab 128 extending through slot 122 to the exterior of guidewire housing 112. In one embodiment, guidewire finger tab 128 has a release mechanism that requires a clinician to actuate in order to slide guidewire advancement assembly 124 longitudinally. For example, as shown in FIG. 2B, guidewire advancement assembly 124 has first and second finger tabs 128A and 128B that require a clinician to pinch and move finger tabs 128A and 128B laterally inward to slide guidewire advancement assembly 124 longitudinally. In one embodiment, finger tab 128 includes an actuator button that must be pressed before guidewire advancement assembly 124 can be slid longitudinally.

[0027] Guidewire carriage 126 is configured to slidably engage the interior of guidewire housing 112. For example, carriage 126 is generally cylindrical in shape and extends longitudinally with a generally circular cross-sectional shape that slidably engages the cylindrical interior of guidewire housing 112. In one embodiment, carriage 126 further includes a number of openings and notches to accommodate other structures disposed within guidewire housing 112, such as a blood flush tube, which will be described in more detail below. Guidewire carriage 126 is coupled to a proximal end of introducer guidewire 120 that is axially disposed within guidewire housing 112. Introducer guidewire 120 extends distally from carriage 126 to the distal end of body 110.

[0028] Guidewire housing 112 further includes a needle advancement assembly 134 having a needle carriage 136 disposed inside guidewire housing 112 and a needle finger tab 138 extending through slot 122 to the outside of guidewire housing 112. In one embodiment, needle finger tab 138 has a release mechanism, such as finger tabs 138A and 138B, that must be actuated by a clinician to slide needle advancement assembly 134 longitudinally. Needle carriage 136 is configured to slidably engage the inside of guidewire housing 112. For example, needle carriage 136 is generally cylindrical in shape and extends longitudinally with a generally circular cross-sectional shape that slidably engages the cylindrical interior of guidewire housing 112. In one embodiment, needle carriage 136 further includes a number of openings and notches to accommodate other structures disposed within guidewire housing 112, such as a blood flush tube, which will be described in more detail below. The needle carriage 136 is coupled to a proximal end of a needle 130 that is axially disposed within the body 110. The needle 130 defines a needle lumen 132 and extends distally from the carriage 126 to a location distal to the distal end of the body 110.

[0029] Guidewire housing 112 further includes a blood flush tube 160 coupled to needle carriage 136 and in communication with needle lumen 132. Blood flush tube 160 extends along the inner surface of guidewire housing 112 between needle carriage 136 and the proximal end of guidewire housing 112. Because blood flush tube 160 is made of a translucent material, and guidewire housing 112 is also formed of a translucent material, the clinician can observe the blood flow within blood flush tube 160 to ensure that the distal tip of the needle has reached the vasculature.

[0030] In one embodiment, the blood flush tube 160 is connected to an actuation mechanism 162, such as a blood flush button. The blood flush tube 160 is evacuated to create a vacuum inside. When the needle is inserted into the patient, the clinician presses the actuation mechanism 162, placing the blood flush tube 160 in communication with the needle lumen 132. The vacuum in the blood flush tube 160 draws blood proximally through the needle lumen 132 and into the blood flush tube 160, allowing easy observation of the blood flow in the blood flush tube 160 and confirmation that the needle tip has reached the vasculature. This allows for quicker blood flow to be drawn in and a quicker indication of vein access than would be the case if the vacuum were not created. This prevents the needle from being advanced too far into the wrong vessel, such as an artery, or from being inserted too far into the vessel and breaching the opposite wall, which could be detrimental to the patient.

[0031] The dilator housing 114 has an elongated slot 142 disposed on a top surface of the dilator housing 114. The slot 142 extends longitudinally and communicates with the interior of the dilator housing 114. The dilator housing 114 includes a dilator advancement assembly 144 having a dilator carriage 146 disposed on the interior of the dilator housing 114 and a dilator finger tab 148 that extends through the dilator housing slot 142 to the exterior of the dilator housing 114. In one embodiment, the dilator finger tab 148 has a release mechanism, such as finger tabs 148A and 148B, that must be actuated by the clinician in order to slide the dilator advancement assembly 144 longitudinally.

[0032] The dilator carriage 146 is configured to slidably engage the interior of the dilator housing 114. For example, the dilator carriage 146 is generally cylindrical in shape and extends longitudinally and has a generally circular cross-sectional shape that slidably engages the cylindrical interior of the dilator housing 114. In one embodiment, the dilator carriage 146 further includes a number of openings and notches to accommodate other structures disposed within the dilator housing 114.

[0033] A dilator carriage 146 is coupled to the proximal end of the dilator 140. The dilator 140 is axially disposed within the dilator housing 114 and defines a dilator lumen 158, as shown in FIG. 2C. The dilator 140 extends distally from the dilator carriage 146 to the distal end of the body 110. A splittable introducer sheath (introducer) 150 is axially disposed on the exterior surface of the dilator 140 and is supported by an introducer hub 152. The introducer 150 defines an introducer lumen 154. The dilator 140 is configured to support the introducer 150 and facilitate insertion of the introducer 150 prior to retraction, as will be described in more detail below.

[0034] The docking station 200 is releasably coupled to a distal end of the body 110, for example, the distal end of the dilator housing 114. In one embodiment, the docking station is releasably secured to the distal end of the body 110 by a spin nut 202, although other suitable attachment mechanisms may be used, such as lugs, interference fits, luer locks, clips, protrusions, detents, and combinations thereof.

[0035] As shown in Figures 2D and 2E, the docking station 200 comprises a body 210 made up of a first body portion 212 and a second body portion 214. The first body portion 212 and the second body portion 214 are engaged along a longitudinal axis to form the docking station body 210. In one embodiment, the first body portion 212 and the second body portion 214 are engaged along a longitudinal vertical plane, although the first body portion 212 and the second body portion 214 may be engaged along a longitudinal horizontal plane or other oriented planes and are within the scope of the present invention. In one embodiment, the first body portion 212 and the second body portion 214 can be separated by pushing the body portions 212 and 214 away from each other in a direction perpendicular to the longitudinal axis. This facilitates removal of the docking station from the insertion site after the catheter has been placed, as will be described in more detail below.

[0036] The docking station body 210 defines a longitudinally extending lumen 218 configured to receive one of the distal portion of the dilator housing 114, the needle 130, the dilator 140, the introducer 150, the introducer hub 152, or a combination thereof. In one embodiment, the lumen 218 is configured to hold the introducer hub 152 therein. This provides an advantage to the clinician being able to release the introducer 150 during the procedure while still maintaining vascular access via the introducer 150. The docking station 200 maintains the introducer 150 at an accessible angle and aligns the introducer lumen 154 with other structures for introduction into the vasculature.

[0037] The docking station body 210 includes a distal surface 216 configured to engage a patient's skin surface, and in one embodiment, an adhesive layer is disposed on the distal surface 216. The distal surface 216 has a large surface area to improve adhesion between the docking station 200 and the patient's skin surface, which increases stability. The distal surface 216 may also be angled relative to the longitudinal axis to stabilize the lumen of the docking station 200 at a preferred insertion angle. In one embodiment, the distal surface 216 may have several other layers with various antimicrobial, antibacterial, hemostatic properties, or combinations thereof. The docking station 200 further includes a concave side configured to allow a comfortable grip by the clinician. The concave shape guides the clinician's fingers to pinch the midpoint of the side of the docking station 200.

[0038] As shown in Figures 3A-3C, the catheter placement system 300 includes a docking section 310 disposed at a distal end thereof, a rail 312 extending proximally from the proximal side of the docking section 310, and a locking hub 314 disposed at a distal end of the rail 312. The locking hub 314 defines a locking hub lumen 342 extending along a longitudinal axis. The locking hub 314 defines a locking hub lumen 342 extending along a longitudinal axis. The rail 312 extends along the longitudinal axis from a lower end of the docking section 310 to axially align the catheter 330 with a central lumen 352 of the docking section 310. A connector 354 is disposed at the distal end of the docking section 310. The connector 354 is configured to engage the proximal end of the docking station 200 and axially align the central lumen 352 of the docking portion 310 with the central lumen 218 of the docking station 200. In one embodiment, the connector 354 is a male luer lock that engages with a female luer lock disposed at the proximal end of the docking station. Other engagement structures may be used, such as having a mechanical fit, an interference fit, a snap fit, a press fit, a spin nut, a clip, a protrusion, a detent, and combinations thereof.

[0039] The catheter frame 316 slidably engages the upper surface of the rail 312 and extends laterally upward and proximally to define a handle 318. A distal portion of the catheter frame 316 is configured to hold a portion of the catheter 330, for example, a catheter hub 332, which is held on the catheter frame 316 by an interference fit. A proximal portion of the catheter frame 316 includes one or more clips, each configured to hold a proximal end of an extension leg extending from a proximal end of the hub 332. For example, as shown in FIG. 3A, the catheter hub 332 has a first extension leg 334, a second extension leg 336, and a third extension leg 338. The catheter frame 316 has a first clip 324, a second clip 326, and a third clip 328 configured to hold the first extension leg 334, the second extension leg 336, and the third extension leg 338, respectively. The clips 324, 326, 328 hold the extension legs 334, 336, 338 at an angle that provides easy access to the extension legs, for example, for flushing the catheter lumen with saline prior to placement.

[0040] In one embodiment, the first clip 324 aligns the first extension leg 334 with the locking hub lumen 342 and is configured to receive the catheter guidewire 320. The first extension leg 334 further includes a flush manifold 382 having one or more valves and a guidewire port 384 configured to allow for saline flushing of the catheter lumen prior to placement but prevent proximal saline flow. The catheter guidewire 320 extends through the locking hub lumen 342 and is aligned with the lumen of the first extension leg 334. In one embodiment, the first extension leg 334 further includes a spin nut 388 or similar connector that couples the catheter 330 and the catheter frame 316 coupled to the catheter 330 to the distal side of the locking hub 314 and prevents longitudinal sliding movement of the catheter frame 316 relative to the rail 312. In one embodiment, the spin nut 388 includes a sterility barrier, such as an extension leg sterility barrier 348 disposed between the spin nut 388 and the locking hub 314, as will be described in more detail below.

[0041] The locking hub 314 further includes a guidewire lock 378, such as a collet lock, that can be turned to lock the catheter guidewire 320 in place relative to the locking hub 314 and turned the other way to allow the catheter guidewire 320 to slide relative to the locking hub 314. The catheter guidewire 320 includes a guidewire hub 322 permanently attached to its proximal end. The guidewire hub 322 is configured to prevent the proximal end of the catheter guidewire 320 from advancing through the locking hub lumen 342. The guidewire lock 378 provides an advantage to the clinician in locking the guidewire 320 in place before releasing the grip on the guidewire 320 to perform other procedures. In contrast, conventional systems require the clinician to maintain grip on the guidewire to prevent the guidewire from being drawn into the patient's vasculature and causing various complications, such as embolism. Additionally, guidewire hub 322 is configured to prevent the proximal end of guidewire 320 from advancing through locking hub lumen 342 and into the lumen of catheter 330, so that guidewire 320 will not be pulled into the patient's vasculature even if the clinician releases guidewire 320 without securing guidewire lock 378, as opposed to conventional systems and methods that require pulling back an instrument over the proximal end of the guidewire.

[0042] The catheter guidewire 320 further includes a sterile barrier 344 that surrounds the catheter guidewire 320 and extends from the guidewire hub 322 to the locking hub 314. The sterile barrier includes a gas impermeable film, such as polyethylene or polypropylene, that maintains the catheter guidewire 320 in a sterile environment and prevents the clinician from contacting the portion of the guidewire 320 that is advanced into the patient's vasculature. Additionally, the barrier 344 prevents exposure of bodily fluids to the clinician as the guidewire 320 is withdrawn from the vasculature. In one embodiment, the barrier 344 is configured to be collapsible to allow distal advancement of the catheter guidewire 320.

[0043] The catheter placement system 300 includes a sterile barrier 346 extending between the locking hub 314 and the first extension leg 334 to maintain the guidewire 320 extending between the locking hub 314 and the first extension leg 334 in a sterile environment. The catheter placement system 300 further includes a rail sterile barrier 348 extending between the locking hub 314 and the proximal end of the docking section 310. The rail sterile barrier 348 surrounds the rail 312 and a portion of the catheter 330. The rail sterile barrier 348 maintains the catheter 330 in a sterile environment and prevents the clinician from contacting the portion of the catheter 330 that is advanced into the patient's vasculature. Additionally, the barrier 348 prevents exposure of bodily fluids to the clinician as the catheter 330 is withdrawn from the vasculature. In one embodiment, the rail barrier 348 has an opening through which one of the catheter frame 316, one or more extension legs 334, 336, 338, catheter hub 332, or a combination thereof extends. In one embodiment, the proximal end of the rail barrier 348 is coupled to a slide ring 356. The slide ring 356 is in slidable engagement with the rail 312 and allows the proximal end of the rail barrier 348 to slide longitudinally. In one embodiment, the distal end of the rail barrier 348 is coupled to a collar 358 that is coupled to a proximal end of the docking portion 310.

[0044] The docking portion 310 has a housing 350 defining a central lumen 352 therethrough. As shown in Figure 3C, the housing 350 has a cap 380 that extends over a portion of the housing's central lumen 352. The cap 380 is separable from the housing 350 in order to remove the catheter 330 from the docking portion 310 after the catheter has been placed in the vein, as will be described in more detail below.

[0045] The docking section 310 further includes an introducer retraction assembly 360 including a clamp 362 configured to engage the introducer hub 152. The clamp 362 defines a clamp lumen 366 that allows the clamp 362 to engage a dilator and allows various elongated medical instruments to pass through the clamp lumen 366. For example, the catheter 330 can pass through the clamp 362 and into the lumen of the introducer 150. In one embodiment, the clamp 362 opens a valve disposed within the introducer hub 152 that is configured to prevent proximal blood flow when the docking station 200 is removed from the introducer placement system 100. The clamp 362 opens the valve when the catheter placement system 300 is connected to provide a pathway for the catheter 330 to pass through. The clamp 362 further includes a break line 364 extending longitudinally therethrough and configured to facilitate separation of the clamp 362 into first and second half portions 362A and 362B. The break line 364 is a line of weakness, such as a score, perforation, laser cut line, or the like, configured to facilitate separation of the clamp 362 into the first and second half portions 362A and 362B.

[0046] The introducer retraction assembly 360 further includes a first reel 370 and a second reel 372 disposed within the housing 350 and spaced laterally apart on either side of a central axis of the housing 350. In one embodiment, the first reel 370 and the second reel 372 are coupled by a gear mechanism such that as the first reel 370 rotates, the gear mechanism also rotates the second reel 372. Similarly, as the second reel 372 rotates, the gear mechanism also rotates the first reel 370. In one embodiment, as the first reel 370 rotates, for example in a clockwise direction, the gear mechanism also rotates the second reel 372 in the opposite direction, such as a counterclockwise direction.

[0047] The first reel 370 has a first pull tab 374 that extends between the first reel 370 and the first clamp half 362A. The second reel 372 has a second pull tab 376 that extends between the second reel 372 and the second clamp half 362B. A rotation knob 368 coupled to the first reel 370 allows the clinician to rotate the first reel 370 and the second reel 372, which causes the first pull tab 374 to retract around the first reel 370 and the second pull tab 376 to retract around the second reel. This causes the clamp 362, introducer hub 152, and introducer 150 coupled to the introducer hub 152 to separate along the longitudinal axis into two half sections, each of which is wound around a corresponding first reel 370 and second reel 372. In one embodiment, the second reel 372 is coupled to a second rotatable knob (not shown), and the first reel 370 and second reel 372 are configured to rotate independently of one another. It will be appreciated that other mechanisms and methods for rotating the reels 370, 372 are within the scope of the present invention.

[0048] How to use Described below is an exemplary method of using the rapid insertion central catheter (RICC) system 10, including the introducer placement system 100, the docking station 200, and the catheter placement system 300. Generally, the method has a two-step process of placing the docking station 200 and introducer 150 in the patient's vasculature using the introducer placement system 100, followed by removing the introducer placement system 100 from the docking station 200 and coupling the catheter placement system 300 to the docking station 200 for placement of the catheter 330.

[0049] As shown in FIG. 4A, the introducer placement system 100 includes a docking station 200 releasably coupled to a distal end. The introducer placement system 100 includes a needle 130 coupled to a needle advancement assembly 134. The needle 130 extends through a lumen 218 of the docking station 200 to a location distal to a distal face 216 of the docking station. The introducer placement system 100 and docking station 200 assembly also includes a cap 102 disposed over a distal portion of the needle 130. The cap 102 engages the distal face 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 a resilient material and is configured to provide a sterility barrier to protect the needle from damage during shipping, prevent unintentional needlestick injuries, and prevent contamination of the needle 130 prior to use. Thus, once the cap 102 is removed, the introducer placement system 100 and docking station 200 assembly is ready for use.

[0050] The introducer placement system 100 and docking station 200 assembly is advanced distally until the distal tip of the needle 130 penetrates the patient's skin surface. The clinician then activates the blood flush button 162, which releases the vacuum in the blood flush tube 160. As shown in FIG. 4B, the needle 130 is advanced until the tip reaches the patient's vasculature 20. The release of vacuum by the blood flush button 162 creates proximal flow through the needle lumen 132 and into the blood flush tube 160, which is in communication with the needle lumen 132. The clinician can determine whether the needle 130 has reached the venous or arterial vasculature by observing the color of the blood and the presence or absence of pulsatile blood flow through the blood flush tube 160.

[0051] As shown in FIG. 4C, once proper access to the vasculature has been confirmed, the guidewire advancement assembly 124 is actuated to advance the distal portion of the introducer guidewire 120 through the needle lumen 132 and into the patient's vasculature 20. To actuate the guidewire advancement assembly 124, the clinician pushes the finger tabs of the guidewire assembly, which are coupled to the guidewire carriage 126, in a distal direction. In one embodiment, the finger tabs 128 have a locking mechanism, and as previously described, the clinician must pinch and move the pair of finger tabs 128A and 128B laterally inward to advance the guidewire advancement assembly 124 distally. As the distal portion of the introducer guidewire 120 advances beyond the tip of the needle 130, the edges of the needle 130 are polished by the guidewire, thereby dulling the tip. Advantageously, this prevents unintentional needlestick injuries as the needle is removed from the vasculature 20.

[0052] The dilator advancing assembly 144 is then advanced distally to advance the dilator 140, and the introducer 150 is placed over the dilator 140, as shown in FIG. 4D. The dilator advancing assembly 144 is advanced by moving the finger tabs 148 distally. In one embodiment, the finger tabs 148 include a locking mechanism that requires the pair of tabs to be pinched and moved laterally inward before the dilator advancing assembly 144 can be advanced distally. The dilator advancing assembly 144 is advanced until the introducer hub 152, which supports the introducer 150, is positioned within the lumen 218 of the docking station 200. In one embodiment, a portion of the docking station lumen 218 is shaped to match the outer surface of the introducer hub 152 such that the introducer hub 152 is retained in the docking station by a friction fit. Various clips, detents, protrusions, barbs, combinations thereof, and the like may further be provided within the lumen 218 to aid in retention of the introducer hub 152 within the docking station lumen 218 .

[0053] 2C, the dilator 140 has a tapered tip that fits snugly against the outer surface of the needle 130. Additionally, the introducer 150 also has a tapered tip that fits snugly against the outer surface of the dilator 140. Thus, as the dilator advancement assembly 144 advances, the dilator 140 dilates the insertion site. The introducer 150 also further dilates the insertion site. As a result, the insertion site expands from the diameter of the needle 130 to a diameter that can receive a catheter 330, such as a triple lumen central venous catheter.

[0054] As shown in FIG. 4E, once the distal portion of the introducer is positioned within the patient's vasculature 20, the needle retraction assembly 134 is actuated to retract the needle 130 proximally, leaving the dilator 140 and introducer 150 in place. It should be noted that both the needle retraction assembly 134 and the guidewire advancement assembly 124 are slidably engaged with the guidewire housing slot 122. Thus, as the needle retraction assembly 134 is actuated proximally, the introducer guidewire 120 is simultaneously retracted proximally as the needle finger tab 138, the needle carriage 136, or a combination thereof abuts the guidewire finger tab 128, the guidewire carriage 126, or a combination thereof. This causes the needle 130 and introducer guidewire 120 to be retracted within the body 110 of the introducer placement system 100. Because the needle and guidewire are contained within the body 110, they are less exposed to the clinician, preventing unintentional needlestick injuries. Additionally, as shown in FIG. 4E, blood flush tube 160, which runs along the inner surface of guidewire housing 112, can flex in response to movement of the associated needle carriage.

[0055] 4F and 4G, with the distal portion of the introducer 150 disposed within the vasculature 20 and the introducer hub 152 disposed within the docking station lumen 218, the dilator 140 can be retracted proximally into the dilator housing 114. Containment of the dilator 140 within the dilator housing 114 prevents exposure to the clinician.

[0056] As previously mentioned, the distal surface 216 of the docking station 200 includes an adhesive layer. A cover is further provided over the adhesive layer 222 to protect the adhesive layer 222 during manufacturing and shipping. The cover 224 is removed to expose the adhesive layer 222, and the docking station 200 is advanced distally until the distal surface 216 contacts the patient's skin surface, securing the docking station 200 to the skin. The introducer placement system 100 is then removed from the docking station 200, for example by unscrewing the spin nut 202, and the introducer 150 remains within the vasculature 20 supported by the docking station 200. The docking station 200 has the advantage of supporting the introducer without the need for the clinician to maintain a grip on the introducer.

[0057] As shown in FIG. 4H, a catheter placement system 300 is provided that includes a catheter 330, such as a three-lumen CVC catheter. The lumens of the catheter 330 can be flushed by attaching a saline syringe or the like to ports located at the proximal ends of the extension legs 336, 338 or to a side port 386 of the manifold 382. The catheter placement system 300 is then coupled to the docking station 200. The connector 354 engages the proximal portion of the docking station lumen 218 by a luer lock or interference fit engagement. When the connector 354 engages the docking station 200, the clamp 362 also engages the introducer hub 152 and, in the optional configuration, a valve located within the introducer hub 152 opens.

[0058] As shown in FIG. 4I, with the catheter placement system 300 coupled to the docking station 200, the catheter guidewire 320 is advanced through the locking hub 314, the lumen of the catheter 330, and the introducer 150 until the distal portion of the catheter guidewire 320 passes beyond the distal end of the introducer 150 and into the patient's vasculature 20. In one embodiment, the catheter guidewire 320 has measurement segments along the shaft of the catheter guidewire 320 that allow the clinician to determine the length of the catheter guidewire 320 that has been placed within the patient's vasculature. Thus, the clinician can advance the catheter guidewire 320 until the distal tip of the catheter guidewire 320 is positioned a desired distance within the patient's vasculature and proximate to the target location. The clinician can then use the guidewire lock 378 to lock the catheter guidewire 320 into place.

[0059] As shown in FIGURE 4J, the first extension leg 334 is released from the locking hub 314 by rotating the spin nut 388, thereby allowing the catheter frame 316 and coupled catheter 330 to slide distally along the rail 312. The clinician grasps the catheter frame 316, such as by the handle 318, and pushes the catheter 330 distally to advance the distal tip over the catheter guidewire 320 through the docking station lumen 218, the clamp lumen 366, and the lumen of the introducer 150 to a location distal to the distal tip of the introducer 150.

[0060] Note that as the catheter frame 316 advances, the folded extension leg sterile barrier 346 unfolds to maintain a sterile barrier between the extension leg 338 and the locking hub 314. Similarly, the rail sterile barrier 348 is configured to allow the catheter 330 and catheter frame 316 to slide along the rail 312 while maintaining the catheter 330 in a sterile environment.

[0061] In FIG. 4K, the distal tip of the catheter 330 is positioned within the vasculature 20. The introducer 150 can be retracted by turning the knob 368. As previously described, movement of the knob 368 rotates the first reel 370 and the second reel 372, which retracts the clamp 362 and splits it into two halves, which splits the introducer hub 152 into two halves and retracts it. This also splits the introducer 150 into two halves and retracts it. The clamp halves, hub halves and introducer sheath halves are wound around their respective reels 370, 372 and stored within the housing 350. The introducer is then removed from the insertion site, leaving the catheter 330 in place within the vasculature 20.

[0062] With the introducer 150 removed from the lumen 352 of the housing 350, the catheter frame 316 can be advanced further to advance the distal tip of the catheter 330 further into the patient's vasculature, as shown in Figure 4L. With the catheter 330 positioned further within the vasculature 20, the guidewire lock 378 is released and the guidewire is pulled back proximally to withdraw the distal end of the catheter guidewire 320 from the catheter 330, as shown in Figure 4M. Optionally, the catheter guidewire 320 is then again locked in place using the guidewire lock 378.

[0063] The catheter placement system 300 and docking station 200 are then removed, as shown in FIGURE 4N. The collar 358, which supports the distal end of the rail sterile barrier 348, is removed from the proximal end of the housing 350. The connector 354 is removed from the docking station 200. The housing cap 380 is removed from the housing 350 to expose the portion of the catheter 330 disposed within the central lumen 352 of the housing 350. The catheter hub 332 is removed from the catheter frame 316, and the extension legs are removed from their respective clips 324, 326, and 328 so that the extension legs 334, 336, and 338 can be pulled from the collar 358. The catheter placement system 300 is then removed from the catheter 330.

[0064] The docking station 200 is then removed from the insertion site by forcing the first body portion 212 and the second body portion 214 laterally outward. The two body portions separate along the break line, allowing the docking station 200 to be removed. The catheter 300 is then secured against the patient's skin surface. The catheter 300 is then secured against the patient's skin surface.

[0065] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Those skilled in the art will appreciate that additional adaptations and / or modifications may be made in the broader aspects, and these adaptations and / or modifications are also encompassed. Thus, deviations from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter system comprising:

1. An introducer placement system configured to place an introducer within a vascular system of a patient, comprising: a needle defining a needle lumen; an introducer guidewire disposed within the needle lumen; a dilator defining a dilator lumen; an introducer supported by an introducer hub and defining an introducer lumen configured to receive the dilator; a guidewire housing having a guidewire advancement assembly coupled to a proximal end of the introducer guidewire and a needle retraction assembly coupled to a proximal end of the needle; a dilator housing coupled to a distal end of the guidewire housing and having a dilator advancement assembly coupled to a proximal end of the dilator; a blood flush indicator tube fluidly connected to said needle lumen; An introducer placement system having a docking station releasably coupled to a distal end of the dilator housing, the docking station defining a lumen configured to hold the introducer hub; a catheter placement system configured to engage a proximal end of the docking station to place a catheter within a patient's vasculature, the catheter placement system comprising: a docking portion configured to engage the docking station to axially align the catheter with the introducer lumen; a rail extending proximally from the docking portion; a locking hub disposed at a proximal end of the rail and defining a locking hub lumen; a catheter guidewire having a guidewire hub permanently attached to a proximal end thereof, a portion of said catheter guidewire disposed within said locking hub lumen; a catheter frame in slidable engagement with the rail, the catheter being supported by the catheter frame; A catheter placement system having A rapid insertion central venous catheter system comprising:

2. 2. The rapid insertion central venous catheter system of claim 1, wherein the introducer placement system further comprises a blood flush actuation mechanism configured to release a vacuum in the blood flush indicator tube, thereby drawing proximal blood flow through the needle lumen and into the blood flush indicator tube.

3. 3. The rapid insertion central venous catheter system of claim 2, wherein the flow of blood in the blood flush indicator tube is observable through the blood flush indicator tube and the guidewire housing.

4. 4. The rapid insertion central venous catheter system of claim 1, wherein one of the rail and the catheter guidewire is disposed within a collapsible sterile barrier to prevent contact with one of the rail and the catheter guidewire.

5. 5. The rapid insertion central venous catheter system of claim 4, wherein the catheter is disposed within the foldable sterile barrier with the rail disposed thereon, and the catheter frame is configured to be grasped by a clinician through an opening in a side wall of the sterile barrier.

6. 6. The rapid insertion central venous catheter system of claim 1, wherein one of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly has a release mechanism that requires a pair of finger tabs to be moved laterally inwardly prior to longitudinal movement of the release mechanism.

7. 7. The rapid insertion central venous catheter system of claim 1, wherein the introducer guidewire of the introducer placement system is configured to blunt the tip of the needle as the introducer guidewire advances distally through the needle lumen.

8. 8. The rapid insertion central venous catheter system of claim 1, wherein distal advancement of the dilator advancement assembly advances the dilator and the introducer distally over the needle and the introducer guidewire.

9. 9. The rapid insertion central venous catheter system of claim 1, wherein the needle and the introducer guidewire are retracted proximally by retracting the needle retraction assembly proximally.

10. 10. The rapid insertion central venous catheter system of claim 1, wherein distal advancement of the dilator advancement assembly advances the introducer from the dilator housing to the docking station.

11. 11. The rapid insertion central venous catheter system of claim 10, wherein the dilator is retracted proximally from the lumen of the introducer by proximally retracting the dilator advancement assembly.

12. 12. The rapid insertion central venous catheter system of claim 1, wherein the docking station defines a distal surface having an adhesive layer configured to adhere the docking station to a skin surface of a patient.

13. 13. The rapid insertion central venous catheter system of claim 1, wherein a width of the guidewire hub of the catheter guidewire is greater than a width of the locking hub lumen, thereby preventing a proximal end of the catheter guidewire from passing through the locking hub lumen.

14. 14. The rapid insertion central venous catheter system of claim 1, wherein the docking portion of the catheter placement system includes an introducer retraction assembly configured to split the introducer along a longitudinal axis into a first half portion and a second half portion, the first half portion being wound on a first reel and the second half portion being wound on a second reel.

15. 15. The rapid insertion central venous catheter system of claim 1, wherein the locking hub further comprises a guidewire lock configured to lock the catheter guidewire and prevent longitudinal movement of the catheter guidewire relative to the locking hub.

16. 16. The rapid insertion central venous catheter system of claim 1, wherein the docking station has a longitudinally extending break line and is configured to separate along the break line when the first and second body portions of the docking station are biased laterally outward.

17. 1. A rapid insertion central venous catheter system comprising: an introducer placement system configured to place an introducer within a vascular system of a patient; a docking station releasably coupled to a distal end of the introducer placement system, the docking station defining a lumen configured to hold an introducer hub; a catheter placement system configured to engage a proximal end of the docking station to place a catheter within a patient's vasculature; wherein the catheter placement system is configured to axially align the catheter with a lumen of the introducer when engaged with the docking station.

18. 20. The rapid insertion central venous catheter system of claim 17, wherein the introducer placement system comprises one of a needle, an introducer guidewire, a dilator, an introducer, an introducer hub, and a blood flush indicator tube.

19. 20. The rapid insertion central venous catheter system of claim 18, wherein the introducer placement system further comprises a blood flush actuation mechanism configured to release a vacuum in a blood flush indicator tube, thereby drawing proximal blood flow through the needle lumen and into the blood flush indicator tube.

20. 20. The rapid insertion central venous catheter system of claim 17, wherein the catheter placement system comprises one of a docking section, a rail, a locking hub, a catheter guidewire, and a catheter frame.

21. 21. The rapid insertion central venous catheter system of claim 20, wherein one of the rail and the catheter guidewire is disposed within a collapsible sterile barrier to prevent contact with one of the rail and the catheter guidewire.

22. 22. The rapid insertion central venous catheter system of any one of claims 17-21, wherein the introducer placement system comprises one of a guidewire advancement assembly, a needle retraction assembly, and a dilator advancement assembly.

23. 23. The rapid insertion central venous catheter system of claim 22, wherein one of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly includes a release mechanism.

Citation Information

Patent Citations

  • A catheter insertion device including a top-mounted advancement component

    JP2018519015A

  • Medical Component Insertion Device Including a Retractable Needle

    US20120220942A1

  • Devices and methods for fluid transfer through a placed peripheral intravenous catheter

    US20180272107A1