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. For example, a RICC assembly includes a RICC and an introducer. The RICC includes a catheter tube, a catheter hub, and one or more extension legs coupled in the foregoing order. The catheter tube includes a side hole opening to an introducer lumen extending at least from the side hole to a distal end of the RICC. The introducer includes a retractable needle device, a syringe, and a coupling hub coupling the retractable needle device and the syringe together proximally of the side hole in an immediate deployment state of the RICC assembly. The retractable needle device includes an introducer needle. A needle tip in a distal end portion of a shaft of the introducer needle extends beyond the distal end of the RICC when the RICC assembly is in the immediate deployment state of the RICC assembly.

Description

[0001] Priority

[0002] This application claims priority benefit of U.S. Provisional Application No. 63 / 028,445, filed May 21, 2020, which is incorporated by reference in its entirety into this application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a rapid insertable central catheter including a catheter assembly and methods thereof. BACKGROUND

[0004] Central venous catheters (“CVCs”) are formed from materials having a relatively low durometer, which results in the CVCs lacking column strength. Due to the lack of column strength, the CVCs are typically introduced into a patient and advanced through the patient’s vasculature with the aid of a Seldinger technique. The Seldinger technique utilizes multiple steps and multiple medical devices (e.g., a needle, a scalpel, a guidewire, an introducer sheath, a dilator, a CVC, etc.). Although the Seldinger technique is effective, the multiple steps are time consuming, the manipulation of the multiple medical devices is cumbersome, and both can result in patient trauma. In addition, due to the need to interchange the multiple medical devices during the multiple steps of the Seldinger technique, the potential for touch contamination is relatively high. As such, 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 vasculature.

[0005] Disclosed herein is a rapid insertable central catheter (“RICC”) including a catheter assembly and methods thereof that solve the above-mentioned problems. SUMMARY

[0006] Disclosed herein is a RICC assembly. In some embodiments, the RICC assembly includes a RICC and an introducer. The RICC includes a catheter tube, a catheter hub coupled to a proximal end portion of the catheter tube, and one or more extension legs, wherein each of the one or more extension legs is coupled to the catheter hub by a distal end portion thereof. The catheter tube includes a first section, a second section, and a side hole through a side of the catheter tube in a distal end portion of the catheter tube but proximal to the first section of the catheter tube. The first section of the catheter tube is formed of a first material having a first durometer. The second section of the catheter tube is formed of a second material having a second durometer, the second durometer being less than the first durometer. The side hole opens to a guide lumen of the catheter tube that extends at least from the side hole to a distal end of the RICC. The introducer includes a retractable needle device, a syringe, and a coupling hub that couples the retractable needle device together with the syringe proximal to the side hole at least in a ready-to-deploy state of the RICC assembly. The retractable needle device includes a guide needle. The guide needle has a shaft and a needle tip in a distal end portion of the shaft. The needle tip extends beyond the distal end of the RICC when the RICC assembly is at least in the ready-to-deploy state of the RICC assembly.

[0007] In some embodiments, at least in the ready-to-deploy state of the RICC assembly, the shaft of the guide needle extends through a longitudinal through-hole of the coupling hub, through the side hole of the catheter tube, and along the guide lumen of the catheter tube.

[0008] In some embodiments, the coupling hub includes a sealed blood-flashback chamber. An incision of the shaft of the guide needle is disposed in the blood-flashback chamber. The incision is configured to release blood into the blood-flashback chamber when the needle tip enters an endoluminal cavity of a patient.

[0009] In some embodiments, the coupling hub includes a side wall extending from a side of the coupling hub. The syringe is fluidly coupled to the blood-flashback chamber through a side arm lumen of the side arm for aspirating blood when entering the endoluminal cavity.

[0010] In some embodiments, the introducer further includes a clamp having a syringe clamping portion and a needle device clamping portion. The syringe clamping portion of the clamp is configured to clamp the syringe through a barrel of the syringe. The needle device clamping portion of the clamp is configured to clamp the retractable needle device through a body of the retractable needle device while allowing the retractable needle device to slide in the needle device clamping portion of the clamp.

[0011] In some embodiments, the syringe includes a plunger disposed in the barrel of the syringe. The plunger includes a plunger extension configured to allow a clinician to withdraw the plunger from the barrel by pushing a tab of the plunger extension proximally while manipulating the RICC assembly about the coupling hub.

[0012] In some embodiments, the coupling hub includes a tab configured to allow a clinician to single-handedly advance the RICC over the needle tip using a single finger of one hand while holding the distal portion of the retractable needle device between the thumb and another finger or fingers of the same hand.

[0013] In some embodiments, the retractable needle device further includes an access guidewire and an access guidewire actuator. The access guidewire is disposed in the needle lumen of the guide needle. The access guidewire actuator is configured to advance a distal portion of the access guidewire beyond the needle tip. The access guidewire actuator is further configured to withdraw the distal portion of the access guidewire into a distal portion of the shaft of the guide needle proximal of the needle tip.

[0014] In some embodiments, the access guidewire actuator includes a slider slidably disposed in a longitudinal slot of a housing of the retractable needle device. The slider includes an extension coupled to a proximal portion of the access guidewire within a cavity of the retractable needle device enclosed by the housing.

[0015] In some embodiments, a proximal portion of the guide needle is disposed in a carriage of the retractable needle device. When actuated, the guide needle actuator of the retractable needle device is configured to release a compressed spring that has been compressed around the carriage and thrust both the carriage and the guide needle proximally into the cavity of the retractable needle device.

[0016] In some embodiments, the carriage is configured to engage the slider of the access guidewire actuator when the carriage is thrust proximally into the cavity of the retractable needle device. When the guide needle actuator is actuated, the access guidewire is withdrawn into the cavity of the retractable needle device along with the guide needle by a distal portion of the access guidewire.

[0017] In some embodiments, the RICC further includes a sterile barrier over the catheter tube above the catheter hub and the side hole of the catheter tube. The sterile barrier is configured to split apart when a sterile barrier tab of a proximal portion of the sterile barrier is pulled away from the catheter tube by the sterile barrier tab.

[0018] In some embodiments, the RICC includes a set of three lumens, including a distal lumen, an intermediate lumen, and a proximal lumen formed by fluidic connections of three catheter tube lumens, three hub lumens, and three extension leg lumens. The guide lumen of the catheter tube is coincident with a distal portion of the distal lumen.

[0019] In some embodiments, the distal lumen has a distal lumen aperture in the distal end of the RICC. The intermediate lumen has an intermediate lumen aperture in one side of the catheter fitting, proximal to the distal lumen aperture. The proximal lumen has a proximal lumen aperture in one side of the catheter fitting, proximal to the intermediate lumen aperture. The side apertures of the catheter fitting are located between the distal lumen aperture and the intermediate lumen aperture, between the intermediate lumen aperture and the proximal lumen aperture, or proximal to the proximal lumen aperture.

[0020] This document also discloses a method for inserting a recombinant intravascular coagulation (RICC) into a patient's vascular lumen. In some embodiments, the method includes an RICC assembly acquisition step, a needle path establishment step, an 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 and a guide. The guide includes a retractable needle device and a syringe connected together via a coupling bushing. The retractable needle device includes a guide needle having a rod portion that, at least in the immediate deployment state of the RICC assembly, extends through a longitudinal through-hole in the coupling bushing, extends through a side hole in the distal portion of the catheter fitting of the RICC, extends along the guide lumen of the catheter fitting, and extends beyond the distal end of the RICC. The needle path establishment step includes establishing a needle path from the patient's skin area to the vascular lumen using the needle tip of the guide needle while holding the distal portion of the retractable needle device. The RICC advancement step includes advancing the distal portion of the catheter fitting into the vascular lumen above the needle tip. The guide needle retraction procedure includes withdrawing the rod of the guide needle from the guide lumen using the side hole of the catheter fitting.

[0021] In some implementations, the needle path establishment step includes ensuring blood return into a sealed blood return chamber of the connecting bushing. An incision in the shaft of the guide needle is positioned within the blood return chamber to release blood into it upon entry into the patient's vascular lumen.

[0022] In some embodiments, the method further includes a blood aspiration step. The blood aspiration step involves aspirating blood using a syringe after the needle channel establishment step but before the guide needle withdrawal step. The syringe is fluidly connected to a blood return chamber via the lumen of the side arm of the connecting bushing for the blood aspiration step. The blood aspiration step confirms that the needle tip is positioned within the lumen of the patient's blood vessel.

[0023] In some implementations, the RICC advancement step includes advancing the catheter fitting into the blood vessel lumen using a single finger of one hand, while holding the distal portion of the retractable needle device between the thumb and one or more other fingers of that hand. The coupling bushing includes a tongue configured for advancing the catheter fitting into the blood vessel lumen using a single finger.

[0024] In some embodiments, the method further includes an entry guidewire advancement step. The entry guidewire advancement step includes advancing a distal portion of the entry guidewire disposed within the needle lumen of the guide needle into the vascular lumen. The distal portion of the entry guidewire is advanced by sliding a slider slidably disposed in a longitudinal slot of the housing of the retractable needle device. The slider includes an extension coupled to a proximal portion of the entry guidewire disposed within a cavity surrounded by the housing of the retractable needle device. The entry guidewire advancement step is performed prior to the RICC advancement step.

[0025] In some embodiments, the guide needle retraction step includes actuating a guide needle actuator of the retractable needle device. The proximal portion of the guide needle is disposed in a carriage of the retractable needle device, the carriage being configured to be pushed proximally into the cavity of the retractable needle device when a compressed spring around the carriage is released by the guide needle actuator.

[0026] In some embodiments, the method further includes a guidewire advancement step. The guidewire advancement step involves advancing the guidewire into the vascular lumen via a distal lumen having a distal endhole in the distal portion of the RICC. The guiding lumen of the catheter fitting coincides with the distal portion of the distal lumen, which mandates that a guide needle withdrawal step be performed prior to the guidewire advancement step.

[0027] In some embodiments, the method further includes a sterile barrier removal step. The sterile barrier removal step includes removing the sterile barrier positioned above the catheter fitting between the catheter liner and the side port of the RICC. The sterile barrier is removed by splitting it apart by pulling the sterile barrier tongue of the proximal portion of the sterile barrier away from the catheter fitting.

[0028] 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.

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

[0030] Figure 1 An isometric view of the RICC components, including the RICC and the guide, is shown according to some implementation schemes.

[0031] Figure 2 A top view of RICC components according to some implementation schemes is shown.

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

[0033] Figure 4 A longitudinal section of a RICC component according to some implementation schemes is shown.

[0034] Figure 5 The distal portion of a RICC conduit fitting is shown according to some implementation schemes.

[0035] Figure 6 The first transverse section of a conduit fitting according to some implementation schemes is shown.

[0036] Figure 7 A second transverse section of a conduit fitting according to some implementation schemes is shown.

[0037] Figure 8 A third or fourth transverse section of the conduit fitting according to some implementation schemes is shown.

[0038] Figure 9 A sterile barrier above the manipulating guidewire of the RICC assembly is shown according to some implementation schemes.

[0039] Figure 10 The sterile barrier above the catheter fitting is shown according to some implementation schemes.

[0040] Figure 11 The plunger extension of the syringe of the guide according to some embodiments is shown.

[0041] Figure 12 The clamps of the guide according to some implementation schemes are shown. Detailed Implementation

[0042] 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 may optionally be combined with or substituted with any of the various other embodiments disclosed herein.

[0043] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain 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 set of features or steps and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in this order, and a particular embodiment including 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 are not intended to 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 plural references unless the context clearly indicates otherwise.

[0044] 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, for example, 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. For example, 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 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 a catheter is not the distal portion or distal length of the catheter.

[0045] 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 intended to 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 intended to 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 intended to 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 need not 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.

[0046] 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.

[0047] 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.

[0048] This document discloses RICCs, including catheter assemblies, and methods thereof for addressing the aforementioned problems. However, it should be understood that RICCs are merely one type of catheter that can be implemented or otherwise incorporated into the concepts presented herein. In fact, peripherally inserted central catheters (“PICCs”), dialysis catheters, etc., can also embody or otherwise incorporate the concepts presented herein for RICCs and their catheter assemblies and methods.

[0049] RICC components

[0050] Figures 1-3 Various views of the RICC component 100, including RICC 102 and guide 104, are shown according to some implementation schemes. Figure 4 A longitudinal section of the RICC component 100 according to some implementation schemes is shown. Figure 5 The distal portion of the conduit fitting 106 of RICC 102 according to some implementation schemes is shown. Figures 6-8 Various transverse sections of the conduit fitting 106 according to some implementation schemes are shown. Figures 9-12 Various other features of the RICC component 100 according to some implementation schemes are shown.

[0051] As shown, in some embodiments, RICC component 100 includes RICC 102 and guide 104. RICC 102 and guide 104 are described sequentially in the sections set forth below; however, given the relationship between RICC 102 and guide 104 in RICC component 100, there is some overlap between portions of RICC 102 and guide 104.

[0052] RICC 102 includes a catheter fitting 106, a catheter bushing 108, and one or more extension legs 110.

[0053] The catheter fitting 106 includes two or more parts, including a catheter tip 112 in the distal portion of the catheter fitting 106, one or more catheter fitting lumens, and a side hole 114 passing through one side of the catheter fitting 106 in the distal portion of the catheter fitting 106.

[0054] Two or more portions of the catheter fitting 106 can be the bodies of the catheter fitting 106 and the catheter tip 112, which can be formed as a single extrusion of a single material or a single co-extrusion of two similar materials. Alternatively, the bodies of the catheter fitting 106 and the catheter tip 112 can be formed as two different extrusions of two similar materials and subsequently joined together. However, Figure 5An embodiment of the conduit fitting 106 is illustrated, wherein the conduit fitting 106 is formed as two different extrusions of two different materials and subsequently joined together. In practice, depending on how the first segment 116 and the second segment 118 of the conduit fitting 106 are joined, the conduit fitting 106 includes a first segment 116 (which includes a conduit tip 112), a second segment 118 (which includes a side hole 114), and an optional transition portion 120 between them. For example, the first segment 116 and the second segment 118 of the conduit fitting 106 can be bonded by high temperature, solvent, or adhesive, such that the first segment 116 and the second segment 118 are adjacent to each other, or the second segment 118 can be inserted into the first segment 116 and bonded thereto by high temperature, solvent, or adhesive, thereby forming the transition portion 120. Advantageously, the latter connection method of inserting the second segment 118 into the first segment 116 facilitates the incorporation of a smooth tapered portion into the transition portion 120, which is useful for expansion during the method of using the RICC assembly 100.

[0055] The first segment 116 of the catheter fitting 106 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 118 of the catheter fitting 106 can be formed of a second material with a second hardness (e.g., a polymer material such as polyvinyl chloride, polyethylene, polyurethane, or silicone), the second hardness being less than the first hardness. For example, each segment of the first segment 116 and the second segment 118 of the catheter fitting 106 can be made of different polyurethanes with different hardnesses. In practice, polyurethane is advantageous because the polyurethane segment of the catheter fitting 106 can be relatively rigid at room temperature but becomes more flexible at body temperature, reducing irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous because it can form fewer thrombi compared to some other polymers.

[0056] The catheter fitting 106, having at least a first segment 116 of a first polymer material and a second segment 118 of a second polymer material, has column strength sufficient to prevent buckling of the catheter fitting 106 when it is inserted into the insertion site and advanced through the patient's vascular system. The column strength of the catheter fitting 106 is significant, allowing for rapid insertion into the insertion site and advancement through the patient's vascular system without the use of the Seldinger technique.

[0057] It should be understood that the first hardness and the second hardness can be on different scales (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 to say, 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.

[0058] Although, as previously stated, the first segment 116 and the second segment 118 of the catheter fitting 106 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 106 is sufficient to prevent the catheter fitting 106 from buckling when inserted into the venous tract and advanced through the patient’s vascular system.

[0059] One or more catheter fitting lumens may extend through the entire catheter fitting 106; 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 of the catheter fitting 106 to the distal end of the catheter fitting 106. In practice, the catheter tip 112 typically includes a single lumen therethrough. Alternatively, the single lumen through the catheter tip 112 may be referred to as the “tip lumen” (particularly referring to the first segment 116 of the catheter fitting 106), which is formed separately from and connected to the remainder of the catheter fitting 106.

[0060] Again, the side hole 114 passes through one side of the distal portion of the catheter fitting 106; however, the side hole 114 is proximal to the first segment 116 of the catheter fitting 106. The side hole 114 leads to a guide lumen 122 of one or more catheter fitting lumens. The guide lumen 122 extends at least from the side hole 114 in the second segment 118 of the catheter fitting 106, extends through the first segment 116 of the catheter fitting 106 distal to the side hole 114, and extends to the distal end of the RICC 102 (e.g., the distal end of the distal catheter fitting 106 or the distal end of the catheter tip 112). The guide lumen 122 coincides with the distal portion of the aforementioned catheter fitting lumen, which typically extends from the proximal end of the catheter fitting 106 to the distal end of the catheter fitting 106 (particularly the distal portion of the catheter fitting lumen distal to the side hole 114).

[0061] The catheter bushing 108 is coupled to the proximal portion of the catheter fitting 106. The catheter bushing 108 includes one or more catheter bushing lumens, the number of which corresponds to the number of catheter fitting lumens. The one or more catheter bushing lumens extend from the proximal end of the catheter bushing 108 through the entire catheter bushing 108 to the distal end of the catheter bushing 108.

[0062] Each of the one or more extension legs 110 is coupled to the catheter bushing 108 via its distal portion. Each of the one or more extension legs 110 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.

[0063] Each of the one or more extension legs 110 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.

[0064] 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.), Figures 1-8 The illustrated RICC 102 is a three-lumen design, comprising a group of three lumens. The group of three lumens includes, for example, a distal lumen 124, an intermediate lumen 126, and a proximal lumen 128, formed by fluid-connected portions of three catheter fitting lumens, three bushing lumens, and three extension leg lumens. Whether the RICC 102 is single-lumen or multi-lumen, it includes at least a distal lumen 124. The distal lumen 124 includes at least one of the aforementioned catheter fitting lumens, typically extending from the proximal end to the distal end of the catheter fitting 106, serving as the catheter fitting lumen portion of the distal lumen 124 and the fluid-connected bushing lumen portion and extension leg lumen portion of the distal lumen 124. According to the aforementioned catheter fitting lumen, the guiding lumen 122 of the catheter fitting 106 coincides with the distal portion of the distal lumen 124, particularly with the distal portion of the distal lumen 124 distal to the side hole 114.

[0065] Further regarding the three-lumen embodiment of RICC 102, the distal lumen 124 has a distal lumen orifice 130 in the distal end of RICC 102 (e.g., the distal end of catheter fitting 106 or the distal end of catheter tip 112). The intermediate lumen 126 has an intermediate lumen orifice 132 in the catheter fitting 106 proximal to the distal lumen orifice 130 and distal to the next proximal lumen orifice, such that the intermediate lumen 126 lies between the distal lumen orifice 130 and the proximal lumen orifice. The proximal lumen 128 has a proximal lumen orifice 134 in the catheter fitting 106 proximal to the intermediate lumen orifice 132. The side orifice 114 of the catheter fitting 106 may be between the distal lumen orifice 130 and the intermediate lumen orifice 132, between the intermediate lumen orifice 132 and the proximal lumen orifice 134, or as shown below. Figure 5The proximal side of the proximal internal cavity 134 is shown such that each of the distal internal cavity 130, the intermediate internal cavity 132 and the proximal internal cavity 134 is distal to the side cavity 114.

[0066] RICC 102 may further include a manipulator guidewire 136. Although not shown, manipulator guidewire 136 may include an atraumatic tip (e.g., a coiled or partially coiled tip) and a lower third of its length sufficient for advancing manipulator guidewire 136 into the superior vena cava (“SVC”) of the heart. In at least an immediate deployment state of RICC assembly 100, manipulator guidewire 136 may be captured and positioned within RICC 102. For example, the manipulating guidewire 136 can be positioned in the distal lumen 124 of the RICC 102, with the proximal or intermediate portion of the manipulating guidewire 136 positioned in the extension leg lumen portion of the distal lumen 124, the intermediate or distal portion positioned in the bushing lumen portion of the distal lumen 124, and the distal portion positioned in the catheter fitting lumen portion of the distal lumen 124 (formed by the aforementioned catheter fitting lumen that typically extends from the proximal end to the distal end of the catheter fitting 106). However, the distal portion of the aforementioned catheter fitting lumen distal to the side hole 114 coincides with the guide lumen 122, which is occupied by the guide needle 146 at least in the immediate deployment state of the RICC assembly 100. Because of the presence of the guide pin 146 in the guide cavity 122, at least in the immediate deployment state of the RICC assembly 100, the distal end of the manipulating guide wire 136 just does not reach the side hole 114.

[0067] The manipulating guidewire 136 may include a blocking element 138 (e.g., a bushing, ball, slug, etc.) surrounding the proximal portion of the manipulating guidewire 136, thereby forming a blocking end (e.g., bushing end, ball end, slug end, etc.) of the manipulating guidewire 136. The blocking end of the manipulating guidewire 136 is larger than the proximal opening of the distal lumen 124 or the lumen portion of its extension leg, thereby providing distal restriction for advancing the manipulating guidewire 136 into the RICC 102. Additionally, the manipulating guidewire 136 may be disposed within a fixed-length sterile barrier 188 (e.g., a longitudinal pouch), the sterile barrier 188 including a closed or sealed proximal end and an additional open distal end removably coupled (e.g., removably adhered) to the proximal end of a Luer connector of the extension leg, allowing for manual removal of both the sterile barrier and the manipulating guidewire 136 if necessary. A combination of a fixed-length sterile barrier, a closed or sealed proximal end of the sterile barrier, and a distal end of the sterile barrier that engages with a Luer connector provides a restricted track within which the manipulating guidewire 136 can be moved proximally, thereby providing proximal restriction for withdrawal of the manipulating guidewire 136 from the RICC 102. The proximal restriction holds the atraumatic tip of the manipulating guidewire 136 within the distal lumen 124, wherein, at least in embodiments with a coiled or partially coiled tip, the atraumatic tip is held in an extended or uncoiled state, for example, as discussed in U.S. Patent Publication Nos. 2015 / 0038943 and 2016 / 0015943, each of which is incorporated herein by reference in its entirety. This is advantageous because reinserting such a guidewire into the lumen of a medical device such as a catheter is particularly difficult.

[0068] Optionally, the blocking end of the manipulating guidewire 136 is coupled (e.g., adhered) to the proximal end of the sterile barrier to maintain the blocking end of the manipulating guidewire 136 proximal to the sterile barrier, thereby reducing the mismatch between the length of the proximal portion of the manipulating guidewire 136 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. Reducing the aforementioned mismatch reduces the likelihood of losing the blocking end of the manipulating guidewire 136 in the middle portion of the sterile barrier, which could require time and effort (which would otherwise be better spent on the patient) for rematching.

[0069] In addition to providing proximal restriction for the withdrawal of the manipulator guidewire from the RICC 102, the sterile barrier is also configured to maintain the sterility of the manipulator guidewire 136 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 is configured to provide a non-contact advance means for advancing the manipulator guidewire 136 into the patient's vascular lumen while establishing a needle path to the patient's vascular lumen. Similarly, the sterile barrier is configured to provide a non-contact withdrawal means for withdrawing the manipulator guidewire 136 from the patient's vascular lumen, for example, after the catheter fitting 106 has been advanced over the manipulator guidewire 136.

[0070] Although not shown, RICC 102 may further include a reinforced core, such as a core in either or both lumens of the intermediate lumen 126 or the proximal lumen 128 in a three-lumen embodiment of RICC 102, to reinforce RICC 102 and thus provide additional column strength to prevent catheter fitting 106 from buckling as it is inserted into the insertion site and advanced through the patient’s vascular system.

[0071] The RICC 102 may further include a sterile barrier 190 (e.g., a bag, a shell, etc.) configured to maintain the sterility of the catheter fitting 106 between the catheter liner 108 and the side hole 114 of the catheter fitting 106 prior to insertion into the patient's vascular lumen. When present, the sterile barrier 190 covers the catheter fitting 106 between the catheter liner 108 and the side hole 114 of the catheter fitting 106, at least in the immediately deployed state of the RICC assembly 100. The sterile barrier 190 is configured to split when the sterile barrier tongue 192 of the proximal portion of the sterile barrier 190 is pulled away from the catheter fitting 106, thereby providing a non-contact mechanism for removing the sterile barrier 190 from the catheter fitting 106.

[0072] Guide device 104 includes a safety needle device, such as a retractable needle device 140, a syringe 142, and a coupling bushing 144 configured to connect the retractable needle device 140 and the syringe 142 together. Except for the distal portion of, for example, the guide needle 146 described below, guide device 104 at least in... Figure 4 The RICC assembly 100 is shown in its immediate deployment state near the side hole 114 of the conduit fitting 106.

[0073] Safety needle devices are configured to ensure the safety of clinicians from injury (e.g., unintentional needle prick), contamination, or both while using the RICC component 100. For example, a retractable needle device 140 includes a guide needle 146, a guide needle actuation mechanism configured to retract the guide needle 146, an entry guidewire 148, and an entry guidewire actuation mechanism configured to advance or retract the entry guidewire 148. An example of a guide needle actuation mechanism that retracts the guide needle 146 to prevent injury and an entry guidewire actuation mechanism that retracts the entry guidewire 148 to prevent contamination is the AccuCath Ace. TM Intravascular catheter systems (Becton, Dickinson and Company (BD), Franklin Lake, New Jersey), aspects thereof are disclosed in U.S. Patent Nos. 8,728,035, 9,162,037, and 10,220,191, each of which is incorporated herein by reference in its entirety. Safety needle devices may alternatively be based on... Midline conduit products such as PowerGlide PRO TM The design principles of the midline duct (BD, Franklin Lake, New Jersey), in various aspects thereof, are disclosed in U.S. Patent Nos. 8,721,546, 8,932,258, 8,986,227, 8,998,852, 9,757,540, 9,872,971, 9,950,139, 10,086,171, 10,384,039, and 10,426,931, each of which is incorporated herein by reference in its entirety.

[0074] The guide needle 146 has a shaft, a needle lumen along the length of the shaft, a cut 149 on one side of the shaft leading to the needle lumen, and a needle tip 150 (e.g., a beveled needle tip) in the distal portion of the shaft. At least in the immediate deployment state of the RICC assembly 100, the proximal portion of the shaft, including the cut 149, is positioned within the blood return chamber 182 of the coupling bushing 144, described below, while the distal portion of the shaft extends through a longitudinal through-hole in the coupling bushing 144, through a side hole 114 in the catheter fitting 106, and along the guide lumen 122 of the catheter fitting 106 in the immediate deployment state of the RICC assembly 100. When the RICC assembly 100 is at least in the immediate deployment state, the needle tip 150 extends beyond the distal end of the RICC 102.

[0075] The guide needle actuation mechanism includes a guide needle actuator 152 and a carriage 154, which is arranged within a cavity 156 surrounded or otherwise defined by a housing 158 formed by the body of the retractable needle assembly 140. The proximal portion of the guide needle 146 (e.g., the proximal portion of the shank) is also arranged in the carriage 154. The carriage 154 may be spring-loaded with a compressed compression spring 160, wherein, at least in the immediate deployment state of the RICC assembly 100, the compression spring 160 is compressed between the proximal flange 162 of the carriage 154 and the distal member of the retractable needle assembly 140 (e.g., the distal wall of the housing 158). The guide needle actuator 152 may include a catch 164 configured to hold the load spring of the carriage 154 via a complementary recess 166 in a connecting bushing portion of the carriage 154 extending through the distal end of the retractable needle device 140 or its housing 158. When the aforementioned guide needle actuator 152 is actuated, for example by a button 168 of the guide needle actuator 152, the guide needle actuator 152 disengages the catch 164 from the recess 166 in the connecting bushing portion of the carriage 154, thereby releasing the load spring of the carriage 154 and the surrounding compression spring 160. Releasing the load spring of the carriage 154 allows the compressed spring 160 to relax, which allows the potential energy stored by the compressed spring 160 to be released. When relaxed, the compression spring 160 extends proximally and pushes both the slide 154 and the guide pin 146 into the cavity 156 of the retractable needle device 140.

[0076] The guidewire 148 is strategically positioned within the combination of the lumen 156 of the retractable needle device 140 and the needle lumen of the guide needle 146. At least in the immediate deployment state of the RICC assembly 100, the proximal portion of the guidewire 148 is positioned within the lumen 156, while the distal portion is positioned within the needle lumen. Advantageously, during most (if not all) of the multiple operational states of the RICC assembly 100, the majority of the guidewire 148 is contained within the retractable needle device 140. Containing the guidewire 148 within the retractable needle device 140 also includes any blood or other bodily fluids generated during withdrawal of the guidewire 148 from the patient's vascular lumen. This minimizes or prevents the possibility of blood or other bodily fluids contaminating the surgical area or any clinician operating within the surgical area.

[0077] The guidewire actuation mechanism includes an entry wire actuator 170 coupled to the proximal portion of the entry wire 148 disposed within the housing 158 of the retractable needle assembly 140. For example, the entry wire actuator 170 includes a slider 172 slidably disposed in an end-closed longitudinal slot of the housing 158 of the retractable needle assembly 140, the closed end of which provides distal and proximal stops for advancing and retracting the entry wire 148, respectively. Although not shown, the slider 172 may include an extension extending into a cavity 156 of the retractable needle assembly 140, where it is coupled to the proximal portion of the entry wire 148. The aforementioned entry wire actuator 170 is configured to advance the distal portion of the entry wire 148 beyond the needle tip 150 as the entry wire actuator 170 moves distally along the longitudinal slot. Similarly, the guidewire actuator 170 is configured to retract the guidewire 148 into the retractable needle device 140 when the guidewire actuator 170 moves proximally along the longitudinal slot, for example, retracting the distal portion of the guidewire 148 into the proximal portion of the rod or into the needle cavity proximally to the needle tip 150.

[0078] The guidewire actuator 170 can be actuated manually or automatically as described above to retract the guidewire 148 into the retractable needle device 140. Regarding automatic actuation, the carriage 154 of the guidewire actuation mechanism can be configured to engage the guidewire actuator 170 when the carriage 154 is proximally pushed into the cavity 156 of the retractable needle device 140 by the compression spring 160 due to relaxation. For example, the proximal end of the carriage 154 can be configured to engage the distal end or an extension of the slide member 172 when the carriage 154 is proximally pushed into the cavity 156 of the retractable needle device 140 by the compression spring 160. When the guidewire actuator 152 is automatically actuated, the guidewire 148, along with the guidewire 146, is retracted into the cavity 156 of the retractable needle device 140 via the distal portion of the guidewire.

[0079] The syringe 142 includes a barrel 174, a plunger 176 disposed in the barrel 174, and a syringe tip 178 extending from the distal end of the barrel 174. The syringe 142 is fluidly coupled to the side arm 180 of the coupling bushing 144 at least when the RICC assembly 100 is at least in its immediate deployment state.

[0080] As shown, plunger 176 may include plunger extension 194 extending distally from the distal portion of the plunger along the syringe barrel 174. Plunger extension 194 includes a tongue 196 configured to allow a clinician to withdraw plunger 176 from the syringe barrel 174 by pushing the tongue 196 proximally (e.g., during the blood aspiration step described below). This configuration for withdrawing plunger 176 from the barrel 174 is advantageous when manipulating the RICC assembly 100 around the coupling bushing 144 (a preferred location for manipulating the RICC assembly 100 to minimize large movements in the distal portion of the RICC 102). In fact, the more proximal the position of manipulating the RICC assembly 100, the greater the small unintentional movements of the hand in the distal portion of the RICC 102 will be.

[0081] As described above, the coupling bushing 144 is configured to connect the retractable needle device 140 and the syringe 142 together, for example, in the immediate deployment state of the RICC assembly 100. The coupling bushing 144 includes: a carriage connector configured to connect to the coupling bushing connection portion of the carriage 154, a side arm 180 extending from one side of the coupling bushing 144, and a side arm connector of the side arm 180 configured to connect to the syringe tip 178 of the syringe 142.

[0082] The connecting bushing 144 is translucent and preferably colorless, for observing blood return generated by venipuncture using the guide needle 146. Specifically, the connecting bushing 144 includes a sealed blood return chamber 182 proximal to the longitudinal through-hole of the connecting bushing 144 for observing blood return. As described above, the proximal portion of the shaft of the guide needle 146, including a cut 149, is positioned in the blood return chamber 182, the cut 149 being configured to release blood into the blood return chamber 182 when the needle tip 150 of the guide needle 146 enters the patient's vascular lumen. Additionally, the side arm 180 of the connecting bushing 144 includes a side arm lumen that fluidly connects the syringe 142 to the blood return chamber 182, at least in the immediate deployment state of the RICC assembly 100. Once blood return is observed in the blood return chamber 182 via venipuncture using the guide needle 146, additional blood can be aspirated using the syringe 142 to confirm entry into the vascular lumen. The seals (e.g., gaskets) at the proximal and distal portions of the blood return chamber and the seal 184 (e.g., gaskets) around the proximal end of the shaft of the guide needle 146 enable the use of the syringe 142 to aspirate additional blood through the exposed, unwound portion of the guidewire 148.

[0083] The connecting bushing 144 may also include a tongue 186 in its distal portion. The tongue 186 is configured to allow a clinician to advance the RICC 102 single-handedly over the needle tip 150 using a single finger of one hand, while holding the distal portion of the retractable needle assembly 140 between the thumb and one or more other fingers of that hand. The tongue 186 facilitates a non-contact mechanism for advancing the RICC 102 (particularly the distal portion of the catheter fitting 106) over the needle tip 150, the distal portion of the guidewire 148, or a combination thereof, and into the patient's vascular lumen.

[0084] The connecting bushing 144, including its side arm 180, can be rigid to hold the syringe 142 in place side-by-side with the retractable needle device 140 in the RICC assembly 100, at least in the immediate deployment state of the RICC assembly 100. That is, in some embodiments, the aforementioned side arm 180 can alternatively be flexible. In such an embodiment, the RICC assembly 100 or its guide 104 includes a clamp 198 having a syringe holding portion and a needle device holding portion, the syringe holding portion being configured to hold the syringe through the barrel 174 of the syringe 142, and the needle device holding portion being configured to hold the retractable needle device through a housing 158 formed by the body of the retractable needle device 140. The needle device holding portion of the clamp 198 is configured to allow the retractable needle device 140 to slide therein. In other words, the retractable needle device 140 is slidably arranged in the needle device holding portion of the clamp 198, which allows for the guide needle retraction step described below.

[0085] Figures 1-4 A RICC assembly 100 in at least an immediately deployed state is shown. When the RICC assembly 100 is in the immediately deployed state, a needle tip 150, slightly longer than the guide needle 146, extends from the distal end of the RICC 102 for venipuncture. In practice, when the RICC assembly 100 is at least in its immediately deployed state, the distal portion of the shaft of the guide needle 146 (e.g., approximately 7 cm) extends along the guide lumen 122 of the catheter fitting 106 through a longitudinal through-hole in the connecting bushing 144, through a side hole 114 of the catheter fitting 106, and through the distal end of the RICC 102. However, in some embodiments, 1 cm to 3 cm or more of the distal portion of the shaft may extend from the distal end of the RICC 102 for venipuncture. In such embodiments, the first segment 116 of the catheter fitting 106 is shorter than the length of the shaft. Other operating states of the RICC component 100 can be understood from the functional aspects of the RICC component 100 described above or from the steps of the method for inserting the RICC 102 described below.

[0086] method

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

[0088] The RICC assembly acquisition step includes acquiring the RICC assembly 100. As described above, the RICC assembly 100 includes an RICC 102 and a guide 104. The guide 104 includes a retractable needle device 140 and a syringe 142 connected together via a coupling bushing 144.

[0089] Prior to the needle path establishment step, the method may further include a needle tip assurance step to ensure that the needle tip 150 of the guide needle 146 extends from the distal end of the RICC 102. As described above, the retractable needle device 140 includes a guide needle 146, at least in the immediate deployment state of the RICC assembly 100, the shank of which extends through a longitudinal through-hole in the connecting bushing 144, through a side hole 114 in the distal portion of the catheter fitting 106 of the RICC 102, along the guide lumen 122 of the catheter fitting 106, and beyond the distal end of the RICC 102.

[0090] The needle path creation step includes: using the needle tip 150 of the guide needle 146 to create a needle path from the patient's skin area to the intravascular lumen, while holding the distal portion of the retractable needle device 140. The needle path creation step may also include ensuring blood return to a sealed blood return chamber 182 of the connecting bushing 144. As described above, a cut 149 on the shaft of the guide needle 146 is arranged in the blood return chamber 182 to release blood into the blood return chamber 182 upon entry into the patient's intravascular lumen.

[0091] The method may further include a blood aspiration step. The blood aspiration step includes aspirating blood using syringe 142 after the needle channel establishment step but before the guide needle withdrawal step. Again, syringe 142 is fluidly connected via the lumen of the side arm 180 to the blood return chamber 182 of the connecting bushing 144 for the blood aspiration step. The blood aspiration step confirms that the needle tip 150 is positioned within the patient's blood vessel lumen.

[0092] The method may further include an entry guidewire advancement step. The entry guidewire advancement step involves advancing the distal portion of the entry guidewire 148 from the needle lumen of the guide needle 146 into the vascular lumen, which facilitates a successful first puncture by making the entry guidewire 148 immediately available before it may be lost due to minor accidental movement of the RICC assembly 100. In some embodiments, the distal portion of the entry guidewire 148 is advanced by sliding a slider 172 distally within a longitudinal slot in the housing 158 of the retractable needle assembly 140. As described above, the slider 172 may include an extension coupled to the proximal portion of the entry guidewire 148, which is disposed within a cavity 156 defined by the housing 158 of the retractable needle assembly 140. Performing the entry guidewire advancement step prior to the first RICC advancement step allows the distal portion of the catheter assembly 106 to be advanced over the entry guidewire 148 and the needle tip 150 of the guide needle 146.

[0093] The first RICC advancement step includes advancing the distal portion of the catheter fitting 106 into the vascular lumen over the needle tip 150, the entry guidewire 148, or both. As described above, the catheter fitting 106 includes a first segment 116 formed of a first material having a first hardness and a second segment 118 formed of a second material having a second hardness less than the first hardness. The first segment 116 of the catheter fitting 106 is configured to have column strength for advancing the catheter fitting 106 into the vascular lumen over the entry guidewire 148 or the manipulation guidewire 136 (which is provided in the manipulation guidewire advancement step). For example, the first RICC advancement step may include advancing the catheter fitting 106 into the vascular lumen using a single finger of one hand (e.g., by a flicking motion of the finger) while holding the distal portion of the retractable needle device 140 between the thumb of that hand and one or more other fingers. The coupling bushing 144 includes a tongue 186 configured for advancing the catheter fitting 106 into the vascular lumen using a single finger. When the connecting bushing is advanced with a single finger, the connecting bushing 144 in turn pushes the catheter fitting 106 into the lumen of the blood vessel.

[0094] The guide needle withdrawal step includes withdrawing the shaft of the guide needle 146 from the patient's intravascular lumen and the guide lumen 122 of the RICC 102 through the side hole 114 of the catheter fitting 106. The guide needle withdrawal step includes (e.g., via button 168) actuating the guide needle actuator 152 of the retractable needle device 140. As described above, the proximal portion of the guide needle 146 is arranged in a spring-loaded carriage 154 of the retractable needle device 140, the carriage 154 being configured to be proximally pushed into the cavity 156 of the retractable needle device 140 upon release of the compressed spring 160 surrounding the carriage 154 via the guide needle actuator 152.

[0095] The method may further include an entry guidewire withdrawal step, at least withdrawing the entry guidewire 148 from the patient's intravascular lumen. The entry guidewire withdrawal step can be manually performed by manually actuating the entry guidewire actuator 170. For example, the entry guidewire 148 can be manually withdrawn from the patient's intravascular lumen by sliding the slider 172 proximally in a longitudinal slot in the housing 158 of the retractable needle device 140. Alternatively, the entry guidewire withdrawal step can be automatically performed by automatically actuating the entry guidewire actuator 170. For example, the carriage 154 of the guidewire actuation mechanism can be configured to engage the entry guidewire actuator 170 (e.g., the slider 172 or an extension thereof) when the carriage 154 is proximally pushed into the cavity 156 of the retractable needle device 140 by a compression spring 160. Thus, the entry guidewire withdrawal step is also performed when the guidewire actuator 152 is actuated in the guidewire withdrawal step to release the spring-loaded carriage 154.

[0096] In combination, the guide needle withdrawal step and the guidewire withdrawal step can be considered as a guide removal step of completely removing the guide wire 104 from the RICC 102. However, depending on the length of the guidewire 148, the guide removal step may further include separating the guide wire 104 from the RICC 102 by a distance sufficient to completely withdraw the guidewire 148 from the guide lumen 122 of the RICC 102 through the side port 114 of the catheter fitting 106. The guide removal step can be performed after the first RICC advancement step (e.g., after properly positioning the distal portion of the catheter fitting 106 within the vascular lumen above both the needle tip 150 and the guidewire 148).

[0097] The method can further manipulate the guidewire advancement step. The manipulating guidewire advancement step involves advancing the manipulating guidewire 136 into the vascular lumen through, for example, the distal lumen 130 in the distal end of the RICC 102. As described above, the guiding lumen 122 of the catheter fitting 106 coincides with the distal portion of the distal lumen 124 (particularly the distal portion of the distal lumen 124 distal to the side hole 114). Thus, prior to the manipulating guidewire advancement step, a guide removal step is required to completely remove the guidewire 104 from the RICC 102 to ensure that neither the guide needle 146 nor the guidewire 148 is present in the distal lumen 124 or its guiding lumen 122.

[0098] The method may further include a second RICC advancement step: further advancing the distal portion of the catheter fitting 106 above the manipulator 136 into the vascular lumen, such as into the SVC. The manipulator 136 provides sufficient column strength for the second segment 118 of the catheter fitting 106 for the second RICC advancement step.

[0099] When a sterile barrier exists above the catheter fitting 106 between the catheter bushing 108 of the RICC 102 and the side port 114 of the catheter fitting 106, the method may further include a sterile barrier removal step. The sterile barrier removal step includes removing the sterile barrier. The sterile barrier is removed by splitting it apart by pulling the sterile barrier tongue of the proximal portion of the sterile barrier away from the catheter fitting 106.

[0100] The method may further include a manipulator guidewire 136 withdrawing from the patient’s intravascular lumen and a manipulator guidewire withdrawal step of completely removing the manipulator guidewire 136 from the RICC 102.

[0101] 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. Additional adaptations and / or modifications may be apparent to those skilled in the art, and such adaptations and / or modifications are also covered 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, the catheter fitting including a side hole in a distal portion of the catheter fitting passing through one side of the catheter fitting, the side hole opening into a guide lumen of the catheter fitting extending from at least the side hole to the distal end of the rapidly insertable central catheter; and A catheter bushing, the catheter bushing being 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: A retractable needle device, comprising a guide needle having a shank and a needle tip in a distal portion of the shank, the proximal portion of the shank being disposed in a carriage of the retractable needle device; and syringe; and A coupling bushing, at least in the immediate deployment state of the quick-insertion central catheter assembly, connects the retractable needle device and the syringe proximal to the side port, wherein the shank of the guide needle extends from the carriage through the sealed blood return chamber of the coupling bushing and from a longitudinal through-hole of the coupling bushing distal to the blood return chamber, such that the needle tip extends beyond the distal end of the quick-insertion central catheter.

2. The quick-insertion central catheter assembly according to claim 1, characterized in that, An incision is made in the shaft of the guide needle within the blood return chamber, the incision being configured to release blood into the blood return chamber when the needle tip enters the patient's vascular lumen.

3. The quick-insertion central catheter assembly according to claim 1, characterized in that, The connecting bushing includes a side arm extending from one side of the connecting bushing, and the syringe is fluidly connected to the blood return chamber through the side arm lumen for aspirating blood when the needle tip enters the patient's blood vessel lumen.

4. The quick-insertion central catheter assembly according to claim 1, characterized in that, The guide further includes: A clamp having a syringe clamping portion and a needle device clamping portion, the syringe clamping portion being configured to clamp the syringe via the syringe barrel, and the needle device clamping portion being configured to clamp the retractable needle device via the body of the retractable needle device, while allowing the retractable needle device to slide within the needle device clamping portion of the clamp.

5. The quick-insertion central catheter assembly according to claim 4, characterized in that, The syringe includes a plunger disposed within the syringe barrel, the plunger including a plunger extension configured to allow a clinician to withdraw the plunger from the barrel by pushing the tongue of the plunger extension proximally while manipulating the quick-insertion central catheter assembly around the coupling bushing.

6. The quick-insertion central catheter assembly according to claim 1, characterized in that, The connecting bushing includes a tongue configured to allow a clinician to advance the rapidly insertable central catheter with one hand using a single finger of one hand above the needle tip, while holding the distal portion of the retractable needle device between the thumb and one or more other fingers of that hand.

7. The quick-insertion central catheter assembly according to claim 1, characterized in that, The retractable needle device further includes: An entry guidewire is inserted, the entry guidewire being arranged within the needle lumen of the guide needle; and An entry guidewire actuator is configured to advance the distal portion of the entry guidewire beyond the needle tip, or to retract the distal portion of the entry guidewire into the distal portion of the shank of the guide needle proximal to the needle tip.

8. The quick-insertion central catheter assembly according to claim 7, characterized in that, The guidewire inlet actuator includes a slider slidably disposed in a longitudinal slot in the housing of the retractable needle device, the slider including an extension coupled to a proximal portion of the guidewire in a cavity of the retractable needle device surrounded by the housing.

9. The quick-insertion central catheter assembly according to claim 8, characterized in that, The guide needle actuator of the retractable needle device is configured to release a compressed spring around the carriage when actuated, and to push both the carriage and the guide needle proximally into the cavity of the retractable needle device.

10. The quick-insertion central catheter assembly according to claim 9, characterized in that, The carriage is configured to engage the sliding member of the guidewire actuator when the carriage is pushed proximally into the cavity of the retractable needle device, thereby retracting the guidewire together with the guidewire into the cavity of the retractable needle device via the distal portion of the guidewire when the guidewire actuator is actuated.

11. The quick-insertion central catheter assembly according to claim 1, characterized in that, The rapidly insertable central catheter further includes a sterile barrier above the catheter fitting between the catheter bushing and the side port of the catheter fitting, the sterile barrier being configured to split open when the sterile barrier tongue is pulled away from the catheter fitting by a sterile barrier tongue at the proximal portion of the sterile barrier.

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. It is formed by fluid connections of three catheter fitting lumens, three bushing lumens, and three extension leg lumens. The guide lumen of the catheter fitting coincides with the distal portion of the distal lumen. The distal lumen has a distal lumen orifice at the distal end of the rapidly insertable central catheter. The intermediate lumen has an intermediate lumen orifice on the proximal side of the catheter fitting near the distal lumen orifice. The proximal lumen has a proximal lumen orifice on the proximal side of the catheter fitting near the intermediate lumen orifice. A side orifice of the catheter fitting is located between the distal lumen orifice and the intermediate lumen orifice, between the intermediate lumen orifice and the proximal lumen orifice, or proximal to the proximal lumen orifice.

13. The quick-insertion central catheter assembly according to claim 1, characterized in that, The blood return chamber includes a seal in the proximal portion of the blood return chamber and an additional seal in the distal portion of the blood return chamber.

14. The quick-insertion central catheter assembly according to claim 7, characterized in that, The exposed, unwound portion of the guidewire passes through a seal around the proximal end of the shaft of the guide needle, thereby enabling the syringe to aspirate blood when the needle tip enters the patient's vascular lumen.

15. A rapidly insertable central catheter assembly, characterized in that, include: A quick-insertion central catheter, the quick-insertion central catheter including a catheter fitting having a side hole passing through one side of the catheter fitting in its distal portion, the side hole leading to a guide lumen of the catheter fitting extending from at least the side hole to the distal end of the quick-insertion central catheter; Guide, the guide comprising: A retractable needle device, comprising a guide needle having a shank, a notch in the shank, and a needle tip in a distal portion of the shank, the proximal portion of the shank being disposed in a carriage of the retractable needle device; and syringe; and Connecting bushing, the connecting bushing comprising: Side arm; A sealed blood return chamber, the blood return chamber having a seal in the proximal portion of the blood return chamber and an additional seal in the distal portion of the blood return chamber; and A longitudinal through-hole, distal to the blood return chamber, at least in the immediate deployment state of the rapidly insertable central catheter assembly, wherein the connecting bushing proximal to the side hole connects the retractable needle device and the syringe, wherein: The shank of the guide needle extends from the carriage through the blood return chamber of the connecting bushing, extends out from the longitudinal through-hole of the connecting bushing, and extends through the guide lumen of the catheter fitting, such that the needle tip extends beyond the distal end of the quick-insertion central catheter. The incision in the rod is positioned within the blood return chamber to release blood into the blood return chamber when the needle tip enters the patient's blood vessel lumen; and The syringe is fluidly connected to the blood return chamber via the inner lumen of the side arm, for drawing blood through the blood return chamber when entering the blood vessel lumen.

Images