QUICKLY INSERTED CENTRAL CATHETERS INCLUDING ASSEMBLIES AND METHODS THEREOF.

Abstract

Rapidly inserted central catheters ("RICCs") are described, including assemblies and methods thereof; in some modalities, an RICC assembly includes an RICC and an introducer; the RICC includes a soft catheter tube having an introduction port that opens into a primary lumen of the RICC; the introducer includes an introducer catheter comprising a hard catheter tube having an introduction port that opens into a single lumen of the introducer catheter; when the RICC assembly is in a ready-to-deploy state, the introducer catheter is placed into the primary lumen of the RICC such that a distal end of the introducer catheter extends beyond a distal end of the RICC;In addition, an introducer needle is placed into the introducer catheter through both the introduction opening and the introduction orifice so that a beveled tip of the introducer needle extends beyond the distal end of the introducer catheter.

Description

Rapidly inserted central catheters, including their assemblies and methods. CROSS REFERENCE This application claims the benefit of priority of U.S. Provisional Application No. 63 / 045,599, filed on June 9, 2020, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION A central venous catheter (CVC) is made of a material with a relatively low durometer, which contributes to its lack of buckling resistance. Because of this lack of buckling resistance, CVCs are commonly inserted into patients and advanced through their vasculature using the Seldinger technique. The Seldinger technique utilizes several steps and medical devices (e.g., a needle, scalpel, guidewire, introducer liner, dilator, CVC, etc.). While the Seldinger technique is effective, the steps are time-consuming, managing the number of medical devices is complicated, and both can lead to trauma for the patient. Furthermore, there is a relatively high potential for contamination due to the number of medical devices that need to be exchanged during the Seldinger technique.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. This paper describes rapidly inserted central catheters (RICCs), including catheter assemblies and methods thereof that address the above. BRIEF DESCRIPTION OF THE INVENTION This document describes a RICC assembly that, in some configurations, includes an RICC and an introducer. The RICC includes a soft catheter tube, a catheter hub, and one or more extension limbs. The soft catheter tube has an introduction opening through one side of the soft catheter tube into a distal end portion of the soft catheter tube. The introduction opening opens into an introduction portion of a primary lumen of the RICC, which portion extends from the introduction opening to a distal end of the RICC. The catheter hub is attached to a proximal end portion of the soft catheter tube. Each extension limb of the one or more extension limbs is attached to the catheter hub by a distal end portion of the extension limb. The introducer includes an introducer catheter and an introducer needle.The introducer catheter includes a rigid catheter tube with an introduction port through one side of the rigid catheter tube into a distal portion of the catheter tube. The introduction port opens into a single-lumen introduction portion of the introducer catheter, which extends from the introduction port to a distal end of the introducer catheter. The introducer catheter is positioned in the primary lumen of the RICO such that the distal end of the introducer catheter extends beyond the distal end of the RICC when the RICC assembly is in a ready-to-deploy state. Additionally, the introducer needle is inserted into the introducer catheter through the introduction port and the introduction port such that a beveled tip on a distal portion of the introducer needle extends beyond the distal end of the introducer catheter. In some models, the RICC assembly also includes an access guide wire. The access guide wire is positioned on the introducer needle so that one distal end of the access guide wire is proximal to the beveled tip but distal to the distal end of the RICC when the RICC assembly is in the ready-to-deploy state. In some modalities, the access guidewire includes a stop around a proximal portion of the guidewire, forming a stop end of the access guidewire. The stop end of the access guidewire is configured to provide a distal limit for advancing the guidewire into the RICC. In some models, the RICC assembly also includes a maneuvering guidewire. The maneuvering guidewire is positioned on the introducer catheter so that one distal end of the guidewire is proximal to the introduction port but distal to the catheter hub when the RICC assembly is in the ready-to-deploy state. In some modalities, the guidewire includes a stop around a proximal portion of the guidewire, forming a stop end. This stop end is configured to provide a distal limit for advancing the guidewire into the RICC. In some models, the soft catheter tube is made of a first material with a first durometer, and the hard catheter tube is made of a second material with a second durometer. The second durometer is larger than the first durometer, providing the RICC assembly with column force to advance the RICC into the lumen of a blood vessel over a guidewire. In some modalities, the RICC includes a three-lumen set. The three-lumen set includes the primary lumen, a secondary lumen, and a tertiary lumen formed from fluidly connected portions of three catheter tubing lumens, three hub lumens, and three extension limb lumens. In some modalities, the primary lumen has a primary lumen opening at the distal end of the RICC. The secondary lumen has a secondary lumen opening on the soft catheter tubing side proximal to the primary lumen opening. The tertiary lumen has a tertiary lumen opening on the soft catheter tubing side proximal to the secondary lumen opening but distal to the insertion opening. Also described herein is a RICC assembly that, in some configurations, includes an RICC and an introducer. The RICC includes a soft catheter tube, a catheter hub, and one or more extension limbs. The soft catheter tube has a primary lumen opening at a distal end and a secondary lumen opening on one side of the tube at a distal end portion. The catheter hub is attached to a proximal end portion of the soft catheter tube. Each extension limb is attached to the catheter hub at a distal end portion. The introducer includes an introducer catheter and an introducer needle. The introducer catheter includes a hard catheter tube with an introduction port through one side of the tube at a distal end portion.The introducer catheter is placed in a primary lumen of the RICC such that a distal end of the introducer catheter extends beyond a distal end of the RICC when the RICC assembly is in a ready-to-deploy state. Additionally, the introducer needle is inserted into the introducer catheter through a combination of the secondary lumen opening, a septum that divides a secondary lumen from the primary lumen, and the introduction port. Positioned as such, a beveled tip on a portion of the distal end of the introducer needle extends beyond the distal end of the introducer catheter when the RICC assembly is in the ready-to-deploy state. In some models, the RICC assembly also includes an access guide wire. The access guide wire is positioned on the introducer needle so that one distal end of the access guide wire is proximal to the beveled tip but distal to the distal end of the RICC when the RICC assembly is in the ready-to-deploy state. In some modalities, the access guidewire includes a stop around a proximal portion of the guidewire, forming a stop end of the access guidewire. The stop end of the access guidewire is configured to provide a distal limit for advancing the guidewire into the RICC. In some models, the RICC assembly also includes a maneuvering guidewire. The maneuvering guidewire is positioned on the introducer catheter so that one distal end of the guidewire is proximal to the introduction port but distal to the catheter hub when the RICC assembly is in the ready-to-deploy state. In some modalities, the guidewire includes a stop around a proximal portion of the guidewire, forming a stop end. This stop end is configured to provide a distal limit for advancing the guidewire into the RICC. In some models, the soft catheter tube is made of a first material with a first durometer, and the hard catheter tube is made of a second material with a second durometer. The second durometer is larger than the first durometer, providing the RICC assembly with column force to advance the RICC into the lumen of a blood vessel over a guidewire. In some modalities, the RICC includes a three-lumen set. The three-lumen set includes the primary lumen, the secondary lumen, and a tertiary lumen formed from fluidly connected portions of three catheter tubing lumens, three hub lumens, and three extension limb lumens. In some modalities, the primary lumen has its primary lumen opening at the distal end of the RICC. The secondary lumen has its secondary lumen opening on the soft catheter tubing side proximal to the primary lumen opening. The tertiary lumen has its tertiary lumen opening on the soft catheter tubing side proximal to the secondary lumen opening. A method for using an RICC assembly is also described. The method includes, in some modalities, an RICC assembly retrieval step, a needle tract establishment step, an access guidewire advancement step, and an introducer needle retraction step. The RICC assembly retrieval step includes obtaining an RICC assembly that includes the RICC and an introducer. The introducer includes an introducer catheter placed in a primary lumen of the RICC such that a portion of the distal end of the introducer catheter extends beyond a distal end of the RICC. The needle tract establishment step includes establishing a needle tract from a skin area to a patient's blood vessel lumen using a beveled tip of an introducer needle.The introducer needle extends through one side of the soft catheter tubing of the RICC, through one side of the hard catheter tubing of the introducer catheter, and out of the distal end of the introducer catheter. The access guidewire advancement step involves advancing an access guidewire through the introducer needle and into the lumen of a patient blood vessel. The introducer needle retraction step involves retracting the introducer needle from the lumen of a blood vessel and the RICC assembly, leaving the access guidewire and introducer catheter in the lumen of a blood vessel. ivia / ιουο In some modalities, the method also includes a verification step to ensure that the distal end of the introducer catheter extends at least approximately 1 to 7 cm beyond the distal end of the RICC before performing the needle path establishment step. In some modalities, the method also includes a first step of advancing the RICC to advance the distal end portion of the introducer catheter into the lumen of a blood vessel over the access guide wire. In some modalities, the method also includes a maneuvering guide wire advancement step to advance a maneuvering guide wire through the introducer catheter and into the lumen of a blood vessel. In some modalities, the advancement step of the maneuvering guide wire requires first folding the introducer needle away from both the blood vessel lumen and the RICC assembly. In some modalities, the method also includes a second RICC advancement step to advance the distal end portion of the introducer catheter and a distal end portion of the RICC further into the lumen of a blood vessel over the maneuvering guidewire. These and other aspects of the concepts provided herein will become more evident to those skilled in the art in view of the accompanying drawings and the following description, which describes particular modalities of such concepts in greater detail. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates an RICC assembly with an RICC that includes an insertion opening in accordance with some embodiments. Figure 2 illustrates an RICC assembly with an RICC lacking the insertion opening in accordance with some embodiments. Figure 3 illustrates the assembly of the RICC of Figure 1 or 2 with a maneuvering guide wire through it in accordance with some modalities. Figure 4 illustrates a distal end portion of a soft RICC catheter tube from Figure 1 or 2, in accordance with some modalities. Figure 5 illustrates a first cross-section of the soft catheter tube in accordance with some modalities. Figure 6 illustrates a second or third cross-section of the soft catheter tube according to some modalities. Figure 7 illustrates a fourth cross-section of the soft catheter tube with an introducer needle through the septum of the same in accordance with some modalities. Figure 8 illustrates a method of assembling the RICC assembly of Figure 1 or 2 in accordance with some modalities. DETAILED DESCRIPTION OF THE INVENTION Before some specific modalities are described in greater detail, it should be understood that the specific modalities described herein do not limit the scope of the concepts provided. It should also be understood that a specific modality described herein may have aspects that can be easily separated from that modality and optionally combined with, or substituted for, aspects of any of a number of other modalities described herein. With regard to the terms used herein, it should also be understood that these terms are intended to describe certain modalities and do not limit the scope of the concepts presented. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different aspects or steps within a group of aspects or steps and do not provide a sequential or numerical limitation. For example, the first, second, and third aspects or steps do not necessarily appear in that order, and the particular modalities that include such aspects or steps need not be limited to these three aspects or steps. Labels such as left, right, top, bottom, front, back, and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction.In contrast, labels are used to reflect, for example, location, orientation, or relative directions. The singular forms of a, an, and the include plural references unless the context clearly dictates otherwise. With respect to "proximal," a proximal portion or proximal end portion of, for example, a catheter described herein includes a portion of the catheter intended to be near a physician when the catheter is used in a patient. Similarly, a proximal length of, for example, the catheter includes a length of the catheter intended to be near the physician when the catheter is used in the patient. A proximal end of, for example, the catheter includes an end of the catheter intended to be near the physician when the catheter is used in the patient. The proximal portion, proximal end portion, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of the catheter need not include the proximal end of the catheter.That is, unless the context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter. With respect to "distal," a distal portion or distal end portion of, for example, a catheter described herein includes a portion of the catheter intended to be near or in a patient when the catheter is used in the patient. Similarly, a distal length of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used in the patient. A distal end of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used in the patient. The distal portion, distal end portion, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter.That is, unless the context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or length of the catheter. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. As previously stated, 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. This document describes RICCs, including catheter assemblies and methods for their use, that address this need. Figure 1 illustrates an assembly of the RICC 100 with an RICC 102 including an insertion opening 104 according to some embodiments. Figure 2 illustrates an assembly of the RICC 200 with an RICC 202 lacking the insertion opening 104 according to some embodiments. As shown, the RICC 100 or 200 assembly includes the RICC 102 or 202 and an introducer 106 coupled together in a ready-to-deploy state of the RICC 100 or 200 assembly. The RICCs 102 and 202 and the introducer 106 are, in turn, described in sections set out later; however, there is some overlap between the sections for the RICCs 102 and 202 and the introducer 106 in view of the interrelationships of the RICCs 102 and 202 and the introducer 106 in the RICC 100 and 200 assemblies. The RICC 102 differs from the RICC 202 in that the RICC 102 has an introduction opening 104, which is dedicated to accommodating the insertion of the introducer needle 126 of the introducer 106 through it to couple the RICC 102 and the introducer 106 together in the RICC 100 assembly. The RICC 202 lacks this dedicated introduction opening 104, thus requiring a different method of coupled between the RICC 202 and the introducer 106 in the RICC 200 assembly than in the RICC 100 assembly. The RICC 102 or 202 can be a monoluminal or multiluminal RICC (e.g., a diluminal RICC, a triluminal RICC, a tetraluminal RICC, a pentaluminal RICC, a hexaluminal RICC, etc.). For example, the RICC 202, which lacks the inlet opening 104, can be monoluminal. ivia / ιουο This RICC also lacks the secondary lumen opening 116 and the tertiary lumen opening 118 shown below. In another example, RICC 102 or 202 can be multiluminal. As shown in Figure 1 or 2, RICC 102 or 202 is triluminal, comprising a set of three lumens. This set of three lumens includes a primary lumen 108 (e.g., a distal lumen), a secondary lumen 110 (e.g., a mid-lumen), and a tertiary lumen 112 (e.g., a proximal lumen) formed from fluidly connected portions of three catheter tubing lumens, three hub lumens, and three extension limb lumens. (See Figures 4 through 7.) Whether the RICC 102 or 202 is single-lumen or multi-luminal, the RICC 102 or 202 includes at least the primary lumen 108. The primary lumen 108 normally extends from a proximal end of the RICC 102 or 202 to a distal end of the RICC 102 or 202, such as from a Luer connector opening corresponding to a primary lumen opening 114 at a distal end of the soft catheter tubing 120 or 220 set down below. When the RICC 102 or 202 has two or more lumens, the RICC 102 or 202 also includes at least the secondary lumen 110. The secondary lumen 110 normally extends from the proximal end of the RICC 102 or 202 to a portion of the distal end of the RICC 102 or 202, such as from a Luer connector opening corresponding to a secondary lumen opening 116 in the distal end portion of the soft catheter tubing 120 or 220 proximal to the primary lumen opening 114.When the RICC 102 or 202 has three or more lumens, the RICC 102 or 202 also includes at least the tertiary lumen 112. The tertiary lumen 112 normally extends from the proximal end of the RICC 102 or 202 to the distal end portion of the RICC 102 or 202, such as from a Luer connector opening corresponding to a tertiary lumen opening 118 in the distal end portion of the soft catheter tubing 120 or 220 proximal to the secondary lumen opening 116. Notwithstanding the foregoing, each secondary lumen 110 and tertiary lumen 112 may extend distally slightly beyond the secondary lumen opening 116 and the tertiary lumen opening 118, respectively, in view of different manufacturing methods. (See figures 4 and 6.) Whether or not RICC 102 or 202 includes the introduction opening 104, RICC 102 or 202 also includes an introduction lumen coinciding with a distal end portion of the primary lumen 108. In other words, the introduction lumen is an introduction portion of the primary lumen 108 of RICC 102 or 202. In RICC 102, the introduction lumen is the distal end portion of the primary lumen 108 that extends from introduction opening 104 to the primary lumen opening 114. Introduction opening 104, which may be distal to the secondary lumen opening 116, between the secondary lumen opening 116 and the tertiary lumen opening 118, or proximal to the tertiary lumen opening 118, opens directly into a proximal end of the introduction portion of the primary lumen 108 of RICC 102 or 202. 102.In the RICC 202, the introduction lumen is the portion of the distal end of the primary lumen 108 that extends from the opening of the secondary lumen 116 or the opening of the tertiary lumen 118 to the opening of the primary lumen 114. Whether the introduction lumen extends from the opening of the secondary lumen 116 or the opening of the tertiary lumen 118 depends on which of the above openings accommodates the introducer needle 126 of the introducer 106. Neither the opening of the secondary lumen 116 nor the opening of the tertiary lumen 118 opens directly into a proximal end of the introduction portion of the primary lumen 108 of the RICC 202. Instead, the introducer needle 126 pierces the septum 128 between the secondary lumen 110 or the tertiary lumen. 112 and the primary lumen 108 respectively by means of the secondary lumen aperture 116 or the tertiary lumen aperture 118. The RICC 102 or 202 includes a soft catheter tube 120 or 220, a catheter hub 122, and one or more extension limbs 124. Figure 4 illustrates a portion of the distal end of the 120 or 220 soft catheter tubing of the RICC 102 or 202 of Figure 1 or 2, according to some modalities. Figures 5 through 7 illustrate various cross-sections of the 120 or 220 soft catheter tubing, according to some modalities. Figure 7 further illustrates an introducer needle 126 through a septum 128 of the 220 catheter tubing, according to some modalities. The 120 or 220 soft catheter tubing includes a distal tip 130 on a portion of the distal end of the 120 or 220 soft catheter tubing that corresponds to the distal end of the 102 or 202 RICC. As described above for the 102 and 202 RICCs, the 120 or 220 soft catheter tubing may be single-lumen or multi-lumen. In fact, the 120 or 220 soft catheter tubing includes one or more catheter tubing lumens that correspond in name and number to those of the 102 or 202 RICC. The one or more catheter tubing lumens extend through the 120 or 220 soft catheter tubing as described above for the 102 or 202 RICC. The soft catheter tubing 120 differs from the soft catheter tubing 120 in that it has an introduction opening 104 along one side of the soft catheter tubing 120 at its distal end. Again, the introduction opening 104 is dedicated to accommodating the insertion of the introducer needle 126 of the introducer 106 through it to couple the RICC 102 and the introducer 106 together in the RICC 100 assembly. The soft catheter tubing 120 lacks this dedicated introduction opening 104, thus requiring a different method of coupled between the RICC 202 and the introducer 106 together in the RICC 200 assembly than in the RICC 100 assembly. Notwithstanding the foregoing, the 120 or 220 soft catheter tubing may include nl lateral openings through the side of the 120 or 220 soft catheter tubing in accordance with a number n lumens of RICC 102 or 202. In fact, taking into consideration the RICC 102 or 202 stated above, which have three lumens, the 120 or 220 soft catheter tubing may include two lateral openings, including the secondary lumen opening 116 on the side of the 120 or 220 soft catheter tubing proximal to the primary lumen opening 114, and the tertiary lumen opening 118 on the side of the 120 or 220 soft catheter tubing proximal to the secondary lumen opening 116. In addition to providing different openings for aspirating blood, delivering fluids, or the like, such openings Lateral lumens are important for establishing an introduction lumen for introducing RICCs such as the RICC 202. The 122 catheter hub is attached to a proximal end portion of the 120 or 220 soft catheter tubing. The 122 catheter hub includes one or more catheter-hub lumens corresponding in number to the one or more lumens of the catheter tubing. The one or more catheter-hub lumens extend through the entirety of the 122 catheter hub from a proximal end of the 122 catheter hub to a distal end of the 122 catheter hub. Each extension limb of the one or more extension limbs 124 is coupled to the catheter hub 122 by a distal extension limb portion. The one or more extension limbs 124 respectively include one or more extension limb lumens, which, in turn, correspond in number to the one or more lumens of the catheter tubing. Each extension limb lumen of the one or more extension limb lumens extends through the entirety of the extension limb from a proximal extension limb end to a distal extension limb end. Each extension limb of the one or more extension limbs 124 typically includes a Luer connector attached to the extension limb, through which Luer connector the extension limb and the extension limb lumen thereof can be connected to another medical device. The introducer 106 includes an introducer catheter 132 and an introducer needle 126. The introducer catheter 132 includes a hard catheter tube 134, an introducer catheter hub 136 around a proximal end portion of the hard catheter tube 134, and a distal tip 138 on a distal end portion of the hard catheter tube 134. The introducer catheter 132 also includes an introduction port 140 through one side of the hard catheter tube 134 at its distal end portion. The introduction port 140 opens into a single-lumen introduction portion of the introducer catheter 132, the introduction portion of which extends from the introduction port 140 to a distal end of the introducer catheter 132. When the RICC 100 or 200 assembly is in the ready-to-deploy position, the introducer catheter 132 is placed in the primary lumen 108 of the RICC 102 or 202 so that the distal end of the introducer catheter 132 extends at least approximately 1–7 cm beyond the distal end of the RICC 102 or 202. This extension is useful for tissue dilation with the distal end portion of the introducer catheter 132 or the hard catheter tube 134 thereof. With regard to the soft catheter tube 120 or 220 of the RICC 102 or 202 and the hard catheter tube 134 of the introducer catheter 132, the soft catheter tube 120 or 220 is formed from a first material having a first durometer and the hard catheter tube 134 is formed from a second material having a second durometer. The first durometer is smaller than the second durometer, thereby making the soft catheter tube 120 or 220 relatively softer than the hard catheter tube 134. In other words, the second durometer is larger than the first durometer, thereby making the hard catheter tube 134 relatively harder than the soft catheter tube 120 or 220. The hard catheter tube 134 provides the RICC assembly 100 or 200 with a column force to advance the RICC 102 or 202 into the lumen of a blood vessel over a guide wire such as the maneuvering guide wire 152 set out below. It should be understood that the first and second durometers may be on different scales (e.g., Type A or Type D), so the first durometer reading of the first polymeric material might not be numerically lower than the second durometer reading of the second polymeric material. Similarly, the second durometer reading of the second polymeric material might not be numerically higher than the first durometer reading of the first polymeric material, given the different scales. That is, the hardness of the first polymeric material may still be lower than the hardness of the second polymeric material, or the hardness of the second polymeric material may still be higher than the hardness of the first polymeric material, since the different scales, each ranging from 0 to 100, are designed to characterize different materials within groups of materials that have similar hardness. Notwithstanding the foregoing, the soft catheter tube 120 or 220 and the hard catheter tube 134 may be made of the same polymeric material or different polymeric materials having substantially equal durometers, provided that the column strength of the soft catheter tube 120 or 220 in combination with the hard catheter tube 134 is sufficient to prevent the soft catheter tube 120 or 220 from bending when inserted into an insertion site and advanced through a patient's vasculature. The introducer needle 126 includes an arrow 142, an introducer needle hub 144 around a proximal end portion of the arrow 142, and a beveled tip 146 on a distal end portion of the arrow 142. When the RICC 100 assembly is in a ready-to-deploy state, the introducer needle 126 or arrow 142 thereof is placed into the single lumen of the introducer catheter 132 through a combination of the introduction opening 104 of the RICC 102 or the soft catheter tube 120 thereof and the introduction hole 140 of the introducer catheter 132 or the hard catheter tube 134 thereof so that the beveled tip 146 of the introducer needle 126 extends beyond the distal end of the introducer catheter 132 to establish a percutaneous puncture.However, when the RICC 200 assembly is in a ready-to-deploy state, the introducer needle 126 or arrow 142 thereof is placed into the single lumen of the introducer catheter 132 through a combination of the secondary lumen opening 116 or the tertiary lumen opening 118 of the RICC 202 or the soft catheter tube 220 thereof, the septum 128 dividing the secondary lumen 110 or the tertiary lumen 112 from the primary lumen 108 of the RICC 202 or the soft catheter tube 220 thereof, and the introduction orifice 140 of the introducer catheter 132 or the hard catheter tube 134 thereof. Positioned as such, the beveled tip 146 on the distal end portion of the introducer needle 126 extends beyond the distal end of the introducer catheter 132 when the RICC 100 or 200 assembly is in the ready-to-deploy state. The RICC 100 or 200 assembly also includes an access guide thread 148. When the RICC 100 or 200 assembly is at least in the ready-to-deploy state, the access guide wire 148 is placed in a needle lumen of the introducer needle 126 so that a distal end of the access guide wire 148 is proximal to the beveled tip 146 of the introducer needle 126 but distal to the distal end of the RICC 102 or 202, allowing immediate advancement of the distal end of the access guide wire 148 past the beveled tip 146 of the introducer needle 126 and into the lumen of a blood vessel when establishing access to it. The access guidewire 148 includes a stop (e.g., a hub, ball, bar, etc.) around a proximal end portion of the access guidewire 148 that forms a stop end (e.g., a hub end, a ball end, a bar end, etc.) of the access guidewire 148. The stop end 150 of the access guidewire 148 is larger than any opening of the RICC 102 or 202 or the soft catheter tubing 120 or 220 thereof, thereby providing a distal limit for advancing the access guidewire 148 into the RICC 102 or 202. Figure 3 illustrates the assembly of the RICC 100 or 200 with a maneuvering guide wire 152 through it in accordance with some modalities. The RICC 100 or 200 assembly further includes a maneuvering guide wire 152 which includes an atraumatic tip 154 ​​(e.g., a coiled or partially coiled tip) and a length sufficient to advance the maneuvering guide wire 152 to the lower 1 / 3 of the superior vena cava (SVC) of the heart. When the RICC 100 or 200 assembly is at least in the ready-to-deploy state, the maneuvering guidewire 152 is placed in the single lumen of the introducer catheter 132 so that a distal end of the maneuvering guidewire 152 is proximal to the introduction port 140 but distal to the catheter hub 122, allowing immediate advancement of the distal end of the maneuvering guidewire 152 into the blood vessel lumen upon withdrawal of the introducer needle 126 or arrow 142 from the single lumen of the introducer catheter 132. In fact, the maneuvering guidewire 152 cannot be advanced further distally in the single lumen of the introducer catheter 132 due to the presence of the introducer needle 126 or arrow 142 in at least the ready-to-deploy state of the RICC 100 or 200 assembly. The maneuvering guidewire 152 includes a stop (e.g., a hub, ball, bar, etc.) around a proximal end portion of the maneuvering guidewire 152 that forms a stop end 156 (e.g., a hub end, ball end, bar end, etc.) of the maneuvering guidewire 152. The stop end 156 of the maneuvering guidewire 152 is larger than a proximal end opening in the hub of the introducer catheter 136, thereby providing a distal limit for advancing the maneuvering guidewire 152 into the RICC 102 or 202. Methods The RICC 100 or 200 assembly methods include a method for assembling the RICC 100 or 200 assembly and a method for using the RICC 100 or 200 assembly. Regarding the assembly method of the RICC 100 or 200 assembly, Figure 8 illustrates the assembly method of the RICC 100 or 200 assembly in accordance with some modalities. As shown, the RICC 100 or 200 assembly method includes an introducer catheter insertion step, an introducer needle insertion step, an access guidewire insertion step, and a maneuvering guidewire insertion step. The introducer catheter insertion step includes inserting the introducer catheter 132 into the primary lumen 108 of the RICC 102 or 202 through the corresponding Luer connector opening at the proximal end of the RICC 102 or 202. Additionally, the introducer catheter insertion step includes aligning the insertion hole 140 of the hard catheter tubing 134 of the introducer catheter 132 with an opening in the soft catheter tubing 120 or 220 of the RICC 102 or 202. For the RICC 102, this alignment includes aligning the insertion hole 140 of the hard catheter tubing 134 with the insertion hole 104 of the soft catheter tubing 120. For the RICC 202, this alignment includes aligning the insertion hole 140 of the hard catheter tubing 134 with the secondary lumen opening 116 or the tertiary lumen opening 118 of the tubing. of the soft catheter 220.Finally, the introducer catheter insertion step includes ensuring that the distal end of the introducer catheter 132 extends at least approximately 1-7 cm beyond the distal end of the RICC 102 or 202. The introducer needle insertion step involves inserting the introducer needle 126 into the single lumen of the introducer catheter 132 through the introduction port 140 of the hard catheter tube 134, thereby locking the introducer and the RICC 102 or 202 together. For the RICC 102, the introducer needle insertion step involves inserting the introducer needle 126 into the introduction port 104 of the soft catheter tube 120, then inserting the introducer needle 126 into the introduction port 140 of the hard catheter tube 134. For the RICC 202, the introducer needle insertion step involves inserting the introducer needle 126 into the secondary lumen opening. 116 or into the opening of the tertiary lumen 118, then pierce the septum 128 between the secondary lumen 110 or the tertiary lumen 112 and the primary lumen 108 of the soft catheter tube 220, and finally insert the introducer needle 126 into the introduction hole 140 of the hard catheter tube 134 disposed in the primary lumen 108. Lastly, the introducer needle insertion step includes ensuring that the beveled tip 146 of the introducer needle 126 extends beyond the distal end of the introducer catheter 132. The access guidewire insertion step includes inserting the access guidewire 148 into the introducer needle 126 through an opening in the introducer needle hub 144 at a proximal end of the introducer needle 126. Additionally, the access guidewire insertion step includes positioning the access guidewire 148 in the introducer needle 126 so that the distal end of the access guidewire 148 is proximal to the beveled tip 146 of the introducer needle 126 but distal to the distal end of the RICO 102 or 202. Again, this positioning of the access guidewire 148 allows immediate advancement of the distal end of the access guidewire 148 beyond the beveled tip 146 of the introducer needle 126 and into a blood vessel lumen after establishing access to it. The guidewire insertion step includes inserting the guidewire 152 into the introducer catheter 132 through an opening in the introducer catheter hub 136 at a proximal end of the introducer catheter 132. Additionally, the guidewire insertion step includes positioning the guidewire 152 in the introducer catheter 132 so that the distal end of the guidewire 152 is proximal to the introduction hole 140 but distal to the catheter hub 122. Again, this positioning of the guidewire 152 allows for immediate advancement of the distal end of the guidewire 152 into the blood vessel lumen after withdrawal of the introducer needle 126 or the arrow 142 from the single lumen of the introducer catheter 132. Regarding the method of using the RICC 100 or 200 assembly, the method of using the RICC 100 or 200 assembly includes a step of obtaining the RICC assembly, a step of establishing the needle path, a step of advancing the access guide thread, and a step of retracting the introducer needle. The RICC assembly obtaining step includes obtaining the RICC 100 or 200 assembly which includes the RICC 102 or 202 and the introducer 106. As stated above regarding the ready-to-deploy state of the RICC 100 or 200 assembly, the introducer 106 includes the introducer catheter 132 disposed in the primary lumen 108 of the RICC 102 or 202 such that the distal end portion of the introducer catheter 132 extends beyond the distal end of the RICC 102 or 202. The method may also include a check step to ensure that the distal end of the introducer catheter 132 extends at least approximately 1 to 7 cm beyond the distal end of the RICC 102 or 202 before performing the needle path establishment step. The needle path establishment step includes establishing a needle path from a skin area to a patient's blood vessel lumen using a beveled tip 146 of the introducer needle 126 of the introducer 106. As previously stated with regard to the ready-to-deploy state of the RICC 100 or 200 assembly, the introducer needle 126 extends through the tube side of the soft catheter 120 or 220 of the RICC 102 or 202, through the tube side of the hard catheter 134 of the introducer catheter 132, and out of the distal end of the introducer catheter 132. The access guidewire advancement step involves advancing an access guidewire 148 through the introducer needle 126 and into the lumen of a patient blood vessel. The method may also include a first RICC advancement step to advance the distal end portion of the introducer catheter 132 into the lumen of a blood vessel over the access guidewire 148. The introducer needle retraction step includes retraction of the introducer needle 126 from the lumen of a blood vessel and assembly of the RICC 100 or 200 leaving the access guidewire 148 and introducer catheter 132 in the lumen of a blood vessel. The method may also include a guidewire advancement step 152 to advance a guidewire 152 through the introducer catheter 132 and into the lumen of a blood vessel. However, the guidewire advancement step 152 requires first withdrawing the introducer needle 126 from both the blood vessel lumen and the RICC assembly 100 or 200. The method may further include a second RICC advancement step to advance both the distal end portion of the introducer catheter 132 and a distal end portion of the RICC 102 or 202 further into the blood vessel lumen over the maneuvering guidewire 152 as in the SVC. Although some specific modalities have been described herein, and although these modalities have been described in some detail, it is not intended that they limit the scope of the concepts presented herein. Further adaptations and / or modifications to those of ordinary experience in the technique may occur, and, in broader respects, these adaptations and / or modifications are also encompassed. Consequently, deviations from the specific modalities described herein are possible without departing from the scope of the concepts presented herein.

Claims

1. A rapidly insertable central catheter assembly (RICC), comprising: an RICC including: a soft catheter tube having an introduction opening through one side of the soft catheter tube into a distal end portion thereof, the introduction opening opening into an introduction portion of a primary lumen of the RICC extending from the introduction opening to a distal end of the RICC; a catheter hub coupled to a proximal end portion of the soft catheter tube; and one or more extension limbs, each extension limb being coupled to the catheter hub by a distal end portion thereof;and an introducer comprising: an introducer catheter comprising a hard catheter tube having an introduction hole through one side of the hard catheter tube in a distal end portion thereof, the introduction hole opening into a single-lumen introduction portion of the introducer catheter extending from the introduction hole to a distal end of the introducer catheter; and an introducer needle, the introducer catheter disposed in the primary lumen of the RICC such that the distal end of the introducer catheter extends beyond the distal end of the RICC and the introducer needle disposed in the introducer catheter through the introduction opening and the introduction hole such that a beveled tip on a distal end portion of the introducer needle extends beyond the distal end of the introducer catheter when the RICC assembly is in a state ready for deployment therefrom; 2.- The RICC assembly according to claim 1, further characterized in that it additionally comprises an access guide thread placed on the introducer needle such that a distal end of the access guide thread is proximal to the beveled tip but distal to the distal end of the RICC when the RICC assembly is in the ready-to-deploy state.

3. The assembly of the RICC according to claim 2, further characterized in that the access guide wire includes a stop around a proximal end portion of the access guide wire forming a stop end thereof, the stop end of the access guide wire configured to provide a distal limit for advancing the access guide wire into the RICC.

4. The RICC assembly in accordance with any of claims 1 to 3, further characterized in that it additionally comprises a maneuvering guide wire placed in the introducer catheter such that a distal end of the maneuvering guide wire is proximal to the introduction orifice but distal to the hub of the catheter when the RICC assembly is in the ivia / t / zuzj / uz iouo state ready to be deployed.

5. The RICC assembly according to claim 4, further characterized in that the maneuvering guide wire includes a stop around a proximal end portion of the maneuvering guide wire forming a stop end thereof, the stop end of the maneuvering guide wire configured to provide a distal limit for advancing the maneuvering guide wire in the RICC.

6. The RICC assembly according to any of claims 1 to 5, further characterized in that the soft catheter tube is formed from a first material having a first durometer and the hard catheter tube is formed from a second material having a second durometer greater than the first durometer, thereby providing the RICC assembly with a column force to advance the RICC in the lumen of a blood vessel on a guide wire.

7. The RICC assembly according to any of claims 1 to 6, further characterized in that the RICC includes a set of three lumens comprising the primary lumen, a secondary lumen, and a tertiary lumen formed from fluidly connected portions of three catheter tube lumens, three hub lumens, and three extension limb lumens.

8. The RICC assembly according to claim 7, further characterized in that the primary lumen has a primary lumen opening at the distal end of the RICC, the secondary lumen has a secondary lumen opening on the soft catheter tube side proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on the soft catheter tube side proximal to the secondary lumen opening but distal to the introduction opening.

9. A rapidly inserted central catheter (RICC) assembly, comprising: an RICC including: a soft catheter tube having a primary lumen opening at a distal end of the soft catheter tube and a secondary lumen opening on one side of the soft catheter tube in a distal end portion thereof; a catheter hub coupled to a proximal end portion of the soft catheter tube; and one or more extension limbs, each extension limb coupled to the catheter hub by a distal end portion thereof; and an introducer including: an introducer catheter including a hard catheter tube having an introduction orifice through one side of the hard catheter tube in a distal end portion thereof;and an introducer needle, the introducer catheter disposed in a primary lumen of the RICC such that a distal end of the introducer catheter extends beyond a distal end of the RICC and the introducer needle disposed in the introducer catheter through a combination of the secondary lumen opening, a septum dividing a secondary lumen from the primary lumen and the introduction orifice such that a beveled tip on a portion of the distal end of the introducer needle extends beyond the distal end of the introducer catheter when the RICC assembly is in a state ready to be deployed from the same.; 10. The RICC assembly according to claim 9, further characterized in that it additionally comprises an access guide thread placed on the introducer needle such that a distal end of the access guide thread is proximal to the beveled tip but distal to the distal end of the RICC when the RICC assembly is in the ready-to-deploy state.

11. The RICC assembly according to claim 10, further characterized in that the access guide wire includes a stop around a proximal end portion of the access guide wire forming a stop end thereof, the stop end of the access guide wire configured to provide a distal limit for advancing the access guide wire into the RICC.

12. The RICC assembly according to any of claims 9 to 11, further characterized in that it additionally comprises a maneuvering guide wire placed in the introducer catheter such that a distal end of the maneuvering guide wire is proximal to the introduction orifice but distal to the hub of the catheter when the RICC assembly is in the ready-to-deploy state.

13. The RICC assembly according to claim 12, further characterized in that the maneuvering guide wire includes a stop around a proximal end portion of the maneuvering guide wire forming a stop end thereof, the stop end of the maneuvering guide wire configured to provide a distal limit for advancing the maneuvering guide wire in the RICC. 14.- The RICC assembly according to any of claims 9 to 13, further characterized in that the soft catheter tube is formed from a first material having a first durometer and the hard catheter tube is formed from a second material having a second durometer greater than the first durometer, thereby providing the RICC assembly with a column force to advance the RICC in the lumen of a blood vessel on a guide wire.

15. The RICC assembly according to any of claims 9 to 14, further characterized in that the RICC includes a set of three lumens comprising the primary lumen, the secondary lumen, and a tertiary lumen formed from fluidly connected portions of three catheter tube lumens, three hub lumens, and three extension limb lumens.

16. The RICC assembly according to claim 15, further characterized in that the primary lumen has the primary lumen opening at the distal end of the RICC, the secondary lumen has a secondary lumen opening on the soft catheter tube side proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on the soft catheter tube side proximal to the secondary lumen opening.

17. A method for using a rapidly inserted central catheter (RICC) assembly, comprising: obtaining an RICC assembly that includes the RICC and an introducer, the introducer including an introducer catheter placed in a primary lumen of the RICC such that a portion of the distal end of the introducer catheter extends beyond a distal end of the RICC; establishing a needle path from a skin area to a patient blood vessel lumen with a beveled tip of an introducer needle of the introducer, the introducer needle extending through one side of a soft catheter tube of the RICC, through one side of the hard catheter tube of the introducer catheter, and out of the distal end of the introducer catheter; advancing an access guidewire through the introducer needle and into the lumen of a patient blood vessel;and retract the introducer needle from the lumen of a blood vessel and the RICC assembly, leaving the access guidewire and introducer catheter in the lumen of a blood vessel.

18. The method according to claim 17, further characterized in that it additionally comprises ensuring that the distal end of the introducer catheter extends at least approximately 1 to 7 cm beyond the distal end of the RICC before establishing the needle path.

19. The method according to any of claims 17 or 18, further characterized in that it additionally comprises advancing the distal end portion of the introducer catheter into the lumen of a blood vessel over the access guide wire.

20. The method according to any of claims 17 to 19, further characterized in that it additionally comprises advancing a maneuvering guide wire through the introducer catheter and into the lumen of a blood vessel.

21. The method according to claim 20, further characterized in that advancing the maneuvering guide wire through the introducer catheter requires first retracting the introducer needle from both the blood vessel lumen and the RICC assembly.

22. The method according to any of claims 17 to 21, further characterized in that it additionally comprises advancing the distal end portion of the introducer catheter and a distal end portion of the RICC further into the lumen of a blood vessel over the maneuvering guidewire.

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