Quick insertable central catheter including a component and method thereof

Abstract

Disclosed herein are rapid insertable central catheters ("RICCs") comprising assemblies and methods thereof. In some embodiments, a RICC assembly comprises a RICC and an introducer. The RICC comprises a soft catheter tubing having a guide aperture leading to a main lumen of the RICC. The introducer comprises a guide catheter comprising a hard catheter tubing having a guide bore leading to a single lumen of the guide catheter. When the RICC assembly is in its ready-to-deploy state, the guide catheter is disposed in the main lumen of the RICC such that a distal end of the guide catheter extends beyond a distal end of the RICC. Furthermore, a guide needle of the introducer is disposed in the guide catheter through both the guide aperture and the guide bore such that a beveled tip of the guide needle extends beyond the distal end of the guide catheter.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 045,599, filed June 29, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD

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

[0004] Central venous catheters (“CVCs”) are formed from materials having relatively low durometer, which results in insufficient column strength of the CVC. Due to the insufficient column strength, the CVC is typically introduced into a patient and advanced through the patient’s vasculature via the Seldinger technique. The Seldinger technique uses multiple steps and medical devices (e.g., needles, scalpels, guide wires, introducer sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the steps are time consuming, it is challenging to manipulate the large number of medical devices, and both of the foregoing disadvantages result in trauma to the patient. In addition, there is a relatively high risk of contact contamination due to the large number of medical devices that need to be exchanged during the multiple steps of the Seldinger technique. Accordingly, 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 problems. SUMMARY

[0006] Disclosed herein is a RICC assembly, which in some embodiments includes a RICC and a introducer. The RICC includes a soft catheter tubing, a catheter hub, and one or more extension legs. The soft catheter tubing has an introducing aperture through a side of the soft catheter tubing in a distal end portion of the soft catheter tubing. The introducing aperture leads to an introducing portion of a main lumen of the RICC, the portion extending from the introducing aperture to a distal end of the RICC. The catheter hub is coupled to a proximal end portion of the soft catheter tubing. Each of the one or more extension legs is coupled to the catheter hub by a distal end portion of the extension leg. The introducer includes an introducing catheter and an introducing needle. The introducing catheter includes a hard catheter tubing having an introducing hole through a side of the hard catheter tubing in a distal end portion of the hard catheter tubing. The introducing hole leads to an introducing portion of a single lumen of the introducing catheter, the portion extending from the introducing hole to a distal end of the introducing catheter. The introducing catheter is disposed in the main lumen of the RICC such that the distal end of the introducing catheter extends beyond the distal end of the RICC when the RICC assembly is in a ready-to-deploy state of the RICC assembly. Further, the introducing needle is disposed in the introducing catheter through both the introducing aperture and the introducing hole such that a beveled tip in a distal end portion of the introducing needle extends beyond the distal end of the introducing catheter.

[0007] In some embodiments, the RICC assembly further includes an access guidewire. The access guidewire is disposed in the introducing needle such that a distal end of the access guidewire 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.

[0008] In some embodiments, the access guidewire includes a stopper around a proximal end portion of the access guidewire, the stopper 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 access guidewire into the RICC.

[0009] In some embodiments, the RICC assembly further includes a steering guidewire. The steering guidewire is disposed in the introducing catheter such that a distal end of the steering guidewire is proximal to the introducing hole but distal to the catheter hub when the RICC assembly is in the ready-to-deploy state.

[0010] In some embodiments, the steering guidewire includes a stopper around a proximal end portion of the steering guidewire, the stopper forming a stop end of the steering guidewire. The stop end of the steering guidewire is configured to provide a distal limit for advancing the steering guidewire into the RICC.

[0011] In some embodiments, the soft catheter tubing is formed of a first material having a first durometer and the hard catheter tubing is formed of a second material having a second durometer. The second durometer is greater than the first durometer, which provides column strength for the RICC assembly to push the RICC over a guidewire into a blood vessel lumen.

[0012] In some embodiments, the RICC includes a set of three lumens. The set of three lumens includes a primary lumen, a secondary lumen, and a tertiary lumen formed of fluidly connected portions of the three catheter tubing lumens, the three hub lumens, and the three extension leg lumens.

[0013] In some embodiments, the primary lumen has a primary lumen port in a distal end of the RICC. The secondary lumen has a secondary lumen port in a side of the soft catheter tubing proximal of the primary lumen port. The tertiary lumen has a tertiary lumen port in a side of the soft catheter tubing proximal of the secondary lumen port but distal of the guide port.

[0014] Also disclosed herein is a RICC assembly, which in some embodiments includes a RICC and a guide. The RICC includes a soft catheter tubing, a catheter hub, and one or more extension legs. The soft catheter tubing has a primary lumen port in a distal end of the soft catheter tubing and a secondary lumen port in a side of the soft catheter tubing in a distal portion of the soft catheter tubing. The catheter hub is coupled to a proximal portion of the soft catheter tubing. Each of the one or more extension legs is coupled to the catheter hub by a distal portion of the extension leg. The guide includes a guide catheter and a guide needle. The guide catheter includes a hard catheter tubing having a guide hole through a side of the hard catheter tubing in a distal portion of the hard catheter tubing. The guide catheter is disposed in the primary lumen of the RICC such that a distal end of the guide catheter extends beyond a distal end of the RICC when the RICC assembly is in an immediate deployment state of the RICC assembly. Further, the guide needle is disposed in the guide catheter through a combination of the secondary lumen port, a septum separating the secondary lumen from the primary lumen, and the guide hole. As so disposed, a beveled tip in a distal portion of the guide needle extends beyond the distal end of the guide catheter when the RICC assembly is in the immediate deployment state.

[0015] In some embodiments, the RICC assembly further includes an access guidewire. The access guidewire is disposed in the guide needle such that a distal end of the access guidewire is proximal of the beveled tip but distal of the distal end of the RICC when the RICC assembly is in the immediate deployment state.

[0016] In some embodiments, the access guidewire includes a stopper around a proximal portion of the access guidewire, the stopper forming a blocked end of the access guidewire. The blocked end of the access guidewire is configured to provide a distal limit for advancing the access guidewire into the RICC.

[0017] In some embodiments, the RICC assembly further includes a steering guidewire. The steering guidewire is disposed in the guide catheter such that a distal end of the steering guidewire is proximal of the guide hole but distal of the catheter hub when the RICC assembly is in the ready-to-deploy state.

[0018] In some embodiments, the steering guidewire includes a stopper around a proximal portion of the steering guidewire, the stopper forming a stop end of the steering guidewire. The stop end of the steering guidewire is configured to provide a distal limit for advancing the steering guidewire into the RICC.

[0019] In some embodiments, the soft catheter tubing is formed of a first material having a first durometer and the hard catheter tubing is formed of a second material having a second durometer. The second durometer is greater than the first durometer, which provides column strength for the RICC assembly to advance the RICC over the guidewire into the endovascular lumen.

[0020] In some embodiments, the RICC includes a set of three lumens. The set of three lumens includes a primary lumen, a secondary lumen, and a tertiary lumen formed of fluidic connections of the three catheter tubing lumens, the three hub lumens, and the three extension leg lumens.

[0021] In some embodiments, the primary lumen has a primary lumen aperture in a distal end of the RICC. The secondary lumen has a secondary lumen aperture in a side of the soft catheter tubing proximal of the primary lumen aperture. The tertiary lumen has a tertiary lumen aperture in the side of the soft catheter tubing proximal of the secondary lumen aperture.

[0022] A method of using the RICC assembly is also disclosed. In some embodiments, the method includes a RICC assembly acquisition step, a needle path establishment step, an access guidewire advancement step, and a guide needle withdrawal step. The RICC assembly acquisition step includes acquiring a RICC assembly including a RICC and a introducer. The introducer includes a guide catheter disposed in a primary lumen of the RICC such that a distal portion of the guide catheter extends beyond a distal end of the RICC. The needle path establishment step includes establishing a needle path from a skin region of a patient to an endovascular lumen with a beveled tip of a guide needle of the introducer. The guide needle extends through a side of a soft catheter tubing of the RICC, through a side of a hard catheter tubing of the guide catheter, and out of a distal end of the guide catheter. The access guidewire advancement step includes advancing an access guidewire through the guide needle and into the endovascular lumen of the patient. The guide needle withdrawal step includes withdrawing the guide needle from both the endovascular lumen and the RICC assembly, leaving the access guidewire and the guide catheter in the endovascular lumen.

[0023] In some embodiments, the method further includes an assurance step of ensuring that the distal end of the guide catheter extends at least about 1-7 cm beyond the distal end of the RICC prior to performing the needle path establishment step.

[0024] In some embodiments, the method further comprises a first RICC advancing step of advancing the distal end portion of the guide catheter over the access guidewire into the endovascular lumen.

[0025] In some embodiments, the method further comprises a steering guidewire advancing step of advancing the steering guidewire through the guide catheter and into the endovascular lumen.

[0026] In some embodiments, the steering guidewire advancing step requires that the guide needle first be withdrawn from both the endovascular lumen and the RICC assembly.

[0027] In some embodiments, the method further comprises a second RICC advancing step of advancing the distal end portion of the guide catheter and the distal end portion of the RICC further into the endovascular lumen over the steering guidewire.

[0028] These and other features of the concepts provided herein will become more apparent from the following description in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 RICC assemblies are shown in accordance with some embodiments in which the RICC includes a guide aperture.

[0030] Figure 2 RICC assemblies are shown in accordance with some embodiments in which the RICC does not include a guide aperture.

[0031] Figure 3 RICC assemblies are shown in accordance with some embodiments in Figure 1 or Figure 2 in which a steering guidewire is passed therethrough.

[0032] Figure 4 Distal end portions of soft catheter tubing of RICC are shown in accordance with some embodiments in Figure 1 or Figure 2

[0033] Figure 5 First cross-sectional profiles of soft catheter tubing are shown in accordance with some embodiments.

[0034] Figure 6 Second or third cross-sectional profiles of soft catheter tubing are shown in accordance with some embodiments.

[0035] Figure 7 Fourth cross-sectional profiles of soft catheter tubing are shown in accordance with some embodiments in which a guide needle is passed through the septum thereof.

[0036] Figure 8 RICC assemblies are shown in accordance with some embodiments in Figure 1 ​or Figure 2 a method of a RICC component in the DETAILED DESCRIPTION

[0037] Before some particular embodiments are disclosed in more detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the particular embodiments disclosed herein can have features that are readily separable from the particular embodiments, and that such features can be employed with or without the knowledge that such features are employed with any of the other embodiments disclosed herein or that such features can be employed with alternative embodiments.

[0038] With respect to the terms used herein, it should also be understood that these terms are used to describe some particular embodiments for the purpose of descriptive convenience and are not limiting with respect to the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily be present in these

[0039] With respect to “proximal,” “proximal portion,” or “proximal end portion” of, for example, a catheter disclosed herein, includes a portion of the catheter that is intended to be proximate to a clinician when the catheter is used with a patient. Likewise, “proximal length” of, for example, a catheter includes a length of the catheter that is intended to be proximate to a clinician when the catheter is used with a patient. “Proximal end” of, for example, a catheter includes an end of the catheter that is intended to be proximate to a clinician when the catheter is used with a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter is not necessarily required to include the proximal end of the catheter. That is, unless otherwise stated in the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0040] “distal,” “distal portion,” or “distal end portion” of, for example, a catheter, includes a portion of the catheter that is intended to be proximal to or within a patient when the catheter is used on the patient. Likewise, “distal length” of, for example, a catheter, includes a length of the catheter that is intended to be proximal to or within a patient when the catheter is used on the patient. “Distal end” of, for example, a catheter, includes an end of the catheter that is intended to be proximal to or within a patient when the catheter is used on the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0041] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art.

[0042] As set forth above, there is a need to reduce the number of steps and medical equipment involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through their vasculature. Disclosed herein are RICCs comprising catheter assemblies and methods thereof that address the foregoing.

[0043] Figure 1 RICC assembly 100 is shown in accordance with some embodiments, wherein RICC 102 includes an introducer aperture 104. Figure 2 RICC assembly 200 is shown in accordance with some embodiments, wherein RICC 202 does not include an introducer aperture 104.

[0044] As shown, RICC assembly 100 or 200 includes RICC 102 or 202 and introducer 106 coupled together in an immediate-to-deploy state of RICC assembly 100 or 200. RICC 102 and 202 and introducer 106 are described in turn in the sections set forth below; however, given the interrelatedness of RICC 102 and 202 and introducer 106 in RICC assemblies 100 and 200, there is some cross-over between the sections directed to RICC 102 and 202 and introducer 106.

[0045] RICC 102 differs from RICC 202 in that introducer aperture 104 is present in RICC 102, which is dedicated to accommodating insertion of introducer needle 126 of introducer 106 therethrough to couple RICC 102 and introducer 106 together in RICC assembly 100. RICC 202 does not have such a dedicated introducer aperture 104, necessitating a different mode of coupling RICC 202 and introducer 106 together in RICC assembly 200 than in RICC assembly 100.

[0046] RICC 102 or 202 can be a single-lumen or multi-lumen RICC (e.g., a dual-lumen RICC, a triple-lumen RICC, a quadruple-lumen RICC, a quintuple-lumen RICC, a sextuple-lumen RICC, etc.). For example, RICC 202 without guide port 104 can be single-lumen. Such a RICC also lacks secondary lumen port 116 and tertiary lumen port 118, which are set forth below. In another example, RICC 102 or 202 can be multi-lumen. As shown, RICC 102 or 202 is triple-lumen, including a set of three lumens. Such a set of three lumens includes primary lumen 108 (e.g., a distal lumen), secondary lumen 110 (e.g., an intermediate lumen), and tertiary lumen 112 (e.g., a proximal lumen) formed by fluidically connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens. (See Figure 1 Figure 2 Figures 4-7

[0047] Regardless of whether RICC 102 or 202 is single-lumen or multi-lumen, RICC 102 or 202 includes at least primary lumen 108. Primary lumen 108 generally extends from a proximal end of RICC 102 or 202 to a distal end of RICC 102 or 202, such as from an opening of a respective luer connector to primary lumen port 114 in a distal end of soft catheter tube 120 or 220 described below. When RICC 102 or 202 has two or more lumens, RICC 102 or 202 further includes at least secondary lumen 110. Secondary lumen 110 generally extends from a proximal end of RICC 102 or 202 to a distal portion of RICC 102 or 202, such as from an opening of a respective luer connector to secondary lumen port 116 in a distal portion of soft catheter tube 120 or 220 proximal of primary lumen port 114. When RICC 102 or 202 has three or more lumens, RICC 102 or 202 further includes at least tertiary lumen 112. Tertiary lumen 112 generally extends from a proximal end of RICC 102 or 202 to a distal portion of RICC 102 or 202, such as from an opening of a respective luer connector to tertiary lumen port 118 in a distal portion of soft catheter tube 120 or 220 proximal of secondary lumen port 116. Nonetheless, each of secondary lumen 110 and tertiary lumen 112 can extend distally slightly further than secondary lumen port 116 and tertiary lumen port 118, respectively, in view of different manufacturing methods. (See Figure 4 6

[0048] ​​​​​Whether the RICC 102 or 202 includes the pilot aperture 104, the RICC 102 or 202 further includes a pilot inner lumen coinciding with a distal end portion of the main inner lumen 108. In other words, the pilot inner lumen is a pilot portion of the main inner lumen 108 of the RICC 102 or 202. In the RICC 102, the pilot inner lumen is a distal end portion of the main inner lumen 108 extending from the pilot aperture 104 to the main inner lumen aperture 114. The pilot aperture 104 can be distal to the secondary inner lumen aperture 116, between the secondary inner lumen aperture 116 and the tertiary inner lumen aperture 118, or proximal to the tertiary inner lumen aperture 118, the pilot aperture directly leading to a proximal end of the pilot portion of the main inner lumen 108 of the RICC 102. In the RICC 202, the pilot inner lumen is a distal end portion of the main inner lumen 108 extending from the secondary inner lumen aperture 116 or the tertiary inner lumen aperture 118 to the main inner lumen aperture 114. Whether the pilot inner lumen extends from the secondary inner lumen aperture 116 or from the tertiary inner lumen aperture 118 depends on which of the aforementioned apertures accommodates the pilot needle 126 of the introducer 106. Neither the secondary inner lumen aperture 116 nor the tertiary inner lumen aperture 118 directly leads to a proximal end of the pilot portion of the main inner lumen 108 of the RICC 202. Rather, the pilot needle 126 pierces a septum 128 between the secondary inner lumen 110 or the tertiary inner lumen 112 and the main inner lumen 108 via the secondary inner lumen aperture 116 or the tertiary inner lumen aperture 118, respectively.

[0049] The RICC 102 or 202 includes a soft catheter tubing 120 or 220, a catheter hub 122, and one or more extension legs 124.

[0050] Figure 4 A distal end portion of the soft catheter tubing 120 or 220 of the RICC 102 or 202 is shown in accordance with some embodiments. Figure 1 or Figure 2 A distal end portion of the soft catheter tubing 120 or 220 of the RICC 102 or 202 is shown in accordance with some embodiments. Figures 5-7 Various cross-sections of the soft catheter tubing 120 or 220 are shown in accordance with some embodiments. Figure 7 A pilot needle 126 piercing a septum 128 of the soft catheter tubing 220 is further shown in accordance with some embodiments.

[0051] The soft catheter tubing 120 or 220 includes a distal tip 130 in a distal end portion of the soft catheter tubing 120 or 220 corresponding to a distal end of the RICC 102 or 202. Similar to that set forth above for the RICC 102 and 202, the soft catheter tubing 120 or 220 can be single-lumen or multi-lumen. Indeed, the soft catheter tubing 120 or 220 includes one or more catheter tubing lumens corresponding in name and number to the lumens of the RICC 102 or 202. The one or more catheter tubing lumens extend through the soft catheter tubing 120 or 220 as set forth above for the RICC 102 or 202.

[0052] Soft catheter tubing 120 differs from soft catheter tubing 220 in that there is a guide aperture 104 through the side of soft catheter tubing 120 in its distal end portion. Again, guide aperture 104 is dedicated to accommodating insertion of a guide needle 126 of introducer 106 therethrough in order to couple RICC 102 and introducer 106 together in RICC assembly 100. Soft catheter tubing 220 does not have such a dedicated guide aperture 104, thereby requiring a different mode of coupling RICC 202 and introducer 106 together in RICC assembly 200 than in RICC assembly 100.

[0053] Nonetheless, soft catheter tubing 120 or 220 can include n-1 side apertures through the side of soft catheter tubing 120 or 220 according to the number n of lumens of RICC 102 or 202. Indeed, considering that RICC 102 or 202 has three lumens as set forth above, soft catheter tubing 120 or 220 can include two side apertures, including a secondary lumen aperture 116 in the side of soft catheter tubing 120 or 220 proximal to primary lumen aperture 114 and a third lumen aperture 118 in the side of soft catheter tubing 120 or 220 proximal to secondary lumen aperture 116. In addition to providing different apertures for aspirating blood, delivering fluid, etc., such side apertures are important for establishing a guide lumen for guiding a RICC, such as RICC 202.

[0054] Catheter hub 122 is coupled to the proximal end portion of soft catheter tubing 120 or 220. Catheter hub 122 includes one or more catheter hub lumens, the number corresponding to the one or more catheter tubing lumens. The one or more catheter hub lumens extend through the entirety of catheter hub 122 from its proximal end to its distal end.

[0055] Each of the one or more extension legs 124 is coupled to catheter hub 122 by a distal end portion of the extension leg. The one or more extension legs 124 each include one or more extension leg lumens, in turn corresponding in number to the one or more catheter tubing lumens. Each of the one or more extension leg lumens extends through the entirety of the extension leg from its proximal end to its distal end.

[0056] Each of the one or more extension legs 124 generally includes a luer connector coupled to the extension leg, through which the extension leg and its extension leg lumens can be connected to another medical device.

[0057] Introducer 106 includes a guide catheter 132 and a guide needle 126.

[0058] The guide catheter 132 includes a hard catheter tubing 134, a guide-catheter hub 136 surrounding a proximal portion of the hard catheter tubing 134, and a distal tip 138 in a distal portion of the hard catheter tubing 134.

[0059] The guide catheter 132 also includes a guide hole 140 through a side of the hard catheter tubing 134 in a distal portion thereof. The guide hole 140 opens into a guide portion of a single lumen of the guide catheter 132, the guide portion extending from the guide hole 140 to a distal end of the guide catheter 132. When the RICC assembly 100 or 200 is in an immediate deployment state, the guide catheter 132 is disposed in the main lumen 108 of the RICC 102 or 202 such that the distal end of the guide catheter 132 extends at least about 1-7 cm beyond the distal end of the RICC 102 or 202, which is useful for dilating tissue with the distal portion of the guide catheter 132 or its hard catheter tubing 134.

[0060] With respect to the soft catheter tubing 120 or 220 of the RICC 102 or 202 and the hard catheter tubing 134 of the guide catheter 132, the soft catheter tubing 120 or 220 is formed of a first material having a first durometer, and the hard catheter tubing 134 is formed of a second material having a second durometer. The first durometer is less than the second durometer, such that the soft catheter tubing 120 or 220 is relatively softer than the hard catheter tubing 134. In other words, the second durometer is greater than the first durometer, such that the hard catheter tubing 134 is relatively harder than the soft catheter tubing 120 or 220. The hard catheter tubing 134 provides column strength to the RICC assembly 100 or 200 for advancing the RICC 102 or 202 over a guidewire (such as the steering guidewire 152 set forth below) into a blood vessel lumen.

[0061] It should be appreciated that the first durometer and the second durometer can have different scales (e.g., A scale or D scale), such that the first durometer of the first polymeric material can not be numerically less than the second durometer of the second polymeric material. Likewise, the second durometer of the second polymeric material can not be numerically greater than the first durometer of the first polymeric material, given the different scales. That is, the first polymeric material can still have a durometer that is less than the second polymeric material, or the second polymeric material can still have a durometer that is greater than the first polymeric material, because the different scales (each scale ranges from 0 to 100) are designed to characterize different materials in a group of materials having similar durometers.

[0062] Nonetheless, the soft catheter tubing 120 or 220 and the hard catheter tubing 134 can be formed of the same polymeric material or different polymeric materials having substantially the same durometer, so long as the column strength of the soft catheter tubing 120 or 220 in combination with the hard catheter tubing 134 is sufficient to prevent buckling of the soft catheter tubing 120 or 220 upon insertion into the insertion site and advancement through the vasculature of the patient.

[0063] The guide needle 126 includes a shaft 142, a needle-guide bushing 144 about a proximal portion of the shaft 142, and a beveled tip 146 in a distal portion of the shaft 142.

[0064] When the RICC assembly 100 is in the ready-to-deploy state, the guide needle 126 or its shaft 142 is disposed in the single lumen of the guide catheter 132 in combination with the guide orifice 104 of the RICC 102 or its soft catheter tubing 120 and the guide hole 140 of the guide catheter 132 or its hard catheter tubing 134, such that the beveled tip 146 of the guide needle 126 extends past the distal end of the guide catheter 132 so as to establish the percutaneous puncture. However, when the RICC assembly 200 is in the ready-to-deploy state, the guide needle 126 or its shaft 142 is disposed in the single lumen of the guide catheter 132 in combination with the secondary lumen orifice 116 or the third lumen orifice 118 of the RICC 202 or its soft catheter tubing 220, the septum 128 separating the secondary lumen 110 or the third lumen 112 of the RICC 202 or its soft catheter tubing 220 from the primary lumen 108, and the guide hole 140 of the guide catheter 132 or its hard catheter tubing 134. So disposed, the beveled tip 146 in the distal portion of the guide needle 126 extends beyond the distal end of the guide catheter 132 when the RICC assembly 100 or 200 is in the ready-to-deploy state.

[0065] The RICC assembly 100 or 200 further includes an access guidewire 148.

[0066] The access guidewire 148 is disposed in the needle lumen of the guide needle 126 such that the distal end of the access guidewire 148 is proximal of the beveled tip 146 of the guide needle 126 but distal of the distal end of the RICC 102 or 202 when the RICC assembly 100 or 200 is at least in the ready-to-deploy state, which allows immediate advancement of the distal end of the access guidewire 148 beyond the beveled tip 146 of the guide needle 126 and into the vascular lumen upon establishment of access to the vascular lumen.

[0067] The access guidewire 148 includes a stopper (e.g., a hub, a ball, a plug, etc.) around a proximal portion of the access guidewire 148 that forms a stop end 150 (e.g., a hub end, a ball end, a plug end, etc.) of the access guidewire 148. The stop end 150 of the access guidewire 148 is larger than any orifice of the RICC 102 or 202 or its soft catheter tubing 120 or 220, thereby providing a distal limit for advancing the access guidewire 148 into the RICC 102 or 202.

[0068] Figure 3 A RICC assembly 100 or 200 is shown in which the steering guidewire 152 passes through.

[0069] The RICC assembly 100 or 200 further includes a steering guidewire 152 that includes an atraumatic tip 154 (e.g., a coiled or partially coiled tip) and a length sufficient to advance the steering guidewire 152 into the lower 1 / 3 of the superior vena cava (“SVC”) of the heart.

[0070] The steering guidewire 152 is disposed in the single lumen of the guide catheter 132 such that the distal end of the steering guidewire 152 is proximal of the guide hole 140 but distal of the catheter hub 122 when the RICC assembly 100 or 200 is at least in the immediate deployment state, which allows the distal end of the steering guidewire 152 to be advanced into the blood vessel lumen immediately after the guide needle 126 or its shaft 142 is removed from the single lumen of the guide catheter 132. Indeed, the steering guidewire 152 cannot be advanced distally further into the single lumen of the guide catheter 132 due to the presence of the guide needle 126 or its shaft 142 at least in the immediate deployment state of the RICC assembly 100 or 200.

[0071] The steering guidewire 152 includes a stopper (e.g., a hub, a ball, a plug, etc.) around a proximal portion of the steering guidewire 152 that forms a stop end 156 (e.g., a hub end, a ball end, a plug end, etc.) of the steering guidewire 152. The stop end 156 of the steering guidewire 152 is larger than the proximal opening in the introducer-catheter hub 136, thereby providing a distal limit for advancing the steering guidewire 152 into the RICC 102 or 202.

[0072] Methods

[0073] Methods of the RICC assembly 100 or 200 include methods of assembling the RICC assembly 100 or 200 and methods of using the RICC assembly 100 or 200.

[0074] With respect to methods of assembling the RICC assembly 100 or 200, Figure 8 Methods of assembling the RICC assembly 100 or 200 are shown in accordance with some embodiments.

[0075] As shown, the method of assembling the RICC assembly 100 or 200 includes a guide-catheter insertion step, a guide-needle insertion step, an access guidewire insertion step, and a steering guidewire insertion step.

[0076] The guide-catheter insertion step includes inserting the guide catheter 132 into the main lumen 108 of the RICC 102 or 202 through the opening of the corresponding luer connector in the proximal end of the RICC 102 or 202. Further, the guide-catheter insertion step includes aligning the guide hole 140 of the hard catheter tubing 134 of the guide catheter 132 with the orifice of the soft catheter tubing 120 or 220 of the RICC 102 or 202. For the RICC 102, this alignment includes aligning the guide hole 140 of the hard catheter tubing 134 with the guide orifice 104 of the soft catheter tubing 120. For the RICC 202, this alignment includes aligning the guide hole 140 of the hard catheter tubing 134 with the secondary lumen orifice 116 or the third lumen orifice 118 of the soft catheter tubing 220. Finally, the guide-catheter insertion step includes ensuring that the distal end of the guide catheter 132 extends at least about 1-7 cm beyond the distal end of the RICC 102 or 202.

[0077] The guide-needle insertion step includes inserting the guide needle 126 into the single lumen of the guide catheter 132 through the guide hole 140 of the hard catheter tubing 134, thereby locking the guide and the RICC 102 or 202 together. For the RICC 102, the guide-needle insertion step includes inserting the guide needle 126 into the guide orifice 104 of the soft catheter tubing 120, and then inserting the guide needle 126 into the guide hole 140 of the hard catheter tubing 134. For the RICC 202, the guide-needle insertion step includes inserting the guide needle 126 into the secondary lumen orifice 116 or the third lumen orifice 118, and then piercing the septum 128 between the secondary lumen 110 or the third lumen 112 and the main lumen 108 of the soft catheter tubing 220, and finally inserting the guide needle 126 into the guide hole 140 of the hard catheter tubing 134 disposed in the main lumen 108. Finally, the guide-needle insertion step includes ensuring that the beveled tip 146 of the guide needle 126 extends beyond the distal end of the guide catheter 132.

[0078] The access guidewire insertion step includes inserting the access guidewire 148 into the introducer needle 126 through the opening of the introducer-needle hub 144 in the proximal end of the introducer needle 126. Further, the access guidewire insertion step includes positioning the access guidewire 148 in the introducer needle 126 such that the distal end of the access guidewire 148 is proximal of the beveled tip 146 of the introducer needle 126 but distal of the distal end of the RICC 102 or 202. Again, this position of the access guidewire 148 allows for immediate advancement of the distal end of the access guidewire 148 beyond the beveled tip 146 of the introducer needle 126 and into the endovascular lumen upon establishing access to the endovascular lumen.

[0079] The steering guidewire insertion step includes inserting the steering guidewire 152 into the introducer catheter 132 through the opening of the introducer-catheter hub 136 in the proximal end of the introducer catheter 132. Further, the steering guidewire insertion step includes positioning the steering guidewire 152 in the introducer catheter 132 such that the distal end of the steering guidewire 152 is proximal of the introducer aperture 140 but distal of the catheter hub 122. Again, this position of the steering guidewire 152 allows for immediate advancement of the distal end of the steering guidewire 152 into the endovascular lumen upon removal of the introducer needle 126 or shaft 142 thereof from the single lumen of the introducer catheter 132.

[0080] With respect to the method of using the RICC assembly 100 or 200, the method of using the RICC assembly 100 or 200 includes a RICC assembly acquisition step, a needle path establishment step, an access guidewire advancement step, and an introducer needle withdrawal step.

[0081] The RICC assembly acquisition step includes obtaining the RICC assembly 100 or 200 including the RICC 102 or 202 and the introducer 106. As set forth above with respect to the ready-to-deploy state of the RICC assembly 100 or 200, the introducer 106 includes the introducer catheter 132 disposed in the main lumen 108 of the RICC 102 or 202 such that a distal end portion of the introducer catheter 132 extends beyond the distal end of the RICC 102 or 202.

[0082] The method can further include an assurance step of ensuring that the distal end of the introducer catheter 132 extends at least about 1-7 cm beyond the distal end of the RICC 102 or 202 prior to performing the needle path establishment step.

[0083] The needle path establishment step includes establishing a needle path from a skin region of the patient to the endovascular lumen with the beveled tip 146 of the introducer needle 126 of the introducer 106. As set forth above with respect to the ready-to-deploy state of the RICC assembly 100 or 200, the introducer needle 126 extends through the side of the soft catheter tubing 120 or 220 of the RICC 102 or 202, through the side of the hard catheter tubing 134 of the introducer catheter 132, and out of the distal end of the introducer catheter 132.

[0084] The entry guidewire advancement step includes advancing the entry guidewire 148 through the introducer needle 126 and into the endovascular lumen of the patient.

[0085] The method can further include a first RICC advancement step of advancing the distal end portion of the introducer catheter 132 over the entry guidewire 148 into the endovascular lumen.

[0086] The introducer needle withdrawal step includes withdrawing the introducer needle 126 from the endovascular lumen and the RICC assembly 100 or 200, leaving the entry guidewire 148 and the introducer catheter 132 in the endovascular lumen.

[0087] The method can further include a steering guidewire 152 advancement step of advancing the steering guidewire 152 through the introducer catheter 132 and into the endovascular lumen. However, the steering guidewire 152 advancement step requires that the introducer needle 126 first be withdrawn from both the endovascular lumen and the RICC assembly 100 or 200.

[0088] The method can further include a second RICC advancement step of further advancing the distal end portion of the introducer catheter 132 and the distal end portion of the RICC 102 or 202 over the steering guidewire 152 into the endovascular lumen, such as into the SVC.

[0089] While certain specific embodiments have been disclosed herein, and while the detailed description has focused on certain specific embodiments, it will be understood that the intent is not to limit the scope of the concepts provided herein to the particular embodiments disclosed. Additional adaptations and / or modifications of the specific embodiments disclosed can occur to those ordinarily skilled in the art. Therefore, it is intended that the scope of the concepts provided herein encompass not only the specific embodiments disclosed in this disclosure, but also the subject matter defining the scope of the concepts provided herein through the claims set forth below.

Claims

1. A rapidly insertable central catheter assembly, characterized in that, include: A quick-insertion central catheter, comprising: A flexible catheter tubing having a guide port in its distal portion that passes through a side portion of the flexible catheter tubing, the guide port leading to a guide portion of the main lumen of a rapidly insertable central catheter, the guide portion extending from the guide port to the distal end of the rapidly insertable central catheter; A catheter bushing, which is connected to the proximal portion of the flexible catheter tubing; and One or more extension legs, each of the one or more extension legs being coupled to the catheter bushing via its distal portion; and Guide, the guide comprising: A guiding catheter includes a rigid conduit having a guiding hole in its distal portion extending through a side portion of the rigid conduit, the guiding hole leading to a guiding portion of a single lumen of the guiding catheter, the guiding portion extending from the guiding hole to the distal end of the guiding catheter; and When the quick-insertion central catheter assembly is in its immediate deployment state, the guide tube is disposed in the main lumen of the quick-insertion central catheter such that the distal end of the guide tube extends beyond the distal end of the quick-insertion central catheter, and the guide pin is disposed in the guide tube through both the guide orifice and the guide hole such that the angled tip of the distal portion of the guide pin extends beyond the distal end of the guide tube.

2. The quick-insertion central catheter assembly according to claim 1, characterized in that, It further includes an entry guidewire disposed in the guide needle such that, when the quick-access central catheter assembly is in an immediately deployed state, the distal end of the entry guidewire is proximal to the inclined tip but distal to the distal end of the quick-access central catheter.

3. The quick-insertion central catheter assembly according to claim 2, characterized in that, The entry guidewire includes a blocking member forming a blocking end around the proximal portion of the entry guidewire, the blocking end of the entry guidewire being configured to provide distal restriction for advancing the entry guidewire into the rapidly insertable central catheter.

4. The quick-insertion central catheter assembly according to claim 1, characterized in that, It further includes a manipulator wire disposed in the guide tube such that, when the rapidly insertable central catheter assembly is in an immediately deployed state, the distal end of the manipulator wire is proximal to the guide hole but distal to the catheter bushing.

5. The quick-insertion central catheter assembly according to claim 4, characterized in that, The manipulating guidewire includes a stop forming its blocking end around the proximal portion of the manipulating guidewire, the blocking end of the manipulating guidewire being configured to provide distal restriction for advancing the manipulating guidewire into the rapidly insertable central catheter.

6. The quick-insertion central catheter assembly according to claim 1, characterized in that, The flexible catheter tubing is formed of a first material having a first hardness, and the rigid catheter tubing is formed of a second material having a second hardness greater than the first hardness, thereby providing the quick-insertion central catheter assembly with column strength for advancing the quick-insertion central catheter onto the guidewire into the vascular lumen.

7. The quick-insertion central catheter assembly according to claim 1, characterized in that, The rapidly insertable central conduit comprises a group of three lumens, including a main lumen, a secondary lumen, and a third lumen, which are formed by fluid connections of three conduit tubing lumens, three bushing lumens, and three extension leg lumens.

8. The quick-insertion central catheter assembly according to claim 7, characterized in that, The main lumen has a main lumen orifice in the distal end of the rapidly insertable central catheter, the secondary lumen has a secondary lumen orifice in the side portion of the flexible catheter material proximal to the main lumen orifice, and the third lumen has a third lumen orifice in the side portion of the flexible catheter material proximal to the secondary lumen orifice but distal to the guide orifice.

9. A quick-insertion central catheter assembly, characterized in that, include: A quick-insertion central catheter, comprising: A flexible conduit having a main lumen orifice at its distal end and a secondary lumen orifice in the side portion of the distal portion of the flexible conduit. A catheter bushing, which is connected to the proximal portion of the flexible catheter tubing; and One or more extension legs, each of the one or more extension legs being coupled to the catheter bushing via its distal portion; and Guide, the guide comprising: A guiding conduit, comprising a rigid conduit having a guide hole in its distal portion extending through a side portion of the rigid conduit; and When the quick-insertion central catheter assembly is in its immediate deployment state, the guide tube is arranged in the main lumen of the quick-insertion central catheter such that the distal end of the guide tube extends beyond the distal end of the quick-insertion central catheter, and the guide needle is arranged in the guide tube through a combination of the secondary lumen orifice, a diaphragm separating the secondary lumen from the main lumen, and the guide hole such that the angled tip in the distal portion of the guide needle extends beyond the distal end of the guide tube.

10. The quick-insertion central catheter assembly according to claim 9, characterized in that, It further includes an entry guidewire disposed in the guide needle such that, when the quick-access central catheter assembly is in an immediately deployed state, the distal end of the entry guidewire is proximal to the inclined tip but distal to the distal end of the quick-access central catheter.

11. The quick-insertion central catheter assembly according to claim 10, characterized in that, The entry guidewire includes a blocking member forming a blocking end around the proximal portion of the entry guidewire, the blocking end of the entry guidewire being configured to provide distal restriction for advancing the entry guidewire into the rapidly insertable central catheter.

12. The quick-insertion central catheter assembly according to claim 9, characterized in that, It further includes a manipulator wire disposed in the guide tube such that, when the rapidly insertable central catheter assembly is in an immediately deployed state, the distal end of the manipulator wire is proximal to the guide hole but distal to the catheter bushing.

13. The quick-insertion central catheter assembly according to claim 12, characterized in that, The manipulating guidewire includes a stop forming its blocking end around the proximal portion of the manipulating guidewire, the blocking end of the manipulating guidewire being configured to provide distal restriction for advancing the manipulating guidewire into the rapidly insertable central catheter.

14. The quick-insertion central catheter assembly according to claim 9, characterized in that, The flexible catheter tubing is formed of a first material having a first hardness, and the rigid catheter tubing is formed of a second material having a second hardness greater than the first hardness, thereby providing the quick-insertion central catheter assembly with column strength for advancing the quick-insertion central catheter onto the guidewire into the vascular lumen.

15. The quick-insertion central catheter assembly according to claim 9, characterized in that, The rapidly insertable central conduit comprises a group of three lumens, including a main lumen, a secondary lumen, and a third lumen, which are formed by fluid connections of three conduit tubing lumens, three bushing lumens, and three extension leg lumens.

16. The quick-insertion central catheter assembly according to claim 15, characterized in that, The main lumen has a main lumen orifice in the distal end of the rapidly insertable central catheter, the secondary lumen has a secondary lumen orifice in the side portion of the flexible catheter material near the main lumen orifice, and the third lumen has a third lumen orifice in the side portion of the flexible catheter material near the secondary lumen orifice.

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