Quick insertion central catheter and method thereof

Abstract

Rapidly inserted central catheters ("RICCs") and methods thereof are disclosed. A RICC can include a catheter tube comprising a first section in a distal portion of the catheter tube, a second section in a distal portion of the catheter tube proximal to the first section, and a junction between the first section and the second section of the catheter tube. The first section of the catheter tube can be formed of a first material having a first durometer. The second section of the catheter tube can be formed of a second material having a second durometer that is less than the first durometer. The first section and the second section of the catheter tube can have a column strength sufficient to prevent the catheter tube from buckling when inserted into an insertion site and advanced through a patient's vasculature.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 898,408, filed September 10, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to a rapidly insertable central catheter and a method thereof. Background Technology

[0004] Central venous catheters (“CVCs”) are formed from materials with relatively low rigidity, resulting in a lack of column strength. Due to this lack of column strength, CVCs are typically introduced into patients and advanced through their vascular system using the Seldinger technique. The Seldinger technique involves numerous steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the numerous steps are time-consuming, manipulating a large number of medical devices is inconvenient, and both can lead to patient trauma. Furthermore, the need to exchange numerous medical devices during the many steps of the Seldinger technique presents a relatively high risk of contact contamination. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing and advancing the catheter through the patient's vascular system.

[0005] This article discloses a rapid insertion central catheter (“RICC”) and its method for solving the above problems. Summary of the Invention

[0006] This document discloses a RICC (Respiratory Injection Control) which, in some embodiments, includes a catheter tube comprising a first section in a distal portion of the catheter tube, a second section in a distal portion of the catheter tube adjacent 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 hardness. The second section of the catheter tube is formed of a second material having a second hardness (less than the first hardness). The first and second sections of the catheter tube have sufficient column strength to prevent buckling of the catheter tube when inserted into the insertion site and advanced through the patient's vascular system.

[0007] In some embodiments, the joint is a third section of a conduit fitting formed of a third material having a third hardness between the first hardness and the second hardness.

[0008] In some embodiments, the junction includes a tapered distal portion, the first segment of the catheter fitting includes a flared proximal portion, and the tapered distal portion of the junction is located within the flared proximal portion of the first segment of the catheter fitting.

[0009] In some embodiments, the junction includes a proximal portion, the second segment of the catheter fitting includes a distal portion, and the proximal portion of the junction is adjacent to the distal portion of the second segment of the catheter fitting.

[0010] In some implementations, each of the first and second sections of the conduit fitting is welded to the joint by thermal welding.

[0011] In some embodiments, each of the first and second sections of the conduit fitting is welded to the joint using solvent welding.

[0012] In some embodiments, the first section of the catheter fitting includes a flared proximal portion, the second section of the catheter fitting includes a tapered distal portion, and the tapered distal portion of the second section of the catheter fitting is located within the flared proximal portion of the first section of the catheter fitting.

[0013] In some embodiments, each of the first and second sections of the conduit fitting is thermally welded to the other section, thereby forming a joint between the first and second sections of the conduit fitting.

[0014] In some embodiments, each of the first and second sections of the catheter fitting is soldered to the other section by solvent welding, thereby forming a joint between the first and second sections of the catheter fitting.

[0015] In some implementations, the RICC includes a necked-down section around the junction. The necked-down section is configured to provide a smooth transition between the first and second sections of the catheter fitting.

[0016] In some implementations, the first section of the conduit fitting is made of polytetrafluoroethylene, polypropylene, or polyurethane.

[0017] In some implementations, the second section of the conduit fitting is made of polyvinyl chloride, polyethylene, polyurethane, or silicone.

[0018] This document also discloses a method for manufacturing RICC, which in some embodiments includes the step of obtaining each of a first segment, a second segment, and a third segment of a catheter fitting. The first segment of the catheter fitting is formed of a first material having a first hardness. The second segment of the catheter fitting is formed of a second material having a second hardness. The third segment of the catheter fitting is formed of a third material having a third hardness, which is between the first and second hardnesses. The method also includes an flaring step of flaring the proximal portion of the first segment of the catheter fitting to form a flared proximal portion of the first segment of the catheter fitting. The method also includes an insertion step of inserting the tapered distal portion of the third segment of the catheter fitting into the flared proximal portion of the first segment of the catheter fitting. The method also includes an abutment step of abutting the distal portion of the second segment of the catheter fitting and the proximal portion of the third segment of the catheter fitting. The method also includes a welding step of welding the first, second, and third segments of the catheter fitting together to form a joint of the third material between the first and second segments of the catheter fitting.

[0019] In some implementations, a welding step of the second and third sections of the catheter fitting occurs before the insertion step (inserting the tapered distal portion of the third section of the catheter fitting into the flared proximal portion of the first section of the catheter fitting) and the welding step (welding the first and third sections of the catheter fitting together).

[0020] In some implementations, each welding step in the welding process is independently either thermal welding or solvent welding.

[0021] In some embodiments, the method further includes a tapering step of dividing the non-tapered distal end of the third segment of the catheter fitting into a tapering to form a tapered distal portion of the third segment of the catheter fitting.

[0022] In some embodiments, the method further includes a necking step of necking the catheter fitting to form a necking section around the junction. The necking section is configured to provide a smooth transition between the first, second, and third sections of the catheter fitting.

[0023] This document also discloses a method for manufacturing RICC, which in some embodiments includes obtaining a first segment of a catheter fitting formed of a first material having a first hardness and obtaining a second segment of a catheter fitting formed of a second material having a second hardness (which is less than the first hardness). The method further includes an expansion step of expanding a proximal portion of the first segment of the catheter fitting to form a flared proximal portion of the first segment of the catheter fitting. The method further includes an insertion step of inserting a tapered distal portion of the second segment of the catheter fitting into the flared proximal portion of the first segment of the catheter fitting. The method further includes a welding step of welding the first and second segments of the catheter fitting together to form a joint between the first and second segments of the catheter fitting.

[0024] In some implementations, the welding steps include thermal welding or solvent welding.

[0025] In some embodiments, the method further includes a tapering step of dividing the non-tapered distal end of the second segment of the catheter fitting into a tapered shape to form a tapered distal portion of the second segment of the catheter fitting.

[0026] In some embodiments, the method further includes a necking step of necking the catheter fitting to form a necking section surrounding the junction. The necking section is configured to provide a smooth transition between a first section and a second section of the catheter fitting.

[0027] This article also discloses a method for RICC, which in some embodiments includes an insertion site creation step for using a needle to enter the patient's vascular system; an insertion step for inserting the distal portion of the RICC catheter fitting into the insertion site above the needle; and an advancement step for advancing the distal portion of the catheter fitting through the patient's vascular system without using the Seldinger technique.

[0028] In some implementations, the method further includes a withdrawal step of withdrawing the needle from the RICC after the insertion site creation step.

[0029] In some implementations, the insertion site is located in the right subclavian vein or the right internal jugular vein.

[0030] In some implementations, the advancement steps include advancing the distal portion of the catheter fitting through the right subclavian vein or right internal jugular vein, right brachiocephalic vein, and into the superior vena cava.

[0031] This document also discloses a RICC, which in some embodiments includes a catheter fitting comprising a first segment having a single lumen in a distal portion of the catheter fitting, a second segment having a pair of lumens in a distal portion of the catheter fitting adjacent to the first segment, and a junction between the first and second segments of the catheter fitting, in which the pair of lumens transitions into a single lumen. The first segment of the catheter fitting is formed of a first material having a first hardness. The second segment of the catheter fitting is formed of a second material having a second hardness (which is less than the first hardness). The first and second segments of the catheter fitting have column strength sufficient to prevent the catheter fitting from buckling when inserted into the insertion site and advanced through the patient's vascular system.

[0032] This document discloses a RICC (Respiratory Intravascular Coupling), which in some embodiments includes a catheter fitting comprising a first segment in a distal portion of the catheter fitting, a second segment in a distal portion of the catheter fitting adjacent to the first segment, and a junction between the first and second segments of the catheter fitting. The first and second segments of the catheter fitting are formed of the same material or different materials having substantially equal hardness, provided that the first and second segments of the catheter fitting have sufficient column strength to prevent the catheter fitting from buckling when inserted into the insertion site and advanced through the patient's vascular system.

[0033] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of these concepts in more detail. Attached Figure Description

[0034] Figure 1A The remote portion of the first RICC is shown according to some implementation schemes.

[0035] Figure 1B Showing Figure 1A The cross-section of the distal portion of the first RICC.

[0036] Figure 2 A cross section of a second RICC according to some implementation schemes is shown.

[0037] Figure 3 A cross section of a third RICC according to some implementation schemes is shown.

[0038] Figure 4A A partial method for manufacturing at least the first RICC according to some implementation schemes is shown.

[0039] Figure 4B Another part of the method for manufacturing at least the first RICC according to some implementation schemes is shown.

[0040] Figure 5A A partial method for manufacturing at least a first RICC alternative is shown according to some implementation schemes.

[0041] Figure 5B Another part of the method for manufacturing at least a second RICC alternative is shown according to some implementation schemes.

[0042] Figure 6A The remote portion of the fourth RICC is shown according to some implementation schemes.

[0043] Figure 6B Showing Figure 6A The cross-section of the distal portion of the fourth RICC.

[0044] Figure 7 Another part of the method for manufacturing at least the fourth RICC according to some implementation schemes is shown. Detailed Implementation

[0045] Before disclosing certain 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 features of the specific embodiments disclosed herein can be readily separated from the specific embodiments and optionally combined with or substituted for features of any of the other embodiments disclosed herein.

[0046] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or a set of steps, and do not provide for a sequence or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily need to appear in order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Labels such as “left,” “right,” “up,” “down,” “front,” “back,” etc., are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless otherwise expressly indicated by the context, the singular forms “a,” “an,” and “the” include plural references.

[0047] For example, the terms "proximal," "proximal portion," or "proximal portion" as used with respect to the catheter disclosed herein include the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Similarly, for example, the term "proximal length" of the catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the term "proximal end" of the catheter includes one end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

[0048] For example, the terms "distal," "distal portion," or "distal part" as used with respect to the catheter disclosed herein include the portion of the catheter intended to be close to or in the patient when the catheter is used on a patient. Similarly, for example, the term "distal length" of the catheter includes the length of the catheter intended to be close to or in the patient when the catheter is used on a patient. For example, the term "distal end" of the catheter includes one end of the catheter intended to be close to or in the patient when the catheter is used on a patient. The distal portion, distal part, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0049] 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.

[0050] As described above, there is a need to reduce the number of steps and medical devices involved in introducing and advancing a catheter through a patient's vascular system. This article discloses a RICC (Respiratory Intravascular Coagulation) and its method for addressing the aforementioned problems.

[0051] Rapidly inserted central catheter

[0052] Figure 1A The remote portion of the RICC 100 is shown according to some implementation schemes. Figure 1B Showing Figure 1A The cross-section of the far end of the RICC100. Figure 2 A cross section of RICC 200 according to some implementation schemes is shown. Figure 3 A cross section of the RICC 300 is shown according to some implementation schemes. Figure 6A The remote portion of the RICC 600 is shown according to some implementation schemes. Figure 6B Showing Figure 6A The cross-section of the far end of the RICC 600.

[0053] As shown, RICC 100 includes a catheter fitting 110, which includes a first segment 120 in the distal portion of the catheter fitting 110, a second segment 130 in the distal portion of the catheter fitting 110 near the first segment 120, and a junction 140 between the first segment 120 and the second segment 130. Similarly, RICC 200 includes a catheter fitting 210, which includes a first segment 220 in the distal portion of the catheter fitting 210, a second segment 130 in the distal portion of the catheter fitting 220 near the first segment 220, and a junction 240 between the first segment 220 and the second segment 130. Similarly, RICC 300 includes a catheter fitting 310, which includes a first segment 220 in the distal portion of the catheter fitting 310, a second segment 330 in the proximal portion of the catheter fitting 310 near the first segment 220, and a junction 340 between the first segment 220 and the second segment 330. Even more similarly, RICC 600 includes a catheter fitting 610, which includes a first segment 620 in the distal portion of the catheter fitting 610, a second segment 130 in the distal portion of the catheter fitting 610 near the first segment 620, and a junction 140 between the first segment 620 and the second segment 130. In summary, the first segment 120, 220, or 620 of catheter fittings 110, 210, 310, or 610, the second segment 130 or 330 of catheter fittings 110, 210, 310, or 610, and the junction 140, 240, or 340 have sufficient column strength to prevent catheter fittings 110, 210, 310, or 610 from buckling when inserted into the insertion site and advanced through the patient's vascular system. While RICCs 100, 200, 300, and 600 have the aforementioned segments, it should be understood that other segments and configurations of RICCs are also possible.

[0054] Although only a single lumen 112 is shown for RICC 100, 200, 300, or 600, RICC 100, 200, 300, or 600 are not limited to single-lumen catheters. In fact, RICC 100, 200, 300, or 600 can optionally be double-lumen catheters, triple-lumen catheters, quadruple-lumen catheters, etc. Multiple lumens in one section of RICC 100, 200, 300, or 600 can also transition to fewer lumens in another section of RICC 100, 200, 300, or 600. For example, a pair of lumens in the second segment 130 of catheter fitting 110 of RICC 100 can transition to a single lumen in the first segment 120 of catheter fitting 110.

[0055] The first segment 120 or 220 of catheter fitting 110, 210, or 310 includes a flared proximal portion 122 or 222 and a tip 124 of the first segment 120 or 220 of catheter fitting 110, 210, or 310, the tip 124 also serving as the tip 124 of catheter fitting 110, 210, or 310. The flared proximal portion 122 or 222 may differ in degree of expansion, wherein the flared proximal portion 122 of the first segment 110 is more expanded than the flared proximal portion 222 of the first segment 220 of the second catheter fitting 210 or the third catheter fitting 310. Although the first section 620 of catheter fitting 610 also includes a tip 124 (which also serves as the tip 124 of catheter fitting 610), the first section 620 of catheter fitting 610 does not include a flared proximal portion identical to the flared proximal portion 122 or 222 of the first section 120 or 220 of catheter fittings 110, 210, or 310. Instead, the proximal portion 622 of the first section 620 of catheter fitting 610 continues with the same outer diameter as the proximal portion of the first section 620 of catheter fitting 610 near the tip 124.

[0056] The first segment 120, 220, or 620 of the catheter fitting 110, 210, 310, or 610 is formed of a first material having a first hardness. The first material may be polytetrafluoroethylene, polypropylene, or polyurethane, but is not limited to the aforementioned polymers. The advantage of polyurethane is that the first segment 120, 220, or 620 of the catheter fitting 110, 210, 310, or 610 can be relatively rigid at room temperature, but becomes more flexible in the body at body temperature, thereby reducing irritation to the vessel wall and phlebitis.

[0057] like Figure 4B The second section 130 or 330 of the best visible conduit fitting 110, 210, 310 or 610 includes the distal portion 132, 232 or 332.

[0058] The second segment 130 or 330 of the catheter fitting 110, 210, 310, or 610 is formed of a second material having a second hardness less than the first hardness of the first material. The first and second hardnesses can be on different scales (e.g., type A or type D), so the second hardness may not be numerically less than the first hardness. Even so, the hardness of the second material can still be less than the hardness of the first material because different scales (each ranging from 0 to 100) are designed to characterize different materials in a group of materials with similar hardness. The second material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the aforementioned polymers. Polyurethane is advantageous because it can form fewer thrombi compared to some other polymers.

[0059] Nevertheless, the first segment 120, 220, or 620 and the second segment 130 or 330 of the catheter fitting 110, 210, 310, or 610 may be formed of the same material or different materials of substantially equal hardness, provided that the column strength of the catheter fitting 110, 210, 310, or 610 is sufficient to prevent the catheter fitting 110, 210, 310, or 610 from buckling when it is inserted into the insertion site and advanced through the patient's vascular system.

[0060] The joint 140, 240, or 340 may be the third section of the conduit fitting 110, 210, 310, or 610. For example... Figure 4B In the most visible configuration, the joint 140, 240, or 340 includes a tapered distal portion 142, 242, or 342, and a proximal portion 144, 244, or 344. Each of the tapered distal portions 142, 242, and 342 may have a different degree of taper. For example, the tapered distal portion 142 of joint 140 may have a greater taper than the tapered distal portions 242 or 342 of joint 240 or 340.

[0061] The joint 140, 240, or 340 is formed of a third material having a third hardness, the third hardness being between the first hardness of the first material of the first segment 120, 220, or 620 of the conduit fitting 110, 210, 310, or 610 and the second hardness of the second material of the second segment 130 or 330 of the conduit fitting 110, 210, 310, or 610. As explained above, such hardness can be on different scales (e.g., Type A or Type D), so the third hardness may not numerically be between the first and second hardnesses. Alternatively, the third material may have the same hardness as the first material of the first segment 120, 220, or 620 of the conduit fitting 110, 210, 310, or 610 or the second material of the second segment 130 or 330 of the conduit fitting 110, 210, 310, or 610.

[0062] The tapered distal portions 142, 242, or 342 of the joints 140, 240, or 340 are at least partially located within the flared proximal portions 122 or 222 of the first segment 120 or 220 of the catheter fitting 110, 210, or 310. However, with respect to the catheter fitting 610, the tapered distal portion 142 of the joint 140 abuts the proximal portion 622 of the first segment 620 of the catheter fitting 610. The proximal portions 144, 244, or 344 of the joints 140, 240, or 340 abut the distal portions 132 or 332 of the second segment 130 or 330 of the catheter fitting 110, 210, 310, or 610. Each of the first segments 120, 220, or 620 and the second segments 130 or 330 of catheter fittings 110, 210, 310, or 610 is independently welded to the joint 140, 240, or 340 by thermal welding or solvent welding. If one type of welding is used, the first segments 120, 220, or 620 and the second segments 130 or 330 of catheter fittings 110, 210, 310, or 610 can be welded to the joint 140, 240, or 340 in a single thermal welding or solvent welding step. The flared proximal portion 122 of the first segment 120 of catheter fitting 110 is exposed, while the flared proximal portion 222 of the first segment 220 of catheter fitting 210 or 310 is covered by the overlying portion of the joint 240 or 340 for a smoother transition. For an even smoother transition, both the second section 330 and the joint 340 of the conduit fitting 310 can be necked in a necked section surrounding the joint 340.

[0063] As an alternative to the aforementioned, the second section 130 or 330 of the conduit fitting 110, 210, 310, or 610 includes a joint 140, 240, or 340 or a third section of the conduit fitting 110, 210, 310, or 610. That is, the third section of the conduit fitting 110, 210, 310, or 610 is not formed separately from and welded to the second section 130 or 330 of the conduit fitting 110, 210, 310, or 610, but is integrally formed with the second section 130 or 330 of the conduit fitting 110, 210, 310, or 610, such as... Figure 5A As shown above with respect to the second segment 530, the second segment 530 includes a tapered distal portion 542, as illustrated above with respect to the joints 140, 240, or 340. The tapered distal portion 542 can vary in taper. For example, the tapered distal portion 542 of the second segment 530 of catheter fitting 110 or 610 can have a greater taper than that of any of catheter fittings 210 and 310.

[0064] The tapered distal portion 542 of the second segment 530 of catheter fittings 110, 210, or 310 is at least partially located within or adjacent to the flared proximal portion 122 or 222 of the first segment 120 or 220 of catheter fittings 110, 210, or 310, or the proximal portion 622 of the first segment 620 of catheter fittings 610. The first segment 120, 220, or 620 of catheter fittings 110, 210, 310, or 610 and the second segment 530 are welded together by thermal welding or solvent welding. The flared proximal portion 122 of the first segment 120 of catheter fitting 120 is exposed, while the flared proximal portion 222 of the first segment 220 of catheter fitting 210 or 310 is covered by the covering portion of the second segment 530 of catheter fitting 210 or 310 for a smoother transition. For an even smoother transition, the second section 530 of the conduit fitting 310 can be necked in the necking section.

[0065] method

[0066] Figure 4A and 4B Methods for manufacturing at least RICC 100 according to some implementation schemes are demonstrated. In fact, Figure 4A and 4B The method shown also applies to RICC 200 and 300. Figure 7 Methods for manufacturing at least RICC 600 according to some implementation schemes are shown. The method for manufacturing RICC 600 is similar to that in... Figure 4B The method for RICC 100 is shown, but the method for the flared proximal portion 122 of the first section 120 of the conduit fitting 110 is not described. For ease of explanation, reference will be made primarily to the description of manufacturing RICC 100. Figure 4A and 4B The method of manufacturing RICC 200, 300, or 600 will be referred to only if the method of manufacturing RICC 100 is significantly different from that of manufacturing RICC 200 or 300. Figure 4A and 4B The method may refer to the description in RICC 600. Figure 7 The method.

[0067] The method of manufacturing RICC 100 includes obtaining each of the first segment 120, the second segment 130, and the joint or third segment 140 of the conduit fitting 110. Furthermore, the first segment 120 of the conduit fitting 110 is formed of a first material having a first hardness, the second segment 130 of the conduit fitting 110 is formed of a second material having a second hardness, and the third segment 140 of the conduit fitting 110 is formed of a third material having a third hardness, the third hardness being between the first and second hardnesses. Such materials with different hardnesses utilize different melting temperatures and facilitate welding between the different segments 120, 130, and 140 of the conduit fitting 110 sufficient for use with RICC 100.

[0068] The method also includes an expansion step of expanding the proximal portion of the initial (nascent) first segment 424 of the catheter fitting 110 to form a first segment 120 of the catheter fitting 110 having a flared proximal portion 122. Note that the first segment 620 of the catheter fitting 610 does not include a flared proximal portion identical to the flared proximal portion 122 of the first segment 120 of the catheter fitting 110. Therefore, the method of manufacturing the RICC 600 does not require the aforementioned expansion step.

[0069] The method also includes an insertion step of inserting the tapered distal portion 142 of the third segment 140 of the catheter fitting 110 into the flared proximal portion 122 of the first segment 120 of the catheter fitting 110. Note that the first segment 620 of the catheter fitting 610 does not include a flared proximal portion identical to the flared proximal portion 122 of the first segment 120 of the catheter fitting 110. Therefore, the method of manufacturing the RICC 600 does not need to include the aforementioned insertion step. Instead, the method of manufacturing the RICC 600 includes an abutment step of abutting the tapered distal portion 142 of the third segment 140 of the catheter fitting 610 against the proximal portion 622 of the first segment 620 of the catheter fitting 610.

[0070] The method also includes an adjacency step that brings the distal portion 132 of the second segment 130 of the catheter fitting 110 and the proximal portion 144 of the third segment 140 of the catheter fitting 110 together.

[0071] The method also includes a welding step of welding the first, second and third sections of the conduit fitting 110 together to form a joint 140 of a third material between the first section 120 and the second section 130 of the conduit fitting 110.

[0072] Before the insertion step of inserting the tapered distal portion 142 of the third segment 140 of the conduit fitting 110 into the flared proximal portion 122 of the first segment 120 of the conduit fitting 110 and the welding step of welding the first segment 120 and the third segment 140 of the conduit fitting 110 together, a welding step of welding the second segment 130 and the third segment 140 of the conduit fitting 110 occurs. Regarding the method of manufacturing RICC 600, before the abutment step of placing the tapered distal portion 142 of the third segment 140 of the conduit fitting 610 adjacent to the proximal portion 622 of the first segment 620 of the conduit fitting 610 and the welding step of welding the first segment 620 and the third segment 140 of the conduit fitting 610 together, a welding step of welding the second segment 130 and the third segment 140 of the conduit fitting 610 occurs. Each welding step is independently thermal welding (e.g., radio frequency [“RF”] welding) or solvent welding.

[0073] Expanding the proximal portion of the initial first segment 424 of the conduit fitting 110 to form a flared proximal portion 122 of the first segment 120 of the conduit fitting 110 and inserting the tapered distal portion 142 of the third segment 140 of the conduit fitting 110 into the flared proximal portion 122 of the first segment 120 of the conduit fitting 110 makes it possible to place an RF welding element at a short distance from the start of the flared proximal portion 122 of the first segment 120 of the conduit fitting 110. This reduces the risk of introducing defects or weaknesses into the conduit fitting 110. The RF welding element will touch off the short distal end and the short proximal end of the portion 121, where the flared proximal portion 122 of the first segment 120 of the conduit fitting 110 begins at portion 121, to avoid excessive heat exposure to the thin wall of the first segment 120 of the conduit fitting 110.

[0074] The method further includes a tapering step of dividing the non-tapered distal end of the third segment 140 of the catheter fitting 110 into a tapered shape to form a tapered distal portion 142 of the third segment 140 of the catheter fitting 110.

[0075] For at least RICC 300, the method further includes a necking step of necking the catheter fitting 310 to form a necked section surrounding the junction 340. The necked section is configured to provide a smooth transition between a first section, a second section, and a third section of the catheter fitting 310.

[0076] Figure 5A and 5B Methods for manufacturing alternatives to RICC 100 according to some implementation schemes are demonstrated.

[0077] A method for manufacturing a substitute for RICC 100 includes the steps of obtaining a first segment 120 of a conduit fitting 110 and a second segment 530 of the conduit fitting 110, the first segment being formed of a first material having a first hardness, and the second segment being formed of a second material having a second hardness (which is less than the first hardness). The method also includes making, as in... Figure 4B The method includes an expansion step in which the initial first segment 424 of the illustrated catheter fitting 110 is expanded to form a flared proximal portion 122 of the first segment 120 of the catheter fitting 110. The method also includes an insertion step in which a tapered distal portion 542 of the second segment 530 of the catheter fitting 110 is inserted into the flared proximal portion 122 of the first segment 120 of the catheter fitting 110. The method further includes a welding step in which the first segment 120 and the second segment 530 of the catheter fitting 110 are thermally or solvent-welded together to form a joint therebetween.

[0078] The method further includes a tapering step of forming a tapered distal portion 132 of the second segment 130 of the conduit fitting 110 into a tapered distal portion 542 of the second segment 530 of the conduit fitting 110. The tapered distal portion 542 of the second segment 530 of the conduit fitting 110 can be formed by removing some material from the non-tapered distal portion 132 of the second segment 130 of the conduit fitting 110 or by melting or dissolving some material during a welding step.

[0079] For at least RICC 300, the method further includes a necking step of necking the catheter fitting 310 to form a necking section surrounding the junction between a first section 120 and a second section 530 of the catheter fitting 110. The necking section is configured to provide a smooth transition between the first section 120 and the second section 530 of the catheter fitting 310.

[0080] The method of manufacturing each of RICCs 100, 200 and 300 further includes a mandrel mounting step to prevent the inner cavity of RICCs 100, 200 and 300 from collapsing during further welding steps.

[0081] The method of the RICC 100 includes an insertion site creation step using a needle to create an insertion site for access to the patient's vascular system; an insertion step inserting the distal portion of the catheter fitting 110 of the RICC 100 into the insertion site above the needle; and an advancement step advancing the distal portion of the catheter fitting 110 through the patient's vascular system without using the Seldinger technique. The smaller outer diameter of the first segment 120 of the RICC 100 facilitates the insertion step, which requires at least pushing through the skin tissue. Furthermore, the transition between the first segment 120 and the second segment 130 eliminates barriers at least in the skin tissue, making it possible to insert the RICC 100 as a peripheral venous (“IV”) catheter.

[0082] The method further includes a withdrawal step that removes the needle from the RICC 100 after the insertion site creation step.

[0083] The insertion site is located in the right subclavian vein or the right internal jugular vein.

[0084] The advancement steps include advancing the distal portion of the catheter fitting 110 through the right subclavian vein or right internal jugular vein, right brachiocephalic vein, and into the superior vena cava.

[0085] While specific embodiments have been disclosed herein, and have been described in detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, departing from the specific embodiments disclosed herein is permissible without departing from the scope of the concepts provided herein.

Claims

1. A central catheter for rapid insertion, comprising: A first section of the conduit fitting, the first section being formed of a first material having a first hardness, the first section being located in the distal portion of the conduit fitting; The second section of the catheter fitting is formed of a second material having a second hardness less than the first hardness, and the second section is located in the distal portion of the catheter fitting proximal to the first section. and A junction is provided between the first and second sections of the catheter fitting, the first and second sections of the catheter fitting having column strength sufficient to prevent the catheter fitting from buckling when the catheter fitting is inserted to the insertion site and advanced through the patient's vascular system. The joint is the third section of the conduit fitting, the third section being formed of a third material having a third hardness, the third hardness being between the first hardness and the second hardness. The joint includes a tapered distal portion, the first section of the catheter fitting includes a flared proximal portion, and the tapered distal portion of the joint is located within the flared proximal portion of the first section of the catheter fitting.

2. The rapid insertion central catheter of claim 1, wherein the junction includes a proximal portion, the second segment of the catheter fitting includes a distal portion, and the proximal portion of the junction is adjacent to the distal portion of the second segment of the catheter fitting.

3. The rapid insertion central conduit according to claim 1 or 2, wherein each of the first and second sections of the conduit fitting is thermally welded to the joint.

4. The rapid insertion central conduit according to claim 1 or 2, wherein each of the first and second sections of the conduit fitting is soldered to the joint by solvent welding.

5. A central catheter for rapid insertion, comprising: A first section of the conduit fitting, the first section being formed of a first material having a first hardness, the first section being located in the distal portion of the conduit fitting; The second section of the catheter fitting is formed of a second material having a second hardness less than the first hardness, and the second section is located in the distal portion of the catheter fitting proximal to the first section. and A junction is provided between the first and second sections of the catheter fitting, the first and second sections of the catheter fitting having column strength sufficient to prevent the catheter fitting from buckling when the catheter fitting is inserted to the insertion site and advanced through the patient's vascular system. The first section of the catheter fitting includes a flared proximal portion, the second section of the catheter fitting includes a tapered distal portion, and the tapered distal portion of the second section of the catheter fitting is located within the flared proximal portion of the first section of the catheter fitting. Each of the first and second sections of the catheter fitting is welded to the other section by thermal welding or solvent welding, thereby forming the joint between the first and second sections of the catheter fitting.

6. The quick-insertion central catheter according to claim 1 or 5, wherein the quick-insertion central catheter includes a necking section around the junction, the necking section being configured to provide a smooth transition between the first section and the second section of the catheter fitting.

7. The rapid insertion central conduit according to claim 1 or 5, wherein the first section of the conduit fitting is polytetrafluoroethylene, polypropylene, or polyurethane.

8. The rapid insertion central conduit according to claim 1 or 5, wherein the second section of the conduit fitting is made of polyvinyl chloride, polyethylene, polyurethane, or silicone.

9. The rapid insertion central catheter according to claim 1 or 5, The first section has a single lumen in the distal portion of the catheter fitting; The second section has a pair of lumens in the distal portion of the catheter fitting located proximal to the first section; and in, In the joint, the pair of cavities transition into the single cavity.

10. A method for manufacturing a rapid-insertion central catheter, comprising: A first section, a second section, and a third section of a catheter fitting are obtained, wherein the first section is formed of a first material having a first hardness, the second section is formed of a second material having a second hardness, and the third section is formed of a third material having a third hardness, wherein the third hardness is between the first hardness and the second hardness; The proximal portion of the first section of the catheter fitting is expanded to form a funnel-shaped proximal portion of the first section of the catheter fitting. The distal conical portion of the third section of the catheter fitting is inserted into the proximal flared portion of the first section of the catheter fitting. The distal portion of the second section of the catheter fitting is adjacent to the proximal portion of the third section of the catheter fitting. and The first section, the second section, and the third section of the conduit fitting are welded together to form a joint of the third material between the first section and the second section of the conduit fitting.

11. The method of claim 10, wherein the second and third segments of the catheter fitting are welded before inserting the tapered distal portion of the third segment of the catheter fitting into the flared proximal portion of the first segment of the catheter fitting and before welding the first and third segments of the catheter fitting together.

12. The method according to claim 10 or 11, wherein the welding is independently thermal welding or solvent welding.

13. The method of claim 10, further comprising dividing the non-tapered distal end of the third segment of the catheter fitting into a tapered shape to form the tapered distal portion of the third segment of the catheter fitting.

14. The method of claim 10, further comprising necking the catheter fitting to form a necked section around the junction, the necked section being configured to provide a smooth transition between the first section, the second section and the third section of the catheter fitting.

15. A method for manufacturing a rapid-insertion central catheter, comprising: A first section of the catheter fitting and a second section of the catheter fitting are obtained, wherein the first section is formed of a first material having a first hardness, and the second section is formed of a second material having a second hardness, wherein the second hardness is less than the first hardness; The proximal portion of the first section of the catheter fitting is expanded to form a funnel-shaped proximal portion of the first section of the catheter fitting. The distal conical portion of the second section of the catheter fitting is inserted into the proximal flared portion of the first section of the catheter fitting. and The first and second sections of the catheter fitting are welded together to form a joint between the first and second sections of the catheter fitting.

16. The method of claim 15, wherein the welding is thermal welding or solvent welding.

17. The method of claim 15 or 16, further comprising dividing the non-tapered distal end of the second segment of the catheter fitting into a tapered portion to form the tapered distal portion of the second segment of the catheter fitting.

18. The method of claim 15, further comprising necking the catheter fitting to form a necked section around the junction, the necked section being configured to provide a smooth transition between the first section and the second section of the catheter fitting.

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