Central Venous Catheter Assembly

Abstract

The rapid insertion central venous catheter (RICC) assembly 100 includes a RICC (102) and an introducer (106). The RICC includes a soft catheter tube (120) having an introduction opening (104) that opens into the primary lumen of the RICC. The introducer includes an introducer catheter (132) including a hard catheter tube (134) having an introduction hole (140) that opens into the single lumen of the introducer catheter. The introducer catheter is positioned within the primary lumen of the RICC such that the distal end of the introducer catheter extends beyond the distal end of the RICC when the RICC assembly is in its ready-to-deploy state. Furthermore, the introducer needle (126) of the introducer is positioned within the introducer catheter through both the introduction opening and the introduction hole such that the beveled tip of the introducer needle extends beyond the distal end of the introducer catheter.

Description

Technical Field

[0001] The present disclosure relates to a rapidly insertable central venous catheter including an assembly.

Background Art

[0002] A central venous catheter (CVC) is formed from a material having a relatively low durometer, which contributes to the CVC lacking column strength. Due to the lack of column strength, the CVC is generally introduced into a patient's body by the Seldinger method and advanced within its vasculature. In the Seldinger method, many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.) are utilized. Although the Seldinger method is effective, many of the steps are time-consuming, handling a large number of medical devices is cumbersome, and all of these can potentially cause trauma to the patient. In addition, since there are many medical devices that need to be replaced during many steps of the Seldinger method, the possibility of contamination by contact is relatively high. Therefore, it is necessary to reduce the number of steps and medical devices involved in introducing the catheter into the patient's body and advancing the catheter within its vasculature.

[0003] The present application discloses a rapidly insertable central venous catheter (「RICC (rapidly inserted central catheter)」) including a catheter assembly for addressing the above, and a method thereof.

Summary of the Invention

[0004] The RICC assembly disclosed herein, in some embodiments, includes a RICC and an introducer. The RICC includes a soft catheter tube, a catheter hub, and one or more extension legs. An introduction opening that penetrates the side surface of the soft catheter tube is formed at the distal end portion of the soft catheter tube. The introduction opening opens into the introduction portion of the primary lumen of the RICC, and that portion extends from the introduction opening to the distal end of the RICC. The catheter hub is connected to the proximal end portion of the soft catheter tube. Each of the one or more extension legs is connected to the catheter hub at its distal end portion. The introducer includes an introducer catheter and an introducer needle. The introducer catheter comprises a hard catheter tube, and an introduction hole that penetrates the side surface of the hard catheter tube is formed at the distal end portion of the hard catheter tube. The introduction hole opens into the introduction portion of the primary lumen of the RICC, and that portion extends from the introduction hole to the distal end of the RICC. The introducer catheter is disposed within the primary lumen of the RICC such that when the RICC assembly is in its ready-to-place state, the distal end of the introducer catheter extends beyond the distal end of the RICC. Further, the introducer needle is disposed within the introducer catheter through both the introduction opening and the introduction hole such that the bevel tip of the distal end portion of the introducer needle extends beyond the distal end of the introducer catheter.

[0005] In some embodiments, the RICC assembly further includes an access guide wire. The access guide wire is disposed within the introducer needle such that when the RICC assembly is in its ready-to-place state, the distal end of the access guide wire is proximal to the bevel tip but distal to the distal end of the RICC.

[0006] In some embodiments, the access guide wire includes a stop portion around a proximal end portion of the access guide wire that forms a stop end of the access guide wire. The stop end of the access guide wire is configured to provide a distal limit for advancing the access guide wire into the RICC.

[0007] In some embodiments, the RICC assembly further includes an operating guide wire. The operating guide wire is disposed within the introducer catheter such that when the RICC assembly is in a ready-to-place state, the distal end of the operating guide wire is proximal to the introduction hole but distal to the catheter hub.

[0008] In some embodiments, the operating guide wire includes a stop portion around a proximal end portion of the operating guide wire that forms a stop end of the operating guide wire. The stop end of the operating guide wire is configured to provide a distal limit for advancing the operating guide wire into the RICC.

[0009] In some embodiments, the soft catheter tube is formed from a first material having a first durometer hardness, and the hard catheter tube is formed from a second material having a second durometer hardness. The second durometer hardness is higher than the first durometer hardness, and the second durometer hardness provides the RICC assembly with a column buckling strength for advancing the RICC within the blood vessel lumen over the guide wire.

[0010] In some embodiments, the RICC includes a set of three lumens. The set of three lumens Formed from the fluid-connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens, a primary lumen, a secondary lumen, and , three a tertiary lumen.

[0011] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the RICC. The secondary lumen has a secondary lumen opening on a side of the soft catheter tube proximal to the primary lumen opening. The tertiary lumen has a tertiary lumen opening on a side of the soft catheter tube proximal to the secondary lumen opening but distal to the introduction opening.

[0012] Also, this specification discloses, in some embodiments, a RICC assembly including a RICC and an introducer. The RICC includes a soft catheter tube, a catheter hub, and one or more extension legs. The soft catheter tube has a primary lumen opening at its distal end and has a secondary lumen opening on its side at its distal end portion. The catheter hub is connected to the proximal end portion of the soft catheter tube. Each extension leg of the one or more extension legs is connected to the catheter hub at its distal end portion. The introducer includes an introducer catheter and an introducer needle. The introducer catheter comprises a hard catheter tube, and an introduction hole penetrating the side surface of the hard catheter tube is formed at the distal end portion of the hard catheter tube. The introducer catheter is disposed within the primary lumen of the RICC such that when the RICC assembly is in a state where it is ready for placement, the distal end of the introducer catheter extends beyond the distal end of the RICC. In addition, the introducer needle is disposed within the introducer catheter through the secondary lumen opening, a partition wall dividing the secondary lumen from the primary lumen, and the introduction hole. When disposed in this manner, when the RICC assembly is in a state where it is ready for placement, the beveled tip of the distal end portion of the introducer needle extends beyond the distal end of the introducer catheter.

[0013] In some embodiments, the RICC assembly further includes an access guide wire. The access guide wire is disposed within the introducer needle such that when the RICC assembly is in a state where it is ready for placement, the distal end of the access guide wire is proximal to the beveled tip but distal to the distal end of the RICC.

[0014] In some embodiments, the access guide wire includes a stop portion around the proximal end portion of the access guide wire that forms the stop end of the access guide wire. The stop end of the access guide wire is configured to provide a distal limit for advancing the access guide wire into the RICC.

[0015] In some embodiments, the RICC assembly further includes an operating guide wire. The operating guide wire is disposed within the introducer catheter such that when the RICC assembly is in a ready-to-place state, the distal end of the operating guide wire is proximal to the introduction hole but distal to the catheter hub.

[0016] In some embodiments, the operating guide wire includes a stop portion around a proximal end portion of the operating guide wire that forms a stop end of the operating guide wire. The stop end of the operating guide wire is configured to provide a distal limit for advancing the operating guide wire into the RICC.

[0017] In some embodiments, the soft catheter tube is formed from a first material having a first durometer hardness, and the hard catheter tube is formed from a second material having a second durometer hardness. The second durometer hardness is higher than the first durometer hardness, and the second durometer hardness provides the RICC assembly with a column buckling strength for advancing the RICC into the blood vessel lumen over the guide wire.

[0018] In some embodiments, the RICC includes a set of three lumens. The set of three lumens includes Formed from the fluid-connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens, a primary lumen, a secondary lumen, and , three a tertiary lumen and .

[0019] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the RICC. The secondary lumen has a secondary lumen opening on a side of the soft catheter tube proximal to the primary lumen opening. The tertiary lumen has a tertiary lumen opening on a side of the soft catheter tube proximal to the secondary lumen opening.

[0020] Also disclosed is a method for using a RICC assembly. In some embodiments, the method includes a RICC assembly acquisition step, a needle path establishment step, an access guide wire advancement step, and an introducer needle withdrawal step. The RICC assembly acquisition step includes acquiring a RICC assembly including a RICC and an introducer. The introducer includes an introducer catheter disposed within a primary lumen of the RICC such that a distal end portion of the introducer catheter extends beyond a distal end of the RICC. The needle path establishment step includes establishing a needle path from a region of a patient's skin to a blood vessel lumen using an angled tip of an introducer needle of the introducer. The introducer needle extends from a side of a soft catheter tube of the RICC, through a side of a hard catheter tube of the introducer catheter, and out of a distal end of the introducer catheter. The access guide wire advancement step includes advancing an access guide wire into a patient's blood vessel lumen via the introducer needle. The introducer needle withdrawal step includes leaving the access guide wire and the introducer catheter within the blood vessel lumen and withdrawing the introducer needle from both the blood vessel lumen and the RICC assembly.

[0021] In some embodiments, the method further includes a confirmation step of confirming that a distal end of the introducer catheter extends at least about 1 to 7 cm beyond a distal end of the RICC before performing the needle path establishment step.

[0022] In some embodiments, the method further includes a first RICC advancement step of advancing a distal end portion of the introducer catheter into a blood vessel lumen over the access guide wire.

[0023] In some embodiments, the method further includes a manipulation guide wire advancement step of advancing a manipulation guide wire into a blood vessel lumen via the introducer catheter. In some embodiments, the operating guide wire advancement step initially requires withdrawing the introducer needle from both the vascular lumen and the RICC assembly.

[0024] In some embodiments, the method further includes a second RICC advancement step of advancing both the distal end portion of the introducer catheter and the distal end portion of the RICC further into the vascular lumen over the operating guide wire.

[0025] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose certain embodiments of such concepts in more detail.

Brief Description of the Drawings

[0026]

Figure 1

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Figure 8

Best Mode for Carrying Out the Invention

[0027] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can be easily separated from the specific embodiments and, optionally, can have features that can be combined with or replaced by features of any of the other multiple embodiments disclosed herein.

[0028] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide a serial or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily appear in that order, and a specific embodiment including such features or steps does not necessarily have to be limited to three features or steps. Indications such as "left", "right", "up", "down", "front", "rear", etc. are for convenience and do not, for example, mean a specific fixed position, direction, orientation, etc. Instead, such indications are used, for example, to reflect relative positions, orientations, or directions. The singular forms of "a", "an", and "the" include plural objects unless clearly indicated otherwise in the context.

[0029] For example, with respect to the "proximal", "proximal portion", or "proximal end portion" of a catheter disclosed herein, it includes the portion of the catheter intended to be near the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used in 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 need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0030] For example, with respect to the "distal", "distal portion", or "distal end portion" of a catheter disclosed herein, it includes the portion of the catheter intended to be near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within the patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within the patient when the catheter is used in a 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 need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As described above, steps involved in introducing a catheter such as a CVC into a patient's body and advancing the catheter within the patient's vascular structure and the number of medical devices need to be reduced. In the present application, a RICC including a catheter assembly for addressing the above and its method are disclosed.

[0032] FIG. 1 shows a RICC assembly 100 comprising a RICC 102 having an introduction opening 104 according to some embodiments. FIG. 2 shows a RICC assembly 200 comprising a RICC 202 without an introduction opening 104 according to some embodiments.

[0033] As shown, the RICC assembly 100 or 200 comprises a RICC 102 or 202 and an introducer 106, and the introducer 106 is coupled to the RICC 102 or 202 in a state where the RICC assembly 100 or 200 is ready for placement. The RICCs 102 and 202 and the introducer 106 will be described in turn in the following paragraphs, but considering the interrelationships of the RICCs 102 and 202 and the introducer 106 in the RICC assemblies 100 and 200, there are overlapping parts between the paragraphs regarding the RICCs 102 and 202 and the introducer 106.

[0034] The RICC 102 is different from the RICC 202 with respect to the presence of the introduction opening 104 within the RICC 102, and this introduction opening 104 is exclusively adapted for inserting the introducer needle 126 of the introducer 106 through the introduction opening 104 to couple the RICC 102 and the introducer 106 in the RICC assembly 100. The RICC 202 does not have such a dedicated introduction opening 104, and thus requires a different mode than the RICC assembly 100 to couple the RICC 202 and the introducer 106 in the RICC assembly 200.

[0035] RICC 102 or 202 may be a single-lumen or multi-lumen RICC (e.g., two-lumen RICC, three-lumen RICC, four-lumen RICC, five-lumen RICC, six-lumen RICC, etc.). For example, RICC 202 without the introduction opening 104 may be single-lumen. Such a RICC also does not have the secondary lumen opening 116 and the tertiary lumen opening 118 described below. In another example, RICC 102 or 202 may be multi-lumen. As shown in FIGS. 1 or 2, RICC 102 or 202 is a three-lumen type including a set of three lumens. Such a set of three lumens Formed from the fluid-connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens, includes a primary lumen 108 (e.g., distal lumen), a secondary lumen 110 (e.g., intermediate lumen), and and three a tertiary lumen 112 (e.g., proximal lumen). (See FIGS. 4-7.) RICC 102 or 202 includes at least a primary lumen 108, whether it is a single-lumen type or a multi-lumen type. The primary lumen 108 generally extends from the proximal end to the distal end of the RICC 102 or 202, such as from the opening of the corresponding luer connector to the primary lumen opening 114 within the distal end of the soft catheter tube 120 or 220 described below. When the RICC 102 or 202 has two or more lumens, the RICC 102 or 202 further has at least a secondary lumen 110. The secondary lumen 110 generally extends from the proximal end to the distal end portion of the RICC 102 or 202, such as from the opening of the corresponding luer connector to the secondary lumen opening 116 within the distal end portion of the soft catheter tube 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 further has at least a tertiary lumen 112. The tertiary lumen 112 generally extends from the proximal end to the distal end portion of the RICC 102 or 202, such as from the opening of the corresponding luer connector to the tertiary lumen opening 118 within the distal end portion of the soft catheter tube 120 or 220 proximal to the secondary lumen opening 116. Nevertheless, each of the secondary lumen 110 and the tertiary lumen 112 can extend slightly distally from the secondary lumen opening 116 and the tertiary lumen opening 118, respectively, from the perspective of different manufacturing methods. (See FIGS. 4 and 6.) RICC 102 or 202 further has an introduction lumen that coincides with the distal end portion of the primary lumen 108, whether or not it includes the introduction opening 104. In other words, the introduction lumen is the 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 the introduction opening 104 to the primary lumen opening 114. The introduction opening 104 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, and directly opens at the proximal end of the introduction portion of the primary lumen 108 of RICC 102. In RICC 202, the introduction lumen is the distal end portion of the primary lumen 108 that extends from either the secondary lumen opening 116 or the tertiary lumen opening 118 to the primary lumen opening 114. Whether the introduction lumen extends from the secondary lumen opening 116 or the tertiary lumen opening 118 depends on which of the aforementioned openings houses the introducer needle 126 of the introducer 106. Neither the secondary lumen opening 116 nor the tertiary lumen opening 118 directly opens at the proximal end of the introduction portion of the primary lumen 108 of RICC 202. Instead, the introducer needle 126 penetrates the partition wall 128 between the secondary lumen 110 or the tertiary lumen 112 and the primary lumen 108 through the secondary lumen opening 116 or the tertiary lumen opening 118, respectively.

[0036] RICC 102 or 202 includes a soft catheter tube 120 or 220, a catheter hub 122, and one or more extension legs 124. FIG. 4 shows the distal end portion of the soft catheter tube 120 or 220 of RICC 102 or 202 of FIGS. 1 or 2 according to some embodiments. FIGS. 5-7 show various cross-sections of the soft catheter tube 120 or 220 according to some embodiments. FIG. 7 further shows the introducer needle 126 passing through the partition wall 128 of the catheter tube 220 according to some embodiments.

[0037] The soft catheter tube 120 or 220 has a distal tip 130 at the distal end portion of the soft catheter tube 120 or 220 corresponding to the distal end of the RICC 102 or 202. Similar to what has been described above for the RICCs 102 and 202, the soft catheter tube 120 or 220 may be of a single-lumen type or a multi-lumen type. In fact, the soft catheter tube 120 or 220 includes one or more catheter tube lumens whose names and numbers correspond to those of the RICC 102 or 202. The one or more catheter tube lumens extend through the soft catheter tube 120 or 220 as described above for the RICC 102 or 202.

[0038] The difference between the soft catheter tube 120 and the soft catheter tube 220 is that an introduction hole 104 penetrating its side surface is provided at the distal end portion of the soft catheter tube 120. Also in this case, the introduction opening 104 is exclusively adapted for inserting the introducer needle 126 of the introducer 106 through the introduction opening 104 in order to couple the RICC 102 and the introducer 106 in the RICC assembly 100. The soft catheter tube 220 does not have such a dedicated introduction opening 104, and therefore requires a different manner than the RICC assembly 100 to couple the RICC 202 and the introducer 106 in the RICC assembly 200.

[0039] Notwithstanding the above, the soft catheter tube 120 or 220 can include n - 1 side openings penetrating the side surface of the soft catheter tube 120 or 220 according to the number n of lumens of the RICC 102 or 202. In fact, considering the above - mentioned RICC 102 or 202 having three lumens, the soft catheter tube 120 or 220 can include two side openings including a secondary lumen opening 116 on the side surface proximal to the primary lumen opening 114 and a tertiary lumen opening 118 on the side surface proximal to the secondary lumen opening 116. In addition to providing different openings for blood suction, fluid delivery, etc., such side openings are important for establishing an introduction lumen for introducing a RICC such as the RICC 202.

[0040] The catheter hub 122 is connected to the proximal end portion of the soft catheter tube 120 or 220. The catheter hub 122 includes one or more catheter hub lumens corresponding to the number of one or more catheter tube lumens. The one or more catheter hub lumens extend through the entire catheter hub 122 from the proximal end to the distal end of the catheter hub 122.

[0041] Each extension leg 124 of the one or more extension legs is coupled to the catheter hub 122 at its distal end portion. Each of the one or more extension legs 124 includes one or more extension leg lumens, and the number of extension leg lumens corresponds to the number of one or more catheter tube lumens. Each extension leg lumen of the one or more extension leg lumens extends through the entire extension leg from the proximal end to the distal end of the extension leg.

[0042] Each extension leg 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 lumen can be connected to another medical device.

[0043] 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 the proximal end portion of the hard catheter tube 134, and a distal tip 138 of the distal end portion of the hard catheter tube 134.

[0044] Also, an introduction hole 140 is formed in the distal end portion of the introducer catheter 132 to penetrate the side surface of the hard catheter tube 134. The introduction hole 140 opens into the introduction portion of the single lumen of the introducer catheter 132, and this introduction portion extends from the introduction hole 140 to the distal end of the introducer catheter 132. When the RICC assembly 100 or 200 is in a state where the indwelling preparation is completed, the introducer catheter 132 is disposed in the primary lumen 108 of the RICC 102 or 202 such that the distal end of the introducer catheter 132 extends at least about 1 to 7 cm beyond the distal end of the RICC 102 or 202. This is useful for tissue dilation by the distal end portion of the introducer catheter 132 or its hard catheter tube 134.

[0045] With respect 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 hardness, and the hard catheter tube 134 is formed from a second material having a second durometer hardness. The first durometer hardness is lower than the second durometer hardness, and thus the soft catheter tube 120 or 220 is relatively softer than the hard catheter tube 134. In other words, the second durometer hardness is higher than the first durometer hardness, and thus the hard catheter tube 134 is relatively harder than the soft catheter tube 120 or 220. The hard catheter tube 134 provides a column buckling strength for advancing the RICC 102 or 202 within the blood vessel lumen on a guide wire such as the operating guide wire 152 described below with respect to the RICC assembly 100 or 200.

[0046] The first durometer hardness and the second durometer hardness may be on different scales (e.g., type A or type D), and thus the first durometer hardness of the first polymeric material is not necessarily numerically lower than the second durometer hardness of the second polymeric material. Similarly, the second durometer hardness of the second polymeric material may not be numerically higher than the first durometer hardness of the first polymeric material from the perspective of different scales. That being said, since each different scale in the range of 0 to 100 is intended to characterize different materials among groups of materials having similar hardnesses, 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.

[0047] Notwithstanding the foregoing, the soft catheter tube 120 or 220, and the hard catheter tube 134 can be formed from the same polymeric material or different polymeric materials having substantially equal durometer hardness as long as the column buckling strength of the soft catheter tube 120 or 220 in combination with the hard catheter tube 134 is sufficient to prevent buckling of the soft catheter tube 120 or 220 when inserted into the insertion site and advanced through the patient's vasculature.

[0048] The introducer needle 126 includes a shaft 142, an introducer needle hub 144 around the proximal end portion of the shaft 142, and a bevel tip 146 at the distal end portion of the shaft 142.

[0049] When the RICC assembly 100 is in a state ready for implantation, the introducer needle 126 or its shaft 142 is disposed within a single lumen of the introducer catheter 132 through a combination of the introduction opening 104 of the RICC 102 or its soft catheter tube 120 and the introduction hole 140 of the introducer catheter 132 or its hard catheter tube 134, and the bevel tip 146 of the introducer needle 126 is extended beyond the distal end of the introducer catheter 132 to establish a percutaneous puncture. However, when the RICC assembly 200 is in a state ready for implantation, the introducer needle 126 or its shaft 142 is disposed within a 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 its soft catheter tube 220, the partition wall 128 that divides the secondary lumen 110 or the tertiary lumen 112 from the primary lumen 108 of the RICC 202 or its soft catheter tube 220, and the introduction hole 140 of the introducer catheter 132 or its hard catheter tube 134. When disposed in this manner, the bevel tip 146 at the distal end portion of the introducer needle 126 extends beyond the distal end of the introducer catheter 132 when the RICC assembly 100 or 200 is in a state ready for implantation.

[0050] The RICC assembly 100 or 200 further includes an access guide wire 148. When the RICC assembly 100 or 200 is at least in a state where the indwelling preparation is completed, the access guide wire 148 is disposed within the needle lumen of the introducer needle 126 such that the distal end of the access guide wire 148 is proximal to the bevel tip 146 of the introducer needle 126 but distal to the distal end of the RICC 102 or 202. Thereby, when access is established, the distal end of the access guide wire 148 can immediately advance into the blood vessel lumen beyond the bevel tip 146 of the introducer needle 126.

[0051] The access guide wire 148 is provided with a stop portion (e.g., a hub, a ball, a slug, etc.) around its proximal end portion, and this stop portion forms a stop end 150 (e.g., a hub end, a ball end, a slug end, etc.) of the access guide wire 148. The stop end 150 of the access guide wire 148 is larger than any opening of the RICC 102 or 202 or its soft catheter tube 120 or 220, thereby providing a distal limit for advancing the access guide wire 148 into the RICC 102 or 202.

[0052] FIG. 3 shows a RICC assembly 100 or 200 according to some embodiments, and includes an operating guide wire 152 passing through the RICC assembly 100 or 200.

[0053] The RICC assembly 100 or 200 further includes an operating guide wire 152 having a non-traumatic tip 154 (e.g., a coiled or partially coiled tip), and the operating guide wire 152 has a length sufficient to advance to the lower 1 / 3 of the superior vena cava ("SVC") of the heart.

[0054] When the RICC assembly 100 or 200 is at least in a state where the preparation for indwelling is completed, the operating guide wire 152 is disposed within a single lumen of the introducer catheter 132 such that its distal end is proximal to the introduction hole 140 but distal to the catheter hub 122. Thereby, when removing the introducer needle 126 or its shaft 142 from the single lumen of the introducer catheter 132, the distal end of the operating guide wire 152 can be rapidly advanced into the blood vessel lumen. In fact, the operating guide wire 152 cannot further advance distally within the single lumen of the introducer catheter 132 due to the presence of the introducer needle 126 or its shaft 142, at least when the RICC assembly 100 or 200 is in a state where the preparation for indwelling is completed.

[0055] The operating guide wire 152 is provided with a stop portion (e.g., a hub, a ball, a slug, etc.) around its proximal end portion, and the stop portion forms a stop end 156 (e.g., a hub end, a ball end, a slug end, etc.) of the operating guide wire 152. The stop end 156 of the operating guide wire 152 is larger than the proximal end opening of the introducer catheter hub 136, and thus provides a distal limit for advancing the operating guide wire 152 into the RICC 102 or 202. Method The method of the RICC assembly 100 or 200 includes a method of assembling the RICC assembly 100 or 200 and a method of using the RICC assembly 100 or 200.

[0056] Regarding the method of assembling the RICC assembly 100 or 200, FIG. 8 shows a method of assembling the RICC assembly 100 or 200 according to some embodiments. As shown in the illustration, the method of assembling the RICC assembly 100 or 200 includes an introducer catheter insertion step, an introducer needle insertion step, an access guide wire insertion step, and an operating guide wire insertion step.

[0057] The introducer catheter insertion step includes inserting the introducer catheter 132 into the primary lumen 108 of the RICC102 or 202 via the opening of the corresponding luer connector within the proximal end of the RICC102 or 202. Additionally, the introducer catheter insertion step includes aligning the introduction hole 140 of the hard catheter tube 134 of the introducer catheter 132 with the opening of the soft catheter tube 120 or 220 of the RICC102 or 202. With respect to the RICC102, such alignment includes aligning the introduction hole 140 of the hard catheter tube 134 with the introduction opening 104 of the soft catheter tube 120. With respect to the RICC202, such alignment includes aligning the introduction hole 140 of the hard catheter tube 134 with the secondary lumen opening 116 or the tertiary lumen opening 118 of the soft catheter tube 220. Finally, the introducer catheter insertion step includes confirming that the distal end of the introducer catheter 132 extends at least about 1 to 7 cm beyond the distal end of the RICC102 or 202.

[0058] The introducer needle insertion step includes inserting the introducer needle 126 into the single lumen of the introducer catheter 132 via the introduction hole 140 of the hard catheter tube 134, thereby locking both the introducer and the RICC 102 or 202 together. In the case of the RICC 102, the introducer-needle insertion step includes inserting the introducer needle 126 into the introduction opening 104 of the soft catheter tube 120 and then inserting the introducer needle 126 into the introduction hole 140 of the hard catheter tube 134. In the case of the RICC 202, the introducer-needle insertion step includes inserting the introducer needle 126 into either the secondary lumen opening 116 or the tertiary lumen opening 118, then puncturing the partition wall 128 between the secondary lumen 110 or the tertiary lumen 112 and the primary lumen 108 of the soft catheter tube 108, and further inserting the introducer needle 126 into the introduction hole 140 of the hard catheter tube 134 disposed within the primary lumen 220. Finally, the introducer-needle insertion step includes verifying that the bevel tip 146 of the introducer needle 126 extends beyond the distal end of the introducer catheter 132.

[0059] The access guide wire insertion step includes inserting the access guide wire 148 into the introducer needle 126 via the opening of the introducer needle hub 144 at the proximal end of the introducer needle 126. In addition, the access guide wire insertion step includes positioning the access guide wire 148 within the introducer needle 126 such that the distal end of the access guide wire 148 is proximal to the bevel tip 146 of the introducer needle 126 but distal to the distal end of the RICC 102 or 202. Further, such a position of the access guide wire 148 enables the distal end of the access guide wire 148 to immediately advance into the blood vessel lumen when establishing access to the blood vessel lumen beyond the bevel tip 146 of the introducer needle 126.

[0060] The operating guide wire insertion step includes inserting the operating guide wire 152 into the introducer catheter 132 via the opening of the introducer catheter hub 136 at the proximal end of the introducer catheter 132. Additionally, the operating guide wire insertion step includes positioning the operating guide wire 152 within the introducer catheter 132 such that the distal end of the operating guide wire 152 is proximal to the introduction hole 140 but distal to the catheter hub 122. Also in this case, due to such a position of the operating guide wire 152, when the introducer needle 126 or its shaft 142 is removed from the single lumen of the introducer catheter 132, the distal end of the operating guide wire 152 can be immediately advanced into the blood vessel lumen.

[0061] Regarding the method of using the RICC assembly 100 or 200, this method includes a RICC assembly acquisition step, a needle path establishment step, an access guide wire advancement step, and an introducer needle retraction step.

[0062] The RICC assembly acquisition step includes acquiring a RICC assembly 100 or 200 including the RICC 102 or 202 and the introducer 106. As described above regarding the state of completion of the preparation for indwelling the RICC assembly 100 or 200, the introducer 106 includes the introducer catheter 132 disposed within 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.

[0063] The method can further include a confirmation step of confirming 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 before performing the needle path establishment step.

[0064] The needle path establishment step includes establishing a needle path from a region of the patient's skin to the vascular lumen using the beveled tip 146 of the introducer needle 126 of the introducer 106. As described above with respect to the ready-for-placement state of the RICC assembly 100 or 200, the introducer needle 126 penetrates the side surface of the soft catheter tube 120 or 220 of the RICC 102 or 202, penetrates the side surface of the hard catheter tube 134 of the introducer catheter 132, and extends from the distal end of the introducer catheter 132.

[0065] The access guide wire advancement step includes advancing an access guide wire 148 into the patient's vascular lumen through the introducer needle 126. The method can further include a first RICC advancement step of advancing the distal end portion of the introducer catheter 132 into the vascular lumen on the access guide wire 148.

[0066] The introducer needle withdrawal step includes withdrawing the introducer needle 126 from both the vascular lumen and the RICC assembly 100 or 200, leaving the access guide wire 148 and the introducer catheter 132 in the vascular lumen.

[0067] The method can further include a step of advancing an operating guide wire 152 into the vascular lumen through the introducer catheter 132. However, the step of advancing the operating guide wire 152 first requires withdrawing the introducer needle 126 from both the vascular lumen and the RICC assembly 100 or 200.

[0068] The method can further include a second RICC advancement step of advancing both the distal end portion of the introducer catheter 132 and the distal end portion of the RICC 102 or 202 further into the vascular lumen, for example, to the SVC, on the operating guide wire 152.

[0069] Some specific embodiments are disclosed herein, and while a particular embodiment is disclosed in some detail, it is not intended that the particular embodiment limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Thus, departures from the particular embodiments disclosed herein can be made without departing from the scope of the concepts provided herein.

Claims

1. A central venous catheter assembly comprising a central venous catheter and an introducer, wherein the central venous catheter is a soft catheter tube having an introduction opening through a side surface at its distal end portion, and the introduction opening opens into an introduction portion of a primary lumen of the central venous catheter extending from the introduction opening to the distal end of the central venous catheter, the soft catheter tube; a catheter hub coupled to a proximal end portion of the soft catheter tube; one or more extension legs, each extension leg being coupled to the catheter hub at its distal end portion, one or more extension legs; wherein the introducer is an introducer catheter having a hard catheter tube, the hard catheter tube having an introduction hole through a side surface at its distal end portion, and the introduction hole opens into an introduction portion of a single lumen of the introducer catheter extending from the introduction hole to the distal end of the introducer catheter, the introducer catheter; an introducer needle, when the central venous catheter assembly is in a state where it is ready for placement, the beveled tip of the distal end portion of the introducer needle extends beyond the distal end of the introducer catheter, and the distal end of the introducer catheter extends beyond the distal end of the central venous catheter, and the introducer needle is disposed within the introducer catheter through both the introduction opening and the introduction hole, and the introducer catheter is disposed within the primary lumen of the central venous catheter, the introducer needle; A central venous catheter assembly comprising.

2. An access guide wire, further comprising an access guide wire disposed within the introducer needle such that when the central venous catheter assembly is in a state where it is ready for placement, the distal end of the access guide wire is proximal to the beveled tip but distal to the distal end of the central venous catheter, the central venous catheter assembly according to claim 1.

3. The access guide wire has a stop portion around its proximal end portion, the stop portion forms a stop end, and the stop end is configured to provide a distal limit for advancing the access guide wire into the central venous catheter. The central venous catheter assembly according to claim 2.

4. An operating guide wire, when the central venous catheter assembly is in a state ready for placement, the distal end of the operating guide wire is proximal to the introduction hole but distal to the catheter hub, and is disposed within the introducer catheter. The central venous catheter assembly according to any one of claims 1 to 3, further comprising an operating guide wire.

5. The operating guide wire has a stop portion around its proximal end portion, the stop portion forms a stop end, and the stop end is configured to provide a distal limit for advancing the operating guide wire into the central venous catheter. The central venous catheter assembly according to claim 4.

6. The soft catheter tube is formed from a first material having a first durometer hardness, and the hard catheter tube is formed from a second material having a second durometer hardness higher than the first durometer hardness, thereby providing the central venous catheter assembly with column buckling strength for advancing the central venous catheter into the blood vessel lumen on the guide wire. The central venous catheter assembly according to any one of claims 1 to 5.

7. The central venous catheter assembly according to any one of claims 1 to 6, comprising a set of three lumens including the primary lumen, the secondary lumen, and the tertiary lumen, the central venous catheter being formed from a fluid-connected portion of three catheter tube lumens, three hub lumens, and three extension leg lumens.

8. A primary lumen has a primary lumen opening at the distal end of the central venous catheter, a secondary lumen has a secondary lumen opening on the side surface of the soft catheter tube proximal to the primary lumen opening, and a tertiary lumen has a tertiary lumen opening on the side surface of the soft catheter tube that is proximal to the secondary lumen opening but distal to the introduction opening. The central venous catheter assembly according to claim 7.

9. A central venous catheter assembly comprising a central venous catheter and an introducer, wherein the central venous catheter is a soft catheter tube having a primary lumen opening at its distal end and a secondary lumen opening on its side surface at its distal end portion, a soft catheter tube, a catheter hub coupled to the proximal end portion of the soft catheter tube, one or more extension legs, each extension leg being coupled to the catheter hub at its distal end portion, one or more extension legs, wherein the introducer is an introducer catheter having a hard catheter tube, the hard catheter tube having an introduction hole passing through its side surface at its distal end portion, an introducer catheter, an introducer needle, when the central venous catheter assembly is in a state ready for placement, the beveled tip of the distal end portion of the introducer needle extends beyond the distal end of the introducer catheter, and the distal end of the introducer catheter extends beyond the distal end of the central venous catheter, and the introducer needle is arranged in the introducer catheter through the secondary lumen opening, the partition wall dividing the secondary lumen from the primary lumen, and the introduction hole. The central venous catheter assembly is arranged in the primary lumen of the central venous catheter, an introducer needle.

10. An access guide wire, further comprising an access guide wire disposed within an introducer needle such that when the central venous catheter assembly is in a state where placement preparation is complete, the distal end of the access guide wire is proximal to the bevel tip but distal to the distal end of the central venous catheter. The central venous catheter assembly according to claim 9.

11. The access guide wire has a stop portion around its proximal end portion, the stop portion forms a stop end, and the stop end is configured to provide a distal limit for advancing the access guide wire into the central venous catheter. The central venous catheter assembly according to claim 10.

12. An operating guide wire, further comprising an operating guide wire disposed within an introducer catheter such that when the central venous catheter assembly is in a state where placement preparation is complete, the distal end of the operating guide wire is proximal to the introduction hole but distal to the catheter hub. The central venous catheter assembly according to any one of claims 9 to 11.

13. The operating guide wire has a stop portion around its proximal end portion, the stop portion forms a stop end, and the stop end is configured to provide a distal limit for advancing the operating guide wire into the central venous catheter. The central venous catheter assembly according to claim 12.

14. The soft catheter tube is formed from a first material having a first durometer hardness, and the hard catheter tube is formed from a second material having a second durometer hardness higher than the first durometer hardness, thereby providing the central venous catheter assembly with a column buckling strength for advancing the central venous catheter into the blood vessel lumen on the guide wire. The central venous catheter assembly according to any one of claims 9 to 13. **Claim 15**: The central venous catheter assembly according to any one of claims 9 to 14, wherein the central venous catheter is formed from a fluid-connected portion of three catheter tube lumens, three hub lumens, and three extension leg lumens, and comprises a set of three lumens including the primary lumen, the secondary lumen, and the tertiary lumen. **Claim 16** The central venous catheter assembly according to claim 15, wherein the primary lumen has a primary lumen opening at the distal end of the central venous catheter, the secondary lumen has a secondary lumen opening on the side of the soft catheter tube proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on the side of the soft catheter tube proximal to the secondary lumen opening.

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