Rapid insertion central venous catheter and method of manufacturing same

Abstract

A rapid insertion central venous catheter (RICC) and method thereof may include a catheter tube having a first section within a distal end portion of the catheter tube, a second section within the distal end portion of the catheter proximal to the first section, and a junction between the first and second sections of the catheter tube. The first section of the catheter tube is formed of a first material having a first durometer. The second section of the catheter tube is formed of a second material having a second durometer lower than the first durometer. The first and second sections of the catheter tube have sufficient column buckling strength to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a patient's vasculature.

Description

[Technical field]

[0001] The present disclosure relates to a rapid insertion central venous catheter and manufacturing It concerns the method. [Background technology]

[0002] Central venous catheters (CVCs) are made of materials with relatively low durometer hardness, which contributes to the CVCs' lack of column buckling strength. Due to the lack of column buckling strength, CVCs are typically introduced into a patient's body and advanced through the vasculature by the Selzinga technique. The Selzinga technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Selzinga technique is effective, the many steps are time consuming and the handling of numerous medical devices is cumbersome, all of which may cause trauma to the patient. In addition, the large number of medical devices that need to be replaced during the many steps of the Selzinga technique creates a relatively high potential for contamination by contact. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing the catheter into a patient's body and advancing the catheter through the vasculature. Summary of the Invention [Means for solving the problem]

[0003] Disclosed herein is a rapidly inserted central catheter (RICC) and method that addresses the above. Disclosed herein is a RICC, which in some embodiments includes a catheter tube including a first portion within a distal end portion of the catheter tube, a second portion within the distal end portion of the catheter proximal to the first portion, and a junction between the first and second portions of the catheter tube. The first portion of the catheter tube is formed of a first material having a first durometer. The second portion of the catheter tube is formed of a second material having a second durometer that is lower than the first durometer. The first and second portions of the catheter tube have sufficient column buckling strength to prevent buckling of the catheter tube when inserted into an insertion site of a patient and advanced within the vasculature.

[0004] In some embodiments, the junction is a third portion of the catheter tube formed from a third material having a third durometer between the first and second durometers.

[0005] In some embodiments, the junction includes a tapered distal end portion and the first section of the catheter tube includes a flared proximal end portion, and the tapered distal end portion of the junction is within the flared proximal end portion of the first section of the catheter tube.

[0006] In some embodiments, the junction comprises a proximal end portion and the second section of the catheter tube comprises a distal end portion, and the proximal end portion of the junction abuts the distal end portion of the second section of the catheter tube.

[0007] In some embodiments, the first and second sections of the catheter tube are welded to the junction with a heat weld. In some embodiments, the first and second sections of the catheter tubing are welded to the junction by solvent welding.

[0008] In some embodiments, a first section of the catheter tube includes a flared proximal end section and a second section of the catheter tube includes a tapered distal end section, and the tapered distal end section of the second section of the catheter tube is within the flared proximal end section of the first section of the catheter tube.

[0009] In some embodiments, each portion of the first and second portions of the catheter tubing is welded to the other portion by heat welding, thereby forming a joint between the first and second portions of the catheter tubing.

[0010] In some embodiments, each section of the first and second sections of the catheter tubing are solvent welded to the other section, thereby forming a joint between the first and second sections of the catheter tubing.

[0011] In some embodiments, the RICC includes a necked-down portion around the junction that is configured to provide a smooth transition between the first and second portions of the catheter tube.

[0012] 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.

[0013] Also disclosed herein is a method of manufacturing a RICC, which in some embodiments includes obtaining a first, second, and third portion of a catheter tube. The first portion of the catheter tube is formed of a first material having a first durometer hardness. The second portion of the catheter tube is formed of a second material having a second durometer hardness. The third portion of the catheter tube is formed of a third material having a third durometer hardness between the first durometer hardness and the second durometer hardness. The method also includes forming a flare on a proximal end portion of the first portion of the catheter tube to form a flared proximal end portion of the first portion of the catheter tube. The method also includes inserting a tapered distal end portion of the third portion of the catheter tube into the flared proximal end portion of the first portion of the catheter tube. The method also includes abutting a distal end portion of the second portion of the catheter tube and a proximal end portion of the third portion of the catheter tube. The method also includes welding the first, second, and third portions of the catheter tube together to form a joint of a third material between the first and second portions of the catheter tube.

[0014] In some embodiments, the welding step of welding the second and third portions of the catheter tube is performed before the inserting and welding step of inserting the tapered distal end portion of the third portion of the catheter tube into the flared proximal end portion of the first portion of the catheter tube and welding the first and third portions of the catheter tube.

[0015] In some embodiments, each of the welding steps is a separate thermal or solvent weld. In some embodiments, the method further comprises a tapering step of forming a taper on the non-tapered distal end portion of the catheter tube to form a tapered distal end portion of the third section of the catheter tube.

[0016] In some embodiments, the method further includes a necking down step of necking down the catheter tube to form a necked down portion around the junction, the necked down portion configured to provide a smooth transition between the first, second and third portions of the catheter tube.

[0017] Also provided herein is a method for manufacturing a RICC, which in some embodiments includes obtaining a first section of a catheter tube formed of a first material having a first durometer hardness and obtaining a second section of a catheter tube formed of a second material having a second durometer hardness lower than the first durometer hardness. The method also includes forming a flare at a proximal end portion of the first section of the catheter tube to form a flared proximal end portion of the first section of the catheter tube. The method also includes inserting a tapered distal end portion of the second section of the catheter tube into the flared proximal end portion of the first section of the catheter tube. The method also includes welding the first and second sections of the catheter tube together to form a joint between the first and second sections of the catheter tube.

[0018] In some embodiments, the welding step comprises heat welding or solvent welding. In some embodiments, the method further comprises a tapering step of forming a taper on a non-tapered distal end portion of the second section of the catheter tube to form a tapered distal end portion of the second section of the catheter tube.

[0019] In some embodiments, the method further includes a necking down step of necking down the catheter tube to form a necked down portion around the junction, the necked down portion configured to provide a smooth transition between the first and second portions of the catheter tube.

[0020] The present application also discloses a method of RICC, which in some embodiments includes an insertion site formation step of forming an insertion site with a needle to access the patient's vasculature, an insertion step of inserting a distal end portion of a catheter tube of the RICC over the needle into the insertion site, and an advancement step of advancing the distal end portion of the catheter tube within the patient's vasculature without using the Seldinga technique.

[0021] In some embodiments, the method further comprises, after the insertion site forming step, a withdrawal step of withdrawing the needle from the RICC. In some embodiments, the insertion site is in the right subclavian vein or the right internal jugular vein.

[0022] In some embodiments, the advancing step includes advancing a distal end portion of the catheter tube through the right subclavian or right internal jugular vein, the right brachiocephalic vein, and into the superior vena cava.

[0023] Also disclosed herein is a RICC, which in some embodiments includes a catheter tube including a first section having a single lumen in a distal end portion of the catheter tube, a second section having a pair of lumens located proximal to the first section in the distal end portion of the catheter tube, and a junction between the first and second sections of the catheter tube where the pair of lumens transition to a single lumen. The first section of the catheter tube is formed of a first material having a first durometer. The second section of the catheter tube is formed of a second material having a second durometer that is lower than the first durometer. The first and second sections of the catheter tube have sufficient column buckling strength to prevent buckling of the catheter tube when inserted into an insertion site and advanced within a patient's vasculature.

[0024] Disclosed herein is a RICC, which in some embodiments includes a catheter tube including a first portion within a distal end portion of the catheter tube, a second portion within the distal end portion of the catheter tube proximal to the first portion, and a junction between the first and second portions of the catheter tube, The first and second portions of the catheter tube are formed of the same material or different materials having substantially equal durometer hardness, so long as the first and second portions of the catheter tube have sufficient column buckling strength to prevent buckling of the catheter tube when inserted into an insertion site and advanced within a patient's vasculature.

[0025] These and other features of the concepts presented herein will become more apparent to those skilled in the art upon review of the accompanying drawings and following description, which more particularly describe specific embodiments of such concepts. [Brief description of the drawings]

[0026] [Figure 1A] 1 illustrates a distal end portion of a first RICC according to some embodiments. [Figure 1B] FIG. 1B shows a cross-sectional view of a distal end portion of the first RICC of FIG. 1A. [Diagram 2] 1 illustrates a cross-sectional view of a second RICC according to some embodiments. [Diagram 3] 13 shows a cross-sectional view of a third RICC according to some embodiments. [Figure 4A] 1 illustrates at least a portion of a method for manufacturing a first RICC according to some embodiments. [Figure 4B] 13 illustrates another portion of a method for manufacturing at least a first RICC according to some embodiments. [Figure 5A] 1 illustrates at least a portion of a method for manufacturing an alternative type of first RICC according to some embodiments. [Figure 5B] 13 illustrates another portion of a method for manufacturing at least an alternative type of second RICC according to some embodiments. [Figure 6A]13 illustrates a distal end portion of a fourth RICC according to some embodiments. [Figure 6B] 6B shows a cross-sectional view of the distal end portion of the fourth RICC of FIG. 6A. [Figure 7] 13 illustrates at least another portion of a fourth method for manufacturing a RICC according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 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. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other several embodiments disclosed herein.

[0028] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms 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 sequential or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "front", "back", "top", and "bottom", or other similar terms, are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0029] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on 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 on 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 on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0030] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a 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 discussed above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient's body and advancing the catheter through its vasculature. Disclosed herein is a corresponding RICC and method thereof. Rapid insertion central venous catheter FIG. 1A shows a distal end portion of a RICC 100 according to some embodiments. FIG. 1B shows a cross-sectional view of the distal end portion of the RICC 100 of FIG. 1A. FIG. 2 shows a cross-sectional view of a RICC 200 according to some embodiments. FIG. 3 shows a cross-sectional view of a RICC 300 according to some embodiments. FIG. 6A shows a distal end portion of a RICC 600 according to some embodiments. FIG. 6B shows a cross-sectional view of the distal end portion of the RICC 600 of FIG. 6A.

[0032] As shown, the RICC 100 includes a catheter tube 110 that includes a first portion 120 within a distal end portion of the catheter tube 110, a second portion 130 within the distal end portion of the catheter tube 110 proximal to the first portion 120, and a junction 140 between the first portion 120 and the second portion 130 of the catheter tube 110. Similarly, the RICC 200 includes a catheter tube 210 that includes a first portion 220 within a distal end portion of the catheter tube 210, a second portion 130 within the distal end portion of the catheter tube 210 proximal to the first portion 220, and a junction 240 between the first portion 220 and the second portion 130 of the catheter tube 210. Similarly, the RICC 300 includes a catheter tube 310 including a first portion 220 within a distal end portion of the catheter tube 310, a second portion 330 within the distal end portion of the catheter tube 310 proximal to the first portion 220, and a junction 340 between the first portion 220 and the second portion 330 of the catheter tube 310. Similarly, the RICC 600 includes a catheter tube 610 including a first portion 620 within a distal end portion of the catheter tube 610, a second portion 130 within the distal end portion of the catheter tube 610 proximal to the first portion 620, and a junction 140 between the first portion 620 and the second portion 130 of the catheter tube 610. Collectively, the first portion 120, 220, or 620 of the catheter tube 110, 210, 310, or 610, the second portion 130 or 330 of the catheter tube 110, 210, 310, or 610, and the joint 140, 240, or 340 have sufficient column buckling strength to prevent buckling of the catheter tube 110, 210, 310, or 610 when inserted into an insertion site and advanced within a patient's vasculature. While the RICCs 100, 200, 300, and 600 have the portions described above, it should be understood that other portions and configurations thereof are possible.

[0033] Although only a single lumen 112 is shown for the RICC 100, 200, 300, or 600, the RICC 100, 200, 300, or 600 is not limited to being a single lumen catheter. Indeed, the RICC 100, 200, 300, or 600 may alternatively be a double lumen catheter, a triple lumen catheter, a tetra lumen catheter, or the like. Also, the number of lumens in one portion of the RICC 100, 200, 300, or 600 may transition to fewer lumens in another portion of the RICC 100, 200, 300, or 600. For example, a pair of lumens in the second portion 130 of the catheter tube 110 of the RICC 100 may transition to a single lumen in the first portion 120 of the catheter tube 110.

[0034] The first section 120 or 220 of the catheter tube 110, 210 or 310 includes a flared proximal end section 122 or 222 and a tip 124 of the first section 120 or 220 of the catheter tube 110, 210 or 310, which also serves as the tip 124 of the catheter tube 110, 210 or 310. The flared proximal end section 122 or 222 can differ in terms of the degree of flare, the degree of the flared proximal end section 122 of the first section 110 being greater than the flared proximal end section 222 of the first section 220 of the second catheter tube 210 or the third catheter tube 310. The first section 620 of the catheter tube 610 similarly includes a tip 124 that doubles as the tip 124 of the catheter tube 610, but the first section 620 of the catheter tube 610 does not include a flared proximal end portion similar to the flared proximal end portion 122 or 222 of the first section 120 or 220 of the catheter tube 110, 210, or 310. Instead, the proximal end portion 622 of the first section 620 of the catheter tube 610 remains the same outer diameter proximal to the tip 124 as the distal end portion of the first section 620 of the catheter tube 610.

[0035] The first portion 120, 220, or 620 of the catheter tube 110, 210, 310, or 610 is formed of a first material having a first durometer hardness. The first material may be, but is not limited to, polytetrafluoroethylene, polypropylene, or polyurethane. Polyurethane is advantageous in that the first portion 120, 220, or 620 of the catheter tube 110, 210, 310, or 610 is relatively rigid at room temperature, but may be more flexible in vivo at body temperature, thereby reducing inflammation and phlebitis of the vessel wall.

[0036] The second section 130 or 330 of the catheter tube 110, 210, 310, or 610 includes a distal end portion 132, 232, or 332, which is best seen in FIG. 4B.

[0037] The second portion 130 or 330 of the catheter tube 110, 210, 310, or 610 is formed of a second material having a second durometer hardness lower than the first durometer hardness of the first material. The first and second durometer hardnesses may be on different scales (e.g., Type A or Type D), so the second durometer hardness may not be numerically lower than the first durometer hardness. That is, the hardness of the second material may still be lower than the hardness of the first material, because other scales, each ranging from 0 to 100, have been devised to characterize different materials in a group of materials having similar hardness. The second material may be polyvinyl chloride, polyethylene, polyurethane, or silicone, but the first material is not limited to the above-mentioned polymers. Polyurethane is advantageous in that it may be less thrombogenic than some other polymers.

[0038] Notwithstanding the above, the first section 120, 220, or 620 and the second section 130 or 330 of the catheter tube 110, 210, 310, or 610 can be formed of the same material or different materials having substantially similar durometer hardness, so long as the column buckling strength of the catheter tube 110, 210, 310, or 610 is sufficient to prevent buckling of the catheter tube 110, 210, 310, or 610 when inserted into an insertion site and advanced within the patient's vasculature.

[0039] The junction 140, 240, or 340 may be a third portion of the catheter tube 110, 210, 310, or 610. The junction 140, 240, or 340 includes a tapered distal end portion 142, 242, or 342, best seen in FIG. 4B, and a proximal end portion 144, 244, or 344. Each of the tapered distal end portions 142, 242, and 342 may differ in terms of the degree of taper. For example, the tapered distal end portion 142 of the junction 140 may have a greater degree of taper than the tapered distal end portion 242 or 342 of the junction 240 or 340.

[0040] The joint 140, 240, or 340 is formed of a third material having a third durometer hardness between the first durometer hardness of the first material of the first portion 120, 220, or 620 of the catheter tube 110, 210, 310, or 610 and the second durometer hardness of the second material of the second portion 130 or 330 of the catheter tube 110, 210, 310, or 610. As before, such durometer hardness may be on a different scale (e.g., Type A or Type D), so that the third durometer hardness may not be numerically between the first and second durometer hardnesses. Alternatively, the third material can have the same durometer hardness as the first material of the first portion 120, 220, or 620 of the catheter tube 110, 210, 310, or 610 or the second material of the second portion 130 or 330 of the catheter tube 110, 210, 310, or 610.

[0041] The tapered distal end portion 142, 242, or 342 of the junction 140, 240, or 340 is at least partially within the flared proximal end portion 122 or 222 of the first section 120 or 220 of the catheter tube 110, 210, or 310. However, with respect to the catheter tube 610, the tapered distal end portion 142 of the junction 140 abuts the proximal end portion 622 of the first section 620 of the catheter tube 610. The proximal end portion 144, 244, or 344 of the junction 140, 240, or 340 abuts the distal end portion 132 or 332 of the second section 130 or 330 of the catheter tube 110, 210, 310, or 610. Each of the first 120, 220, or 620 and second 130 or 330 portions of the catheter tube 110, 210, 310, or 610 is welded by separate heat or solvent welding to the junction 140, 240, or 340. If one type of welding is used, the first 120, 220, or 620 and second 130 or 330 portions of the catheter tube 110, 210, 310, or 610 can be welded in one welding step by heat or solvent welding to the junction 140, 240, or 340. The flared proximal end portion 122 of the first 120 portion of the catheter tube 110 is exposed, whereas the flared proximal end portion 222 of the first 220 portion of the catheter tube 210 or 310 is hidden by the overlapping portion of the junction 240 or 340 for a smoother transition. For an even smoother transition, both the second section 330 of the catheter tube 310 and the junction 340 may be necked down with a compound necked down section around the junction 340 .

[0042] As an alternative to the above, the second section 130 or 330 of the catheter tube 110, 210, 310 or 610 includes the junction 140, 240 or 340, i.e., the third section, of the catheter tube 110, 210, 310 or 610. That is, the third section of the catheter tube 110, 210, 310 or 610 is not formed separately from and welded to the second section 130 or 330 of the catheter tube 110, 210, 310 or 610, but is formed integrally with the second section 130 or 330 of the catheter tube 110, 210, 310 or 610, as shown in FIG. 5A for the second section 530. Similar to that described above for the junction 140, 240 or 340, the second section 530 includes a tapered distal end section 542. The tapered distal end section 542 can vary in terms of the degree of taper. For example, the tapered distal end portion 542 of the second section 530 may have a greater degree of taper relative to the catheter tube 110 or 610 than either of the catheter tubes 210 and 310 .

[0043] The tapered distal end portion 542 of the second section 530 of the catheter tube 110, 210, or 310 is at least partially within the flared proximal end portion 122 or 222 of the first section 120 or 220 of the catheter tube 110, 210, or 310, or abuts the proximal end portion 622 of the first section 620 of the catheter tube 610. The first section 120, 220, or 620 and the second section 530 of the catheter tube 110, 210, 310, or 610 are welded together by heat welding or solvent welding. The flared proximal end portion 122 of the first section 120 of the catheter tube 120 is exposed, whereas the flared proximal end portion 222 of the first section 220 of the catheter tube 210 or 310 is hidden by the overlapping portion of the second section 530 of the catheter tube 210 or 310 for a smoother transition. For an even smoother transition, the second portion 530 of the catheter tube 310 can be necked down in a necked down section. method 4A and 4B illustrate at least a method for manufacturing the RICC 100 according to some embodiments. In fact, the method illustrated in FIG. 4A and 4B also applies to the RICCs 200 and 300. FIG. 7 illustrates at least a method for manufacturing the RICC 600 according to some embodiments. The method for manufacturing the RICC 600 is similar to that illustrated in FIG. 4B for the RICC 100, except that the method is related to the flared proximal end portion 122 of the first portion 120 of the catheter tube 110. For ease of explanation, the method of FIG. 4A and 4B will be described primarily with respect to the manufacture of the RICC 100. Only when the method for manufacturing the RICCs 200, 300, or 600 is clearly different from that of the RICC 100, will the method of FIG. 4A and 4B be described with respect to the RICCs 200 or 300, or the method of FIG. 7 be described with respect to the RICC 600.

[0044] The method of manufacturing the RICC 100 includes obtaining the first portion 120, the second portion 130, and the joint or third portion 140 of the catheter tube 110. Again, the first portion 120 of the catheter tube 110 is formed of a first material having a first durometer, the second portion 130 of the catheter tube 110 is formed of a second material having a second durometer, and the third portion 140 of the catheter tube 110 is formed of a third material having a third durometer between the first and second durometers. Such materials with such durometers take advantage of the different melting points and facilitate welding between the different portions 120, 130, and 140 of the catheter tube 110 to a degree sufficient for use of the RICC 100.

[0045] The method also includes a flaring step of forming a flare at the proximal end portion of the initial first section 424 of the catheter tube 110 to form the first section 120 of the catheter tube 110 having a flared proximal end portion 122. Notably, the first section 620 of the catheter tube 610 does not include a proximal end portion having a flare similar to the flared proximal end portion 122 of the first section 120 of the catheter tube 110. Therefore, the manufacturing method of the RICC 600 does not need to include the above-mentioned flaring step.

[0046] The method also includes an inserting step of inserting the tapered distal end portion 142 of the third portion 140 of the catheter tube 110 into the flared proximal end portion 122 of the first portion 120 of the catheter tube 110. Obviously, the first portion 620 of the catheter tube 610 does not include a flared proximal end portion similar to the flared proximal end portion 122 of the first portion 120 of the catheter tube 110. Therefore, the manufacturing method of the RICC 600 does not need to include the above-mentioned inserting step. Instead, the manufacturing method of the RICC 600 includes an abutting step of abutting the tapered distal end portion 142 of the third portion 140 of the catheter tube 610 against the proximal end portion 622 of the first portion 620 of the catheter tube 610.

[0047] The method also includes the step of abutting the distal end portion 132 of the second portion 130 of the catheter tube 110 and the proximal end portion 144 of the third portion 140 of the catheter tube 110 .

[0048] The method also includes welding the first, second, and third portions of the catheter tube 110 together to form a third material joint 140 between the first portion 120 and the second portion 130 of the catheter tube 110.

[0049] The welding step of welding the second and third catheter tube sections 130 and 140 together occurs before the inserting and welding step of inserting the tapered distal end section 142 of the third catheter tube section 140 of the catheter tube 110 into the flared proximal end section 122 of the first catheter tube section 120 of the catheter tube 110 and welding the first and third catheter tube sections 120 and 140 together. With respect to the method of manufacturing the RICC 600, the welding step of welding the second and third catheter tube sections 130 and 140 together occurs before the abutting and welding step of abutting the tapered distal end section 142 of the third catheter tube section 140 of the catheter tube 610 with the proximal end section 622 of the first catheter tube section 620 of the catheter tube 610 and welding the first and third catheter tube sections 620 and 140 together. Each of the welding steps is a separate heat weld (e.g., radio frequency [RF] weld) or solvent weld.

[0050] By flaring the proximal end portion of the initial first section 424 of the catheter tube 110 to form the flared proximal end portion 122 of the first section 120 of the catheter tube 110 and inserting the tapered distal end portion 142 of the third section 140 of the catheter tube 110 into the flared proximal end portion 122 of the first section 120 of the catheter tube 110, it is possible to place the RF welding element a short distance from the beginning of the flared proximal end portion 122 of the first section 120 of the catheter tube 110. This reduces the risk of creating a defect or weak spot in the catheter tube 110. The RF welding element is fired a short distance distal to the section 121 where the flared proximal end portion 122 of the first section 120 of the catheter tube 110 begins and a short distance proximal to the section 121, thereby preventing too much heat from hitting the thin wall of the first section 120 of the catheter tube 110.

[0051] The method further includes a tapering step of forming a taper on the non-tapered distal end portion of the third portion 140 of the catheter tube 110 to form a tapered distal end portion 142 of the third portion 140 of the catheter tube 110.

[0052] At least with respect to the RICC 300, the method further includes a necking down step of necking down the catheter tube 310 to form a necked down portion about the junction 340. The necked down portion is configured to provide a smooth transition between the first, second, and third portions of the catheter tube 310.

[0053] 5A and 5B illustrate an alternative method of manufacturing the RICC 100 according to some embodiments. An alternative method of manufacturing the RICC 100 includes obtaining a first portion 120 of the catheter tube 110 formed of a first material having a first durometer hardness and a second portion 530 of the catheter tube 110 formed of a second material having a second durometer hardness lower than the first durometer hardness. The method also includes a flaring step of forming a flare in the initial first portion 424 of the catheter tube 110 to form a flared proximal end portion 122 of the first portion 120 of the catheter tube 110 as shown in FIG. 4B. The method also includes an inserting step of inserting a tapered distal end portion 542 of the second portion 530 of the catheter tube 110 into the flared proximal end portion 122 of the first portion 120 of the catheter tube 110. The method also includes a welding step of heat or solvent welding the first portion 120 and the second portion 530 of the catheter tube 110 together to form a joint between the first portion 120 and the second portion 530 of the catheter tube 110.

[0054] The method further includes a tapering step of forming a taper in the non-tapered distal end portion 132 of the second portion 130 of the catheter tube 110 to form a tapered distal end portion 542 of the second portion 530 of the catheter tube 110. Forming the tapered distal end portion 542 of the second portion 530 of the catheter tube 110 can be achieved by removing some material from the non-tapered distal end portion 132 of the second portion 130 of the catheter tube 110 or by melting or dissolving some of the material of the non-tapered distal end portion 132 of the second portion 130 of the catheter tube 110 during a welding step.

[0055] For at least the RICC 300, the method further includes a necking down step of necking down the catheter tube 310 to form a necked down portion around the junction between the first portion 120 and the second portion 530 of the catheter tube 110. The necked down portion is configured to provide a smooth transition between the first portion 220 and the second portion 530 of the catheter tube 310.

[0056] The method of manufacturing each of the RICCs 100, 200, and 300 further includes a mandrel attachment step in which the parts used in the manufacture of the RICCs 100, 200, and 300 are attached to a mandrel to prevent their lumens from collapsing during further welding steps.

[0057] The RICC 100 method includes an insertion site preparation step of preparing an insertion site with a needle to access the patient's vasculature, an insertion step of inserting a distal end portion of the catheter tube 110 of the RICC 100 over a needle into the insertion site, and an advancement step of advancing the distal end portion of the catheter tube 110 without the use of the Selzinger technique through the patient's vasculature. The smaller outer diameter of the first portion 120 of the RICC 100 facilitates the insertion step, which requires pushing through at least skin tissue. Additionally, the transition between the first portion 120 and the second portion 130 at least avoids snagging on skin tissue, thereby allowing the RICC 100 to be inserted like a peripheral intravenous (IV) catheter.

[0058] The method further includes a withdrawal step of withdrawing the needle from the RICC 100 after the insertion site formation step. The insertion site is in the right subclavian vein or the right internal jugular vein.

[0059] The advancing step involves advancing the distal end portion of the catheter tube 110 through the right subclavian vein or the right internal jugular vein, the right brachiocephalic vein, and into the superior vena cava. Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Those skilled in the art will appreciate that additional adaptations and / or modifications may be made in the broader aspects, and these adaptations and / or modifications are also encompassed. Thus, deviations from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central venous catheter comprising: a first section of a catheter tube constructed from a first material having a first durometer hardness, the first section being located at a distal end portion of the catheter tube; a second portion of the catheter tube, the second portion being made of a second material having a second durometer hardness lower than the first durometer hardness, the second portion being located proximal to the first portion at the distal end portion of the catheter tube; a junction comprising a third material having a third durometer hardness between the first durometer hardness and the second durometer hardness of the catheter tube, the junction being a third portion of the catheter tube; Equipped with the first and second portions of the catheter tube have a column buckling strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site of a patient and advanced within a vasculature; 1. A rapid insertion central venous catheter comprising: a catheter tubing having a distal end portion and a proximal end portion and a distal end portion of the catheter tubing having a flared proximal end portion, the proximal end portion of the catheter tubing having a flared distal end portion and the distal end portion of the catheter tubing having a flared proximal end portion.

2. 2. The rapid insertion central venous catheter of claim 1, wherein the junction includes a proximal end portion and the second section of the catheter tube includes a distal end portion, the proximal end portion of the junction abutting the distal end portion of the second section of the catheter tube.

3. 3. The rapid insertion central venous catheter of claim 1, wherein the first and second portions of the catheter tube are welded to the junction by heat welding.

4. 3. The rapid insertion central venous catheter of claim 1, wherein the first and second portions of the catheter tube are welded to the junction by solvent welding.

5. 5. The rapid insertion central venous catheter of claim 1, wherein the rapid insertion central venous catheter includes a necked-down portion about the junction, the necked-down portion configured to provide a smooth transition between the first and second portions of the catheter tube.

6. 6. The rapid insertion central venous catheter of claim 1, wherein the first section of the catheter tube is polytetrafluoroethylene, polypropylene, or polyurethane.

7. 7. The rapid insertion central venous catheter of claim 1, wherein the second portion of the catheter tube is polyvinyl chloride, polyethylene, polyurethane, or silicone.

8. 1. A method of manufacturing a rapid insertion central venous catheter, comprising: obtaining a first portion of a catheter tube constructed from a first material having a first durometer hardness, a second portion of a catheter tube constructed from a second material having a second durometer hardness lower than the first durometer hardness, and a third portion of a catheter tube constructed from a third material having a third durometer hardness between the first durometer hardness and the second durometer hardness; forming a flare on the proximal end portion of the first section of the catheter tube to form a flared proximal end portion on the first section of the catheter tube; inserting a tapered distal end portion including a distal end of the third section of the catheter tube into the flared proximal end portion of the first section of the catheter tube; abutting the distal end portion of the second section of the catheter tube and the proximal end portion of the third section of the catheter tube; welding together the first portion, the second portion, and the third portion of the catheter tube to form a joint of a third material between the first portion and the second portion of the catheter tube. The method includes:

9. 9. The method of claim 8, wherein welding the second and third portions of the catheter tube occurs prior to inserting the tapered distal end portion of the third portion of the catheter tube into the flared proximal end portion of the first portion of the catheter tube and welding the first and third portions of the catheter tube.

10. 10. The method according to claim 8 or 9, wherein the welding is a separate heat or solvent welding.

11. 11. The method of any one of claims 8 to 10, further comprising tapering a non-tapered distal end portion of the catheter tube to taper the distal end portion of the third section of the catheter tube.

12. 12. The method of claim 8, further comprising necking down the catheter tube to form a necked-down portion around the junction, the necked-down portion configured to provide a smooth transition between the first, second, and third portions of the catheter tube.

13. 1. A method of manufacturing a rapid insertion central venous catheter, comprising: Obtaining a first portion of a catheter tube constructed from a first material having a first durometer hardness and a second portion of the catheter tube constructed from a second material having a second durometer hardness lower than the first durometer hardness; forming a flare on the proximal end portion of the first section of the catheter tube to form a flared proximal end portion on the first section of the catheter tube; inserting a tapered distal end portion having a distal end of the second section of the catheter tube into the flared proximal end portion of the first section of the catheter tube; welding the first and second portions of the catheter tube together to form a joint between the first and second portions of the catheter tube. The method includes:

14. The method of claim 13, wherein the welding is heat welding or solvent welding.

15. 15. The method of claim 13 or 14, further comprising forming a taper on a non-tapered distal end portion of the second section of the catheter tube to form a tapered distal end portion of the second section of the catheter tube.

16. 16. The method of any one of claims 13-15, further comprising necking down the catheter tube to form a necked-down portion around the junction, the necked-down portion configured to provide a smooth transition between the first and second portions of the catheter tube.

17. A rapid insertion central venous catheter as described in claim 1, wherein the first portion of the catheter tube has a single lumen, the second portion of the catheter tube located on the proximal end side of the first portion has a pair of lumens, and at the junction, the pair of lumens transition into the single lumen.

18. A rapid insertion central venous catheter, comprising: a first section of a catheter tube constructed from a first material having a first durometer hardness, the first section being located at a distal end portion of the catheter tube; a second portion of the catheter tube, the second portion being made of a second material having a second durometer hardness lower than the first durometer hardness, the second portion being located proximal to the first portion at the distal end portion of the catheter tube; a junction between the first and second portions of the catheter tube; Equipped with the first and second sections of the catheter tube have a column buckling strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site of a patient and advanced within the vasculature; 1. A rapid insertion central venous catheter, wherein the first section of the catheter tube includes a flared proximal end section and the second section of the catheter tube includes a tapered distal end section, the tapered distal end section of the second section of the catheter tube including a distal end within the flared proximal end section of the first section of the catheter tube.

19. The rapid insertion central venous catheter of claim 18, comprising a necked-down portion around the junction, the necked-down portion configured to provide a smooth transition between the first and second portions of the catheter tube.

20. The rapid insertion central venous catheter of claim 18, wherein the first portion of the catheter tube is polytetrafluoroethylene, polypropylene, or polyurethane.

21. The rapid insertion central venous catheter of claim 18, wherein the second portion of the catheter tube is polyvinyl chloride, polyethylene, polyurethane, or silicone.

22. The rapid insertion central venous catheter of claim 18, wherein the first portion of the catheter tube has a single lumen and the second portion of the catheter tube has a pair of lumens, and at the junction, the pair of lumens transition into the single lumen.

23. The rapid insertion central venous catheter of claim 22, wherein the first and second portions of the catheter tube are welded together by thermal welding, thereby forming the joint between the first and second portions of the catheter tube.

24. The rapid insertion central venous catheter of claim 22, wherein the first and second portions of the catheter tube are welded together by solvent welding to form the joint between the first and second portions of the catheter tube.

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