Rapid Insertion-Type Central Venous Catheter and Method Thereof

Abstract

A rapid insertion central venous catheter (RICC) and method thereof are disclosed. For example, the RICC may include a catheter tube, suture wings disposed on an intermediate portion of the catheter tube, a hub connected to a proximal end portion of the catheter tube, and a plurality of extension legs. The catheter tube may include a first portion located at a distal portion of the catheter tube and a second portion located proximal to the first portion. The second portion of the catheter tube may include an outer layer extruded over an inner layer such that the outer diameter of the catheter tube is larger at the second portion than at the first portion of the catheter tube. The catheter tube has sufficient column buckling strength to prevent buckling when the catheter tube is inserted into an insertion site and advanced through a patient's vasculature.

Description

Technical Field

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

Background Art

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

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

Summary of the Invention

[0004] Disclosed herein is a RICC, and in some embodiments, the RICC includes a catheter tube, a suture wing disposed on an intermediate portion of the catheter tube, a hub coupled to a proximal end portion of the catheter tube, and a plurality of extension legs equal in number to the number of lumens extending through the RICC. The catheter tube includes a first portion located at a distal portion of the catheter tube and a second portion proximal to the first portion. The second portion of the catheter tube includes an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that an outer diameter of the catheter tube is larger at the second portion than at the first portion of the catheter tube.

[0005] In some embodiments, the inner layer of the catheter tube is formed of a first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of a second polymer material having a second durometer hardness less than the first durometer hardness.

[0006] In some embodiments, the inner layer of the catheter tube is formed of a first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of a second polymer material having a second durometer hardness substantially equal to the first durometer hardness.

[0007] In some embodiments, each of the first and second polymer materials is polyurethane. In some embodiments, each of the inner and outer layers of the catheter tube is formed of the same polymer material.

[0008] In some embodiments, the polymer material is polyurethane. In some embodiments, the catheter tube further includes a bump that defines a boundary of a third portion of the catheter tube proximal to the second portion. The third portion has an outer diameter larger than both the first portion and the second portion of the catheter tube.

[0009] In some embodiments, the suture wing is disposed on the bump of the catheter tube such that the catheter tube proximal to the suture wing has an outer diameter larger than the catheter tube distal to the suture wing.

[0010] In some embodiments, the catheter tube between the suture wing and the hub has a reverse taper in which the outer diameter of the catheter tube continuously increases from the suture wing to the hub.

[0011] In some embodiments, the RICC is a three-lumen catheter that includes a trifurcated hub as the hub. The RICC also has three extension legs extending from the hub. Each of the three extension legs includes a luer connector connected to the proximal end portion of the extension leg.

[0012] In some embodiments, the RICC includes a first lumen extending from the opening at the proximal end of the first luer connector to the opening at the distal end of the first portion of the catheter tube, a second lumen extending from the opening at the proximal end of the second luer connector to the first eyelet at the distal portion of the second portion of the catheter tube, and a third lumen extending from the opening at the proximal end of the third luer connector to the second eyelet at the distal portion of the second portion of the catheter tube.

[0013] In some embodiments, the RICC is a two-lumen catheter that includes a bifurcated hub as the hub. The RICC also has two extension legs extending from the hub. Each of the two extension legs includes a luer connector connected to the proximal end portion of the extension leg.

[0014] In some embodiments, the RICC includes a first lumen extending from an opening at the proximal end of a first luer connector to an opening at the distal end of the first portion of the catheter tube, and a second lumen extending from an opening at the proximal end of a second luer connector to an eyelet at the distal portion of the second portion of the catheter tube.

[0015] In some embodiments, the catheter tube has a column buckling strength sufficient to prevent buckling of the catheter tube when inserted at an insertion site and advanced within a patient's vasculature.

[0016] Also disclosed herein is a catheter tube, and in some embodiments, the catheter tube includes a first portion located at a distal portion of the catheter tube and a second portion proximal to the first portion. The second portion of the catheter tube includes an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that an outer diameter of the catheter tube is larger at the second portion than at the first portion of the catheter tube. The catheter tube has a column buckling strength sufficient to prevent buckling of the catheter tube when inserted at an insertion site and advanced within a patient's vasculature without using the Seldinger technique.

[0017] In some embodiments, the inner layer of the catheter tube is formed of a first polymeric material having a first durometer hardness, and the outer layer of the catheter tube is formed of a second polymeric material having a second durometer hardness that is less than the first durometer hardness.

[0018] In some embodiments, the inner layer of the catheter tube is formed of a first polymeric material having a first durometer hardness, and the outer layer of the catheter tube is formed of a second polymeric material having a second durometer hardness that is substantially equal to the first durometer hardness.

[0019] In some embodiments, each of the first and second polymer materials is polyurethane. In some embodiments, each of the inner layer and the outer layer of the catheter tube is formed of the same polymer material.

[0020] In some embodiments, the polymer material is polyurethane. In some embodiments, the catheter tube further includes a bump that defines a boundary of a third portion of the catheter tube that is proximal to the second portion. The third portion has an outer diameter that is larger than both the first portion and the second portion of the catheter tube.

[0021] In some embodiments, the catheter tube between the bump and the proximal end of the third portion of the catheter tube has a reverse taper in which the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third portion of the catheter tube.

[0022] In some embodiments, the catheter tube is a three-lumen catheter tube including a first lumen extending from a first opening at the proximal end of the catheter tube to an opening at the distal end of the first portion of the catheter tube, a second lumen extending from a second opening at the proximal end of the catheter tube to a first eyelet at the distal portion of the second portion of the catheter tube, and a third lumen extending from a third opening at the proximal end of the catheter tube to a second eyelet at the distal portion of the second portion of the catheter tube.

[0023] In some embodiments, the catheter tube is a two-lumen catheter tube including a first lumen extending from a first opening at the proximal end of the catheter tube to an opening at the distal end of the first portion of the catheter tube, and a second lumen extending from a second opening at the proximal end of the catheter tube to an eyelet at the distal portion of the second portion of the catheter tube.

[0024] Also disclosed herein is a method for manufacturing a layered catheter tube such as the aforementioned catheter tube, including an inner layer forming step of forming an inner layer of the catheter tube by extruding a single lumen tube made of a first polymer material. The method further includes an inserting step of inserting an end of the single lumen tube into a die of an extruder. The method further includes a second layer forming step of forming the outer layer of the catheter tube by forming a mixed layer tube having portions of the single lumen tube interspersed with portions of the layered tube by periodically extruding a melt made of a second polymer material through the die around the single lumen tube. Further, the method includes a pulling step of pulling the mixed layer tube through a cooling bath equipped with a puller to cool the mixed layer tube. The method further includes a cutting step of cutting the mixed layer tube at at least the portion of the single lumen tube with a cutter to form a layered catheter tube.

[0025] In some embodiments, the method further includes a lumen forming step of forming one or more additional lumens in the single lumen tube by injecting air into the melt made of the second polymer material while extruding the melt made of the second polymer material through the die around the die.

[0026] In some embodiments, the method further includes an eyelet forming step of creating one or more eyelets in the portion of the layered tube to correspondingly establish one or more openings to the one or more additional lumens.

[0027] In some embodiments, the method is a bump forming step of forming bumps on an outer diameter of the portion of the layered tube, further including increasing an outer diameter after the bumps by periodically slowing a speed at which the mixed layer tube is pulled by the puller.

[0028] In some embodiments, the method further includes an inverse taper forming step of forming the outer diameter of the portion of the layered tube into an inverse taper after the bumps by continuously slowing a speed at which the mixed layer tube is pulled by the puller.

[0029] In some embodiments, the method further includes an adhesive layer forming step of forming an adhesive layer on the single lumen tube before extruding the melt made of the second polymer material through the die around the single lumen tube.

[0030] In some embodiments, the first polymer material has a first durometer hardness, and the second polymer material has a second durometer hardness smaller than the first durometer hardness.

[0031] In some embodiments, the first polymer material has a first durometer hardness, and the second polymer material has a second durometer hardness substantially equal to the first durometer hardness.

[0032] In some embodiments, each of the first and second polymer materials is polyurethane. These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly describe certain embodiments of such concepts.

Brief Description of the Drawings

[0033]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5

MODE FOR CARRYING OUT THE INVENTION

[0034] 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 be easily separated from the specific embodiments and can optionally have features that can be combined with or substituted for the features of any of the many other embodiments disclosed herein.

[0035] Regarding the terms used in this specification, it should also be understood that the terms are for the purpose of describing some specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or multiple steps and do not provide successive limitations or numerical restrictions. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left", "right", "front", "rear", "upper", "lower", etc. are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless clearly indicated otherwise in the context.

[0036] Regarding "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 does not necessarily have to include the distal end of the catheter. That is, except as suggested by the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0037] Regarding "distal", for example, the "distal portion" or "distal end portion" of the catheter disclosed herein includes the portion of the catheter that is intended to be near or within the patient when the catheter is used in the patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used in the patient. For example, the "distal end" of the needle includes the end of the catheter that is intended to be near or within the patient when the catheter is used in the patient. The distal portion, distal end portion, or distal length of the catheter can include the distal end of the catheter, but the distal portion, distal end portion, or distal length of the catheter does not necessarily include the distal end of the catheter. That is, except as suggested by the context, the distal portion, distal end portion, or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0038] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As described above, 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 within its vasculature. In the present application, a RICC and its method for addressing the above are disclosed.

[0039] Rapid Insertion Central Catheter FIG. 1 shows an isometric view of a RICC 100 according to some embodiments. FIG. 2 shows an exploded view of a RICC 100 according to some embodiments.

[0040] As shown, the RICC 100 includes a catheter tube 110, a suture wing 140, a hub 150, and several extension legs 160 extending from the hub 150. The suture wing 140 is disposed over an intermediate portion of the catheter tube 110 between the proximal portion and the distal portion of the catheter tube 110. The suture wing 140 includes a through hole that extends longitudinally through the suture wing 140 configured to insert the catheter tube 110. (See, for example, FIG. 2.) The suture wing 140 includes a pair of wings 142 that include a plurality of through holes 244 for suturing the suture wing 140 to the patient. Each wing of the pair of wings 142 may include one, two, three, or four through holes for suturing the suture wing 140 to the patient.

[0041] The hub 150 is connected to the proximal end portion of the catheter tube 110, such as by inserting the proximal end portion of the catheter tube 110 into a bore located at the distal end portion of the hub 150. Although not shown, the hub 150 includes a plurality of bores corresponding to the number of extension legs 160 at the proximal end portion of the hub 150. The plurality of bores located at the distal end portion of the hub 150 are configured to receive insertion of the plurality of extension legs 160 into the plurality of bores.

[0042] The RICC 100 may be a single lumen catheter or a multi-lumen catheter such as a two-lumen catheter, a three-lumen catheter, a four-lumen catheter, a five-lumen catheter, or a six-lumen catheter. Thus, the hub 150 is either unbranched for a single lumen catheter or branched according to the plurality of lumens extending through the RICC 100. For example, the hub 150 may bifurcate into two branches for a two-lumen catheter or divide into three branches for a three-lumen catheter. Depending on the selected manufacturing method, the hub 150 may be molded over a plurality of core pins for a plurality of fluid paths that extend longitudinally through the hub 150 configured to fluidly connect the plurality of catheter tube lumens of the catheter tube 110 to the plurality of extension leg lumens of the plurality of extension legs 160. Alternatively, the hub 150 may be molded over a plurality of cannulas that extend longitudinally through the hub 150 configured to fluidly connect the plurality of catheter tube lumens of the catheter tube 110 to the plurality of extension leg lumens of the plurality of extension legs 160.

[0043] The plurality of extension legs 160 extend from the hub 150 via their distal end portions. The number of extension legs 160 is the same as the number of lumens extending through the RICC 100. For example, if the RICC 100 is a single-lumen catheter, one extension leg extends from the hub 150. If the RICC 100 is a two-lumen catheter, two extension legs extend from the hub 150. If the RICC 100 is a three-lumen catheter, three extension legs extend from the hub 150.

[0044] The RICC 100 further includes a plurality of luer connectors 170 for fluidly connecting a plurality of medical devices to the RICC 100. Each extension leg of the plurality of extension legs 160 includes one of the plurality of luer connectors 170 coupled to the proximal end portion of the extension leg. In view of the above, the number of luer connectors 170 is equal to the number of extension legs 160, and then the number of extension legs 160 is equal to the number of lumens extending through the RICC 100. For example, if the RICC 100 is a single-lumen catheter, one extension leg extends from the hub 150 and one luer connector is coupled to the one extension leg. If the RICC 100 is a two-lumen catheter, two extension legs extend from the hub 150 and two luer connectors are respectively coupled to the two extension legs. If the RICC 100 is a three-lumen catheter, three extension legs extend from the hub 150 and three luer connectors are respectively coupled to the three extension legs.

[0045] The catheter tube 110 includes at least a first portion 212 located at the distal portion of the catheter tube 110 and a second portion 214 located proximal to the first portion 212 of the catheter tube 110. The catheter tube 110 can include a transition portion 216 between the first section 212 and the second section 214 of the catheter tube 110 according to the method of manufacturing the catheter tube 110 shown below. In fact, according to the manufacturing method described below, the second portion 214 of the catheter tube 110 has an outer diameter of the catheter tube 110 larger in the second portion 214 than in the first portion 212 of the catheter tube 110 starting from the transition portion 216 between the first portion 212 and the second portion 214 of the catheter tube 110, and includes an outer layer 414 (see FIG. 4B) of the catheter tube 110 extruded onto an inner layer 412 (see FIGS. 4A to 4D) of the catheter tube 110.

[0046] The inner layer 412 of the catheter tube 110 is formed of a first polymer material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer hardness, while the outer layer 414 of the catheter tube 110 has a second durometer hardness that is less than, greater than, or substantially equal to the first durometer hardness, and is formed of a second polymer material (polyvinyl chloride, polyethylene, polyurethane, or silicone). For example, each layer of the inner layer 412 and the outer layer 414 of the catheter tube 110 may be manufactured from different polyurethanes having different durometer hardnesses (e.g., those obtained by reacting the same or different diisocyanates or triisocyanates with different diols or triols, those obtained by reacting the same or different diisocyanates or triisocyanates with different diols or triols, etc.). In fact, polyurethane is advantageous for the catheter tube 110 in that it is relatively rigid at room temperature but becomes more flexible in vivo at body temperature, reducing irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous in that it has a lower thrombogenicity than some other polymers.

[0047] It should be understood that the first durometer hardness and the second durometer hardness may be on different scales (e.g., type A or type D). Thus, if the second durometer hardness of the second polymer material is less than the first durometer of the first polymer material, the second durometer hardness may not be numerically less than the first durometer hardness. Similarly, if the second durometer hardness of the second polymer material is greater than the first durometer of the first polymer material, the second durometer hardness may not be numerically greater than the first durometer hardness. That is, since different scales (each in the range from 0 to 100) are designed to characterize different materials in groups of materials having similar hardnesses, the hardness of the second polymer material may still be less than or greater than the hardness of the first polymer material.

[0048] Notwithstanding the foregoing description, the inner layer 412 and the outer layer 414 of the catheter tube 110 may be formed of the same polymer material (e.g., polyurethane) having substantially the same durometer hardness if the column buckling strength of the catheter tube 110 is sufficient to prevent buckling of the catheter tube 110 when inserted into the insertion site and advanced through the patient's vasculature.

[0049] The catheter tube 110 having at least a first portion 212 made of a first polymer material and a second portion 214 having an inner layer 412 made of a first polymer material and an outer layer 414 made of a second polymer material has a column buckling strength sufficient to prevent buckling of the catheter tube 110 as the catheter tube 110 is inserted into the insertion site and advances through the patient's vasculature. The column buckling strength of the catheter tube 110 is notable in that the catheter tube 110 can be quickly inserted into the insertion site and advanced through the patient's vasculature without using the Seldinger technique.

[0050] The catheter tube 110 can include a third portion 218 that is located proximal to a second portion 214 of the catheter tube 110 and includes a bump diameter bounded by a bump 217 in an intermediate portion of the catheter tube 110. The third portion 218 of the catheter tube 110 has an outer diameter that is larger than both the first portion 212 and the second portion 214 of the catheter tube 110. As shown in FIGS. 1 and 2, the suture wing 140 can be disposed on the bump 217. Thus, the proximal catheter tube 110 of the suture wing 140 has an outer diameter that is larger than the distal catheter tube 110 of the suture wing 140, as also referred to herein as a catheter tube extension. The larger outer diameter of the third portion 218 of the proximal catheter tube 110 of the suture wing 140 provides a catheter-tube wall that is thicker and more torsion-resistant, which is useful for bending the hub 150 and the plurality of extension legs 160 away from the patient's head or neck during use of the RICC 100. Further, any lumens present in the catheter tube 110 may have a larger diameter in the third portion 218 of the proximal catheter tube 110 of the suture wing 140 than distal to the suture wing 140. This prevents a decrease in flow rate, particularly when the third portion 218 of the proximal catheter tube 110 of the suture wing 140 is bent away from the patient's head or neck.

[0051] The catheter tube 110 between the suture wing 140 and the hub 150 has a reverse taper in which the outer diameter of the catheter tube 110 continuously increases from the suture wing 140 to the hub 150. In other words, the catheter tube 110 tapers from the hub 150 towards the suture wing 140, but continues to have a larger outer diameter than the catheter tube 110 distal to the suture wing 140. In connection with the outer diameter of the catheter tube 110 continuously increasing from the suture wing 140 to the hub 150, the thickness of the catheter tube wall may continuously increase, any lumen of the catheter tube 110 may have a continuously increasing cross-sectional area, or a combination thereof. As a result, in particular when the catheter tube 110 proximal to the suture wing 140 is bent away from the patient's head or neck, the catheter tube 110 between the suture wing 140 and the hub 150 is more resistant to twisting and flow reduction. Despite the above description, the catheter tube 110 between the suture wing 140 and the hub 150 may instead have a constant diameter from the suture wing 140 to the hub 150.

[0052] Advantageously, the catheter tube 110 (e.g., the third portion 218 of the catheter tube 110) between the suture wing 140 and the hub 150, or the catheter tube extension, is a single catheter tube configured to reduce bacterial entry between the dressing applied over the suture wing 140 and the patient's skin. Existing CVCs or peripherally inserted central catheters (PICCs) have multiple extension legs extending from a combination of suture wings and hubs common to the CVC and PICC. The multiple extension legs of the CVC or PICC provide multiple pathways under the dressing for microbial entry. The catheter tube 110, which is a single catheter tube at least between the suture wing 140 and the hub 150, allows the dressing to be clamped more tightly around the catheter tube 110 than the multiple extension legs of existing CVCs or PICCs. For example, the dressing can be easily wrapped around the entire catheter tube 110 and clamped together under the catheter tube 110 between the catheter tube 110 and the patient. In contrast, as described for the extension portion of the catheter tube, even if the dressing is wound around the multiple extension legs of an existing CVC or PICC, gaps for bacteria to enter are created between adjacent extension tubes. Thus, the catheter tube 110, which is a single catheter tube, limits the entry of bacteria between the dressing applied over the suture wing 140 and the patient's skin.

[0053] The catheter tube 110 between the suture wing 140 and the hub 150, or the catheter tube extension, is also configured to reduce patient discomfort due to the multiple extension legs 160 adjacent to the patient's head or neck. As described above, the third portion 218 of the catheter tube 110 proximal to the suture wing 140 provides a thicker and more kink-resistant catheter-tube wall, but the third portion 218 of the catheter tube 110 is sufficiently flexible to bend the catheter tube 110 away from the patient's head or neck and be secured to the patient for the patient's comfort.

[0054] FIG. 3 shows the distal portion of the catheter tube 110 of the RICC100 according to some embodiments. FIGS. 4A through 4D show various cross-sections of the catheter tube according to some embodiments.

[0055] In this case as well, the RICC100 may be a single-lumen catheter or a multi-lumen catheter such as a two-lumen catheter, a three-lumen catheter, a four-lumen catheter, a five-lumen catheter, or a six-lumen catheter. The catheter tube 110 may correspondingly be a single-lumen catheter tube or a multi-lumen catheter tube such as a two-lumen catheter tube, a three-lumen catheter tube, a four-lumen catheter tube, a five-lumen catheter tube, or a six-lumen catheter tube.

[0056] As shown in FIGS. 1, 2, and 4A through 4D, when the RICC100 is configured as a three-lumen catheter, the RICC100 includes a first lumen, a second lumen, and a third lumen. The first lumen extends from the opening at the proximal end of the first luer connector among the plurality of luer connectors 170 to the tip or the distal end opening of the first portion 212 of the catheter tube 110. The second lumen extends from the opening at the proximal end of the second luer connector among the plurality of luer connectors 170 to the eyelet 320 at the distal portion of the second portion 214 of the catheter tube 110. The third lumen extends from the opening at the proximal end of the third luer connector among the plurality of luer connectors 170 to the base end eyelet 322 of the eyelet 320 located at the distal portion of the second portion 214 of the catheter tube 110. Each of the first lumen, the second lumen, and the third lumen will be described in detail in another paragraph described below.

[0057] The first lumen of the RICC100 includes a first catheter tube lumen 424 that extends along the entire length of the catheter tube 110, a first flow path or first cannula lumen of the hub 150, a first extension leg lumen of a first one of the plurality of extension legs 160 (e.g., the extension leg labeled "distal" in FIGS. 1 and 2), and a first luer connector lumen of a first one of the plurality of luer connectors 170, and includes a fluidly connected lumen portion.

[0058] The second lumen of the RICC100 includes a fluidly connected lumen portion that includes a second catheter tube lumen 426 that extends proximally from the outlet 320 of the distal portion of the second portion 214 of the catheter tube 110 along the remainder of the catheter tube 110. The fluidly connected lumen portion of the second lumen of the RICC100 further includes a second flow path or second cannula lumen of the hub 150, a second extension leg lumen of a second one of the plurality of extension legs 160 (e.g., the extension leg labeled "intermediate" in FIGS. 1 and 2), and a second luer connector lumen of a second one of the plurality of luer connectors 170.

[0059] The third lumen of the RICC100 includes a fluidly connected lumen portion that includes a third catheter tube lumen 428 that extends proximally from the outlet 322 of the distal portion of the second portion 214 of the catheter tube 110 along the remainder of the catheter tube 110. The fluidly connected lumen portion of the third lumen of the RICC100 further includes a third flow path or third cannula lumen of the hub 150, a third extension leg lumen of a third one of the plurality of extension legs 160 (e.g., the extension leg labeled "proximal" in FIGS. 1 and 2), and a third luer connector lumen of a third one of the plurality of luer connectors 170.

[0060] When the RICC100 is configured as a two-lumen catheter, the RICC100 includes a first lumen and a second lumen. Similarly, when the RICC100 is configured as a three-lumen catheter, the first lumen extends from the opening at the proximal end of the first luer connector among the plurality of luer connectors 170 to the tip or the distal opening of the first portion 212 of the catheter tube 110. The second lumen extends from the opening at the proximal end of the second luer connector among the plurality of luer connectors 170 to the eyelet 320 at the distal portion of the second portion 214 of the catheter tube 110. Since the first lumen and the second lumen of the RICC100 configured as a two-lumen catheter are similar to the first lumen and the second lumen of the RICC100 configured as a three-lumen catheter, additional details regarding each of the first lumen and the second lumen can be recognized from the above description of the first lumen and the second lumen of the RICC100 configured as a two-lumen catheter.

[0061] When the RICC100 is configured as a single-lumen catheter, the RICC100 includes a single lumen, which is referred to herein as the first lumen for the sake of consistency with the above description. Similarly, when the RICC100 is configured as a three-lumen catheter, the first lumen extends from the opening at the proximal end of the first luer connector among the plurality of luer connectors 170 to the tip or the distal opening of the first portion 212 of the catheter tube 110. Since the first lumen of the RICC100 configured as a single-lumen catheter is similar to the first lumen of the RICC100 configured as a three-lumen catheter, additional details regarding the first lumen of the RICC100 can be recognized from the above description of the first lumen of the RICC100 configured as a single-lumen catheter.

[0062] Method The method for manufacturing the RICC100 includes one or more of the steps described below for manufacturing the catheter tube 110. One or more extrusion steps of extruding one or more extrudable components other than the catheter tube 110, such as the plurality of extension legs 160, one or more molding steps of molding one or more moldable components, and one or more assembly steps of assembling the RICC100 or any part of the RICC100 by connecting together the catheter tube 110 including the extrudable components and the moldable components.

[0063] One or more of the extrusion steps can include extruding any one or more of the plurality of extension legs 160 according to the description given above for the one or more extension legs.

[0064] One or more of the molding steps can include molding any one or more of the moldable components selected from the suture wings 140 and the hub 150 according to the description given above for the one or more moldable components. One or more of the molding steps can further include molding any one or more of the plurality of luer connectors 170 according to the description given above for the one or more luer connectors.

[0065] One or more of the assembly steps of assembling the RICC100 or any part of the RICC100 can include assembling the RICC100 according to that shown in FIG. 2, understanding that the distal end portion of the catheter tube 110 is inserted into the proximal end portion of the suture wings 140.

[0066] FIG. 5 shows a part of the method for manufacturing the catheter tube 110 according to some embodiments. A method for manufacturing a layered catheter tube, such as catheter tube 110, includes an inner layer forming step of forming an inner layer 412 of catheter tube 110 by extruding a single lumen tube 512 made of a first polymer material.

[0067] The method further includes an insertion step of inserting an end of the single lumen tube 512 into a die 592 of an extruder 590. The method further includes a second layer forming step of forming an outer layer 414 of catheter tube 110 by forming a hybrid layer tube having portions of the single lumen tube 512 periodically interspersed with portions of a layered tube 514 by periodically extruding a melt 594 made of a second polymer material through the die 592 around the single lumen tube 512.

[0068] The method further includes an adhesive layer forming step of forming an adhesive layer on the single lumen tube 512 before extruding the melt 594 made of the second polymer material through the die 592 around the single lumen tube 512 in the second layer forming step.

[0069] The method further includes a lumen forming step of forming one or more additional lumens (e.g., a second catheter tube lumen 426, a third catheter tube lumen 428, etc.) in the single lumen tube 512 by injecting air into the melt 594 made of the second polymer material while extruding the melt 594 made of the second polymer material through the die 592 around the single lumen tube 512.

[0070] The method further includes an inlet forming step of creating one or more inlets (e.g., inlet 320, inlet 322, etc.) in the portions of the layered tube 514 to correspondingly establish one or more openings to the one or more additional lumens.

[0071] The method may further include a bump forming step of forming a bump (e.g., bump 217 located in the middle portion of the catheter tube 110) on the outer diameter of a portion of the layered tube 514, by periodically slowing down the speed at which the mixed layer tube is pulled by a puller to increase the outer diameter after the bump.

[0072] The method further includes an inverse taper forming step of forming the outer diameter of the said portion of the layered tube 514 into an inverse taper shape after the bump, by continuously slowing down the speed at which the mixed layer tube is pulled by a puller.

[0073] The method may further include a pulling step of pulling the mixed layer tube through a cooling bath equipped with a puller to cool the said mixed layer tube. The method further includes a cutting step of cutting the mixed layer tube at at least the said portion of the single lumen tube 512 with a cutter to form a layered catheter tube.

[0074] The method of using the RICC100 includes a forming step of forming an insertion site to access the patient's vasculature with a needle disposed inside the lumen of the RICC100. The insertion site may be in the subclavian vein such as the right or left subclavian vein, the internal jugular vein such as the right or left internal jugular vein, or the femoral vein.

[0075] The method further includes an insertion step of inserting the distal end portion of the catheter tube 110 into the insertion site. The method further includes a retracting step of retracting the needle from the lumen of the RICC100 after forming the insertion site and inserting at least a part of the first portion 212 of the catheter tube 110 into the insertion site.

[0076] The method further includes a forward step of advancing the catheter tube 110 through the patient's vasculature without the need to use the Seldinger method. For example, when the insertion site is the right subclavian vein or the right internal jugular vein, the forward step can further include inserting the catheter tube 110 further into the insertion site so as to advance the catheter tube 110 or at least the distal end portion of the catheter tube 110 through the right subclavian vein or the right internal jugular vein and the right brachiocephalic vein into the superior vena cava. At other insertion sites such as the left subclavian vein or the left internal jugular vein, it is necessary to advance the distal end portion of the catheter tube 110 through the corresponding vasculature. Since the catheter tube 110 has sufficient column buckling strength to prevent buckling of the catheter tube 110 when it is inserted into the insertion site and advanced within the patient's vasculature, there is no need to use the Seldinger method.

[0077] Some specific embodiments are disclosed herein, and while a particular embodiment is disclosed to a certain degree of detail, it is not intended that the particular embodiment limit the scope of the concepts provided herein. Those skilled in the art can understand that additional adaptations and / or modifications can be made in a broader aspect, and these adaptations and / or modifications are also included. Accordingly, embodiments may be practiced that depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

**Claim 1** A rapid insertion type central venous catheter, comprising a catheter tube including a layered tube portion, a first portion located at the distal portion of the catheter tube, defined by a tube extruded from only a first polymer material, a second portion located proximal to the first portion, defined by a transition portion to the layered tube, and including an outer layer of a second polymer material extruded onto the inner layer of the tube of the first polymer material such that the outer diameter of the catheter tube is larger in the second portion than in the first portion, a suture wing disposed on an intermediate portion of the catheter tube, a hub connected to the proximal end portion of the catheter tube, and a plurality of extension legs equal in number to the number of lumens extending through the rapid insertion type central venous catheter. A rapid insertion type central venous catheter comprising the above. **Claim 2** The rapid insertion type central venous catheter according to claim 1, wherein the inner layer of the catheter tube is formed of the first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of the second polymer material having a second durometer hardness smaller than the first durometer hardness. **Claim 3** The rapid insertion type central venous catheter according to claim 1, wherein the inner layer of the catheter tube is formed of the first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of the second polymer material having a second durometer hardness substantially equal to the first durometer hardness. **Claim 4** The rapid insertion type central venous catheter according to claim 2 or 3, wherein each of the first and second polymer materials is polyurethane. **Claim 5** The rapid insertion type central venous catheter according to claim 1, wherein each of the inner and outer layers of the catheter tube is formed of the same polymer material. **Claim 6** The rapid insertion type central venous catheter according to claim 5, wherein the polymer material is polyurethane. **Claim 7** The catheter tube further includes a bump that defines a boundary of a third portion of the catheter tube proximal to the second portion, and the third portion has an outer diameter larger than both the first portion and the second portion of the catheter tube. The rapid insertion type central venous catheter according to any one of claims 1 to 6.

8. The suture wing is disposed on the bump of the catheter tube such that the catheter tube proximal to the suture wing has an outer diameter larger than the catheter tube distal to the suture wing. The rapid insertion type central venous catheter according to claim 7.

9. The catheter tube between the suture wing and the hub has an inverse taper in which the outer diameter of the catheter tube continuously increases from the suture wing to the hub. The rapid insertion type central venous catheter according to any one of claims 1 to 8.

10. The rapid insertion type central venous catheter is a three-lumen catheter including a trifurcated hub as the hub, the hub has three extension legs extending from the hub, and each extension leg of the three extension legs includes a luer connector connected to the proximal end portion of the extension leg. The rapid insertion type central venous catheter according to any one of claims 1 to 9.

11. The rapid insertion type central venous catheter includes a first lumen extending from an opening at the proximal end of the first luer connector to an opening at the distal end of the first portion of the catheter tube, a second lumen extending from an opening at the proximal end of the second luer connector to a first eyelet at the distal portion of the second portion of the catheter tube, and a third lumen extending from an opening at the proximal end of the third luer connector to a second eyelet at the distal portion of the second portion of the catheter tube. The rapid insertion type central venous catheter according to claim 10.

12. The rapid insertion type central venous catheter is a two-lumen catheter including a bifurcated hub as the hub, the hub has two extension legs extending from the hub, and each extension leg of the two extension legs includes a luer connector connected to the proximal end portion of the extension leg. The rapid insertion type central venous catheter according to any one of claims 1 to 9.

13. The insertable central venous catheter according to claim 12 includes a first lumen extending from an opening at the proximal end of the first Luer connector to an opening at the distal end of the first portion of the catheter tube, and a second lumen extending from an opening at the proximal end of the second Luer connector to an eyelet at the distal portion of the second portion of the catheter tube.

14. The rapid insertion type central venous catheter according to any one of claims 1 to 13, wherein the first and second portions of the catheter tube have sufficient column buckling strength to prevent buckling of the catheter tube when inserted into the insertion site and advanced within the patient's vascular structure.

15. A catheter tube including a portion of a layered tube, A first portion located at the distal portion of the catheter tube, the first portion defined by a tube extruded from only a first polymer material, A second portion located proximal to the first portion, defined by a transition portion to the layered tube, and including an outer layer of a second polymer material extruded over the inner layer of the tube of the first polymer material such that the outer diameter of the catheter tube is larger in the second portion than in the first portion. The catheter tube is provided with sufficient column buckling strength to prevent buckling of the catheter tube when inserted into the insertion site and advanced within the patient's vascular structure without using the Seldinger method.

16. The catheter tube according to claim 15, wherein the inner layer of the catheter tube is formed of the first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of the second polymer material having a second durometer hardness smaller than the first durometer hardness.

17. The catheter tube according to claim 15, wherein the inner layer of the catheter tube is formed of the first polymer material having a first durometer hardness, and the outer layer of the catheter tube is formed of the second polymer material having a second durometer hardness substantially equal to the first durometer hardness.

18. The catheter tube according to claim 16 or 17, wherein each of the first and second polymer materials is polyurethane.

19. The catheter tube according to claim 15, wherein each of the inner layer and the outer layer of the catheter tube is formed of the same polymer material.

20. The catheter tube according to claim 19, wherein the polymer material is polyurethane.

21. The catheter tube according to any one of claims 15 to 20, further comprising a bump defining a boundary of a third portion of the catheter tube proximal to the second portion, the third portion having an outer diameter larger than both the first portion and the second portion of the catheter tube.

22. The catheter tube according to claim 21, wherein the catheter tube between the bump and the proximal end of the third portion of the catheter tube has a reverse taper in which the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third portion of the catheter tube.

23. The catheter tube according to any one of claims 15 to 22, which is a three-lumen catheter tube including a first lumen extending from a first opening at the proximal end of the catheter tube to an opening at the distal end of the first portion of the catheter tube, a second lumen extending from a second opening at the proximal end of the catheter tube to a first eyelet at the distal portion of the second portion of the catheter tube, and a third lumen extending from a third opening at the proximal end of the catheter tube to a second eyelet at the distal portion of the second portion of the catheter tube.

24. The catheter tube according to any one of claims 15 to 22, which is a two-lumen catheter tube including a first lumen extending from a first opening at the proximal end of the catheter tube to an opening at the distal end of the first portion of the catheter tube, and a second lumen extending from a second opening at the proximal end of the catheter tube to an eyelet at the distal portion of the second portion of the catheter tube.

25. A method for manufacturing a layered catheter tube, comprising: Forming an inner layer of a catheter tube by extruding a single lumen tube consisting only of a first polymer material; Inserting an end of the single lumen tube into a die of an extruder; Forming a mixed layer tube having portions of the single lumen tube with portions of the layered tube scattered therein by periodically extruding a melt of a second polymer material through the die around the single lumen tube to form an outer layer of the catheter tube; Pulling the mixed layer tube through a cooling bath equipped with a puller to cool the mixed layer tube; Cutting the mixed layer tube at at least the portion of the single lumen tube with a cutter to form the layered catheter tube; Each layered catheter tube of the layered catheter tube; A first portion located at a distal portion of the layered catheter tube, the first portion defined by a single tube made of the first polymer material; A second portion located proximal to the first portion, defined by a transition to a layered tube, and including the outer layer of the second polymer material extruded over the inner layer of the tube of the first polymer material such that an outer diameter of the catheter tube is larger at the second portion than at the first portion; cutting the mixed layer tube including a catheter tube; A method comprising.

26. The method according to claim 25, further comprising forming one or more additional lumens in the single lumen tube by injecting air into the melt of the second polymer material while extruding the melt of the second polymer material through the die around the die.

27. The method according to claim 26, further comprising forming one or more eyelets in the portion of the layered tube to establish one or more openings corresponding to the one or more additional lumens.

28. The method according to any one of claims 25 to 27, further comprising forming bumps on an outer diameter of the portion of the layered tube, and increasing the outer diameter after the bumps by periodically slowing a speed at which the mixed layer tube is pulled by the puller.

29. The method according to claim 28, further comprising forming the outer diameter of the portion of the layered tube in a reverse taper shape after the bump by continuously slowing down the speed at which the mixing layer tube is pulled by the puller.

30. The method according to any one of claims 25 to 29, further comprising forming an adhesive layer on the single lumen tube before extruding the melt made of the second polymer material through the die around the single lumen tube.

31. The method according to any one of claims 25 to 30, wherein the first polymer material has a first durometer hardness and the second polymer material has a second durometer hardness that is less than the first durometer hardness.

32. The method according to any one of claims 25 to 30, wherein the first polymer material has a first durometer hardness and the second polymer material has a second durometer hardness that is substantially equal to the first durometer hardness.

33. The method according to any one of claims 25 to 32, wherein each of the first and second polymer materials is polyurethane.

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