Detachable catheter docking station systems and methods
Through the two-step rapid insertion of the central catheter system, the introducer placement system and the catheter placement system are utilized, combined with the docking station and locking features, to solve the complex problems of the existing central catheter insertion process, and achieve the effect of simplifying the operation and improving efficiency.
Patent Information
- Application Number
- CN202110091138.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-01-23
- Filing Date
- 2021-01-22
- Publication Date
- 2025-10-14
- Estimated Expiration
- 2041-01-22
AI Technical Summary
The existing central catheter insertion process is complex, requiring multiple components and steps, and it is difficult for clinicians to release the introducer during the process, which increases the difficulty and risk of the operation.
The two-step rapid insertion central catheter system includes an introducer placement system and a catheter placement system. It uses a docking station to support the introducer, allowing clinicians to release the introducer during catheter insertion, and simplifies the operation through components such as the guidewire hub and dilator. It uses a foldable sterile barrier and locking feature to prevent premature advancement.
It simplifies the central catheter insertion process, reduces components and steps, improves operational efficiency, reduces operational difficulty and risk, and ensures the sterility of the guidewire and catheter.
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Figure CN113144380B_ABST
Abstract
Description
[0001] Priority
[0002] This application claims priority to U.S. Provisional Application No. 62 / 965,064, filed January 23, 2020, the entirety of which is incorporated by reference into the present application. SUMMARY
[0003] Briefly summarized, the embodiments disclosed herein are directed to a two-step rapid insertion central catheter (“RICC”) system. In one embodiment, the two-step RICC system includes an introducer placement system, a docking station, and a catheter placement system. The introducer placement system can place an introducer within the vasculature, which can be supported by the docking station that detaches from the distal end of the introducer placement system. The docking station can provide a means of maintaining access to the vasculature and allow the clinician to let go of the introducer while it remains in the vasculature. In embodiments, the catheter placement system is coupled with the docking station, and a catheter can be advanced through the introducer into the vasculature. The introducer can then be detached and withdrawn before the catheter placement system is disengaged from the docking station. Finally, the docking station can be detached from the catheter and disengaged. Some embodiments include a guidewire hub that prevents guidewire kinking, a collapsible sterile barrier that prevents contamination, and a locking feature that prevents premature advancement of the guidewire, dilator, etc.
[0004] The embodiments described herein provide a simplification of the insertion process of a CVC catheter or similar device. This requires fewer components, fewer process steps, and incorporates components to be inserted into a sterile barrier, etc. Embodiments can include a guidewire hub and locking device that prevents guidewire kinking, and a docking station that supports the introducer. The docking station allows the clinician to release the introducer during the process, which is not possible in current methods where the clinician must maintain a grip on the introducer while performing additional steps with a single hand.
[0005] Disclosed herein is a rapid insertion central catheter system including an introducer placement system configured to place an introducer within a vasculature of a patient, 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 disposed therein, a guidewire housing including 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 including a dilator advancement assembly coupled to a proximal end of the dilator, and a blood flash indicator tube fluidly coupled with the needle lumen. The rapid insertion central catheter system can further include a docking station releasably coupled to a distal end of the dilator housing and defining a lumen configured to hold the introducer hub, and a catheter placement system configured to engage a proximal end of the docking station and place a catheter within the vasculature of the patient, the catheter placement system having a docking portion configured to engage the docking station to axially align the catheter with the introducer lumen, a track extending proximally from the docking portion, a locking hub disposed at a proximal end of the track, the locking hub defining a locking hub lumen, a catheter guidewire including a guidewire hub permanently attached to a distal end thereof, a portion of the guidewire disposed in the locking hub lumen, a catheter rack slidably engaged with the track, and a catheter supported by the catheter rack.
[0006] In some embodiments, the introducer placement system further includes a blood flash actuator configured to release a vacuum disposed within the blood flash indicator tube to draw proximal blood flow through the needle lumen and into the blood flash indicator tube. The blood flow disposed within the blood flash indicator tube is observable through the blood flash indicator tube and through the guidewire housing. One of the track and the catheter guidewire is disposed within a foldable sterile barrier to prevent contact therewith. The catheter is disposed within the foldable sterile barrier, the foldable sterile barrier including the track disposed therein, the catheter rack extending through an aperture of a sidewall of the sterile barrier and configured to be grasped by a clinician.
[0007] In some embodiments, one of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly includes a release mechanism that requires a pair of finger tabs to move laterally inward before allowing any longitudinal movement thereof. The guidewire of the dilator placement system is configured to blunt the tip of the needle as the guidewire is advanced distally through the needle lumen. Distal advancement of the dilator assembly results in distal advancement of the dilator and the introducer over the needle and the guidewire. Proximal withdrawal of the needle retraction assembly results in proximal withdrawal of the needle and the introducer guidewire. Distal advancement of the dilator advancement assembly transfers the introducer from the dilator housing to the docking station. Proximal withdrawal of the dilator advancement assembly results in proximal withdrawal of the dilator from the lumen of the introducer.
[0008] In some embodiments, the docking station defines a distal surface that includes an adhesive layer configured to adhere the docking station to a skin surface of a patient. The guidewire hub of the catheter guidewire is wider than the width of the locking hub lumen to prevent the 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 separate the introducer into a first half and a second half along a longitudinal axis, the first half being wound on a first spool and the second half being wound on a second spool. The locking hub further includes a guidewire lock configured to lock the catheter guidewire and prevent longitudinal movement thereof relative to the locking hub. The docking station includes a longitudinally extending split line and is configured to separate along the split line when the first body portion and the second body portion of the docking station are urged laterally outward.
[0009] Also disclosed is a two-step method of placing a catheter within a patient's vasculature, the two-step method comprising a first step of placing an introducer using an introducer placement system, and a second step of placing a catheter using a catheter placement system, the introducer placement system comprising a main body, a docking station releasably coupled to a distal end of the main body, a needle, an introducer guidewire, a dilator, and an introducer, the catheter placement system comprising a docking portion, a track comprising a catheter mount slidably engaged therewith, a catheter releasably coupled to the catheter mount, and a locking hub disposed at a proximal end of the track, the method comprising: accessing the vasculature using the needle; advancing the introducer guidewire through a lumen of the needle; advancing the dilator comprising the introducer disposed thereon over the needle to transfer the introducer from the main body to the docking station; withdrawing the needle and the guidewire from the dilator; withdrawing the dilator from the introducer; dismounting the main body of the introducer placement system from the docking station; coupling the docking portion of the catheter placement system with a proximal end of the docking station; advancing a catheter guidewire distally through a lumen of the catheter and through a lumen of the introducer until a distal portion is disposed distal to a distal tip of the introducer; advancing a catheter mount distally to pass the catheter through the lumen of the introducer; actuating an introducer withdrawal assembly to separate the introducer along a longitudinal axis into a first half and a second half, to wind the first half of the introducer on a first spool, and to wind the second half of the introducer on a second spool; withdrawing the catheter distally with the catheter guidewire; removing the catheter placement system from the docking station; and removing the docking station from the catheter.
[0010] In some embodiments, accessing the vasculature using the needle further comprises actuating a blood flash actuator configured to release a vacuum disposed within a blood flash indicator tube to draw proximal blood flow through the needle lumen and into the blood flash indicator tube to confirm vascular access of the needle. Accessing the vasculature using the needle further comprises observing blood flow through the blood flash indicator tube and through the main body of the introducer placement system. One of advancing the introducer guidewire, advancing the dilator, and withdrawing the needle comprises releasing a locking mechanism by pinching a pair of finger tabs together prior to longitudinal movement of the finger tabs relative to the introducer placement system. Advancing the catheter guidewire distally comprises folding a guidewire sterile barrier between a locking hub of the catheter placement system and a guidewire hub, the guidewire sterile barrier surrounding the catheter guidewire and preventing a clinician from accessing the catheter guidewire.
[0011] In some embodiments, advancing the catheter hub distally includes folding a portion of a track sterile barrier of the catheter placement system between a docking portion and the catheter hub, the track sterile barrier surrounding the track and a portion of the catheter to prevent a clinician from accessing the portion of the catheter. A portion of the catheter hub extends through an aperture disposed in a sidewall of the track sterile barrier and is configured to allow the clinician to grasp the portion of the catheter hub to urge the catheter hub distally. Advancing the catheter hub distally includes expanding an extension leg sterile barrier between an extension leg of the catheter and the locking hub, the extension leg sterile barrier surrounding the catheter guidewire and preventing the clinician from accessing the catheter guidewire. Advancing the introducer guidewire through the lumen of the needle also includes blunting a tip of the needle.
[0012] In some embodiments, transferring the introducer from the main body to the docking station also includes retaining an introducer hub within a lumen of the docking station. Removing the docking station from the main body also includes adhering a distal surface of the docking station to a skin surface of a patient. The catheter guidewire also includes 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. Coupling the catheter placement system to the proximal end of the docking station also includes coupling a clamp of the introducer retrieval assembly to an introducer hub, the clamp opening a valve disposed within the introducer hub. Advancing the catheter guidewire proximally also includes unlocking a guidewire lock to allow longitudinal movement of the catheter guidewire relative to the catheter placement system, followed by locking the guidewire lock to inhibit longitudinal movement of the catheter guidewire relative to the catheter placement system when a distal tip of the catheter guidewire is disposed proximate a target location.
[0013] In some embodiments, actuating the introducer retrieval assembly also includes rotating a twist knob of the introducer retrieval assembly. Removing the catheter placement system from the docking station also includes removing a cap portion of the catheter placement system to allow lateral movement of the catheter placement system relative to the catheter. Removing the docking station from the catheter also includes separating the docking station longitudinally along a split line by pushing a first portion and a second portion laterally outward.
[0014] A rapid insertion central catheter system is also disclosed, the rapid insertion central catheter system including an introducer placement system configured to place an introducer within a vasculature of a patient, 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 and place a catheter within the vasculature of the patient.
[0015] 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 flash indicator tube. The introducer placement system further includes a blood flash actuator configured to release a vacuum disposed within the blood flash indicator tube to draw proximal blood flow through a lumen of the needle and into the blood flash indicator tube. The catheter placement system includes one of a docking portion, a track, a locking hub, a catheter guidewire, and a catheter mount. One of the track, the catheter, and the catheter guidewire is disposed within a foldable sterile barrier to prevent contact therewith. The introducer placement system includes one of a guidewire advancement assembly, a needle retraction assembly, and a dilator advancement assembly. One of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly includes a release mechanism.
[0016] A method of placing a catheter within a vasculature of a patient is also disclosed, the method including placing an introducer within the vasculature of the patient using an introducer placement system including a main body and a docking station; detaching the main body of the introducer placement system from the docking station; coupling a catheter placement system with the docking station; advancing a catheter into the vasculature of the patient; removing the introducer using an introducer retraction assembly; and removing the catheter placement system and the docking station.
[0017] In some embodiments, placing the introducer further includes transferring the introducer from the main body of the introducer placement system to the docking station. The method further includes retaining an introducer hub of the introducer within a lumen of the docking station. The method further includes actuating a blood flash actuator configured to release a vacuum disposed within a blood flash indicator tube to draw proximal blood flow through a needle lumen and into the blood flash indicator tube to confirm vascular access of the needle.
[0018] In some embodiments, placing an introducer within the vasculature of the patient further includes advancing the introducer guidewire through the needle lumen and blunting a tip of the needle. Advancing a catheter into the vasculature of the patient further includes a guidewire hub permanently attached to a proximal end of a catheter guidewire, the guidewire hub configured to prevent the proximal end of the catheter guidewire from entering a lumen of the catheter. Removing the introducer further includes separating the introducer along a longitudinal axis. BRIEF DESCRIPTION OF DRAWINGS
[0019] A more particular description of the disclosure will be presented by reference to particular embodiments thereof illustrated in the attached drawings. It is to be noted that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. Example embodiments of the disclosure will be described and explained with additional specificity and detail by the use of the accompanying drawings in which: - FIG. 1 illustrates an example of a catheter placement system 100, according to an embodiment of the present disclosure. The catheter placement system 100 includes a docking station 102, a catheter 104, a catheter guidewire 106, a catheter mount 108, a track 110, a locking hub 112, a catheter advancement assembly 114, a catheter retraction assembly 116, a guidewire advancement assembly 118, a needle retraction assembly 120, a needle 122, a needle guidewire 124, a needle hub 126, a dilator 128, a dilator guidewire 130, a dilator advancement assembly 132, a blood flash indicator tube 134, a blood flash actuator 136, and a guidewire hub 138. - FIG. 2 illustrates an example of a catheter placement system 200, according to an embodiment of the present disclosure. The catheter placement system 200 includes a docking station 202, a catheter 204, a catheter guidewire 206, a catheter mount 208, a track 210, a locking hub 212, a catheter advancement assembly 214, a catheter retraction assembly 216, a guidewire advancement assembly 218, a needle retraction assembly 220, a needle 222, a needle guidewire 224, a needle hub 226, a dilator 228, a dilator guidewire 230, a dilator advancement assembly 232, a blood flash indicator tube 234, a blood flash actuator 236, and a guidewire hub 238. - FIG. 3 illustrates an example of a catheter placement system 300, according to an embodiment of the present disclosure. The catheter placement system 300 includes a docking station 302, a catheter 304, a catheter guidewire 306, a catheter mount 308, a track 310, a locking hub 312, a catheter advancement assembly 314, a catheter retraction assembly 316, a guidewire advancement assembly 318, a needle retraction assembly 320, a needle 322, a needle guidewire 324, a needle hub 326, a dilator 328, a dilator guidewire 330, a dilator advancement assembly 332, a blood flash indicator tube 334, a blood flash actuator 336, and a guidewire hub 338. - FIG. 4 illustrates an example of a catheter placement system 400, according to an embodiment of the present disclosure. The catheter placement system 400 includes a docking station 402, a catheter 404, a catheter guidewire 406, a catheter mount 408, a track 410, a locking hub 412, a catheter advancement assembly 414, a catheter retraction assembly 416, a guidewire advancement assembly 418, a needle retraction assembly 420, a needle 422, a needle guidewire 424, a needle hub 426, a dilator 428, a dilator guidewire 430, a dilator advancement assembly 432, a blood flash indicator tube 434, a blood flash actuator 436, and a guidewire hub 438.
[0020] Figures 1A-1C A perspective view of a two-step rapid insertion catheter system including an introducer placement system, a docking station, and a catheter placement system is shown according to embodiments disclosed herein.
[0021] Figures 2A-2E Shown is an embodiment according to the present disclosure Figures 1A-1B Various details of the introducer placement system.
[0022] Figures 3A-3C Shown is an embodiment according to the present disclosure Figure 1C Various details of the catheter placement system.
[0023] Figures 4A-4G The use of the embodiments disclosed herein is shown Figures 1A-1B The introducer placement system provides various stages of introducer placement.
[0024] Figures 4H-4N The use of the embodiments disclosed herein is shown Figure 1C The catheter placement system covers the various stages of catheter placement. DETAILED DESCRIPTION
[0025] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the features of the specific embodiments disclosed herein can be easily separated from the specific embodiments and optionally combined with or substituted for the features of any of the multiple other embodiments disclosed herein.
[0026] About the terms used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these 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 the different features or different steps in a set of features or a set of steps, and do not provide sequence or numerical restrictions. For example, "first," "second," and "third" features or steps do not necessarily need to appear in the order described, and the specific embodiment including such features or steps does not necessarily need to be limited to these three features or steps. Labels such as "left," "right," "top," "bottom," "front," "back" are used for convenience, rather than being intended to imply such as any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect such as relative position, orientation or direction. The singular "a," "an," and "the" include plural forms, unless the context clearly indicates otherwise.
[0027] For example, a "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that should be proximal to a clinician when the catheter is used on a patient. Likewise, for example, a "proximal length" of a catheter includes a length of the catheter that should be proximal to a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter that is intended to be proximal to a clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include a proximal end of the catheter; however, a proximal portion, proximal end portion, or proximal length of a catheter need not include a proximal end of the catheter. That is, unless context dictates otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not an end portion or end length of the catheter.
[0028] For example, a "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that should be proximal to a clinician when the catheter is used on a patient. Likewise, for example, a "proximal length" of a catheter includes a length of the catheter that should be proximal to a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter that is intended to be proximal to a clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include a proximal end of the catheter; however, a proximal portion, proximal end portion, or proximal length of a catheter need not include a proximal end of the catheter. That is, unless context dictates otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not an end portion or end length of the catheter.
[0029] To aid in describing the embodiments described herein, as Figure 1A As shown, a longitudinal axis extends substantially parallel to an axial length of the needle 130. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal axis and the lateral axis.
[0030] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs.
[0031] Figures 1A-1C Various details of a two-step rapid insertion central catheter ("RICC") system 10 according to embodiments described herein are shown, including a introducer placement system 100, a docking station 200, and a catheter placement system 300.
[0032] Figures 2A-2E Further details of the introducer placement system 100 and the docking station 200 are shown.
[0033] Figures 3A-3BFurther details of the catheter placement system 300 and docking station 200 are shown. Although the embodiments disclosed herein are directed to placement of a central venous catheter (CVC), it should be appreciated that this is exemplary and that the systems and methods disclosed herein can be used to place a variety of elongated medical devices, including but not limited to a peripherally inserted central catheter (PICC), a dialysis catheter, a midline catheter, a peripheral catheter, and the like.
[0034] The introducer placement system 100 includes a generally cylindrical body 110 extending from a proximal end to a distal end and defining a generally circular cross-section. Although it should be appreciated that other cross-sectional shapes are also contemplated. In embodiments, the body 110 is formed of a translucent material, which advantageously allows a clinician to view components disposed therein, as will be discussed in greater detail herein. A proximal portion of the body 110 includes a guidewire housing 112, and a distal portion of the body 110 includes a dilator housing 114.
[0035] The guidewire housing 112 includes an elongated slot 122 disposed in an upper surface of the guidewire housing 112. The slot 122 extends longitudinally and is in communication with an interior of the guidewire housing 112. The guidewire housing 112 includes a guidewire advancement assembly 124 including a guidewire carriage 126 disposed within the interior of the guidewire housing 112, and a guidewire finger tab 128 extending through the slot 122 to an exterior of the guidewire housing 112. In embodiments, the guidewire finger tab 128 includes a release mechanism requiring actuation by a clinician in order to allow longitudinal sliding of the guidewire advancement assembly 124. For example, as shown, the guidewire advancement assembly 124 can include first and second finger tabs 128A, 128B requiring a clinician to pinch the finger tabs 128A, 128B laterally inwardly before allowing longitudinal sliding of the guidewire advancement assembly 124. In embodiments, the guidewire finger tab 128 includes an actuator button that must be depressed before the guidewire advancement assembly 124 can slide longitudinally. Figure 2B
[0036] The guidewire carriage 126 is configured to slidably engage with the interior of the guidewire housing 112. For example, the guidewire carriage 126 defines a generally cylindrical shape extending longitudinally, and defines a generally circular cross-sectional shape slidably engaged with the cylindrical interior of the guidewire housing 112. In embodiments, the guidewire carriage 126 can also include various holes and notches in order to accommodate various additional structures disposed within the guidewire housing 112, such as a blood flash tube, and the like, as will be described in greater detail herein. The guidewire carriage 126 is coupled with a proximal end of an introducer guidewire 120 disposed axially within the guidewire housing 112. The introducer guidewire 120 extends distally from the guidewire carriage 126 to the distal end of the body 110.
[0037] The guidewire housing 112 also includes a needle advancement assembly 134 that includes a needle carriage 136 disposed within the interior of the guidewire housing 112, and a needle finger tab 138 that extends through the slot 122 to the exterior of the guidewire housing 112. In embodiments, the needle finger tab 138 includes release mechanisms (e.g., finger tabs 138A, 138B) that require clinician actuation in order to allow the needle advancement assembly 134 to slide longitudinally, as described herein. The needle carriage 136 is configured to slidably engage with the interior of the guidewire housing 112. For example, the needle carriage 136 defines a generally cylindrical shape that extends longitudinally, and defines a generally circular cross-sectional shape that slidably engages with the cylindrical interior of the guidewire housing 112. In embodiments, the needle carriage 136 also includes various holes and notches in order to accommodate various additional structures disposed within the guidewire housing 112, such as a blood flash tube, as will be described in greater detail herein. The needle carriage 136 is coupled with the proximal end of the needle 130 that is disposed axially within the body 110. The needle 130 defines a needle lumen 132, and extends distally from the needle carriage 136 to a distal point of the distal end of the body 110.
[0038] The guidewire housing 112 also includes a blood flash tube 160 that is coupled to the needle carriage 136 and is in fluid communication with the needle lumen 132. The blood flash tube 160 extends along the interior surface of the guidewire housing 112 between the needle carriage 136 and the proximal end of the guidewire housing 112. The blood flash tube 160 is made of a translucent material that, along with the translucent material of the guidewire housing 112, allows a clinician to view blood flow within the blood flash tube 160 to confirm that the distal tip of the needle has entered the patient’s vasculature.
[0039] In embodiments, the blood flash tube 160 is coupled with an actuator 162 (e.g., a blood flash button). The blood flash tube 160 is evacuated to provide a vacuum therein. When the needle is inserted into the patient, the clinician can depress the actuator 162, which in turn provides fluid communication between the blood flash tube 160 and the needle lumen 132. The vacuum within the blood flash tube 160 draws blood flow proximally through the needle lumen 132 and into the blood flash tube 160 to facilitate observation of blood flow within the blood flash tube 160 to confirm that the needle tip has entered the vasculature. Advantageously, the vacuum draws blood flow faster than it would otherwise, providing a faster venous access result, and preventing the needle from advancing further into an incorrect blood vessel (e.g., an artery), or preventing the needle 130 from over-inserting, damaging the distal wall of the blood vessel. Both of these can be harmful to the patient.
[0040] The dilator housing 114 includes an elongated slot 142 disposed in an upper surface of the dilator housing 114. The slot 142 extends longitudinally and is in communication with the interior of the dilator housing 114. The dilator housing 114 includes a dilator advancement assembly 144 that includes a dilator carriage 146 disposed within 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 embodiments, the dilator finger tab 148 includes release mechanisms (e.g., finger tabs 148A, 148B) that require clinician actuation in order to allow longitudinal sliding of the dilator advancement assembly 144, as described herein.
[0041] The dilator carriage 146 is configured to slidably engage the interior of the dilator housing 114. For example, the dilator carriage 146 defines a generally cylindrical shape that extends longitudinally, and defines a generally circular cross-sectional shape that slidably engages the cylindrical interior of the dilator housing 114. In embodiments, the dilator carriage 146 also includes various holes and notches in order to accommodate various additional structures disposed within the dilator housing 114, as described herein.
[0042] The dilator carriage 146 is coupled with a proximal end of a dilator 140 that is disposed axially within the dilator housing 114, and defines a dilator lumen 158, as shown. Figure 2C The dilator 140 extends distally from the dilator carriage 146 to the distal end of the main body 110. A separable introducer sheath ("introducer") 150 is disposed axially over an outer surface of the dilator 140, and is supported by an introducer hub 152. The introducer 150 defines an introducer lumen 154. The dilator 140 supports the introducer 150 and facilitates its insertion prior to its retraction, as will be discussed in greater detail herein.
[0043] The docking station 200 is releasably coupled to the distal end of the main body 110, e.g., the distal end of the dilator housing 114. In embodiments, a rotating nut 202 releasably secures the docking station to the distal end of the main body 110, although other suitable attachment mechanisms are contemplated, such as lugs, interference fits, luer locks, clips, protrusions and detents, combinations thereof, and the like.
[0044] As Figures 2D-2EAs shown, docking station 200 includes a body 210 formed from a first body portion 212 and a second body portion 214 joined along a longitudinal axis to define docking station body 210. In embodiments, first body portion 212 is joined with second body portion 214 along a longitudinal vertical plane, although it should be appreciated that first body portion 212 can be joined with second body portion 214 along a longitudinal horizontal plane or other oriented plane and fall within the scope of the present disclosure. In embodiments, first body portion 212 and second body portion 214 can be separated by urging the body portions 212, 214 perpendicular to the longitudinal axis. This facilitates removal of the docking station from the insertion site once the catheter has been placed, as will be described in greater detail herein.
[0045] Docking station body 210 defines a cavity 218 extending along the longitudinal direction and is configured to receive one of needle 130, dilator 140, introducer 150, introducer hub 152, or a distal portion of dilator housing 114, or combinations thereof. In embodiments, cavity 218 is configured to hold introducer hub 152 therein. Advantageously, this allows the clinician to release introducer 150 during the procedure and still maintain vascular access therethrough. Docking station 200 holds introducer 150 at an accessible angle and can align additional structures with introducer lumen 154 for introduction into the vasculature, as described herein.
[0046] Docking station body 210 includes a distal surface 216 configured to engage a skin surface of a patient and, in embodiments, includes an adhesive layer disposed thereon. Distal surface 216 provides an increased surface area to improve adhesion between docking station 200 and the skin surface of the patient, providing increased stability. Further, distal surface 216 can be angled relative to the longitudinal axis to stabilize the cavity of docking station 200 at a preferred insertion angle. In embodiments, distal surface 216 can also include various other layers including various antimicrobial, antibacterial, hemostatic properties, or combinations thereof, among others. Docking station 200 also includes a concave side configured to provide a comfortable gripping surface for the clinician. The concave shape directs the clinician's fingers to grip the midpoint of the side of docking station 200.
[0047] As Figures 3A-3CAs shown, the catheter placement system 300 includes a docking portion 310 disposed at a distal end, a track 312 extending proximally from the docking portion 310, and a locking hub 314 disposed at a distal end of the track 312, the locking hub 314 defining a locking hub cavity 342 extending along a longitudinal axis. The track 312 extends from a lower edge of the docking portion 310 along the longitudinal axis so as to axially align a catheter 330 with a central cavity 352 of the docking portion 310. A distal end of the docking portion 310 includes a connector 354 configured to engage a proximal end of the docking station 200 and axially align the central cavity 352 of the docking portion 310 with the central cavity 218 of the docking station 200. In embodiments, the connector 354 can be a male luer lock that engages a female luer lock disposed at the proximal end of the docking station. It should be appreciated that other engagement structures are also contemplated, including mechanical fits, interference fits, slip fits, press fits, rotating nuts, clips, protrusions and detents, combinations thereof, and the like.
[0048] The catheter holder 316 is slidably engaged with an upper surface of the track 312 and extends laterally upward and proximally to define a handle 318. A distal portion of the catheter holder 316 is configured to hold a portion of the catheter 330, for example, a catheter hub 332 is held by the catheter holder 316 in an interference fit. A proximal portion of the catheter holder 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, the catheter hub 332 includes a first extension leg 334, a second extension leg 336, and a third extension leg 338. The catheter holder 316 includes a first clip 324, a second clip 326, and a third clip 328, each 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 can hold the extension legs 334, 336, 338 at a convenient angle for accessing the extension legs, for example, to flush the lumen of the catheter with saline prior to placement. Figure 3A As shown, the catheter hub 332 includes a first extension leg 334, a second extension leg 336, and a third extension leg 338. The catheter holder 316 includes a first clip 324, a second clip 326, and a third clip 328, each 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 can hold the extension legs 334, 336, 338 at a convenient angle for accessing the extension legs, for example, to flush the lumen of the catheter with saline prior to placement.
[0049] In embodiments, the first clip 324 aligns the first extension leg 334 with the locking hub cavity 342 and is configured to receive the catheter guidewire 320. The first extension leg 334 can also include a flushing manifold 382 that includes one or more valves, a guidewire port 384, and allows for flushing of the catheter's lumen with saline prior to placement, but prevents proximal flow therefrom. The catheter guidewire 320 extends through the locking hub cavity 342 and is aligned with the lumen of the first extension leg 334. In embodiments, the first extension leg 334 also includes a rotation nut 388 or similar coupler that couples the catheter 330, and the catheter mount 316 coupled thereto, distally to the locking hub 314 and prevents longitudinal sliding of the catheter mount 316 relative to the rail 312. In embodiments, the rotation nut 388 also includes a sterile barrier, for example, the extension leg sterile barrier 348 disposed between the rotation nut 388 and the locking hub 314 as discussed in greater detail herein.
[0050] The locking hub 314 also includes a guidewire lock 378, for example, a collet lock, that can be twisted relative to the locking hub 314 to secure the catheter guidewire 320 in place and twisted in the opposite direction 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 the proximal end of the catheter guidewire. The guidewire hub 322 is configured to prevent the proximal end of the catheter guidewire 320 from being advanced through the locking hub cavity 342. Advantageously, the guidewire lock 378 allows the clinician to lock the catheter guidewire 320 in place and release the catheter guidewire 320 to perform other procedures. This is in contrast to current systems that require the clinician to maintain a grip on the guidewire to prevent the guidewire from being pulled into the patient's vasculature causing embolism and various associated complications. Further, the guidewire hub 322 is configured to prevent the proximal end of the catheter guidewire 320 from being advanced through the locking hub cavity 342 and into the lumen of the catheter 330 such that if the clinician releases the catheter guidewire 320 without the securing guidewire lock 378, the catheter guidewire 320 still cannot be pulled into the patient's vasculature. This is in contrast to current systems and methods that require the device to be withdrawn over the proximal end of the guidewire.
[0051] The catheter guidewire 320 also 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 can include a gas impermeable membrane (e.g., polyethylene, polypropylene, etc.) to maintain the catheter guidewire 320 in a sterile environment and prevent the clinician from contacting the portion of the catheter guidewire 320 that is to be advanced into the patient's vasculature. Further, the barrier 344 prevents exposure of bodily fluids to the clinician when the catheter guidewire 320 is withdrawn from the vasculature. In embodiments, the barrier 344 is foldable to allow the catheter guidewire 320 to be advanced distally.
[0052] 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 catheter guidewire 320 in a sterile environment as it extends between the locking hub 314 and the first extension leg 334. The catheter placement system 300 also includes a track sterile barrier 348 extending between the locking hub 314 and the proximal end of the docking portion 310. The track sterile barrier 348 surrounds the track 312 and a portion of the catheter 330. Advantageously, the track sterile barrier 348 maintains the catheter 330 in a sterile environment and prevents the clinician from accessing the portion of the catheter 330 that is to be advanced into the patient’s vasculature. Further, the barrier 348 prevents bodily fluids from being exposed to the clinician as the catheter 330 is withdrawn from the vasculature. In embodiments, the track barrier 348 includes an opening through which the catheter mount 316, one or more of the extension legs 334, 336, 338, one of the catheter hubs 332, or a combination thereof can extend. In embodiments, the proximal end of the track barrier 348 is coupled to a sliding ring 356 that slidably engages the track 312 and allows the proximal end of the track barrier 348 to slide longitudinally. In embodiments, the distal end of the track barrier 348 is coupled to a collar 358 that is coupled to the proximal end of the docking portion 310.
[0053] The docking portion 310 includes a housing 350 that defines a central lumen 352 extending therethrough. As shown, the housing 350 includes a cap 380 extending over a portion of the central lumen 352 of the housing. The cap 380 is separable from the housing 350 to allow the catheter 330 to be released from the docking portion 310 once the catheter has been intravenously placed, as will be described in greater detail herein. Figure 3C
[0054] The docking portion 310 also includes an introducer retraction assembly 360 that includes a clamp 362 that is configured to engage the introducer hub 152. The clamp 362 defines a clamp cavity 366 that allows the clamp 362 to engage the dilator and allows various elongated medical devices to pass therethrough. For example, a catheter 330 can pass through the clamp 362 and into the lumen of the introducer 150. In embodiments, the clamp 362 opens a valve disposed within the introducer hub 152. The valve is configured to prevent proximal blood flow when the docking station 200 is decoupled from the introducer placement system 100. When the catheter placement system 300 is coupled, the clamp 362 opens the valve to provide a path for the catheter 330 to pass through. The clamp 362 also includes a parting 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 parting line 364 can include a score line, a perforation, a laser cut line, or similar line of weakness to facilitate separating the clamp 362 into the first half 362A and the second half 362B.
[0055] The introducer retraction assembly 360 also includes a first reel 370 and a second reel 372 that are disposed within the housing 350 and laterally spaced apart so as to be disposed on opposite sides of the central axis of the housing 350. In embodiments, the first reel 370 is coupled to the second reel 372 by way of a gear mechanism such that when the first reel 370 is turned, the gear mechanism causes the second reel 372 to also turn. Similarly, it should be appreciated that as the second reel 372 is turned, the gear mechanism causes the first reel 370 to also turn. In embodiments, when the first reel 370 is turned, for example, in a clockwise direction, the gear mechanism causes the second reel 372 to turn in an opposite direction, for example, a counterclockwise direction.
[0056] The first reel 370 includes a first pull tab 374 extending between the first reel 370 and the first half of the clamp 362A. The second reel 372 includes a second pull tab 376 extending between the second reel 372 and the second half of the clamp 362B. A twist knob 368 is coupled to the first reel 370 to allow the clinician to rotate the first reel 370 and the second reel 372, which in turn 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 372, which in turn separates the clamp 362, the introducer hub 152, and the introducer 150 coupled thereto into two separate halves along the longitudinal axis and winds each half around its 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. It should be understood that other mechanisms and methods of rotating the reels 370, 372 are also contemplated to be within the scope of the present invention.
[0057] How to use
[0058] In an exemplary method of use, a rapidly insertable central catheter (RICC) system 10 is provided that includes an introducer placement system 100, a docking station 200, and a catheter placement system 300. Generally, the method includes a two-step process of placing the docking station 200 and introducer 150 within the patient's vasculature using the introducer placement system 100, and then removing the introducer placement system 100 from the docking station 200 and removing the coupling of the catheter placement system 300 to the docking station 200 to place the catheter 330.
[0059] like Figure 4A As shown, an introducer placement system 100 is provided, comprising a docking station 200 releasably coupled to its distal end, as described herein. The introducer placement system 100 includes a needle 130 coupled to a needle advancement assembly 134 and extending distally through a cavity 218 of the docking station 200 to a point distal to a distal surface 216 of the docking station. The introducer placement system 100 and docking station 200 assembly further comprises a cap 102 disposed over the distal portion of the needle 130 and engaging the distal surface 216 of the docking station 200, the distal end of the docking station cavity 218, or a combination thereof. The cap 102 is formed of an elastomeric material and is configured to protect the needle from damage during transport, prevent accidental needlestick injuries, and provide a sterile barrier to prevent contamination of the needle 130 prior to use. Thus, the cap 102 is removed and the introducer placement system 100 and docking station 200 assembly is ready for use.
[0060] 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 actuates the blood flash button 162, which releases the vacuum within the blood flash tube 160. Figure 4B As shown, the needle 130 is advanced until the tip enters the patient's vasculature 20. The vacuum released by the blood flash button 162 causes proximal flow through the needle lumen 132 and into the blood flash tube 160, which is in fluid communication with the needle lumen 132. The clinician can observe the color of the blood and the presence / absence of pulsatile blood flow through the blood flash tube 160 to determine whether the needle 130 has entered the venous or arterial vasculature.
[0061] like Figure 4C As shown, once correct vascular access has been confirmed, the guidewire advancement assembly 124 can be actuated to advance the distal portion of the introducer guidewire 120 through the needle cavity 132 and into the patient's vascular system 20. In order to actuate the guidewire advancement assembly 124, the clinician can promote the finger-shaped tabs of the guidewire assembly that is connected with the guidewire carriage 126 in the distal direction. In an embodiment, the guidewire finger-shaped tabs 128 comprise a locking mechanism as described herein, which requires the clinician to pinch the finger-shaped tabs 128A, 128B laterally inwardly to allow the guidewire advancement assembly 124 to advance distally. When the distal portion of the introducer guidewire 120 advances through the tip of the needle 130, the guidewire can wear the edge of the needle 130, thereby making the needle blunt. Advantageously, when the needle is removed from the vascular system 20, this prevents accidental needle stick injuries.
[0062] like Figure 4D As shown, the expander advancement assembly 144 is then advanced distally to advance the expander 140 and the introducer 150 disposed thereon. The expander advancement assembly 144 is advanced by actuating the expander finger tabs 148 in the distal direction. In an embodiment, as described herein, the expander finger tabs 148 may include a locking mechanism that requires pinching the tabs laterally inward before the expander advancement assembly 144 can be advanced distally. The expander advancement assembly 144 is advanced until the introducer hub 152 supporting the introducer 150 is placed within the cavity 218 of the docking station 200. In an embodiment, a portion of the docking station cavity 218 is shaped to mate with the outer surface of the introducer hub 152 so that the introducer hub 152 is retained by the docking station in a friction-fit engagement. It should be understood that the docking station cavity 218 may also include various clips, detents, protrusions, barbs, combinations thereof, etc. to further retain the introducer hub 152 within the cavity 218.
[0063] like Figure 2CAs shown, dilator 140 includes a tapered tip that mates closely with the outer surface of needle 130. Furthermore, introducer 150 also includes a tapered tip that mates closely with the outer surface of dilator 140. Accordingly, as dilator advancement assembly 144 is advanced, dilator 140 expands the insertion site. Furthermore, introducer 150 further expands the insertion site. This expands the insertion site from the diameter of needle 130 to a diameter sufficient to accommodate a catheter (e.g., a triple-lumen central venous catheter) 330.
[0064] like Figure 4E As shown, once the distal portion of the introducer is placed within the patient's vasculature 20, the needle advancement assembly 134 can be actuated to retract the needle 130 proximally, thereby placing the dilator 140 and introducer 150 in place. Note that both the needle advancement assembly 134 and the guidewire advancement assembly 124 are slidably engaged with the guidewire housing slot 122. Accordingly, when the needle advancement assembly 134 is actuated proximally, the needle finger tabs 138, the needle slide 136, or a combination thereof abut against the guidewire finger tabs 128, the guidewire slide 126, or a combination thereof, and cause the introducer guidewire 120 to be simultaneously retracted proximally. Accordingly, the needle 130 and the introducer guidewire 120 are retracted into the body 110 of the introducer placement system 100. Advantageously, the needle and guidewire are housed within the body 110 to prevent exposure to the clinician and to prevent accidental sticking injuries. Additionally, as Figure 4E As shown, the blood flash tube 160 extending along the inner surface of the guidewire housing 112 flexes to accommodate the movement of the needle carriage to which it is coupled.
[0065] like Figures 4F-4G As shown, 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 expander advancement assembly 144 can be proximally retracted to retract the expander 140 into the expander housing 114. Advantageously, this contains the expander 140 within the expander housing 114, thereby preventing exposure to the clinician.
[0066] The distal surface 216 of the docking station 200 includes an adhesive layer, as described herein. The adhesive layer 222 also includes a cover disposed thereon to protect the adhesive layer 222 during manufacturing and shipping. 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 contacts the patient's skin surface, thereby securing the docking station 200 thereto. The introducer placement system 100 can then be removed from the docking station 200, for example, by twisting and releasing the rotating nut 202, leaving the introducer 150 disposed within the vascular system 20 supported by the docking station 200. Advantageously, the docking station 200 supports the introducer without requiring the clinician to maintain a grip on the introducer.
[0067] like Figure 4H As shown, a catheter placement system 300 is provided, which includes a catheter 330 (e.g., a three-lumen CVC catheter), as described herein. The lumen of the catheter 330 can be flushed by attaching a syringe of saline fluid, etc., to the side port 386 of the manifold 382 or to the port at the proximal end of the extension legs 336, 338. The catheter placement system 300 is then coupled to the docking station 200. The connector 354 engages the proximal portion of the docking station cavity 218 in a Luer lock or interference fit engagement, as described herein. When the connector 354 engages the docking station 200, the clamp 362 also engages the introducer hub 152 and optionally opens a valve disposed within the introducer hub 152.
[0068] like Figure 4I As shown, with the catheter placement system 300 coupled to the docking station 200, the catheter guidewire 320 can be advanced through the locking hub 314, through the lumen of the catheter 330, through the introducer 150, until the distal portion of the catheter guidewire 320 extends beyond the distal tip of the introducer 150 and into the patient's vasculature 20. In an embodiment, the catheter guidewire 320 includes a measurement boundary arranged along the axis of the catheter guidewire 320 to indicate to the clinician the length of the catheter guidewire 320 arranged within the patient's vasculature. Accordingly, the clinician can advance the catheter guidewire 320 until its distal tip is arranged at a desired distance near the target location within the patient's vasculature. The clinician can then lock the catheter guidewire 320 in place using the guidewire lock 378.
[0069] like Figure 4J As shown, by rotating the rotation nut 388, the first extension leg 334 is released from the locking hub 314. This allows the catheter holder 316 and the catheter 330 coupled thereto to slide distally along the track 312. The clinician can grasp the catheter holder 316, for example, at the handle 318, and push the catheter 330 distally so that the distal tip advances through the docking station lumen 218, through the clamp lumen 366, through the introducer 150 lumen, and over the catheter guidewire 320 to a point distal to the introducer 150 distal tip.
[0070] Note that as catheter holder 316 is advanced, folded extension leg sterile barrier 346 unfolds to maintain a sterile barrier between extension leg 338 and locking hub 314. Similarly, track sterile barrier 348 allows catheter 330 and catheter holder 316 to slide along track 312 while maintaining catheter 330 in a sterile environment.
[0071] like Figure 4KAs shown, the distal tip of the catheter 330 is disposed within the vasculature 20. The introducer 150 can be retracted by twisting the knob 368. As described herein, actuating the knob 368 causes the first spool 370 and the second spool 372 to rotate, withdrawing the clamp 362 and separating it into two halves, which in turn separates and retracts the introducer hub 152 into two halves, which in turn separates and retracts the introducer hub 150 into two separate halves. Each clamp half, hub half, and introducer sheath half is wound on the respective spool 370, 372 and stored in the housing 350. This removes the introducer from the insertion site while the catheter 330 remains disposed within the vasculature 20.
[0072] As Figure 4L shown, with the introducer 150 removed from the cavity 352 of the housing 350, the catheter shelf 316 can be further advanced to further advance the distal tip of the catheter 330 into the vasculature of the patient. As Figure 4M shown, with the catheter 330 further disposed within the vasculature 20, the guidewire lock 378 can be released and the guidewire is withdrawn proximally until the distal tip of the catheter guidewire 320 is withdrawn from the catheter 330. Optionally, the catheter guidewire 320 can then be re-locked into place using the guidewire lock 378.
[0073] As Figure 4N shown, the catheter placement system 300 and the docking station 200 can then be removed. The collar 358, which supports the distal end of the sterile barrier 348, is unthreaded from the proximal end of the housing 350. The connector 354 is unthreaded from the docking station 200. The housing cap 380 is unthreaded from the housing 350 to expose the portion of the catheter 330 disposed within the central cavity 352 of the housing 350. The catheter hub 332 is unthreaded from the catheter shelf 316, and the extension legs 334, 336, 338 are unthreaded from the respective clips 324, 326, 328 to allow the extension legs to be pulled through the collar 358. The catheter placement system 300 can then be removed from the catheter 330.
[0074] The docking station 200 can then be removed from the insertion site by pushing the first body portion 212 and the second body portion 214 laterally outward. The two body portions can be separated along the split line to allow the docking station 200 to be removed. The catheter 330 can then be stabilized against the skin surface of the patient.
[0075] While some specific embodiments have been disclosed herein, and while some details regarding specific embodiments have been set forth, the particular embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can occur to one of ordinary skill in the art, and such adaptations and / or modifications are encompassed within the scope of the concepts provided herein. Accordingly, while the particular embodiments have been disclosed, various alternatives, modifications and equivalents can be used. It is intended that the following claims be construed to include all such alternatives, modifications and equivalents.
Claims
1. A rapid insertion central catheter system comprising: An introducer placement system configured to place an introducer within a patient's vasculature, the introducer placement system comprising: a needle defining a needle lumen; an introducer guidewire disposed within the needle lumen; a dilator defining a dilator lumen; the introducer, the introducer being supported by an introducer hub, the introducer defining an introducer lumen configured to receive the dilator disposed therein; a guidewire housing comprising 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 the distal end of the guidewire housing and including a dilator advancement assembly coupled to the proximal end of the dilator; and a blood flash indicator tube, the blood flash indicator tube being fluidically connected to the needle cavity; a docking station releasably coupled to a distal end of the dilator housing, the docking station defining a lumen configured to retain the introducer hub; and a catheter placement system configured to engage a proximal end of the docking station and place a catheter within the vasculature of the patient, the catheter placement system comprising: a docking portion configured to engage the docking station to axially align the catheter with the introducer lumen; a track extending proximally from the docking portion; a locking hub disposed at a proximal end of the track, the locking hub defining a locking hub cavity; a catheter guidewire including a guidewire hub permanently attached to a distal end thereof, wherein a portion of the catheter guidewire is disposed within the locking hub lumen; and A catheter frame is slidably engaged with the track, wherein the catheter is supported by the catheter frame.
2. The rapid insertion central catheter system according to claim 1, wherein: The introducer placement system also includes a blood flash actuator configured to release a vacuum disposed within the blood flash indicating tube to draw proximal blood flow through the needle lumen and into the blood flash indicating tube.
3. The rapid insertion central catheter system according to claim 2, wherein: The proximal blood flow disposed within the blood flash indicating tube is observable through the blood flash indicating tube and through the guidewire housing.
4. The rapid insertion central catheter system according to claim 1, wherein: One of the track and the catheter guidewire is disposed within a collapsible sterile barrier to prevent contact therewith.
5. The rapid insertion central catheter system according to claim 1, wherein: The catheter is disposed within a collapsible sterile barrier including the track disposed therein, with the catheter holder extending through an aperture disposed in a sidewall of the collapsible sterile barrier and configured to be grasped by a clinician.
6. The rapid insertion central catheter system according to claim 1, wherein: One of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly includes a release mechanism that requires a pair of finger-like tabs to move laterally inwardly before allowing any longitudinal movement thereof.
7. The rapid insertion central catheter system according to claim 1, wherein: The introducer wire of the dilator advancement assembly is configured to blunt the tip of the needle as the introducer wire is advanced distally through the needle lumen.
8. The rapid insertion central catheter system according to claim 1, wherein: Distal advancement of the dilator advancement assembly causes the dilator and introducer to be advanced distally over the needle and introducer guidewire.
9. The rapid insertion central catheter system according to claim 1, wherein: Proximal withdrawal of the needle retraction assembly results in proximal withdrawal of the needle and the introducer guidewire.
10. The rapid insertion central catheter system according to claim 1, wherein: Distal advancement of the expander advancement assembly transfers the introducer from the expander housing to the docking station.
11. The rapid insertion central catheter system according to claim 10, wherein: Proximal withdrawal of the dilator advancement assembly causes proximal withdrawal of the dilator from the lumen of the introducer.
12. The rapid insertion central catheter system according to claim 1, wherein: The docking station defines a distal surface including an adhesive layer configured to adhere the docking station to a skin surface of the patient.
13. The rapid insertion central catheter system according to claim 1, wherein: The width of the guidewire hub of the catheter guidewire is greater than the width of the locking hub cavity to prevent the proximal end of the catheter guidewire from passing through the locking hub cavity.
14. The rapid insertion central catheter system according to claim 1, wherein: The docking portion of the catheter placement system includes an introducer retrieval assembly configured to separate the introducer along a longitudinal axis into a first half and a second half, the first half being wound on a first spool and the second half being wound on a second spool.
15. The rapid insertion central catheter system according to claim 1, wherein: The locking hub also includes a guidewire lock configured to lock the catheter guidewire and prevent longitudinal movement relative to the locking hub.
16. The rapid insertion central catheter system according to claim 1, wherein: The docking station includes a longitudinally extending tear line and is configured to separate along the tear line when the first and second body portions of the docking station are pushed laterally outward.
17. A rapid-insertion central catheter system for placing a catheter within the vasculature of a patient, comprising: an introducer placement system comprising a dilator and an introducer having an introducer hub, the introducer placement system being configured to place a distal portion of the introducer within the vasculature of the patient; a docking station having a proximal end releasably coupled to a distal end of the introducer placement system and configured to receive the introducer hub from the introducer placement system as the introducer is advanced into the vasculature; as well as A catheter placement system is configured to engage the proximal end of the docking station, place a catheter within the vasculature of the patient, engage the introducer hub, and remove the introducer from the vasculature of the patient.
18. The rapid insertion central catheter system according to claim 17, wherein: The introducer placement system includes a needle, an introducer guidewire, and a blood flash indicator tube.
19. The rapid insertion central catheter system according to claim 18, wherein: The introducer placement system also includes a blood flash actuator configured to release a vacuum disposed within the blood flash indicating tube to draw proximal blood flow through the lumen of the needle and into the blood flash indicating tube.
20. The rapid insertion central catheter system according to claim 17, wherein: The catheter placement system includes one of a docking portion, a track, a locking hub, a catheter guidewire, and a catheter holder.
21. The rapid insertion central catheter system according to claim 20, wherein: One of the track, the catheter, and the catheter guidewire is disposed within a collapsible sterile barrier to prevent contact therewith.
22. The rapid insertion central catheter system according to claim 17, wherein: The introducer placement system includes one of a guidewire advancement assembly, a needle retraction assembly, and a dilator advancement assembly.
23. The rapid insertion central catheter system according to claim 21, wherein: One of the guidewire advancement assembly, the needle retraction assembly, and the dilator advancement assembly includes a release mechanism.
Citation Information
Patent Citations
Quick insertion central catheter system
CN216091806U