Rapid Insertion-Type Central Venous Catheter and Method Thereof

Abstract

A rapid insertion central venous catheter ("RICC") and method thereof are disclosed. For example, the RICC may have a first section at a distal end of a catheter tube, a second section at a distal end of the catheter tube located proximal to the first section of the catheter tube, and a connector connecting the first and second sections of the catheter tube. The first section of the catheter tube may be formed of a first polymeric material having a first durometer. The second section of the catheter tube may be formed of a second polymeric material having a second durometer lower than the first durometer. The first section of the catheter tube may have a proximal end disposed in and solvent bonded to a connector receiver. For example, a method may include a method of making or using a RICC.

Description

Technical Field

[0001] The present disclosure relates to a rapidly insertable central venous catheter and a method thereof.

Background Art

[0002] A central venous catheter (CVC) is formed of a material having a relatively low durometer hardness, 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 vascular structure. 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 any of these may cause trauma to the patient. In addition, since there are many medical devices that need to be replaced during many of the 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 vascular structure.

[0003] In the present application, a rapidly insertable central venous catheter ("RICC (rapidly inserted central catheter)") and a method thereof for addressing the above are disclosed.

Summary of the Invention

[0004] The RICC disclosed in this specification, in some embodiments, has a first portion of the distal end of the catheter tube, a second portion of the distal end of the catheter tube located proximal to the first portion of the catheter tube, and a connection portion connecting the first portion and the second portion of the catheter tube. The first portion of the catheter tube is formed of a first polymeric material having a first durometer hardness. The second portion of the catheter tube is formed of a second polymeric material having a second durometer hardness lower than the first durometer hardness. The first portion of the catheter tube has a proximal end portion disposed in the receiving portion of the connection portion and solvent-bonded thereto.

[0005] In some embodiments, the connection portion is the tapered distal end of the second portion of the catheter tube. In some embodiments, the anti-lumen side transition between the tapered distal end of the second portion of the catheter tube and the proximal end of the first portion of the catheter tube is a smooth transition consisting of a solvent-interdiffused polymeric material of the first polymeric material and the second polymeric material.

[0006] In some embodiments, the connection portion is a tapered third portion of the catheter tube coupled or welded to the second portion of the catheter tube. The third portion of the catheter tube is formed of a third material having a third durometer hardness lower than the first durometer hardness.

[0007] In some embodiments, the anti-lumen side transition between the tapered third portion of the catheter tube and the proximal end of the first portion of the catheter tube is a smooth transition consisting of a solvent-interdiffused polymeric material of the first polymeric material and the second polymeric material.

[0008] In some embodiments, the RICC is a three-lumen catheter. The first lumen of the three-lumen catheter terminates at an opening at the distal end of the first portion of the catheter tube. The second lumen of the three-lumen catheter terminates at a first outlet of the second portion of the catheter tube adjacent to the connection portion. The third lumen of the three-lumen catheter terminates at a second outlet of the second portion of the catheter tube adjacent to the connection portion.

[0009] In some embodiments, the RICC is a two-lumen catheter. The first lumen of the two-lumen catheter terminates at an opening at the distal end of the first portion of the catheter tube. The second lumen of the two-lumen catheter terminates at a first outlet of the second portion of the catheter tube adjacent to the connection portion.

[0010] In some embodiments, the first portion of the catheter tube is polytetrafluoroethylene, polypropylene, or polyurethane. In some embodiments, the second portion of the catheter tube is polyvinyl chloride, polyethylene, polyurethane, or silicone.

[0011] In some embodiments, the RICC has a column strength that can prevent bending of the catheter tube when inserted at the insertion site and advanced through the patient's vasculature. In addition, in some embodiments, the method for manufacturing the RICC disclosed in this specification includes an acquisition step of acquiring a first portion of a catheter tube formed of a first polymer material having a first durometer hardness and a second portion of the catheter tube formed of a second polymer material having a second durometer hardness lower than the first durometer hardness. The method includes an application step of applying a solvent to the proximal end of the first portion of the catheter tube, the receiving portion of the tapered distal end of the second portion of the catheter tube, or both the proximal end of the first portion of the catheter tube and the receiving portion of the tapered distal end of the second portion of the catheter tube. Further, the method includes an insertion step of inserting the proximal end of the first portion of the catheter tube into the receiving portion of the tapered distal end of the second portion of the catheter tube. The method also includes an evaporation step of forming a connection portion by solvent bonding between the first portion of the catheter tube and the second portion of the catheter tube by evaporating the solvent.

[0012] In some embodiments, the method further includes a tapering step of tapering the non-tapered distal end of the second portion of the catheter tube to form the tapered distal end of the second portion of the catheter tube.

[0013] In some embodiments, the method further includes a rotation step of rotating the catheter tube along its longitudinal axis. The method also includes an application step of applying the solvent or another solvent to the anti-lumen side transition portion between the proximal end of the first portion of the catheter tube and the tapered distal end of the second portion of the catheter tube. As a result of the application step, solvent molecules diffuse into the first polymer material and the second polymer material. Further, the method includes a smoothing step of smoothing the transition portion using an interdiffused polymer material resulting from the entanglement of at least the solvated side chains of the first polymer material and the second polymer material.

[0014] Also, in some embodiments, the present specification discloses a method for manufacturing a RICC including an acquisition step of acquiring a first portion of a catheter tube formed of a first polymer material having a first durometer hardness, a second portion of the catheter tube formed of a second polymer material having a second durometer hardness lower than the first durometer hardness, and a tapered third portion of the catheter tube formed of a third material having a third durometer hardness lower than the first durometer hardness. The method includes an application step of applying a solvent to a proximal end portion of the first portion of the catheter tube, a receiving portion at a distal end portion of the tapered third portion of the catheter tube, or both the proximal end portion of the first portion of the catheter tube and the receiving portion at the distal end portion of the tapered third portion of the catheter tube. The method also includes an insertion step of inserting the proximal end portion of the first portion of the catheter tube into the receiving portion at the distal end portion of the third portion of the catheter tube. Further, the method includes an evaporation step of forming a connection portion by solvent bonding between the first portion of the catheter tube and the tapered third portion of the catheter tube by evaporating the solvent.

[0015] In some embodiments, the method further includes a bonding or welding step of bonding or welding the distal end portion of the second portion of the catheter tube to the proximal end portion of the tapered third portion of the catheter tube at or near the position where the taper of the tapered third portion begins.

[0016] In some embodiments, the method further includes a rotation step of rotating the catheter tube along its longitudinal axis. The method also includes an application step of applying the solvent or another solvent to an intraluminal side transition portion between the proximal end portion of the first portion of the catheter tube and the tapered distal end portion of the third portion of the catheter tube. As a result of the application step, solvent molecules diffuse into the first polymer material and the third polymer material. Further, the method includes a smoothing step of smoothing the transition portion using an interdiffused polymer material resulting from the entanglement of at least the solvated side chains of the first polymer material and the third polymer material.

[0017] Also, a method of using the RICC is disclosed herein, which in some embodiments includes a forming step of forming an insertion site for reaching a patient's vasculature with a needle disposed within the lumen of the RICC. The method also includes an insertion step of inserting the distal end of the catheter tube of the RICC into the insertion site. Further, the method includes an advancing step of advancing the distal end of the catheter tube through the patient's vasculature without using the Seldinger technique.

[0018] In some embodiments, the method further includes a withdrawing step of withdrawing the needle from the lumen of the RICC after forming the insertion site and inserting at least a portion of the distal end of the catheter tube into the insertion site.

[0019] In some embodiments, the insertion site is located in the right subclavian vein or the right internal jugular vein. In some embodiments, the advancing step includes advancing the distal end of the catheter tube through the right subclavian vein or the right internal jugular vein and the right brachiocephalic vein into the superior vena cava.

[0020] Such features 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 more particularly describe specific embodiments of such concepts.

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 4

DETAILED DESCRIPTION OF THE INVENTION

[0022] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. The specific embodiments disclosed herein can be easily separated from the specific embodiments and, optionally, can have features that can be combined with or substituted for any of the many other embodiments disclosed herein.

[0023] Regarding the terms used herein, it should also be understood that the 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 multiple features or multiple steps and do not provide successive limitations or numerical restrictions. 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. Labels such as "left", "right", "front", "rear", "up", "down", etc. are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly dictates otherwise.

[0024] Regarding "proximal", for example, the "proximal portion" or "proximal end" of a catheter as disclosed herein 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 needle 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, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end, or proximal length of a catheter need not include the proximal end of the catheter. That is, except as suggested by the context, the proximal portion, proximal end, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0025] Regarding "distal", for example, the "distal portion" or "distal end" of a catheter as disclosed herein 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 needle 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, or distal length of a catheter can include the distal end of the catheter, but the distal portion, distal end, or distal length of a catheter need not include the distal end of the catheter. That is, except as suggested by the context, the distal portion, distal end, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0026] Unless defined otherwise, 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 into a patient's body and advancing the catheter within the vasculature and the number of medical devices need to be reduced. In the present application, a RICC and its method for addressing the above are disclosed.

[0027] Rapid Insertion Central Catheter FIG. 1 shows the distal end of the catheter tube 110 of the RICC 100 according to some embodiments. FIG. 3A is a cross-sectional view of the first portion 120 of the catheter tube 110 according to some embodiments. FIG. 3B is a cross-sectional view of the second portion 130 of the catheter tube 110 according to some embodiments. FIG. 3C is a cross-sectional view of the connection portion 140 of the catheter tube 110 according to some embodiments.

[0028] As shown, the RICC 100 has a first portion 120 of the distal end of the catheter tube 110, a second portion 130 of the distal end of the catheter tube 110 located proximal to the first portion 120 of the catheter tube 110, and a connection portion 140 connecting the first portion 120 and the second portion 130 of the catheter tube 110. The first portion 120 of the catheter tube 110 is formed of a first polymeric material having a first durometer hardness. The second portion 130 of the catheter tube 110 is formed of a second polymeric material having a second durometer hardness lower than the first durometer hardness. The connection portion 140 may be a third portion of the catheter tube 110 connecting the first portion 120 and the second portion 130 of the catheter tube 110, or may simply be the location where the first portion 120 and the second portion 130 of the catheter tube 110 are connected. The first portion 120 of the catheter tube 110, the second portion 130 of the catheter tube 110, and the connection portion 140 as a whole have a column strength capable of preventing the catheter tube 110 from bending when inserted into the insertion site and advancing within the patient's vasculature. Although the RICC 100 has the above-described portions, it is understood that other portions and configurations are possible.

[0029] The RICC100 is a three-lumen catheter. The first lumen of the three-lumen catheter includes a fluid-connected lumen portion that includes the lumen 122 of the first portion 120 of the catheter tube 110, the first lumen 132 of the second portion 130 of the catheter tube 110, and the lumen 142 of the connection portion 140. The first lumen terminates at the opening at the distal end of the first portion 120 of the catheter tube 110. The second lumen of the three-lumen catheter includes the second lumen 134 of the second portion 130 of the catheter tube 110. The second lumen 134 terminates at the first outlet 135 of the second portion 130 of the catheter tube 110 adjacent to the connection portion 140. The third lumen of the three-lumen catheter includes the third lumen 136 of the second portion 130 of the catheter tube 110. The third lumen 136 terminates at the second outlet 137 of the second portion 130 of the catheter tube 110 adjacent to the connection portion 140.

[0030] Alternatively, the RICC100 is a two-lumen catheter. Similar to the above three-lumen catheter, the first lumen of the two-lumen catheter includes a fluid-connected lumen portion that includes the lumen 122 of the first portion 120 of the catheter tube 110, the first lumen 132 of the second portion 130 of the catheter tube 110, and the lumen 142 of the connection portion 140. The first lumen terminates at the opening at the distal end of the first portion 120 of the catheter tube 110. The second lumen of the two-lumen catheter includes the second lumen 134 of the second portion 130 of the catheter tube 110. The second lumen 134 terminates at the first outlet 135 of the second portion 130 of the catheter tube 110 adjacent to the connection portion 140. The third lumen 136 of the second portion 130 of the catheter tube 110 does not exist in the two-lumen catheter.

[0031] In yet another example, the RICC100 is a single-lumen catheter. Similar to the aforementioned triple-lumen catheter and double-lumen catheter, the lumen of the single-lumen catheter includes fluid-connected lumen portions including the lumen 122 of the first portion 120 of the catheter tube 110, the first lumen 132 of the second portion 130 of the catheter tube 110, and the lumen 142 of the connection portion 140. The first lumen terminates at an opening at the distal end of the first portion 120 of the catheter tube 110. The second lumen 134 and the third lumen 136 of the second portion 130 of the catheter tube 110 are not present in the single-lumen catheter.

[0032] FIG. 4 shows a longitudinal cross-section of the first portion 120 of the catheter tube 110, the second portion 130 of the catheter tube 110, and the connection portion 140 according to some embodiments. The first portion 120 of the catheter tube 110 has a distal end portion including a tip and a proximal end portion configured to be disposed in the receiving portion 144 of the connection portion 140 and solvent-bonded thereto.

[0033] As described above, the first portion 120 of the catheter tube 110 is formed of a first polymeric material having a first durometer hardness. The first polymeric material is, for example, polytetrafluoroethylene, polypropylene, or polyurethane, but the first polymeric material is not limited to these polymers. In the case of polyurethane, the first portion 120 of the catheter tube 110 is advantageously relatively rigid at room temperature but becomes more flexible by body temperature in the body, suppressing irritation to the blood vessel wall and phlebitis.

[0034] The second portion 130 of the catheter tube 110 has a distal end portion optionally including one or both of the first eyelet 135 and the second eyelet 137 depending on whether the catheter is single-lumen, double-lumen, or triple-lumen. Although not shown, the second portion 130 of the catheter tube 110 has a proximal end portion connected to the hub of the RICC100.

[0035] As described above, the second portion 130 of the catheter tube 110 is formed of a second polymeric material having a second durometer hardness that is lower than the first durometer hardness of the first polymeric material. Since the first durometer hardness and the second durometer hardness may be by different scales (e.g., type A or type D), the second durometer hardness may not be numerically lower than the first durometer hardness. Even in this case, since the different scales (each in the range from 0 to 100) are intended to represent the characteristics of different materials within a group of materials having similar hardness, the hardness of the second polymeric material is lower than the hardness of the first polymeric material. The second polymeric material is, for example, polyvinyl chloride, polyethylene, polyurethane, or silicone, etc., but the first polymeric material is not limited to these polymers. Polyurethane is advantageous in that it has a lower thrombogenicity than other polymers.

[0036] Notwithstanding the above, if the catheter tube 110 has a column strength that can prevent the catheter tube 110 from bending when inserted into the insertion site and advancing within the patient's vasculature, the first portion 120 and the second portion 130 of the catheter tube 110 may be formed of the same polymeric material or of different polymeric materials having substantially equal durometer hardnesses.

[0037] The connection portion 140 may be the third portion of the catheter tube 110. The connection portion 140 has a tapered distal end portion and a proximal end portion. The proximal end portion is not tapered or has a taper at or near the position where the taper of the tapered distal end portion of the connection portion 140 begins. The proximal end portion of the connection portion 140 abuts against the distal end portion of the second portion 130 of the catheter tube 110 by solvent bonding or heat welding.

[0038] The connecting portion 140 is formed of a third polymeric material having a third durometer hardness that is lower than the first durometer hardness of the first polymeric material of the first portion 120 of the catheter tube 110. As described above, since such durometer hardness may be by different scales (e.g., type A or type D), the third durometer hardness may not be numerically lower than the first durometer hardness. Alternatively, if the catheter tube 110 has a column strength that can prevent the catheter tube 110 from bending when inserted into the insertion site and advancing within the patient's vasculature, the durometer hardness of the third polymeric material may be approximately equal to the durometer hardness of the first polymeric material of the first portion 120 of the catheter tube 110, or may be higher than the first polymeric material of the first portion 120 of the catheter tube 110. The durometer hardness of the third polymeric material may be approximately equal to the durometer hardness of the second polymeric material of the second portion 130 of the catheter tube 110, or may be different from the durometer hardness of the second polymeric material of the second portion 130 of the catheter tube 110. For example, it may be higher than the durometer hardness of the second polymeric material of the second portion 130 of the catheter tube 110. As described above, if the catheter tube 110 has a column strength that can prevent the catheter tube 110 from bending when inserted into the insertion site and advancing within the patient's vasculature, the durometer hardnesses may be different.

[0039] In the above alternative example, the second portion 130 of the catheter tube 110 includes the connection portion 140 or the third portion of the catheter tube 110. That is, the third portion of the catheter tube 110 is not formed separately from the second portion 130 of the catheter tube 110 and joined or welded to the second portion 130, but is formed integrally with the second portion 130 of the catheter tube 110. As described above for the connection portion 140, when the second portion 130 of the catheter tube 110 includes the connection portion 140 or the third portion of the catheter tube 110, the second portion 130 of the catheter tube 110 has a tapered distal end. The polymer material of the second portion 130 is as described above.

[0040] The anti-lumen side transition portion between the proximal end of the first portion 120 of the catheter tube 110 and the tapered distal end of the connection portion 140 is a smooth transition portion made of a solvent interdiffusion polymer material of the first polymer material and the third polymer material. Alternatively, when the second portion 130 of the catheter tube 110 is integral with the connection portion 140 or the third portion of the catheter tube 110, the anti-lumen side transition portion between the proximal end of the first portion 120 of the catheter tube 110 and the second portion 130 of the catheter tube 110 is a smooth transition portion made of a solvent interdiffusion polymer material of the first polymer material and the second polymer material. The above anti-lumen side transition portion is most clearly shown at the bottom of FIG. 4. In any of the above smooth transition portions, "smooth" means that the edge included in the anti-lumen side transition portion between the first portion 120 of the catheter tube 110 and the tapered distal end of the connection portion 140 is sufficiently small or minute and the RICC 100 will not catch on the skin when inserted into the patient's insertion site.

[0041] Figure 2 shows the distal end of the catheter tube 210 of another RICC200 according to some embodiments. The RICC200 and its method are detailed in International Application PCT / US2020 / 048583 filed on August 28, 2020 and International Application PCT / US2020 / 052536 filed on September 24, 2020. These are hereby incorporated by reference in their entirety into this application.

[0042] Method Figure 4 shows the insertion step of the method for manufacturing the RICC100 of Figure 1 according to some embodiments. The first method for manufacturing the RICC100, including the insertion step of Figure 4, relates to forming the catheter tube 110 from a first portion 120 of the catheter tube 110, a second portion 130 of the catheter tube 110, and a connection portion 140. The second method for manufacturing the RICC100, including the insertion step of Figure 4, relates to forming the catheter tube 110 from a first portion 120 of the catheter tube 110 and a second portion 130 of the catheter tube 110, where the second portion 130 of the catheter tube 110 includes a connection portion 140 or a third portion of the catheter tube 110.

[0043] The first method for manufacturing the RICC100 includes an acquisition step of acquiring a first portion 120 of the catheter tube 110 formed of a first polymer material having a first durometer hardness, a second portion 130 of the catheter tube 110 formed of a second polymer material having a second durometer hardness lower than the first durometer hardness, and a third portion or a connection portion 140 of the catheter tube 110 formed of a third material having a third durometer hardness lower than the first durometer hardness. The connection portion 140 has its tapered distal end as described above.

[0044] Further, the first method includes an application step of applying a solvent to the proximal end of the first portion 120 of the catheter tube 110, the receiving portion 144 at the distal end of the connecting portion 140, or both the proximal end of the first portion 120 of the catheter tube 110 and the receiving portion 144 at the distal end of the connecting portion 140.

[0045] As shown in FIG. 4, the first method also includes an insertion step of inserting the proximal end of the first portion 120 of the catheter tube 110 into the receiving portion 144 at the distal end of the connecting portion 140.

[0046] Further, the first method includes an evaporation step of forming a connection portion by solvent bonding between the first portion 120 of the catheter tube 110 and the connecting portion 140 by evaporating the solvent.

[0047] In some embodiments, the first method further includes a bonding or welding step of bonding or welding the distal end of the second portion 130 of the catheter tube 110 to the proximal end of the connecting portion 140 at or near the position where the taper of the tapered distal end of the connecting portion 140 begins.

[0048] The first method may include a rotation step of rotating the catheter tube 110 along its longitudinal axis. Further, the first method may include an application step of applying the solvent or another solvent to the anti-lumen side transition portion between the proximal end of the first portion 120 of the catheter tube 110 and the tapered distal end of the connecting portion 140. As a result of the application step, solvent molecules diffuse into the first polymer material and the third polymer material.

[0049] Further, the first method may include a smoothing step of smoothing the anti-lumen side transition portion using an interdiffused polymer material resulting from the entanglement of at least the solvated side chains of the first polymer material and the third polymer material.

[0050] A second method of fabricating the RICC100 includes an acquisition step of obtaining a first portion 120 of a catheter tube 110 formed of a first polymeric material having a first durometer hardness and a second portion 130 of the catheter tube 110 formed of a second polymeric material having a second durometer hardness lower than the first durometer hardness.

[0051] The second method may further include a tapering step of tapering a non-tapered distal end portion of the second portion 130 of the catheter tube 110 to form a tapered distal end portion of the second portion 130 of the catheter tube 110.

[0052] Also, the second method includes an application step of applying a solvent to a proximal end portion of the first portion 120 of the catheter tube 110, a receiving portion 144 of the tapered distal end portion of the second portion 130 of the catheter tube 110, or both the proximal end portion of the first portion 120 of the catheter tube 110 and the receiving portion 144 of the tapered distal end portion of the second portion 130 of the catheter tube 110.

[0053] As shown in FIG. 4, the second method also includes an insertion step of inserting a proximal end portion of the first portion 120 of the catheter tube 110 into a receiving portion 144 of the tapered distal end portion of the second portion 130 of the catheter tube 110.

[0054] Furthermore, the second method includes an evaporation step of forming a solvent-bonded connection between the first portion 120 of the catheter tube 110 and the second portion 130 of the catheter tube 110 by evaporating the solvent.

[0055] The second method may include a rotation step of rotating the catheter tube 110 along its longitudinal axis. Further, the second method may include an application step of applying the solvent or another solvent to the anti-lumen side transition portion between the proximal end of the first portion 120 of the catheter tube 110 and the tapered distal end of the second portion 130 of the catheter tube 110. As a result of the application step, solvent molecules diffuse into the first polymer material and the second polymer material.

[0056] Further, the second method may include a smoothing step of smoothing the anti-lumen side transition portion using an interdiffused polymer material resulting from the entanglement of at least the solvated side chains of the first polymer material and the second polymer material.

[0057] The method of using the RICC100 includes a forming step of forming an insertion site for reaching the patient's vasculature with a needle disposed within the lumen of the RICC100. The insertion site may be located in the subclavian vein such as the right subclavian vein or the left subclavian vein, the internal jugular vein such as the right internal jugular vein or the left internal jugular vein, or the femoral vein.

[0058] The method also includes an insertion step of inserting the distal end of the catheter tube 110 of the RICC100 into the insertion site. The method further includes a withdrawal step of withdrawing the needle from the lumen of the RICC100 after forming the insertion site and inserting at least a part of the distal end of the catheter tube 110 into the insertion site.

[0059] Furthermore, the method includes an advancing step of advancing the distal end of the catheter tube 110 through the patient's vasculature without using the Seldinger method. For example, when the insertion site is in the right subclavian vein or the right internal jugular vein, the advancing step may include advancing the distal end of the catheter tube 110 through the right subclavian vein or the right internal jugular vein and the right brachiocephalic vein to the superior vena cava. In the case of other insertion sites such as the left subclavian vein or the left internal jugular vein, it is necessary to advance the distal end of the catheter tube 110 through the corresponding vasculature.

[0060] Some specific embodiments are disclosed herein. Although the specific embodiments are disclosed to some extent in detail, it is not intended to limit the scope of the concepts provided herein. Those skilled in the art can understand that additional adaptations and / or modifications can be made in a broader aspect, and these adaptations and / or modifications are also included. Therefore, without departing from the scope of the concepts provided herein, it may be implemented deviating from the specific embodiments disclosed herein.

Claims

**Claim 1** A method for manufacturing a central venous catheter, comprising: obtaining a first portion of a catheter tube made of a first polymer material having a first durometer hardness and a second portion of the catheter tube made of a second polymer material having a second durometer hardness lower than the first durometer hardness; applying a solvent to a proximal end portion of the first portion of the catheter tube, a receiving portion at a distal end portion of the second portion of the catheter tube, or both the proximal end portion of the first portion of the catheter tube and the receiving portion at the distal end portion of the second portion of the catheter tube, wherein an outer circumference of the distal end portion of the second portion of the catheter tube is tapered along a longitudinal axis of the catheter tube; inserting the proximal end portion of the first portion of the catheter tube into the receiving portion at the tapered distal end portion of the second portion of the catheter tube; forming a connection portion by solvent bonding between the first portion of the catheter tube and the second portion of the catheter tube by evaporating the solvent. **Claim 2** The method according to claim 1, further comprising tapering an outer circumference of a non-tapered distal end portion of the second portion of the catheter tube to form the tapered distal end portion of the second portion of the catheter tube. **Claim 3** rotating the catheter tube along a longitudinal axis of the catheter tube; applying the solvent or another solvent to an intraluminal side transition portion between the proximal end portion of the first portion of the catheter tube and the tapered distal end portion of the second portion of the catheter tube to diffuse solvent molecules into the first polymer material and the second polymer material; smoothing the transition portion using an interdiffused polymer material resulting from entanglement of at least solvated side chains of the first polymer material and the second polymer material. The method according to claim 1 or claim 2. **Claim 4** A method for manufacturing a central venous catheter, comprising: A first portion of a catheter tube made of a first polymer material having a first durometer hardness, a second portion of the catheter tube made of a second polymer material having a second durometer hardness lower than the first durometer hardness, and a third portion of the catheter tube formed of a third polymer material having a third durometer hardness lower than the first durometer hardness, wherein an outer periphery of the third portion is tapered along a longitudinal axis of the catheter tube, and obtaining the third portion; Applying a solvent to a proximal end of the first portion of the catheter tube, a receiving portion at a distal end of the tapered third portion of the catheter tube, or both the proximal end of the first portion of the catheter tube and the receiving portion at the distal end of the tapered third portion of the catheter tube; Inserting the proximal end of the first portion of the catheter tube into the receiving portion at the distal end of the third portion of the catheter tube; Forming a connection portion by solvent bonding between the first portion of the catheter tube and the tapered third portion of the catheter tube by evaporating the solvent, the method comprising.

5. The method according to claim 4, further comprising joining or welding a distal end of the second portion of the catheter tube to a proximal end of the tapered third portion at or near a position where the taper of the tapered third portion begins.

6. Rotating the catheter tube along a longitudinal axis of the catheter tube; Diffusing solvent molecules into the first polymer material and the third polymer material by applying the solvent or another solvent to an anti-lumen side transition portion between the proximal end of the first portion of the catheter tube and the tapered distal end of the third portion of the catheter tube; The method according to claim 4 or claim 5, further comprising smoothing the transition portion using an interdiffused polymer material resulting from entanglement of at least solvated side chains of the first polymer material and the third polymer material.

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