Quick insertable central catheter comprising a catheter assembly and method thereof

Abstract

A rapidly insertable central catheter ("RICC") including a catheter assembly and methods thereof are disclosed. The RICC assembly can include a RICC, an introducer, and a coupling system configured to couple the RICC and the introducer together. The catheter tube of the RICC includes a side hole in a distal end portion of the catheter tube that opens into a guide lumen that extends from the side hole to a distal end of the RICC. The introducer includes a syringe and a guide needle having a cannula. The coupling system includes a distal coupler that is slidably attached to the catheter tube proximal of the side hole. When the RICC assembly is at least in its immediate deployment state, the cannula extends through a longitudinal through hole of the distal coupler, through the side hole of the catheter tube, along the guide lumen of the catheter tube, and through the distal end of the RICC.

Description

[0001] priority

[0002] This application claims priority to U.S. Patent Application No. 63 / 014,555, filed April 23, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to a rapidly insertable central catheter including a catheter assembly and a method thereof. Background Technology

[0004] Central venous catheters (“CVCs”) are formed from relatively low-rigidity materials, resulting in a lack of column strength. Due to this lack of column strength, CVCs are typically introduced into and advanced through the patient’s vascular system using the Seldinger technique. The Seldinger technique utilizes numerous steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the numerous steps are time-consuming, the handling of a large number of medical devices is inconvenient, and both can lead to patient trauma. Furthermore, the possibility of contact contamination is relatively high due to the need to exchange numerous medical devices during the many steps of the Seldinger technique. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing and advancing catheters, such as CVCs, into the patient’s vascular system.

[0005] This article discloses a rapidly insertable central catheter (“RICC”) including catheter assemblies and a method thereof for solving the aforementioned problems. Summary of the Invention

[0006] This document discloses a RICC assembly. In some embodiments, the RICC assembly includes a RICC, a guide, and a coupling system configured to connect the RICC and the guide. The RICC includes a catheter fitting, a catheter bushing, and one or more extension legs. The catheter fitting includes: a first segment formed of a first material having a first hardness; and a second segment formed of a second material having a second hardness less than the first hardness. The catheter fitting includes a side hole that passes through the side of the catheter fitting in a distal portion of the catheter fitting but proximal to the first segment of the catheter fitting. The side hole opens into a guide lumen of the catheter fitting that extends at least from the side hole to the distal end of the RICC. The catheter bushing is coupled to the proximal portion of the catheter fitting. Each of the one or more extension legs is coupled to the catheter bushing through its distal portion. The guide includes a guide needle with a cannula that extends through the distal end of the RICC when the RICC assembly is at least in a ready-to-deploy state. The connection system includes a distal connector that is slidably attached to the conduit fitting on the proximal side of the side hole.

[0007] In some implementations, when the RICC assembly is at least in its immediately deployed state, the cannula extends further through the longitudinal through-hole of the distal connector, through the side hole of the conduit fitting, and along the guide lumen of the conduit fitting, before exiting through the distal end of the RICC.

[0008] In some implementations, the distal connector includes a tab configured to allow a clinician to push the RICC out of the cannula with one hand using a single finger of one hand, while holding the guide between the thumb and one or more other fingers of that hand.

[0009] In some embodiments, the guide further includes a syringe and an entry guidewire. The syringe has a syringe tip that is coupled to a needle bushing of the guide needle. The entry guidewire is disposed within an entry guidewire lumen, which is formed at least by the plunger lumen of the syringe plunger and the needle lumen of the guide needle. The entry guidewire is long enough to extend through the distal end of the RICC.

[0010] In some implementations, the plunger includes a sealing mechanism in its proximal portion for sealing the lumen of the guidewire. The sealing mechanism is configured to prevent blood from leaking through the proximal end of the plunger during venipuncture or as the guidewire is withdrawn from the patient's vascular lumen.

[0011] In some implementations, the entry guidewire is captured and positioned within the guidewire via a blocking element surrounding the proximal portion of the entry guidewire and a closed end of a fixed-length entry guidewire sterile barrier coupled to the proximal end of the plunger. The blocking element provides distal restriction to the advancement of the entry guidewire. The closed end of the entry guidewire sterile barrier surrounding the entry guidewire provides proximal restriction to its withdrawal.

[0012] In some embodiments, the guide further includes a fluid pressure indicator extending from the side arm of the needle bushing. The fluid pressure indicator is fluidly connected to the needle lumen of the guide needle via the side arm lumen for observing blood flashback.

[0013] In some embodiments, the coupling system further includes a proximal connector that is slidably attached to the catheter liner and removably attached to the syringe, at least in the immediate deployment state of the RICC assembly. The coupling system is configured to allow the RICC to slide relative to the guide.

[0014] In some implementations, the proximal connector includes a catheter liner clip, and the RICC is configured to be suspended from the catheter liner clip via the catheter liner, at least in the immediate deployment state of the RICC assembly. In the operational state of the RICC assembly, when the proximal connector is advanced thereon, the RICC is configured to be suspended from the catheter liner clip via one or more extension legs.

[0015] In some implementations, the proximal connector includes a syringe clamp. The guide is configured to be rested in the syringe clamp, at least in the immediate deployment state of the RICC assembly, by the distal portion of the syringe barrel.

[0016] In some embodiments, the RICC further includes a collapsible catheter fitting sterile barrier above the catheter fitting between the catheter liner and the distal connector (to which the catheter fitting sterile barrier is coupled). The catheter fitting sterile barrier is configured to tear when the sterile barrier tab is removed from the catheter liner clamp and the catheter fitting sterile barrier is pulled apart from the catheter fitting through the sterile barrier tab.

[0017] In some implementations, the sterile barrier of the catheter fitting has sufficient tensile strength to pull the distal connector away from the catheter fitting without breaking it when the sterile barrier is pulled away from the catheter fitting and when the sterile barrier tears downwards to the distal connector.

[0018] In some implementations, the RICC includes a group of three lumens: a distal lumen, an intermediate lumen, and a proximal lumen. The group of three lumens is formed by fluid connections of three catheter fitting lumens, three bushing lumens, and three extension leg lumens. The guiding lumen of the catheter fitting coincides with the distal portion of the distal lumen.

[0019] In some embodiments, the distal lumen has a distal lumen hole in the distal end of the RICC, the intermediate lumen has an intermediate lumen hole in the side of the catheter fitting distal to the side hole, and the proximal lumen has a proximal lumen hole in the side of the catheter fitting distal to the side hole and proximal to the intermediate lumen hole.

[0020] In some embodiments, the RICC further includes a manipulator guidewire disposed in the distal lumen. The manipulator guidewire is long enough to extend to the lower third of the superior vena cava of the heart. The manipulator guidewire is captured and disposed in the RICC by a blocking element surrounding the proximal portion of the manipulator guidewire and a closed end of a fixed-length sterile barrier of the manipulator guidewire coupled to a Luer connector. The blocking element provides distal restriction on advance of the manipulator guidewire. The closed end of the sterile barrier of the manipulator guidewire surrounding the manipulator guidewire provides proximal restriction on withdrawal of the manipulator guidewire.

[0021] This document also discloses a method for inserting a RICC into a patient's vascular lumen. In some embodiments, the method includes an RICC assembly acquisition step, a needle path establishment step, a first RICC advancement step, and a guide needle withdrawal step. The RICC assembly acquisition step includes acquiring the RICC assembly. The RICC assembly includes the RICC, a guide needle, and a coupling system for connecting the RICC to the guide needle. The guide needle includes a syringe coupled to a guide needle. The coupling system includes a distal connector that connects the RICC and the guide needle together, at least in the immediate deployment state of the RICC assembly, through their distal portions. The needle path establishment step includes establishing a needle path from the skin region to the patient's vascular lumen using a cannula of the guide needle while retaining the distal portion of the syringe barrel. The cannula extends through a longitudinal through-hole of the distal connector, through a side hole in the distal portion of the RICC catheter fitting, along the guide lumen of the catheter fitting, and out of the distal end of the RICC to establish the needle path. The first RICC advancement step includes advancing the distal portion of the catheter fitting into the vascular lumen over the cannula. The guide extraction step includes withdrawing the sleeve from the guide lumen using the side holes of the guide fitting.

[0022] In some embodiments, the method further includes a blood aspiration step. The blood aspiration step involves using a syringe to aspirate blood before withdrawing the cannula from the guiding lumen. The blood aspiration step confirms that the cannula is positioned within the patient's blood vessel lumen.

[0023] In some implementations, the needle path establishment step includes ensuring blood flow back into the needle bushing of the guide needle, the side arm of the needle bushing, or a fluid pressure indicator extending from the side arm of the needle bushing.

[0024] In some implementations, the needle path establishment step includes holding the syringe body around the distal portion of the syringe body using a syringe clamp. The syringe clamp is part of the proximal connector of the coupling system.

[0025] In some embodiments, the first RICC advancement step includes advancing the catheter fitting into the vascular lumen using a single finger of the hand while holding the syringe barrel between the thumb and one or more fingers of the hand via a syringe clamp. The distal connector includes a tongue configured for advancing the catheter fitting into the vascular lumen using a single finger.

[0026] In some implementations, the first RICC advancement step includes advancing the catheter liner of the RICC from the catheter liner clamp of the proximal connector. After advancing the catheter liner from the catheter liner clamp, one or more extension legs of the RICC are advanced within the catheter liner clamp. The RICC is configured to suspend in the connector system until the cannula is withdrawn from at least both the guide lumen and the longitudinal through-hole of the distal connector.

[0027] In some embodiments, the method further includes an entry guidewire advancement step. The entry guidewire advancement step includes advancing an entry guidewire disposed in an entry guidewire lumen formed at least by the plunger lumen of the syringe plunger and the needle lumen of the guide needle into the vascular lumen, beyond the distal end of the cannula, prior to the first RICC advancement step.

[0028] In some embodiments, the method further includes a manipulating guidewire advancement step. The manipulating guidewire advancement step involves advancing the manipulating guidewire into the vascular lumen via a distal lumen having a distal lumen port in the distal portion of the RICC. The guiding lumen of the catheter fitting coincides with the distal portion of the distal lumen, thereby allowing the cannula to be withdrawn from the guiding lumen prior to the manipulating guidewire advancement step.

[0029] In some embodiments, the method further includes a second RICC advancement step. The second RICC advancement step includes advancing the distal portion of the catheter fitting further into the vascular lumen above the manipulating guidewire. The second RICC advancement step also includes simultaneously sliding the distal connector proximally toward the proximal portion of the catheter fitting to expose the catheter fitting. At least in the immediately deployed state of the RICC assembly, the catheter fitting is covered by a contractile sterile barrier between the proximal portion of the catheter fitting and the distal connector.

[0030] In some embodiments, the method further includes a sterile barrier removal step. The sterile barrier removal step includes removing the sterile barrier and distal connector from the RICC by: pulling the sterile barrier tongue of the sterile barrier away from the catheter fitting relative to the distal connector to tear the sterile barrier, and then pulling the distal connector away from the catheter fitting through the sterile barrier (to which the distal connector is slidably attached).

[0031] In some embodiments, the catheter fitting includes a first segment formed of a first material having a first hardness and a second segment proximal to the first segment formed of a second material having a second hardness less than the first hardness. The first segment of the catheter fitting is configured with column strength for advancing the catheter fitting into the vascular lumen above an entry guidewire or manipulation guidewire.

[0032] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of these concepts in more detail. Attached Figure Description

[0033] Figure 1 An oblique view of an RICC assembly, including an RICC, a guide, and a coupling system, is shown according to some implementation schemes.

[0034] Figure 2 A top view of a RICC component according to some implementation schemes is shown.

[0035] Figure 3 A bottom view of a RICC component according to some implementation schemes is shown.

[0036] Figure 4 A side view of a RICC component according to some implementation schemes is shown.

[0037] Figure 5 A detailed view of the bottom of the RICC component according to some implementation schemes is shown.

[0038] Figure 6 A detailed view of the top of the RICC component according to some implementation schemes is shown.

[0039] Figure 7 Another detailed view of the top of the RICC components according to some implementation schemes is shown.

[0040] Figure 8 A longitudinal section of a RICC component according to some implementation schemes is shown.

[0041] Figure 9 The distal portion of a RICC conduit fitting according to some embodiments is shown.

[0042] Figure 10 A first transverse section of a conduit fitting according to some embodiments is shown.

[0043] Figure 11 A second transverse section of a conduit fitting according to some embodiments is shown.

[0044] Figure 12 A third or fourth transverse section of a conduit fitting according to some embodiments is shown. Detailed Implementation

[0045] Before providing some specific embodiments in more detail, it should be understood that the specific embodiments provided herein do not limit the scope of the concepts disclosed herein. It should also be understood that features of the specific embodiments disclosed herein can be readily separated from the specific embodiments and optionally combined with or substituted with features of any of the other embodiments disclosed herein.

[0046] Regarding the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments, and the terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or a set of steps, and do not provide for a sequence or numerical limitation. For example, features or steps that are “first,” “second,” and “third” do not necessarily need to appear in order, and a particular embodiment that includes such features or steps is not necessarily limited to these three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used for convenience and do not imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise.

[0047] For example, the terms "proximal," "proximal portion," or "proximal portion" as used with respect to the catheter disclosed herein include the portion of the catheter that should be close to the clinician when the catheter is used on a patient. Similarly, for example, the term "proximal length" of the catheter includes the length of the catheter that should be close to the clinician when the catheter is used on a patient. For example, the term "proximal end" of the catheter includes one end of the catheter that should be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

[0048] For example, the terms "distal," "distal portion," or "distal part" as used with respect to the catheter disclosed herein include the portion of the catheter that should be close to or in the patient when the catheter is used on a patient. Similarly, for example, the term "distal length" of the catheter includes the length of the catheter that should be close to or in the patient when the catheter is used on a patient. For example, the term "distal end" of the catheter includes one end of the catheter that should be close to or in the patient when the catheter is used on a patient. The distal portion, distal part, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of the catheter does not need to include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0049] 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.

[0050] As mentioned above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system.

[0051] This document discloses a rapidly insertable central catheter (“RICC”) comprising a catheter assembly and methods thereof that address the aforementioned problems. However, it should be understood that RICC is merely one type of catheter that can embody or otherwise incorporate the concepts presented herein. In fact, peripherally inserted central venous catheters (“PICC”), dialysis catheters, etc., can also embody or otherwise incorporate the concepts presented herein for RICC and the catheter assembly and methods thereof.

[0052] RICC components

[0053] Figure 1-7 Various views of the RICC component 100, including RICC 102, guide 104, and coupling system 106, are shown according to some embodiments. Figure 8 A longitudinal section of an RICC component 100 according to some embodiments is shown. Figure 9 The distal portion of the conduit fitting 108 of the RICC 102 according to some embodiments is shown. Figure 10-12 Various transverse sections of the conduit fitting 108 according to some embodiments are shown.

[0054] As shown in the figure, in some embodiments, the RICC assembly 100 includes an RICC 102, a guide 104, and a coupling system 106 configured to connect the RICC 102 to the guide 104. The RICC 102, the guide 104, and the coupling system 106 are described sequentially in the sections set forth below; however, given the interrelationships between the RICC 102, the guide 104, and the coupling system 106 in the RICC assembly 100, there are some overlaps between portions of the RICC 102, the guide 104, and the coupling system 106.

[0055] RICC 102 includes a catheter fitting 108, a catheter bushing 110, and one or more extension legs 112.

[0056] The catheter fitting 108 includes two or more sections, including a tip 114 in the distal portion of the catheter fitting 108, one or more catheter fitting lumens, and a side hole 116 passing through the side of the catheter fitting 108 in the distal portion of the catheter fitting 108.

[0057] Two or more sections of the conduit fitting 108 can be the body and tip 114 of the conduit fitting 108, which can be formed as a single extrusion of a single material or a single co-extrusion of two similar materials. Alternatively, the body and tip 114 of the conduit fitting 108 can be formed as two different extrusions of two similar materials and subsequently joined together. However, Figure 9One embodiment of the conduit fitting 108 is shown, wherein the conduit fitting 108 is formed as two different extrusions of two different materials and subsequently joined together. In practice, depending on the joining method of the first segment 118 and the second segment 120 of the conduit fitting 108, the conduit fitting 108 includes a first segment 118 containing a tip 114, a second segment 120 containing a side hole 116, and an optional transition segment 122 between them. For example, the first segment 118 and the second segment 120 of the conduit fitting 108 can be joined by heat, solvent, or adhesive, such that the first segment 118 and the second segment 120 abut each other, or the second segment 120 can be inserted into the first segment 118 and joined to the first segment 118 by heat, solvent, or adhesive, thereby forming the transition segment 122. Advantageously, the latter joining method, in which the second segment 120 is inserted into the first segment 118, facilitates the incorporation of a smooth taper into the transition segment 122, which is useful for expansion during the method using the RICC assembly 100.

[0058] The first segment 118 of the catheter fitting 108 can be formed of a first material with a first hardness (e.g., a polymer material such as polytetrafluoroethylene, polypropylene, or polyurethane), while the second segment 120 of the catheter fitting 108 can be formed of a second material with a second hardness less than the first hardness (e.g., a polymer material such as polyvinyl chloride, polyethylene, polyurethane, or silicone). For example, each segment of the first segment 118 and the second segment 120 of the catheter fitting 108 can be made of different polyurethanes with different hardnesses. In practice, the advantage of polyurethane is that the polyurethane segments of the catheter fitting 108 can be relatively rigid at room temperature, but become more flexible at body temperature in vivo, reducing irritation to the vessel walls and phlebitis. Polyurethane also has the advantage of forming fewer thrombi compared to some other polymers.

[0059] The catheter fitting 108, having at least a first segment 118 of a first polymer material and a second segment 120 of a second polymer material, has sufficient column strength to prevent bending of the catheter fitting 108 when it is inserted into the insertion site and advanced through the patient's vascular system. The column strength of the catheter fitting 108 is noteworthy because it allows for rapid insertion into the insertion site and advancement through the patient's vascular system without the need for the Seldinger technique.

[0060] It should be understood that the first hardness and the second hardness can be different grades (e.g., Type A or Type D), so the second hardness of the second polymer material may not be numerically less than the first hardness of the first polymer material. That is, the hardness of the second polymer material can still be less than the hardness of the first polymer material because different scales (each scale ranging from 0 to 100) are designed to characterize different materials in a group of materials with similar hardness.

[0061] Despite the foregoing, the first section 118 and the second section 120 of the catheter fitting 108 may be formed of the same polymer material or different polymer materials having substantially equal hardness, provided that the column strength of the catheter fitting 108 is sufficient to prevent the catheter fitting 108 from bending when inserted into the insertion site and advanced through the patient's vascular system.

[0062] One or more catheter fitting lumens may extend through the entire catheter fitting 108; however, in multi-lumen RICCs (e.g., double-lumen RICCs, triple-lumen RICCs, quadruple-lumen RICCs, quintuple-lumen RICCs, hexaple-lumen RICCs, etc.), typically only one catheter fitting lumen extends from the proximal end to the distal end of the catheter fitting 108. In practice, the tip 114 typically includes a single lumen passing through it. Alternatively, the single lumen passing through the tip 114 may be referred to as the “tip lumen,” specifically the first segment 118 of the guiding catheter fitting 108, which is separated from and connected to the rest of the catheter fitting 108.

[0063] Similarly, the side hole 116 passes through the side of the catheter fitting 108 in the distal portion of the catheter fitting 108; however, the side hole 116 is proximal to the first segment 118 of the catheter fitting 108. The side hole 116 opens into a guide lumen 124 in one or more catheter fitting lumens. The guide lumen 124 extends at least from the side hole 116 in the second segment 120 of the catheter fitting 108 through the first segment 118 of the catheter fitting 108 distal thereto and extends to the distal end of the RICC 102 (e.g., the distal end of the catheter fitting 108 or the distal end of the tip 114). The guide lumen 124 coincides with the distal portion of the aforementioned catheter fitting lumen, which generally extends from the proximal end of the catheter fitting 108 to the distal end of the catheter fitting 108, particularly the distal portion of the catheter fitting lumen distal to the side hole 116.

[0064] The catheter bushing 110 is coupled to the proximal portion of the catheter fitting 108. The catheter bushing 110 includes one or more catheter bushing lumens corresponding in number to the lumens of one or more catheter fittings. The one or more catheter bushing lumens extend from the proximal end of the catheter bushing 110 through the entire catheter bushing 110 to the distal end of the catheter bushing 110.

[0065] Each of the one or more extension legs 112 is coupled to the catheter bushing 110 via its distal portion. Each of the one or more extension legs 112 includes one or more extension leg lumens, which in turn correspond in number to one or more catheter fitting lumens. Each of the one or more extension leg lumens extends from the proximal end of the extension leg through the entire extension leg to the distal end of the extension leg.

[0066] Each of the one or more extension legs 112 typically includes a Luer connector attached to the extension leg, through which the extension leg and its interior can be connected to another medical device.

[0067] Although RICC 102 can be a single-lumen or multi-lumen RICC (e.g., dual-lumen RICC, triple-lumen RICC, quadruple-lumen RICC, penta-lumen RICC, hexa-lumen RICC, etc.), Figure 1-12 The RICC 102 shown is a three-lumen RICC, comprising a group of three lumens. The group of three lumens includes, for example, a distal lumen 126, an intermediate lumen 128, and a proximal lumen 130, formed by fluid-connected portions of three fitting lumens, three bushing lumens, and three extension leg lumens. Whether the RICC 102 is single-lumen or multi-lumen, the RICC 102 includes at least a distal lumen 126. The distal lumen 126 includes at least one of the aforementioned fitting lumens, which generally extends from the proximal end to the distal end of the fitting 108, serving as the fitting lumen portion of the distal lumen 126, and the fluid-connected bushing and extension leg lumen portions of the distal lumen 126. According to the aforementioned catheter fitting lumen, the guiding lumen 124 of the catheter fitting 108 coincides with the distal portion of the distal lumen 126, particularly with the distal portion of the distal lumen 126 distal to the side hole 116. Furthermore, the distal lumen 126 has a distal lumen hole 132 in the distal end of the RICC 102 (e.g., the distal end of the catheter fitting 108 or the distal end of the tip 114). The intermediate lumen 128 has an intermediate lumen hole 134 in the side of the catheter fitting 108, proximal to the distal lumen hole 132 and distal to the proximal lumen hole 136 (hereinafter referred to as the proximal lumen hole), such that the intermediate lumen 128 lies between the distal lumen hole 132 and the proximal lumen hole 136. The proximal lumen 130 has a proximal lumen hole 136 in the side of the catheter fitting 108 proximal to the intermediate lumen hole 134. The side hole 116 of the catheter fitting 108 can be located between the distal inner lumen hole 132 and the intermediate inner lumen hole 134, between the intermediate inner lumen hole 134 and the proximal inner lumen hole 136, or as follows: Figure 9 As shown, the proximal side of the proximal internal cavity 136 is such that each of the distal internal cavity 132, the intermediate internal cavity 134 and the proximal internal cavity 136 is distal to the side cavity 116.

[0068] RICC 102 may further include a manipulator guidewire 138. Although not shown, manipulator guidewire 138 may include a non-invasive tip (e.g., a coiled or partially coiled tip) and a lower third of its length sufficient to advance manipulator guidewire 138 into the superior vena cava (“SVC”) of the heart. Manipulator guidewire 138 can be captured and positioned in RICC 102 at least in the immediate deployment state of RICC assembly 100. For example, the manipulating guidewire 138 can be positioned in the distal lumen 126 of the RICC 102, with the proximal or intermediate portion of the manipulating guidewire 138 positioned in the extension leg lumen portion of the distal lumen 126, the intermediate or distal portion positioned in the bushing lumen portion of the distal lumen 126, and the distal portion positioned in the catheter fitting lumen portion of the distal lumen 126, which is formed by the aforementioned catheter fitting lumen, which typically extends from the proximal end to the distal end of the catheter fitting 108. However, the distal portion of the aforementioned catheter fitting lumen distal to the side port 116 coincides with the guide lumen 124, as described below, at least in the immediate deployment state of the RICC assembly 100, the guide needle 143 occupies the guide lumen. At least in the immediate deployment state of the RICC assembly 100, the distal end of the manipulating guide wire 138 just does not reach the side hole 116 due to the presence of the guide pin 143 in the guide cavity 124.

[0069] The manipulating guidewire 138 includes a blocking element 140 (e.g., a bushing, ball, plug, etc.) surrounding the proximal portion of the manipulating guidewire 138, forming a blocking end (e.g., bushing end, ball end, plug end, etc.) of the manipulating guidewire 138. The blocking end of the manipulating guidewire 138 is larger than the proximal opening of the distal lumen 126 or the lumen portion of its extension leg, thereby providing distal restriction on the advancement of the manipulating guidewire 138 into the RICC 102. Furthermore, the manipulating guidewire 138 is disposed within a fixed-length sterile barrier 142 (e.g., a longitudinal pouch), the sterile barrier including a closed or sealed proximal end and an open distal end removably coupled (e.g., removably adhered) to the proximal end of a Luer connector of the extension leg for manual removal of the sterile barrier 142 and the manipulating guidewire 138 when necessary. The combination of a fixed-length sterile barrier 142, a closed or sealed proximal end of the sterile barrier 142, and a distal end of the sterile barrier 142 coupled to a Luer connector provides a restricted passage through which the manipulating guidewire 138 can move proximally, thus providing proximal restriction on the withdrawal of the manipulating guidewire 138 from the RICC 102. This proximal restriction holds the abductive tip of the manipulating guidewire 138 within the distal lumen 126, wherein, at least in embodiments with a coiled or partially coiled tip, the abductive tip remains straight or unfolded. This is advantageous because reinserting such a guidewire into the lumen of a medical device such as a catheter can be particularly difficult. Optionally, the blocking end of the manipulating guidewire 138 is coupled (e.g., adhered) to the proximal end of the sterile barrier 142 to retain the blocking end of the manipulating guidewire 138 at the proximal end of the sterile barrier 142, thereby reducing the mismatch between the length of the proximal portion of the manipulating guidewire 138 extending beyond the proximal end of the RICC 102 (e.g., the proximal end of the Luer connector) and the unpleasant length of the sterile barrier 142. Reducing the aforementioned mismatch between lengths lowers the likelihood of losing the blocking end of the manipulating guidewire 138 in the middle portion of the sterile barrier 142, which could require time and effort to re-match, and that time and effort can be better used to treat the patient.

[0070] In addition to providing proximal restriction for withdrawal of the manipulator guidewire from the RICC 102, the sterile barrier 142 is configured to maintain the sterility of the manipulator guidewire 138 prior to (e.g., during transport and handling, storage, etc.) and during use of the RICC assembly 100. During use of the RICC assembly 100, the sterile barrier 142 is configured to provide a contactless advance means for advancing the manipulator guidewire 138 into the patient's intravascular lumen after needle tract establishment. Similarly, the sterile barrier 142 is configured to provide a contactless withdrawal means for withdrawing the manipulator guidewire 138 from the patient's intravascular lumen, for example, after the catheter fitting 108 has been advanced over the manipulator guidewire 138.

[0071] Although not shown, RICC 102 may further include reinforcing needles, such as needles in the middle lumen and proximal lumen of a three-lumen embodiment of RICC 102, or in both lumens, to reinforce RICC 102, thereby providing additional column strength to prevent catheter fitting 108 from bending as it is inserted into the insertion site and advanced through the patient's vascular system.

[0072] Guide device 104 includes a guide needle 143, a syringe 144 operatively connected to the guide needle 143, and an entry guide wire 146 disposed within the guide device 104. Guide device 104 may further include a fluid pressure indicator 148 operatively connected to the guide needle 143.

[0073] The guide needle 143 includes a needle liner 150 and a cannula 152 extending from the needle liner 150. The needle liner 150 is translucent, preferably colorless, for observing blood return from venous puncture via the cannula 152. When the RICC assembly 100 is at least in the position as Figure 1-7 In the immediately deployed state, the cannula tip 154 ​​(e.g., a beveled tip) of the cannula 152 extends from the distal end of the RICC 102 to facilitate venous puncture. In practice, when the RICC assembly 100 is at least in its immediately deployed state, the distal portion of the cannula 152 (e.g., approximately 7 cm) extends through the longitudinal through-hole of the distal connector of the connection system 106 described below, through the side hole 116 of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and through the distal end of the RICC 102. However, in some embodiments, a 2-3 cm or longer distal portion of the cannula 152 may extend from the distal end of the RICC 102 to facilitate venous puncture. In such embodiments, the first segment 118 of the catheter fitting 108 is shorter, while the cannula 152 is longer.

[0074] When present, a fluid pressure indicator 148 extends from the side arm 156 of the needle sheath 150. The fluid pressure indicator 148 includes a closed end and an open end, the open end being fluidly connected to the needle lumen of the guide needle 143 via the side arm lumen of the side arm 156. The fluid pressure indicator 148 is configured as a built-in incident arterial indicator, wherein blood at sufficient pressure (e.g., arterial blood) can enter the fluid pressure indicator 148 and compress the air column within it. However, blood return from venous puncture via the cannula 152 can also be observed in the fluid pressure indicator 148. That is, blood return is typically observed in the needle sheath 150, the side arm 156 of the needle sheath 150, or the syringe 144.

[0075] Syringe 144 includes a barrel 158, a plunger 160 disposed within the barrel 158, and a syringe tip 162 extending from the distal end of the barrel 158. When the RICC assembly 100 is at least in its immediately deployed state, the syringe tip is coupled to the needle bushing 150 of the guide needle 143. Syringe 144 also includes a syringe portion entering the guidewire lumen 164 formed by a fluid connection between the plunger cavity of the plunger 160 and the syringe tip cavity of the syringe tip 162, and any space formed within the barrel 158, for example, in one of the various operating states of the RICC assembly 100 (e.g., during the blood aspiration step of the method described below). Another portion entering the guidewire lumen 164 is the guide needle portion entering the guidewire lumen 164, i.e., the needle lumen of the guide needle 143, particularly when the guide needle 143 is operatively connected to the syringe 144 in most states of the RICC assembly 100.

[0076] The plunger 160 includes a sealing mechanism in its proximal portion for sealing the guidewire lumen 164. The sealing mechanism is configured to seal the guidewire lumen 164 to prevent blood from leaking through the proximal end of the plunger 160 during venipuncture or when blood is withdrawn from the patient's vascular lumen into the guidewire 146 (e.g., reflux), thereby minimizing or preventing the possibility of contamination of the surgical area or any clinician operating within the surgical area. Despite the sealing mechanism, the guidewire 146 is also arranged within a sterile barrier 170, as described below, which complements the sealing mechanism in minimizing or preventing the possibility of contamination of the surgical area or any clinician operating within the surgical area.

[0077] like Figure 8 As shown, the sealing mechanism may be a cylinder 166 disposed in a cavity in the distal portion of the body of the plunger 160 and held in the cavity by the flange end of the plunger 160. The cylinder 166 is coaxially aligned with the guidewire inlet cavity 164 or its plunger cavity portion such that the unwound bare wire portion of the guidewire 146 passes through the proximal and distal through-holes of the cylinder 166, the inner diameters of which are equivalent to the outer diameter of the guidewire 146. Optionally, the sealing mechanism includes one or more gaskets, such as O-rings within the cylinder 166, or alternatives to the cylinder 166. For example, instead of the cylinder 166, one or more O-rings may be axially compressed in the cavity by the flange end of the plunger 160, which in turn radially compresses the O-rings around the guidewire 146, thereby sealing the guidewire inlet cavity 164.

[0078] The guidewire 146 is positioned within the guide 104 such that at least a portion of the guidewire 146 is always within a portion of the guidewire lumen 164 (e.g., the plunger lumen portion, the needle lumen portion, etc.) regardless of the state of the RICC assembly 100. For example, when the guidewire 146 is withdrawn to its proximal limit, the distal portion of the guidewire 146 is positioned at least within the distal portion of the plunger lumen. Simultaneously, the proximal portion of the guidewire 146 extends through or beyond the proximal end of the guide 104 (e.g., the proximal end of the plunger 160). When the RICC assembly 100 is at least in its immediately deployed state, and the distal end of the guidewire 146 has just not reached the cannula tip 154, the intermediate portion of the guidewire 146 is positioned between the distal portion of the plunger lumen and the proximal portion of the needle lumen. Furthermore, when the guidewire 146 is advanced to its distal limit in some of the various operating states of the RICC assembly 100 (e.g., during the guidewire advancement step of the method described below), the proximal portion of the guidewire 146 is positioned within at least the proximal portion of the plunger lumen. Simultaneously, due to its sufficient length, the distal portion of the guidewire 146 extends through or beyond the distal end of the RICC 102 (e.g., the distal end of the catheter fitting 108 or the distal end of the tip 114).

[0079] The guidewire 146 includes a blocking element 168 (e.g., a bushing, ball, plug, etc.) surrounding the proximal portion of the guidewire 146, forming a blocking end of the guidewire 146 (e.g., a bushing end, a ball end, a plug end, etc.). The blocking end of the guidewire 146 is larger than the proximal opening of the guidewire lumen 164 or its plunger lumen, thereby providing the aforementioned distal restriction on advancing the guidewire 146 into the guide 104. Furthermore, the guidewire 146 is disposed within a fixed-length sterile barrier 170 (e.g., a longitudinal pouch), the sterile barrier including a closed or sealed proximal end and an open distal end, on the other hand, coupled (e.g., adhered) to the proximal end of the plunger 160. The combination of the fixed length of the sterile barrier 170, the closed or sealed proximal end of the sterile barrier 170, and the distal end of the sterile barrier 170 coupled to the plunger 160 provides a restricted passage through which the guidewire 146 can move proximally, thereby providing the aforementioned proximal restriction for withdrawing the guidewire 146 from the guide 104. Optionally, the blocking end of the guidewire 146 is coupled (e.g., adhered) to the proximal end of the sterile barrier 170 to retain the blocking end of the guidewire 146 proximal to the sterile barrier 170, thereby reducing the mismatch between the length of the proximal portion of the guidewire 146 extending beyond the proximal end of the guide 104 (e.g., the proximal end of the plunger 160) and the unpleasant length of the sterile barrier 170. Reducing the aforementioned mismatch between lengths decreases the likelihood of losing the blocking end of the guidewire 146 in the middle portion of the sterile barrier 170, which could require time and effort to re-match, and that time and effort can be better used to treat the patient.

[0080] In addition to providing proximal restriction on the withdrawal of the guidewire 146 from the guide 104, the sterile barrier 170 is configured to maintain the sterility of the guidewire 146 before (e.g., during transport and handling, storage, etc.) and during use of the RICC assembly 100. During use of the RICC assembly 100, the sterile barrier 170 is configured to provide a contactless advance means for advancing the guidewire 146 into the patient's vascular lumen after needle tract establishment. Similarly, the sterile barrier 170 is configured to provide a contactless withdrawal means for withdrawing the guidewire 146 from the patient's vascular lumen, for example, after the catheter fitting 108 has been advanced over the guidewire 146. Furthermore, as described above, the sterile barrier 170 complements the sealing mechanism in minimizing or preventing blood contamination of the surgical area or any clinician operating within the surgical area. In fact, the sterile barrier 170 is configured as a secondary protection against any blood that may be drained (e.g., backflow) through the proximal end of the plunger 160 during venipuncture or when the guidewire 146 is withdrawn from the lumen of a patient’s blood vessel, when the sealing mechanism is in no way able to prevent blood from draining through the proximal end of the plunger 160.

[0081] The coupling system 106 includes a distal coupling 172 and a proximal coupling 174, which are configured to couple the RICC 102 and the guide 104 together via their respective proximal and distal portions, at least in the immediate deployment state of the RICC assembly 100, while allowing the guide 104 to slide relative to the RICC 102 (and vice versa).

[0082] The distal connector 172 includes a catheter fitting clamp configured to be slidably and removably attached to a catheter fitting 108 proximal to a side port 116. The distal connector 172 also includes a longitudinal through port and a tongue 176 in the distal portion of the distal connector 172. When the RICC assembly 100 is at least in its immediately deployed state, the cannula 152 of the guide pin 143 extends through the longitudinal through port of the distal connector 172, through the side port 116 of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and through the distal end of the RICC 102. The tongue 176 is configured to allow a clinician to hold the guide 104 (e.g., by means of the distal portion of the barrel 158 of a syringe 144 including a syringe clamp 180 as described below) between the thumb and one or more fingers of one hand while using a single finger of the same hand (e.g., with a flicking motion of the finger) to advance the RICC 102 away from the cannula 152, thereby providing a contactless mechanism for advancing the RICC 102 (particularly the distal portion of the catheter fitting 108) over the cannula 152 and into the patient's vascular lumen.

[0083] The proximal connector 174 includes a catheter bushing clamp 178 and a syringe clamp 180. The catheter bushing clamp is configured to be slidably and removably attached to the catheter bushing 110 or one or more extension legs 112, and the syringe clamp is configured to be removably attached to the syringe 144. The catheter bushing clamp 178 is configured to suspend the RICC 102 through the catheter bushing 110 at least in the immediate deployment state of the RICC assembly 100, thereby preventing the RICC 102 from sagging. The catheter bushing clamp 178 is also configured to suspend the RICC 102 through one or more extension legs 112 in some of the various operating states of the RICC assembly 100 (e.g., during the guide removal step of the method described below), thereby further preventing the RICC 102 from sagging. The syringe clamp 180 is configured to support the syringe 144 such that, in at least the immediate deployment state of the RICC assembly 100, the syringe 144 rests in the syringe clamp 180 with the distal portion of the barrel 158 resting in the syringe clamp 180. The distal placement of the syringe clip 180 around the distal portion of the barrel 158 of the syringe 144 facilitates holding or manipulating the guide 104 in a position that provides better control over the distal portion of the RICC 102, including the cannula tip 154 ​​of the cannula 152, for example, when establishing a needle path from the skin area to the patient's intravascular lumen. The syringe clip 180 may include gripping portions (e.g., an arrangement of bumps, through holes, etc.) configured to facilitate gripping the syringe clip 180 to hold or manipulate the guide 104.

[0084] The RICC 102 may further include a sterile barrier 182 (e.g., a retractable or pleated bag, sheath, etc.) configured to maintain the sterility of the catheter fitting 108 between the catheter liner 110 and the distal connector 172 prior to insertion of the catheter fitting 108 into the patient's vascular lumen. At least in the immediately deployed state of the RICC assembly 100, the sterile barrier 182 is fitted over the catheter fitting 108, located between the catheter liner 110 and the distal connector 172 around the proximal portion of the catheter fitting 108, and is coupled to the distal connector 172. The sterile barrier 182 is configured to tear when the sterile barrier tongue 184 of the sterile barrier 182 is removed from the catheter liner clamp 178 (in which it is retracted) and pulled away from the catheter fitting 108, thereby providing a contactless mechanism for removing the sterile barrier 182 from the catheter fitting 108. The sterile barrier 182 has sufficient tensile strength to pull the distal connector 172 away from the catheter fitting 108 without breaking it as the sterile barrier 182 is pulled apart from the catheter fitting 108 and torn all the way to the distal connector 172.

[0085] As mentioned above, Figure 1-7The RICC component 100 is shown at least in its immediate deployment state. Although some of the multiple operating states of the RICC component 100 have been described above, other operating states of the RICC component 100 can be identified from the steps of the method for inserting the RICC 102 described below.

[0086] method

[0087] The method of RICC assembly 100 includes a method of inserting RICC 102 into the lumen of a patient's blood vessel. In some embodiments, this method includes an RICC assembly acquisition step, a needle path establishment step, a first RICC advancement step, and a guide device withdrawal step.

[0088] The RICC assembly acquisition step includes acquiring the RICC assembly 100. As described above, the RICC assembly 100 includes the RICC 102, the guide 104, and the coupling system 106. The guide includes a syringe 144 coupled to a guide needle 143, and the coupling system includes a distal connector 172 that connects the RICC 102 and the guide 104 together via their distal portions, at least in the immediate deployment state of the RICC assembly 100.

[0089] Prior to the needle channel establishment step, the method may further include a cannula tip securing step to ensure that the cannula tip 154 ​​extends from the distal end of the RICC 102. As described above, the cannula 152 extends through the longitudinal through-hole of the distal connector 172, through the side hole 116 in the distal portion of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and extends from the distal end of the RICC 102.

[0090] The needle path establishment step includes establishing a needle path from the skin region to the patient's intravascular lumen using the cannula 152 of the guide needle 143 while holding the distal portion of the barrel 158 of the syringe 144 (e.g., together with the syringe clip 180 of the proximal connector 174 surrounding the distal portion of the barrel 158). The needle path establishment step may also include ensuring blood return to the needle liner 150 of the guide needle 143, the side arm 156 of the needle liner 150, or a fluid pressure indicator 148 extending from the side arm 156 of the needle liner 150.

[0091] The method may further include a blood aspiration step. The blood aspiration step involves aspirating blood using syringe 144 prior to the guidewire advancement step or guide device withdrawal step described below. The blood aspiration step confirms that the cannula tip 154 ​​is positioned within the patient's blood vessel lumen.

[0092] Prior to the first RICC advancement step, the method may further include an entry guidewire advancement step, advancing the entry guidewire 146 into the vascular lumen beyond the distal end (e.g., cannula tip 154) of the cannula 152. As described above, the entry guidewire 146 is positioned within an entry guidewire lumen 164, formed at least by the plunger lumen of the plunger 160 of the syringe 144 and the needle lumen of the guide needle 143. This facilitates initial puncture success by making the entry guidewire 146 immediately available before it is lost from the vascular lumen due to small unintentional movements. The entry guidewire advancement step should be performed prior to the first RICC advancement step so that the distal portion of the catheter fitting 108 can also be advanced over the entry guidewire 146.

[0093] The first RICC advancement step includes advancing the distal portion of the catheter fitting 108 into the vascular lumen on the cannula 152, the access guidewire 146, or both. As described above, the catheter fitting 108 includes a first segment 118 formed of a first material having a first hardness and a second segment 120 formed of a second material having a second hardness less than the first hardness. The first segment 118 of the catheter fitting 108 is configured to have column strength for advancing the catheter fitting 108 into the vascular lumen on the access guidewire 146 or the manipulation guidewire 138 after the manipulation guidewire advancement step described below. For example, the first RICC advancement step may include advancing the catheter fitting 108 into the vascular lumen with a single finger of the same hand (e.g., with a flicking motion of that finger) while holding the barrel 158 of the syringe 144 between the thumb and one or more fingers of one hand via a syringe clamp 180. The distal connector 172 includes a tongue 176 configured to advance the catheter fitting 108 into the lumen of a blood vessel using a single finger.

[0094] The first catheter advancement step may further include advancing the catheter bushing 110 of the RICC 102 from the catheter bushing clamp 178 of the proximal connector 174. Following the advancement of the catheter bushing 110 from the catheter bushing clamp 178, one or more extension legs 112 of the RICC 102 are advanced within the catheter bushing clamp 178 according to the first catheter advancement step. The RICC 102 is configured to suspend on the coupling system 106 until the sleeve 152 is withdrawn from at least both the guide lumen 124 and the longitudinal through-hole of the distal connector 172, for example, after the guide removal step described below.

[0095] The method may further include, for example, an entry wire withdrawal step, in which the entry wire 146 is withdrawn from the patient's vascular lumen via the blocking end of the entry wire 146. The entry wire withdrawal step may be performed after the first catheter advancement step, for example after the distal portion of the catheter fitting 108 has been properly positioned within the vascular lumen on both the cannula 152 and the entry wire 146.

[0096] The guide device withdrawal step includes withdrawing the cannula 152 from the guide lumen 124 through the side hole 116 of the catheter fitting 108. Similar to the guidewire withdrawal step, the guide device withdrawal step can be performed after the first catheter advancement step, for example, after the distal portion of the catheter fitting 108 has been properly positioned within the vascular lumen on both the cannula 152 and the guidewire 146.

[0097] Following the guide removal step, the method may further include a guide removal step of completely removing the guide 104 from the RICC assembly 100. The guide removal step includes withdrawing the sleeve 152 from the longitudinal through-hole of the distal connector 172 while sliding the catheter bushing clamp 178 proximally along one or more extension legs 112. When the sleeve 152 is withdrawn from the longitudinal through-hole of the distal connector 172, each of the one or more extension legs 112 can be removed through an opening in the catheter bushing clamp 178, the diameter of which is comparable to or slightly wider than the diameter of any extension leg.

[0098] The method may further include a manipulator advance step, advancing the manipulator guidewire 138 into the vascular lumen through, for example, a distal lumen port 132 in the distal portion of the RICC 102. As described above, the guiding lumen 124 of the catheter fitting 108 coincides with the distal portion of the distal lumen 126, particularly with the distal portion of the distal lumen 126 distal to the side port 116. Thus, the guide removal step, which completely removes the guide 104 from the RICC assembly 100, should be performed before the manipulator advance step to ensure that the distal lumen 126 or its guiding lumen 124 is free of the cannula 152 and the entry guidewire 146.

[0099] The method may further include a second RICC advancement step, in which the distal portion of the catheter fitting 108 is advanced further into the vascular lumen on the manipulating guidewire 138, for example, to the SVC. The manipulating guidewire 138 provides column strength to a second segment 120 of the catheter fitting 108 for the second RICC advancement step. Simultaneously, the second catheter advancement step includes sliding the distal connector 172 proximally toward the catheter liner 110 to expose the catheter fitting 108. As described above, at least in the immediately deployed state of the RICC assembly 100, the catheter fitting 108 is covered by a sterile barrier 182 located between the catheter liner 110 and the distal connector 172 around the proximal portion of the catheter fitting 108.

[0100] The method may further include a sterile barrier removal step of removing the sterile barrier 182 and the remainder of the coupling system 106 from the RICC 102. The sterile barrier removal step includes: tearing the sterile barrier 182 along its length by pulling the sterile barrier tongue 184 of the sterile barrier 182, which is opposite to the distal connector 172, away from the catheter fitting 108, thereby removing the sterile barrier 182 and the distal connector 172 from the RICC 102.

[0101] The method may further include a manipulator guidewire 138 manipulator step of withdrawing the manipulator guidewire 138 from the patient’s intravascular lumen and withdrawing the manipulator guidewire 138 from the RICC 102.

[0102] While specific embodiments have been disclosed herein, and while some details of particular embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments provided herein are permissible without departing from the scope of the concepts disclosed herein.

Claims

1. A rapidly insertable central catheter assembly, characterized in that, include: A quick-insertion central catheter, comprising: A catheter fitting, the catheter fitting including a side port passing through a side of the catheter fitting in a distal portion of the catheter fitting, the side port opening into a guide lumen of the catheter fitting, the guide lumen extending at least from the side port to the distal end of the rapidly insertable central catheter; and A catheter bushing, which is connected to the proximal portion of the catheter fitting; Guide, the guide comprising: A guide needle with a cannula, wherein the cannula extends through the distal end of the quick-insertion central catheter when the quick-insertion central catheter assembly is at least in the immediately deployed state of the quick-insertion central catheter assembly; and A syringe having a syringe tip connected to a needle bushing of the guide needle; and A coupling system configured to connect the quick-insertion central catheter and the guide device together, the coupling system comprising: A distal connector, which is slidably attached to the conduit fitting proximal to the side hole; and A proximal connector, which is slidably attached to the catheter bushing and removably attached to the syringe in the immediate deployment state of the quick-insertion central catheter assembly, the coupling system being configured to allow the quick-insertion central catheter to slide relative to the guide.

2. The quick-insertion central catheter assembly according to claim 1, characterized in that, When the quick-insertion central catheter assembly is at least in its immediately deployed state, the cannula extends further through the longitudinal through-hole of the distal connector, through the side hole of the catheter fitting, and along the guide lumen of the catheter fitting, and then exits through the distal end of the quick-insertion central catheter.

3. The quick-insertion central catheter assembly according to claim 1, characterized in that, The distal connector includes a tongue configured to allow a clinician to use a single finger of one hand to maneuver the rapidly insertable central catheter away from the cannula while holding the guide between the thumb of the hand and another finger or more fingers.

4. The quick-insertion central catheter assembly according to claim 1, characterized in that, The guide further includes: An entry guidewire is arranged in an entry guidewire lumen, the entry guidewire lumen being formed at least by the plunger lumen of the syringe plunger and the needle lumen of the guide needle, the entry guidewire having a length sufficient to allow the entry guidewire to extend through the distal end of the rapidly insertable central catheter.

5. The quick-insertion central catheter assembly according to claim 4, characterized in that, The plunger includes a sealing mechanism in its proximal portion for sealing the lumen of the guidewire, the sealing mechanism being configured to prevent blood from leaking through the proximal end of the plunger during venipuncture or as the guidewire is withdrawn from the patient's blood vessel lumen.

6. The quick-insertion central catheter assembly according to claim 5, characterized in that, The entry guidewire is captured and positioned in the guide by a blocking element surrounding the proximal portion of the entry guidewire and a closed end of a fixed-length entry guidewire sterile barrier coupled to the proximal end of the plunger. The blocking element provides distal restriction on the advancement of the entry guidewire, while the closed end of the entry guidewire sterile barrier surrounding the entry guidewire provides proximal restriction on the withdrawal of the entry guidewire.

7. The quick-insertion central catheter assembly according to claim 4, characterized in that, The guide further includes a fluid pressure indicator extending from a side arm of the needle bushing, the fluid pressure indicator being fluidly connected to the needle lumen of the guide needle via a side arm cavity for observing blood return.

8. The quick-insertion central catheter assembly according to claim 1, characterized in that, The conduit fitting further includes: The first segment is formed of a first material having a first hardness; and The second section is formed of a second material having a second hardness, which is less than the first hardness. The side hole is located on the proximal side of the first section of the conduit fitting.

9. The quick-insertion central catheter assembly according to claim 4, characterized in that, The quick-insertion central catheter further includes one or more extension legs, each of the one or more extension legs being coupled to the catheter bushing via its distal portion, and wherein the proximal connector includes a catheter bushing clamp, the quick-insertion central catheter being configured to be suspended by the catheter bushing clamp via the catheter bushing at least in the immediate deployment state of the quick-insertion central catheter assembly, or suspended by the one or more extension legs via the catheter bushing clamp when the proximal connector is advanced over the one or more extension legs in the operational state of the quick-insertion central catheter assembly.

10. The quick-insertion central catheter assembly according to claim 9, characterized in that, The proximal connector includes a syringe clamp, and the guide is configured to rest within the syringe clamp at least in the immediate deployment state of the rapidly insertable central catheter assembly, with the distal portion of the syringe barrel resting within the syringe clamp.

11. The quick-insertion central catheter assembly according to claim 9, characterized in that, The rapidly insertable central catheter further includes a retractable catheter fitting sterile barrier above the catheter fitting between the catheter liner and the distal connector, the catheter fitting sterile barrier being coupled to the distal connector, the catheter fitting sterile barrier being configured to tear open when the sterile barrier tongue of the catheter fitting sterile barrier is removed from the catheter liner clamp and the catheter fitting sterile barrier is pulled open from the catheter fitting by the sterile barrier tongue.

12. The quick-insertion central catheter assembly according to claim 11, characterized in that, The sterile barrier of the catheter fitting has sufficient tensile strength to pull the distal connector away from the catheter fitting without breaking when the sterile barrier is torn downwards to the distal connector while being pulled apart from the catheter fitting.

13. The quick-insertion central catheter assembly according to claim 1 or 8, characterized in that, The quick-insertion central catheter further includes one or more extension legs, each of which is coupled to the catheter bushing via its distal portion.

14. The quick-insertion central catheter assembly according to claim 13, characterized in that, The rapidly insertable central catheter includes a group of three lumens: a distal lumen, an intermediate lumen, and a proximal lumen. These lumens are formed by fluid connections of three catheter fitting lumens, three bushing lumens, and three extension leg lumens. The guiding lumen of the catheter fitting coincides with the distal portion of the distal lumen.

15. The quick-insertion central catheter assembly according to claim 14, characterized in that, The distal lumen has a distal lumen hole in the distal end of the rapidly insertable central catheter, the intermediate lumen has an intermediate lumen hole in the side of the catheter fitting distal to the side hole, and the proximal lumen has a proximal lumen hole in the side of the catheter fitting distal to the side hole and proximal to the intermediate lumen hole.

16. The quick-insertion central catheter assembly according to claim 14, characterized in that, The rapidly insertable central catheter further includes a manipulator guidewire disposed in the distal lumen, the manipulator guidewire having a length sufficient to extend to the lower third of the superior vena cava of the heart. The manipulator guidewire is captured within the rapidly insertable central catheter by a blocking element surrounding the proximal portion of the manipulator guidewire and a closed end of a fixed-length sterile barrier of the manipulator guidewire coupled to a Luer connector. The blocking element provides distal restriction for advance of the manipulator guidewire, while the closed end of the sterile barrier of the manipulator guidewire surrounding the manipulator guidewire provides proximal restriction for withdrawal of the manipulator guidewire.

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