Quick insertable central catheter comprising a catheter assembly and method thereof

Abstract

A rapidly insertable central catheter (“RICC”) including a catheter assembly and a method thereof are disclosed. The RICC assembly may include the RICC, a guide, and a coupling system configured to connect the RICC and the guide. The catheter fitting of the RICC may include a side port in the distal portion of the catheter fitting, the side port opening into a guide lumen extending from the side port to the distal end of the RICC. The guide may include a guide needle with a cannula. The coupling system may include a distal connector slidably attached proximally to the catheter fitting via the side port. When the RICC assembly is in an immediately deployable state, the cannula extends through a longitudinal through-hole of the distal connector, through the side port of the catheter fitting, along the guide lumen of the catheter fitting, and through the distal end of the RICC.

Description

[0001] priority

[0002] This application claims the priority benefit of U.S. Patent Application No. 63 / 016,085, filed April 27, 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 materials with relatively low rigidity, resulting in a lack of column strength. Due to this lack of column strength, CVCs are typically introduced into patients and advanced through their vascular system using the Seldinger technique. The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the multiple steps are time-consuming, the handling of multiple medical devices is difficult, and both can lead to patient trauma. Furthermore, the relatively high potential for contact contamination arises from the need to interchange multiple medical devices during the various steps of the Seldinger technique. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing catheters, such as CVCs, into patients and advancing them through their 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 of which the RICC assembly includes a RICC, a guide, and a coupling system configured to couple the RICC to the guide. The RICC includes a catheter fitting, a catheter bushing, and one or more extension legs. The catheter fitting includes a side hole passing through a side of the catheter fitting in a distal portion. The side hole opens into a guide lumen of the catheter fitting that extends from at least the side hole to the distal end of the RICC. The catheter bushing is coupled to a 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 having a cannula. The coupling system includes a distal coupling slidably attached proximally to the side hole of the catheter fitting. When the RICC assembly is in its ready-to-deploy state, the cannula extends through a longitudinal through-hole of the distal coupling, extends through the side hole of the catheter fitting, extends along the guide lumen of the catheter fitting, and extends through the distal end of the RICC.

[0007] In some implementations, with the RICC immediately deployed, the cannula of the guide needle extends at least 2-7 cm from the distal end of the RICC for venipuncture using the cannula.

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

[0009] In some embodiments, the guide device further includes a guidewire conduit and an entry guidewire disposed within the guidewire conduit. The guidewire conduit is coupled to a needle bushing of the guide needle. The guidewire conduit is configured to maintain the sterility of the entry guidewire.

[0010] In some implementations, the guidewire catheter includes a longitudinal slit, and the access guidewire includes a handle coupled to the proximal portion of the access guidewire. The handle protrudes through the longitudinal slit for gripping the handle and advancing the access guidewire through the distal end of the RICC without direct contact with the access guidewire.

[0011] In some implementations, the longitudinal slit includes a closed end configured to provide a stop for the handle. The stop prevents the guidewire from being lost from the patient's vascular lumen due to excessive advancement of the guidewire. The stop also prevents the guidewire from being withdrawn from the guidewire catheter due to excessive withdrawal of the guidewire.

[0012] In some implementations, the guide also 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 return.

[0013] In some embodiments, the coupling system also includes a proximal connector that is removably attached to the catheter liner and slidably attached to the guidewire catheter. The coupling system is configured to couple the RICC and the guidewire together via the respective proximal and distal portions of the RICC and guidewire in an immediately deployed state, while allowing the guidewire to slide relative to the RICC.

[0014] In some embodiments, the proximal connector includes a tilted side configured to push the guidewire catheter out of the proximal connector when the proximal connector interacting portion of the guide interacts with the tilted side while the cannula is withdrawn from the side hole of the catheter fitting.

[0015] In some implementations, the proximal connector includes a post, and the catheter bushing includes suture wings with suture wing holes. In the immediate deployment state of the RICC assembly, the post is positioned within the suture wing holes.

[0016] In some embodiments, the RICC also includes a sterile barrier above the catheter fitting between the proximal connector and the distal connector, the sterile barrier being coupled to the catheter fitting. The sterile barrier is configured to split open when the proximal connector is removed from the catheter liner and the sterile barrier is pulled away from the catheter fitting.

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

[0018] In some implementations, the RICC includes a group of three lumens: a distal lumen, an intermediate lumen, and a proximal lumen, which 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.

[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 but proximal to the intermediate lumen hole.

[0020] This article also discloses a method for inserting a RICC into a patient's vascular lumen, including an RICC assembly acquisition step, a needle path establishment step, a first catheter advancement step, and a cannula withdrawal step. The RICC assembly acquisition step acquires an RICC assembly comprising: an RICC; a guide including a guide needle; and a coupling system including a distal connector, which, in an immediately deployed state, connects the RICC and the guide via the distal portions of the RICC and the guide. The needle path establishment step includes establishing a needle path from the patient's skin region to the vascular lumen using a cannula of the guide needle. The cannula extends through a longitudinal through-hole of the distal connector, through a side hole in the distal portion of the catheter fitting of the RICC, along the guide lumen of the catheter fitting, and exits from the distal portion of the RICC. The first catheter advancement step includes advancing the distal portion of the catheter fitting into the vascular lumen above the cannula. The cannula withdrawal step includes withdrawing the cannula from the guide lumen via the side hole of the catheter fitting.

[0021] In some implementations, the method also includes a cannula assurance step that ensures the cannula extends at least 2-7 cm beyond the distal end of the RICC before the needle channel establishment step.

[0022] 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.

[0023] In some implementations, the method further includes an entry guidewire advancement step: the entry guidewire is advanced into the vascular lumen beyond the distal end of the cannula via a handle coupled to the proximal portion of the entry guidewire. The handle protrudes through a longitudinal slit in the guidewire catheter coupled to the guide needle.

[0024] In some implementations, the first catheter advancement step includes advancing the catheter fitting into the vascular lumen using a single finger of one hand, while holding the guidewire catheter between the thumb and one or more other fingers of that hand. The distal connector includes a tongue configured to advance the catheter fitting into the vascular lumen using a single finger.

[0025] In some embodiments, the first catheter advancement step includes advancing the catheter fitting into the vascular lumen until a proximal connector of the coupling system slidably attached to the guidewire catheter pushes the guidewire catheter out of the proximal connector. The guide includes a proximal connector interaction portion configured to interact with the tilted side of the proximal connector and push the guidewire catheter out of the proximal connector.

[0026] In some implementations, the method further includes a guidewire advancement step: the guidewire is advanced into the vascular lumen via a distal lumen having a distal endhole in the distal end of the RICC. The guiding lumen of the catheter fitting coincides with the distal portion of the distal lumen.

[0027] In some embodiments, the method further includes a second catheter advancement step: advancing the distal portion of the catheter fitting further into the vascular lumen above the manipulating guidewire. The second catheter advancement step also includes simultaneously sliding the distal connector proximally toward the proximal connector to expose the catheter fitting. In the immediately deployed state of the RICC assembly, the catheter fitting is covered by a sterile barrier between the proximal and distal connectors.

[0028] In some embodiments, the method further includes a sterile barrier removal step of removing the sterile barrier from the RICC and the remainder of the coupling system. The sterile barrier removal step includes removing the proximal connector from the catheter bushing of the RICC, pulling the sterile barrier away from the catheter fitting to split the sterile barrier, and removing the distal connector from the catheter fitting to which the distal connector is slidably attached.

[0029] These and other features of the concepts provided herein will become more apparent to those skilled in the art, taking into account the accompanying drawings which describe specific embodiments of these concepts in more detail and the following description. Attached Figure Description

[0030] Figure 1 A top view of the RICC components, including the RICC, guide, and coupling system, is shown according to some implementation schemes.

[0031] Figure 2 A bottom view of a RICC component according to some implementation schemes is shown.

[0032] Figure 3 A side view of a RICC component according to some implementation schemes is shown.

[0033] Figure 4 A detailed top view of the RICC component according to some implementation schemes is shown.

[0034] Figure 5 A detailed side view of the RICC component according to some implementation schemes is shown.

[0035] Figure 6 The remote portion of a RICC component according to some implementation schemes is shown.

[0036] Figure 7 The distal portion of a RICC conduit fitting according to some embodiments is shown.

[0037] Figure 8 A first transverse section of a conduit fitting according to some embodiments is shown.

[0038] Figure 9 A second or third transverse section of a conduit fitting according to some embodiments is shown. Detailed Implementation

[0039] 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 specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and optionally combined with or substituted for any feature of any of the many other embodiments disclosed herein.

[0040] Regarding the terminology used herein, it should be understood that these terms are for describing specific embodiments and 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 in a group and do not provide for a series or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily appear in sequence, and a specific embodiment including these features or steps is not limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms “an,” “a,” and “the” include plural references.

[0041] For example, the terms "proximal," "proximal portion," or "proximal portion" of a catheter disclosed herein include the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Similarly, the term "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. The term "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0042] The terms "distal," "distal portion," or "distal part" as used with respect to catheters, for example, disclosed herein, include the portion of the catheter intended to be near or in the patient when the catheter is used. Similarly, the term "distal length" of a catheter, for example, includes the length of the catheter intended to be near or in the patient when the catheter is used. The term "distal end" of a catheter, for example, includes one end of the catheter intended to be near or in the patient when the catheter is used. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0043] 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.

[0044] As mentioned above, there is a need to reduce the number of steps and medical devices involved in introducing catheters, such as CVC catheters, into patients and advancing the catheters through their vascular systems.

[0045] 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 provided herein. In fact, peripherally inserted central catheters (“PICC”), dialysis catheters, etc., can also embody or otherwise incorporate the concepts provided herein for RICC and catheter assemblies and methods thereof.

[0046] RICC components

[0047] Figure 1-5 Various views of the RICC component 100, including RICC 102, guide 104, and coupling system 106, are shown according to some embodiments. Figure 6 The remote portion of RICC component 100 according to some implementation schemes is shown. Figure 7 The distal portion of the conduit fitting 108 of the RICC 102 according to some embodiments is shown. Figure 8 and 9 Various transverse sections of the conduit fitting 108 according to some embodiments are shown.

[0048] 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 and the guide 104 together. The RICC 102, guide 104, and coupling system 106 are described sequentially in the following sections; however, given the interrelationships between the RICC 102, guide 104, and coupling system 106 in the RICC assembly 100, there are some overlaps between portions of the RICC 102, guide 104, and coupling system 106.

[0049] RICC 102 includes a catheter fitting 108, a catheter bushing 110, and one or more extension legs 112.

[0050] The catheter fitting 108 includes one or more catheter fitting lumens, a side hole 114 passing through the side of the catheter fitting 108 in the distal portion of the catheter fitting 108, and a tip 116 in the distal portion of the catheter fitting 108.

[0051] 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, penta-lumen RICCs, hexa-lumen RICCs, etc.), typically only one catheter fitting lumen extends from the proximal end of the catheter fitting 108 to the distal end of the catheter fitting 108. In practice, the tip 116 typically includes a single lumen passing through it, whether the tip 116 is integrally formed with the catheter fitting 108 or is separately formed and connected to the catheter fitting 108. Optionally, the single lumen through the tip 116 may be referred to as the "tip lumen," particularly if the tip 116 is separately formed and connected to the catheter fitting 108, which, in addition to being coaxially aligned with the tip lumen, effectively blocks all catheter fitting lumens at the distal end of the catheter fitting 108.

[0052] Side port 114 leads to a guide lumen 118 of one or more catheter fitting lumens. The guide lumen 118 extends from at least the side port 114 to the distal end of RICC 102 (e.g., the distal end of catheter fitting 108 or the distal end of tip 116). The guide lumen 118 coincides with a distal portion of the lumen of one of the catheter fittings described above, which typically extends from the proximal end to the distal end of catheter fitting 108.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] As shown in the figure, the RICC 102 can be three-lumen, comprising a group of three lumens. The group of three lumens includes, for example, a distal lumen 120, an intermediate lumen 122, and a proximal lumen 124, which are formed by fluid connections of three fitting lumens, three bushing lumens, and three extension leg lumens. The distal lumen 120 has a distal lumen orifice 126 in the distal end of the RICC 102 (e.g., the distal end of fitting 108 or the distal end of tip 116), the intermediate lumen 122 has an intermediate lumen orifice 127 in the side of fitting 108 distal to side orifice 114, and the proximal lumen 124 has a proximal lumen orifice 129 in the side of fitting 108 distal to side orifice 114 but proximal to intermediate lumen orifice 127. The guide lumen 118 of fitting 108 coincides with the distal portion of the distal lumen 120.

[0057] Guide device 104 includes a guide needle 128 and a guidewire conduit 130, the guidewire conduit 130 including an entry guidewire 132 captured within the guidewire conduit 130 to maintain the sterility of the entry guidewire 132. Guide device 104 may also include a fluid pressure indicator 134 operatively connected to the guide needle 128.

[0058] The guide needle 128 includes a needle liner 136 and a cannula 138 extending from the needle liner 136. The needle liner 136 is translucent and preferably colorless, for observing blood return during venous puncture using the cannula 138. When the RICC 102 is in the position as Figure 1-5When the RICC 102 is in its immediately deployed state, the cannula 138 extends at least 2-7 cm from the distal end of the RICC 102 for venous puncture. In practice, when the RICC assembly 100 is in its immediately deployed state, the cannula 138 extends through the longitudinal through-hole of the distal connector 146 of the connection system 106 (described below), through the side hole 114 of the catheter fitting 108, along the guide lumen 118 of the catheter fitting 108, and through the distal end of the RICC 102.

[0059] When present, a fluid pressure indicator 134 extends from the side arm 140 of the needle bushing 136. The fluid pressure indicator 134 includes a closed end and an open end, the open end being fluidly connected to the needle lumen of the guide needle 128 via the side arm lumen of the side arm 140. The fluid pressure indicator 134 is configured as a built-in incident arterial indicator, wherein blood at sufficient pressure (e.g., arterial blood) can enter the fluid pressure indicator 134 and compress the air column within it. However, it is also possible to use the cannula 138 in the fluid pressure indicator 134 to observe blood return from a venous puncture.

[0060] The guidewire catheter 130 includes a proximal closed portion and a distal portion coupled to a needle liner 136 of the guide needle 128. The guidewire catheter 130 also includes a longitudinally closed end slit 142. The access guidewire 132 includes a handle 144 coupled to the proximal portion of the access guidewire 132. In the immediate deployment state of the RICC 102, the handle 144 protrudes through the longitudinal slit 142 for gripping the handle 144 and advancing the distal portion of the access guidewire 132 through the distal portion of the cannula 138, where the access guidewire 132 is positioned (e.g., just before reaching the bevel of the cannula 138). Thus, the aforementioned components of the guide device 104 provide a non-contact mechanism for advancing the access guidewire 132 into the patient's vascular lumen during needle channel establishment. The aforementioned components of the guidewire 104 also provide a non-contact mechanism for withdrawing the guidewire 132 from the patient's vascular lumen, for example, after the catheter fitting 108 has been advanced above the guidewire 132. Advantageously, the closed end of the longitudinal slit 142 provides a stop for the handle 144 protruding through the longitudinal slit 142. The stop prevents the guidewire 132 from being lost from the patient's vascular lumen due to excessive advancement of the guidewire 132, and prevents the guidewire 132 from being pulled out of the guidewire catheter 130 due to excessive withdrawal of the guidewire 132, thus reducing contamination.

[0061] The coupling system 106 includes a distal coupling 146 and a proximal coupling 148. The distal coupling 146 is configured to couple the RICC 102 and the guide 104 together via the respective proximal and distal portions of the RICC 102 and the guide 104 in an immediately deployed state of the RICC assembly 100, while allowing the guide 104 to slide relative to the RICC 102 (and vice versa).

[0062] The distal connector 146 is slidably attached to the catheter fitting 108 proximal to the side port 114. When the RICC assembly 100 is in its immediate deployment state, the cannula 138 extends through the longitudinal through-hole of the distal connector 146, through the side port 114 of the catheter fitting 108, along the guide lumen 118 of the catheter fitting 108, and through the distal end of the RICC 102. The distal connector 146 includes a tongue 150 configured to allow a clinician to single-handedly advance the RICC 102 from the cannula 138 using a single finger of one hand (e.g., using a flicking motion of the finger) while holding the guidewire catheter 130 between the thumb and one or more fingers of that hand, thus providing a non-contact mechanism for advancing the RICC 102 (particularly the distal portion of the catheter fitting 108) over the cannula 138 and into the patient's vascular lumen.

[0063] The proximal connector 148 is removably attached to the catheter bushing 110 and slidably attached to the guidewire catheter 130. Specifically, the proximal connector 148 includes a post 149, and the catheter bushing 110 includes a suture wing with a suture wing hole. In the immediate deployment state of the RICC assembly 100, the post 149 of the proximal connector 148 is positioned within the suture wing hole of the catheter bushing 110. The proximal connector 148 also includes a tilting side configured to push the guidewire catheter 130 out of the proximal connector 148 when the proximal connector interaction portion of the guide needle 104 (e.g., the needle bushing 136 of the guide needle 128, the wider portion of the guidewire catheter 130 such as the connection portion connecting the guidewire catheter 130 to the needle bushing 136, etc.) interacts with the tilting side while the cannula 138 is withdrawn from the side hole 114 of the catheter fitting 108.

[0064] The RICC 102 may also include a sterile barrier 152 (e.g., a bag, housing, etc.) configured to maintain the sterility of the catheter fitting 108 between the distal connector 146 and the proximal connector 148 prior to insertion of the catheter fitting 108 into the patient's vascular lumen. In the immediately deployed state of the RICC assembly 100, the sterile barrier 152 is positioned above the catheter fitting 108, between the distal connector 146 and the proximal connector 148, and is coupled to both connectors. The sterile barrier 152 is configured to split when the proximal connector 148 is removed from the catheter bushing 110 and the sterile barrier 152 is pulled away from the catheter fitting 108, thereby providing a non-contact mechanism for removing the sterile barrier 152 from the catheter fitting 108. The sterile barrier 152 has sufficient tensile strength to pull the distal connector 146 away from the catheter fitting 108 without breaking when the sterile barrier 152 is pulled away from the catheter fitting 108 and splits downward to the distal connector 146.

[0065] method

[0066] 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 tract establishment step, a first catheter advancement step, and a cannula withdrawal step.

[0067] The RICC component acquisition step includes acquiring the RICC component 100. As described above, the RICC component 100 includes: RICC 102; a guide 104 including a guide pin 128; and a coupling system 106 including a distal connector 146, which, in the immediate deployment state of the RICC component 100, connects the RICC 102 and the guide 104 together via its distal portion.

[0068] The method may also include a cannula assurance step that ensures the cannula 138 extends at least 2-7 cm beyond the distal end of the RICC 102 prior to the needle channel establishment step. As described above, the cannula 138 extends through the longitudinal through-hole of the distal connector 146, through the side hole 114 in the distal portion of the catheter fitting 108 of the RICC 102, along the guide lumen 118 of the catheter fitting 108, and exits the distal end of the RICC 102.

[0069] The needle path creation step includes using the cannula 138 of the guide needle 128 to create a needle path from the patient's skin area to the lumen of the blood vessel. The needle path creation step may also include ensuring blood return to the needle bushing 136 of the guide needle 128, the side arm 140 of the needle bushing 136, or a fluid pressure indicator 134 extending from the side arm 140 of the needle bushing 136.

[0070] The method may further include an entry guidewire advancement step: the entry guidewire 132 is advanced into the vascular lumen via a handle 144, beyond the distal end of the cannula 138. As described above, the handle 144 is coupled to the proximal portion of the entry guidewire 132 and protrudes through a longitudinal slit 142 in the guidewire catheter 130, which is coupled to the guide needle 128. The entry guidewire advancement step should be performed before the first catheter advancement step, so that the distal portion of the catheter fitting 108 can also be advanced over the entry guidewire 132. The entry guidewire 132 provides columnar strength to the catheter fitting 108 during the first catheter advancement step.

[0071] The first catheter advancement step includes advancing the distal portion of the catheter fitting 108 into the vascular lumen above the cannula 138. For example, the first catheter advancement step may include advancing the catheter fitting 108 into the vascular lumen using a single finger of one hand (e.g., by a flicking motion of the finger) while holding the guidewire catheter 130 between the thumb and one or more fingers of that hand. The distal connector 146 includes a tongue 150 configured to advance the catheter fitting 108 into the vascular lumen using a single finger.

[0072] The first catheter advancement step may further include advancing the catheter fitting 108 into the vascular lumen until the proximal connector 148 of the coupling system 106 pushes the guidewire catheter 130 out of the proximal connector 148. As described above, the guide device 104 includes a proximal connector interaction portion (e.g., the needle bushing 136 of the guide needle 128, the wider portion of the guidewire catheter 130 such as the connection portion that connects the guidewire catheter 130 to the needle bushing 136, etc.) configured to interact with the inclined side of the proximal connector 148 and push the guidewire catheter 130 out of the proximal connector 148.

[0073] The method may also include an entry guidewire withdrawal step, in which the entry guidewire 132 is withdrawn from the entry guidewire catheter 130 via the handle 144. The entry guidewire 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 lumen of the blood vessel above the cannula 138 and the entry guidewire 132.

[0074] The cannula withdrawal step involves withdrawing the cannula 138 from the guide lumen 118 via the side port 114 of the catheter fitting 108. Similar to the guidewire withdrawal step, the cannula 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 above the cannula 138 and the guidewire 132.

[0075] The method may also include a guide removal step of completely removing the guide 104 from the RICC assembly 100 after the guidewire catheter 130 is pushed out of the proximal connector 148. The cannula withdrawal step may be part of the guide removal step.

[0076] The method may also include a guidewire advancement step: advancing the guidewire into the vascular lumen via, for example, a distal lumen port 126 in the distal end of the RICC 102. As described above, the guiding lumen 118 of the catheter fitting 108 coincides with the distal portion of the distal lumen 120. Thus, the guide removal step, which completely removes the guide 104 from the RICC assembly 100, should be performed before the guidewire advancement step to ensure that the distal lumen or its guiding lumen 118 does not contain either the cannula 138 or the guidewire 132. That is, the guidewire advancement step may be performed partially before the guide removal step. For example, the guidewire advancement step may include a guidewire loading step that loads the guidewire into the distal lumen 120 without advancing the guidewire into the portion of the distal lumen 120 that coincides with the guiding lumen 118.

[0077] The manipulating guidewire in the manipulating guidewire advancement step can be of sufficient length to advance the catheter fitting 108 of the RICC 102 to the lower third of the superior vena cava (SVC) of the heart. The manipulating guidewire can be part of a guidewire management device configured to maintain the sterility of the manipulating guidewire and facilitate the manipulating guidewire advancement step. Alternatively, the manipulating guidewire can be a separate manipulating guidewire packaged in a sterile barrier (e.g., a bag, housing, etc.) configured to maintain the sterility of the manipulating guidewire. Such a manipulating guidewire may include a blocking device to stop the advancement of the manipulating guidewire during the manipulating guidewire advancement step, thus preventing loss of the manipulating guidewire in the patient. The blocking device can be a ball, block, etc., coupled to the proximal portion of the manipulating guidewire, configured not to pass through a Luer connector, such as an extension leg, in which at least the proximal portion of the manipulating guidewire is positioned during the manipulating guidewire advancement step.

[0078] The method may further include a second catheter advancement step: advancing the distal portion of the catheter fitting 108 further into the vascular lumen, such as to the SVC, above the manipulating guidewire. Accompanyingly, the second catheter advancement step includes sliding the distal connector 146 proximally toward the proximal connector 148 to expose the catheter fitting 108. As described above, in the immediately deployed state of the RICC assembly 100, the catheter fitting 108 is covered by a sterile barrier 152 between the proximal connector 148 and the distal connector 146.

[0079] The method may also include a sterile barrier removal step of removing the sterile barrier 152 and the remainder of the coupling system 106 from the RICC 102. The sterile barrier removal step includes removing the proximal connector 148 from the catheter bushing 110 of the RICC 102 (e.g., pulling out the post 149 of the proximal connector from the suture wing hole of the catheter bushing 110), pulling the sterile barrier 152 out of the catheter fitting 108 to split the sterile barrier 152 along its length, and removing the distal connector 146 from the catheter fitting 108, the distal connector 146 being slidably attached to the catheter fitting 108.

[0080] The method may also include a manipulator guidewire retrieval step: retrieving the manipulator guidewire from the patient's intravascular lumen and from the RICC 102.

[0081] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Other 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 disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A rapidly insertable central catheter assembly, characterized in that, include: A quick-insertion central catheter, comprising: A catheter fitting includes a side hole passing through a side of the catheter fitting in a distal portion of the catheter fitting, the side hole leading to a guide lumen of the catheter fitting, the guide lumen extending at least from the side hole to the distal end of the rapidly insertable central catheter; A catheter bushing, which is connected to the proximal portion of the catheter fitting; and One or more extension legs, each of the one or more extension legs being coupled to the catheter bushing via its distal portion; Guide, the guide comprising: Guide needle, which has a needle bushing and a cannula; and A coupling system includes a distal connector slidably attached proximally to the catheter fitting via a side port. When the quick-insertion central catheter assembly is in its immediate deployment state, the cannula extends from the needle bushing, through a longitudinal through-hole of the distal connector, through a side port of the catheter fitting, along the guide lumen of the catheter fitting, and through the distal end of the quick-insertion central catheter. The distal connector includes a tongue configured to allow a clinician to single-handedly eject the quick-insertion central catheter from the cannula using a flicking motion of a single finger of one hand, while holding the guide between the thumb and one or more fingers of the hand. The quick-insertion central catheter assembly thus provides a mechanism for advancing the quick-insertion central catheter without contacting the catheter fitting.

2. The quick-insertion central catheter assembly according to claim 1, characterized in that, In the immediate deployment state of the quick-insertion central catheter, the cannula of the guide needle extends 2-7 cm from the distal end of the quick-insertion central catheter for venipuncture using the cannula.

3. The quick-insertion central catheter assembly according to claim 1, characterized in that, The guide also includes: A guidewire catheter, which is connected to the needle bushing of the guide needle; and An inlet guidewire is inserted, which is arranged in the guidewire conduit, the guidewire conduit being configured to maintain the sterility of the inlet guidewire.

4. The quick-insertion central catheter assembly according to claim 3, characterized in that, The guidewire catheter includes a longitudinal slit, and the entry guidewire includes a handle coupled to the proximal portion of the entry guidewire, the handle protruding through the longitudinal slit for gripping the handle and advancing the entry guidewire through the distal end of the rapidly insertable central catheter without direct contact with the entry guidewire.

5. The quick-insertion central catheter assembly according to claim 4, characterized in that, The longitudinal slit includes a closed end configured to provide a stop for the handle, the stop preventing the guidewire from being lost in the patient's vascular lumen due to excessive advancement of the guidewire, or preventing the guidewire from being withdrawn from the guidewire catheter due to excessive withdrawal of the guidewire.

6. The quick-insertion central catheter assembly according to claim 3, characterized in that, The guide also includes a fluid pressure indicator extending from the side arm of the needle bushing, the fluid pressure indicator being fluidly connected to the needle lumen of the guide needle via the side arm lumen for observing blood return.

7. The quick-insertion central catheter assembly according to claim 3, characterized in that, The coupling system also includes a proximal connector removably attached to the catheter bushing and slidably attached to the guidewire catheter. The coupling system is configured to connect the quick-insertable central catheter and the guide via corresponding proximal and distal portions of the quick-insertable central catheter and the guide in an immediately deployed state of the quick-insertable central catheter assembly, while allowing the guide to slide relative to the quick-insertable central catheter.

8. The quick-insertion central catheter assembly according to claim 7, characterized in that, The proximal connector includes a tilted side configured to push the guidewire out of the proximal connector when the proximal connector interaction portion of the guide interacts with the tilted side and the cannula is withdrawn from the side hole of the catheter fitting.

9. The quick-insertion central catheter assembly according to claim 7, characterized in that, The proximal connector includes a post, and the catheter bushing includes a suture wing with a suture wing hole, wherein the post is arranged in the suture wing hole in the immediate deployment state of the quick-insertion central catheter assembly.

10. The quick-insertion central catheter assembly according to claim 7, characterized in that, The quick-insertion central catheter also includes a sterile barrier above the catheter fitting between the proximal connector and the distal connector, the sterile barrier being coupled to the proximal connector and the distal connector, the sterile barrier being configured to split when the proximal connector is removed from the catheter bushing and the sterile barrier is pulled away from the catheter fitting.

11. The quick-insertion central catheter assembly according to claim 10, characterized in that, The sterile barrier has sufficient tensile strength to pull the distal connector away from the catheter fitting without causing the sterile barrier to break when the sterile barrier splits downwards to the distal connector and is simultaneously pulled away from the catheter fitting.

12. The quick-insertion central catheter assembly according to claim 1, characterized in that, The rapidly insertable central catheter includes a group of three lumens: a distal lumen, an intermediate lumen, and a proximal lumen. Each of the three lumens is formed by a fluid connection portion of a catheter fitting lumen, a bushing lumen, and an extension leg lumen. The guide lumen of the catheter fitting coincides with the distal portion of the distal lumen.

13. The quick-insertion central catheter assembly according to claim 12, 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 but proximal to the intermediate lumen hole.

Images