Two-piece catheter

Abstract

The two-piece catheter 100 includes a proximal catheter component 102 and a distal catheter component 110. The proximal catheter component includes a proximal catheter hub component 104 and one or more extension legs 108. The distal catheter component 110 includes a distal catheter hub component 112 and a catheter tube 114 including one or more catheter tube lumens. The catheter tube is coupled at its proximal end portion to the distal catheter hub component. The two-piece catheter has a connection in which the proximal catheter hub component is connected to the distal catheter hub component such that one or more catheter tube lumens are fluidly connected to one or more extension leg lumens, respectively, across the two-piece catheter hub.

Description

[Technical Field]

[0001] The present invention relates to medical devices, and more particularly to two-piece catheters. [Background technology]

[0002] Existing catheters are manufactured as ready-to-use catheters. Such catheters can be 30–40 cm long, measured from the proximal end to the distal end. Rapidly insertable central catheters (RICCs) currently under development are introduced over an introducer needle, but introducing a RICC over a 30–40 cm introducer needle can be burdensome for clinicians. Furthermore, it can be difficult to timely determine whether blood flashback has occurred and access the vascular lumen established during RICC introduction with a 30–40 cm introducer needle. Therefore, catheters such as RICCs would be advantageously shorter than existing catheters, at least during introduction.

[0003] The present application provides a two-part catheter that addresses the above needs. Lu Disclose. Summary of the Invention

[0004] In some embodiments, the two-piece catheter disclosed herein includes a proximal catheter component and a distal catheter component. The proximal catheter component includes a proximal catheter hub component of a two-piece catheter hub and one or more extension legs. Each of the one or more extension legs includes one or more extension leg lumens. Each of the one or more extension legs is coupled at its distal end portion to the proximal catheter hub component. The distal catheter component includes a distal catheter hub component of the two-piece catheter hub and a catheter tube. The catheter tube has one or more catheter tube lumens. The catheter tube is coupled at its proximal end portion to the distal catheter hub component. The two-piece catheter has a connection in which the proximal catheter hub component is connected to the distal catheter hub component such that the one or more catheter tube lumens are fluidly connected to one or more extension leg lumens, respectively, across the two-piece catheter hub.

[0005] In some embodiments, the proximal catheter hub component includes one or more rigid tubes disposed within one or more proximal catheter hub lumens, respectively, and extending from a distal end of the proximal catheter hub component.

[0006] In some embodiments, the distal catheter hub component includes one or more seals disposed within one or more distal catheter hub lumens, respectively, configured to be positioned between one or more rigid tubes and one or more distal catheter hub lumens in the connected state of the two-piece catheter assembly.

[0007] In some embodiments, the distal catheter hub component includes one or more rigid tubes disposed within one or more distal catheter hub lumens, respectively, the one or more rigid tubes extending from the proximal end of the distal catheter hub component.

[0008] In some embodiments, the proximal catheter hub component includes one or more seals disposed within one or more proximal catheter hub lumens, respectively, configured to be positioned between one or more rigid tubes and one or more proximal catheter hub lumens in the connected state of the two-piece catheter assembly.

[0009] In some embodiments, the distal catheter hub component includes an integral clip having tabbed arms extending proximally from the distal catheter hub component, and the proximal catheter hub component includes surface recesses configured to seat the tabs of the arms in the connected state of the two-piece catheter assembly.

[0010] In some embodiments, the proximal catheter hub piece includes surface undercut grooves configured to seat the tips of the arms therein in the connected state of the two-piece catheter assembly.

[0011] In some embodiments, the arms extend from a major side of the distal catheter hub component and the surface recess is on a major surface of the proximal catheter hub component.

[0012] In some embodiments, the arms extend from a minor side of the distal catheter hub component and the surface recess is on a minor surface of the proximal catheter hub component.

[0013] In some embodiments, the proximal catheter hub piece includes an integral clip having tabbed arms extending distally from the proximal catheter hub piece, and the distal catheter hub piece includes surface recesses configured to receive the tabs of the arms therein in the connected state of the two-piece catheter assembly.

[0014] In some embodiments, the distal catheter hub component includes surface undercut grooves configured to receive the tips of the arms therein in the connected state of the two-piece catheter assembly.

[0015] In some embodiments, the arms extend from a long side of the proximal catheter hub component and the surface recess is on a major surface of the distal catheter hub component. In some embodiments, the arms extend from a short side of the proximal catheter hub component and the surface recess is on a minor surface of the distal catheter hub component.

[0016] In some embodiments, the two-piece catheter comprises a set of three lumens in the connected state of the two-piece catheter assembly, the set of three lumens comprising a primary lumen, a secondary lumen, and a tertiary lumen.

[0017] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the two-part catheter, the secondary lumen has a secondary lumen opening on a side of the catheter tube proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on a side of the catheter tube proximal to the secondary lumen opening.

[0018] Some embodiments also disclose a method of using a two-piece catheter, including a catheter obtaining step, a needle path establishing step, a needle withdrawal step, and a catheter hub clipping step. The catheter obtaining step includes obtaining a two-piece catheter including a distal catheter component and a proximal catheter component. The distal catheter component includes a catheter tube coupled to a distal catheter hub component at a proximal end portion of the catheter tube. The needle path establishing step includes establishing a needle path from an area of ​​the patient's skin to a blood vessel lumen using an introducer needle disposed within an introducer lumen of the distal catheter component. The introducer needle is disposed within the distal catheter component such that its needle tip extends from an introducer lumen opening of the introducer lumen. The needle withdrawal step includes withdrawing the introducer needle from the introducer lumen. The catheter hub clipping step includes clipping the distal catheter hub component and the proximal catheter hub component together. When the distal catheter hub component and the proximal catheter hub component are clipped together, one or more catheter tube lumens of the catheter tube are each fluidly connected to one or more extension leg lumens of one or more extension legs coupled to the proximal catheter hub component of the proximal catheter component.

[0019] In some embodiments, the catheter hub clipping step includes clipping the integral clip of the distal catheter hub component to the proximal catheter hub component such that, upon clipping the integral clip of the distal catheter hub component to the proximal catheter hub component, tabs of the arms of the integral clip seat within surface recesses of a major or minor surface of the proximal catheter hub component.

[0020] In some embodiments, the catheter hub clipping step includes clipping the integral clip of the proximal catheter hub component to the distal catheter hub component such that when the integral clip of the proximal catheter hub component is clipped to the distal catheter hub component, the tabs of the arms of the integral clip are received in surface recesses of a major or minor surface of the distal catheter hub component.

[0021] In some embodiments, the method further includes an access guidewire advancement step, a first catheter advancement step, and an access guidewire retraction step. The access guidewire advancement step includes advancing an access guidewire disposed within a needle lumen of an introducer needle past the needle tip and into the blood vessel lumen. The first catheter advancement step includes advancing a distal end portion of the first section of the catheter tube over the introducer needle and into the blood vessel lumen using the access guidewire as a guide. The access guidewire retraction step includes withdrawing the access guidewire together with the introducer needle when withdrawing the introducer needle from the introducing lumen.

[0022] In some embodiments, the method further includes a steering guidewire advancement step, a second catheter advancement step, and a steering guidewire retraction step. The steering guidewire advancement step includes advancing a steering guidewire through a primary lumen of the two-piece catheter, into the vessel lumen, and to the target location. The primary lumen is established by clipping the distal catheter hub component and the proximal catheter hub component together. The second catheter advancement step includes advancing the remainder of the distal end portion of the first catheter tubing section into the vessel lumen, using the steering guidewire as a guide, down to the proximal end portion of the second catheter tubing section. The catheter advancement by the second catheter advancement step is stopped when the distal end of the two-piece catheter reaches the target location. The steering guidewire retraction step includes withdrawing the steering guidewire, leaving the two-piece catheter in place within the patient.

[0023] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0024] [Figure 1] 1 illustrates a two-part catheter in an unconnected state according to some embodiments. [Figure 2] 1 illustrates a two-part catheter in a connected state according to some embodiments. [Figure 3] 1 illustrates the proximal and distal catheter hub components of a two-piece catheter hub in an unconnected state according to some embodiments. [Figure 4] 1 illustrates the proximal and distal catheter hub components in a connected state according to some embodiments. [Figure 5] 10 illustrates another proximal catheter hub component and another distal catheter hub component of another two-piece catheter hub in a connected state according to some embodiments. [Figure 6] 3 illustrates a distal end portion of the catheter tube of the two-piece catheter of FIGS. 1 and 2, according to some embodiments. [Figure 7] 7 illustrates a first cross-section of the catheter tube of FIG. 6 according to some embodiments. [Figure 8] 7 illustrates a second cross-section of the catheter tube of FIG. 6 according to some embodiments. [Figure 9] 7 illustrates a third cross-section of the catheter tube of FIG. 6 according to some embodiments. [Figure 10] 7 illustrates a fourth cross-section of the catheter tube of FIG. 6 according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0025] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0026] Regarding the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are for convenience and do not imply, for example, a specific fixed location, direction, or orientation. Instead, such designations are used, for example, to reflect relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0027] For example, references to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein include 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 catheter 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. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0028] For example, references to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is in use with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0029] As mentioned above, existing catheters are manufactured as ready-to-use catheters with lengths of 30-40 cm. Rapidly insertable central catheters (RICCs) currently under development are introduced over an introducer needle, but introducing a 30-40 cm introducer needle can be burdensome for clinicians. Furthermore, it can be difficult to timely determine whether blood flashback has occurred and access the vascular lumen established during introduction of a RICC with a 30-40 cm introducer needle. Therefore, catheters such as RICCs would be advantageous, at least for insertion, but not limited to, if they are shorter than existing catheters. Disclosed herein are two-piece catheters and methods thereof that address the above needs.

[0030] 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. Two-piece catheter 1 and 2 show a two-part catheter 100 in an unconnected and connected state, according to some embodiments.

[0031] As shown, the two-piece catheter 100 has two pieces, including, in such an embodiment, a proximal catheter piece 102 and a distal catheter piece 110. The two-piece catheter 100 may include different or additional pieces than those in the illustrated embodiment. Indeed, the "two pieces" of the two-piece catheter 100 generally refers to the at least two pieces that result from dividing such a catheter along its length, in this case at the two-piece catheter hub 106 described below.

[0032] The proximal catheter component 102 includes a proximal catheter hub component 104 of a two-piece catheter hub 106 and one or more extension legs 108. The distal catheter component 110 includes a distal catheter hub component 112 of the two-piece catheter hub 106 and a catheter tube 114. The two-piece catheter hub 106 will be described first, followed by a description of the catheter tube 114, one or more extension legs 108, and other aspects of the two-piece catheter 100.

[0033] 3 and 4 show the proximal catheter hub component 104 and the distal catheter hub component 112 of the two-piece catheter hub 106 in the unconnected and connected states of the two-piece catheter 100, according to some embodiments.

[0034] The proximal catheter hub component 104 of the two-piece catheter hub 106 includes one or more rigid tubes 116 (e.g., metal tubes) respectively disposed within one or more proximal catheter hub lumens 118, thereby effectively extending the one or more proximal catheter hub lumens 118 within the connector. The proximal catheter hub component 104 can be molded onto the one or more rigid tubes 116 during manufacture, such that the one or more rigid tubes 116 extend from the distal end of the proximal catheter hub component 104. Alternatively, the one or more rigid tubes 116 are inserted into the one or more proximal catheter hub lumens 118 during manufacture, such that the one or more rigid tubes 116 extend from the distal end of the proximal catheter hub component 104.

[0035] The distal catheter hub component 112 of the two-piece catheter hub 106 includes one or more distal catheter hub lumens 120 each having one or more mechanical gaskets 122 disposed therein. The one or more mechanical gaskets 122 are configured to be positioned between the abluminal surface of the one or more rigid tubes 116 and the luminal surface of the one or more distal catheter hub lumens 120 in the connected state of the two-piece catheter 100. The one or more mechanical gaskets 122 include, but are not limited to, an "O" ring or a cylinder. The one or more mechanical gaskets 122 can be formed from a compressible polymeric material, such as silicone. The use of a compressible polymer material such as silicone is advantageous in that, when the one or more rigid tubes 116 are inserted into the one or more distal catheter hub lumens 120, the compression rings 123 axially compress the one or more mechanical gaskets 122, causing the one or more mechanical gaskets 122 to radially expand within the confined space between the abluminal surface of the one or more rigid tubes 116 and the luminal surface of the one or more distal catheter hub lumens 120, thereby forming one or more fluid-tight lumen seals between the proximal catheter hub component 104 and the distal catheter hub component 112 of the two-piece catheter hub 106 and connecting the one or more proximal catheter hub lumens 118 into the one or more distal catheter hub lumens 120, respectively.

[0036] In the above alternative, the distal catheter hub component 112 may instead include one or more rigid tubes 116 disposed within one or more distal catheter hub lumens 120, respectively. Similarly, the proximal catheter hub component 104 may instead include one or more mechanical gaskets 122 disposed within one or more proximal catheter hub lumens 118, respectively. The foregoing descriptions of the one or more rigid tubes 116, one or more mechanical gaskets 122, etc., for the illustrated embodiments of the distal catheter hub component 112 and the proximal catheter hub component 104 apply to the one or more rigid tubes 116 when part of the distal catheter hub component 112, the one or more mechanical gaskets 122, etc., when part of the proximal catheter hub component 104.

[0037] Continuing with the illustrated embodiment of the proximal catheter hub component 104 and the distal catheter hub component 112, the proximal catheter hub component 104 and the distal catheter hub component 112 comprise complementary connectors of a connection system configured to securely, and in some embodiments, irreversibly, connect the proximal catheter hub component 104 and the distal catheter hub component 112 in the connected state of the two-piece catheter 100. "Irreversibly" connecting the proximal catheter hub component 104 and the distal catheter hub component 112, in this context, means that the proximal catheter hub component 104 and the distal catheter hub component 112 cannot be separated without the use of tools or damage to the proximal catheter hub component 104 or the distal catheter hub component 112.

[0038] With respect to the connection system, the distal catheter hub component 112 can include an integral clip molded with itself, the integral clip having a tabbed arm 124 extending proximally from the distal catheter hub component 112. The proximal catheter hub component 104 can include a complementary receiving portion, such as a surface recess 126, configured to receive both the tabbed arm 124 and a tab 128 of the tabbed arm 124 therein when the two-piece catheter 100 is in the connected state. As best shown in FIG. 3 , the tabbed arm 124 can extend from a major side of the distal catheter hub component 112, and the surface recess 126 can be in a major surface of the proximal catheter hub component 104. However, the tabbed arm 124 can alternatively extend from a minor side of the distal catheter hub component 112, and the surface recess 126 can be in a minor surface of the proximal catheter hub component 104. Due to the larger design space available across the width of the two-piece catheter hub 106, the complementary receiving portion may instead be a longitudinal cavity on the inside of a minor surface of the proximal catheter hub part 104, into which a tabbed arm 124 extending from a short side of the distal catheter hub part 112 is configured to be inserted, similar to that of a typical plastic buckle found on a backpack or the like.

[0039] FIG. 5 shows an alternative proximal catheter hub component 130 and an alternative distal catheter hub component 132 of an alternative two-piece catheter hub 134 in a connected state of a two-piece catheter 100 according to some embodiments.

[0040] With regard to irreversibly connecting the proximal catheter hub component 104 and the distal catheter hub component 112, the connection system may include additional features between the proximal catheter hub component 104 and the distal catheter hub component 112 that are configured to irreversibly connect the proximal catheter hub component 104 and the distal catheter hub component 112. For example, the tabbed arm 124 of the distal catheter hub component 112 may include a chamfered tip 136, like the tabbed arm 138 of the distal catheter hub component 132. The proximal catheter hub component 104 may include a complementary receiving portion, such as a surface undercut groove 140 similar to that of the proximal catheter hub component 130, that is configured to receive the chamfered tip 136 of the tabbed arm 138 therein when the two-piece catheter 100 is in the connected state. When the chamfered tip 136 of the tabbed arm 138 is received within the surface undercut groove 140, the tabbed arm 138 of the distal catheter hub component 132 cannot be easily lifted from its complementary receiving portion in the proximal catheter hub component 130 without the use of tools or damage to the proximal catheter hub component 130 or the distal catheter hub component 132, thereby irreversibly connecting the proximal catheter hub component 130 and the distal catheter hub component 132 in the connected state of the two-piece catheter 100.

[0041] In the above alternative, the proximal catheter hub component 104 may instead include an integral clip having tabbed arms 124 and, optionally, chamfered tips 136 of the tabbed arms 138. Indeed, if one or more rigid tubes 116 are also disposed within one or more proximal catheter hub lumens 118 of the proximal catheter hub component 104, the integral clip effectively protects the one or more rigid tubes 116 from accidental damage. Similarly, the distal catheter hub component 112 may instead have a complementary receiving portion including a surface recess 126 configured to receive the tabbed arms 138 and, optionally, a surface undercut groove 140 configured to receive the chamfered tips 136 of the tabbed arms 124. With respect to the illustrated embodiments of the distal catheter hub component 112 and the proximal catheter hub component 104, the foregoing descriptions of the tabbed arms 124 or 138, complementary receiving portions, etc., apply to the tabbed arms 124 or 138 when part of the proximal catheter hub component 104, the complementary receiving portions when part of the distal catheter hub component 112, etc.

[0042] Figure 6 shows the distal end portion of the catheter tube 114 of the two-piece catheter 100 according to some embodiments. Figures 7-10 show various cross sections of the catheter tube 114 according to some embodiments.

[0043] The catheter tube 114 is coupled to the distal catheter hub component 112 at the proximal end portion of the catheter tube 114. Thus, one or more distal catheter hub lumens 120 continue as one or more catheter hub lumens, respectively.

[0044] The catheter tube 114 includes a rigid section and a flexible section, and "rigid" and "flexible" are used in a relative sense in that the rigid section of the catheter tube 114 is more rigid than the flexible section of the catheter tube 114. For example, when the catheter tube 114 is part of a two-piece RICC, the catheter tube 114 includes the aforementioned rigid and flexible sections; otherwise, the catheter tube 114 may be relatively flexible with sufficient compliance to advance the catheter tube 114 over a steering guidewire through a patient's vasculature to a target location (e.g., the superior vena cava ["SVC"]).

[0045] The rigid section of the catheter tube 114 has a first portion 142 at the distal end portion of the catheter tube 114, and the flexible section of the catheter tube 114 has a second portion 144 that extends from the proximal end portion of the catheter tube 114 to the distal end portion of the catheter tube 114 but proximal to the first portion 142. Although the tapered junction 146 of the catheter tube 114 includes the proximal end portion of the rigid section of the catheter tube 114 disposed therein, the flexible section of the catheter tube 114 is generally considered to include the junction 146 in terms of its structure. The above-described configuration of the first portion 142 of the catheter tube 114, the second portion 144 of the catheter tube 114, and the junction 146 collectively provides both sufficient column buckling strength to prevent buckling of the catheter tube 114 when inserted into an insertion site established by percutaneous puncture, and sufficient compliance to allow the catheter tube 114 to be advanced through a patient's vasculature to a target location (e.g., the SVC).

[0046] The first portion 142 of the catheter tube 114 is at the distal end portion of the catheter tube 114. The first portion 142 includes a distal tip 148 having a relatively short taper configured to continue from the beveled tip of the introducer needle to the outer diameter of the remainder of the first portion 142 when the introducer needle is disposed within the catheter tube 114 of the distal catheter component 110. The short taper of the distal tip 148 is configured for immediate dilation of tissue around the percutaneous puncture established by the introducer needle to the outer diameter of the remainder of the first portion 142 of the catheter tube 114. The first portion 142 also includes a proximal end portion that is disposed within the receptacle of the joint 146 and fixedly bonded thereto (e.g., solvent bonded, adhesively, welded, etc.).

[0047] The first section 142 of the catheter tube 114 is formed from a first polymeric material having a first durometer. The first polymeric material may be, but is not limited to, polytetrafluoroethylene, polypropylene, or polyurethane. Polyurethane is advantageous in that the first section 142 of the catheter tube 114 is relatively rigid at room temperature but becomes more flexible in vivo at body temperature, reducing irritation to the blood vessel wall and phlebitis.

[0048] The second portion 144 of the catheter tube 114 extends from the proximal end portion of the catheter tube 114 to the distal end portion of the catheter tube 114 but proximal to the first portion 142 of the catheter tube 114. The second portion 144 includes a distal end joined to a joint 146 and a proximal end portion that is disposed within the distal catheter hub component 112 and fixedly joined thereto (e.g., by solvent bonding, welding, adhesive, etc.).

[0049] The second section 144 of the catheter tube 114 is formed from a second polymeric material having a second durometer that is lower than the first durometer. The second polymeric material may be, but is not limited to, polyvinyl chloride, polyethylene, polyurethane, or silicone. In addition to what was discussed above about polyurethane in the first section 142 of the catheter tube 114, polyurethane is advantageous in that it is less thrombogenic than some other polymers.

[0050] A junction 146 of the catheter tube 114 joins the first and second sections 142, 144 of the catheter tube 114. The junction 146 includes a receptacle at a distal end portion disposed therein and fixedly joined (e.g., solvent bonded, welded, adhesively, etc.) thereto with the proximal end portion of the first section 142 of the catheter tube 114. The junction 146 also includes a flat-faced proximal end fixedly joined (e.g., solvent bonded, welded, adhesively, etc.) to the flat-faced distal end of the second section 144 of the catheter tube 114, which, when joined, effectively terminates no lumen of the second section 144 of the catheter tube 114 other than a lumen corresponding to the primary lumen 150 of the two-piece catheter 100 passing through the junction 146. The junction 146 also includes a taper along its length from the distal end to the proximal end configured to immediately dilate the tissue around the percutaneous puncture to the outer diameter of the second section 144 of the catheter tube 114. The abluminal surface of the junction 146 does not have any edges that may catch on the skin when inserted into a patient's insertion site, and it transitions smoothly from the abluminal surface of the proximal end portion of the first section 142. In addition to the negligible edge, the edge may include a solvent interdiffusion polymer material between the first polymer material and the polymer material of the junction 146, which provides a smooth transition from the first section 142 of the catheter tube 114 to the junction 146.

[0051] The joint 146 of the catheter tube 114 is formed from a second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer, and the second polymeric material may be, but is not limited to, polyvinyl chloride, polyethylene, polyurethane, or silicone.

[0052] Again, the first section 142 of the catheter tube 114 is formed from a first polymeric material having a first durometer, the second section 144 of the catheter tube 114 is formed from a second polymeric material having a second durometer that is lower than the first durometer, and the junction 146 of the catheter tube 114 is formed from either the second polymeric material or a third polymeric material having a third durometer that is closer to the second durometer than the first durometer. Because the second and third durometers are lower than the first durometer, the soft section of the catheter tube 114, including the second section and the junction 146, is softer than the hard section of the catheter tube 114, including the first section of the catheter tube 114. In other words, the first durometer is higher than the second and third durometers, and because the first durometer is higher than the second and third durometers, the hard portion of the catheter tube 114, including the first portion of the catheter tube 114, is harder than the soft portion of the catheter tube 114, including the second portion of the catheter tube 114 and the junction 146.

[0053] The first durometer hardness of the first polymeric material, the second durometer hardness of the second polymeric material, and the third durometer hardness of the third polymeric material may be on different scales (e.g., Type A or Type D), and therefore the second or third durometer hardness may not necessarily be numerically less than the first durometer hardness. In other words, a material of the first durometer hardness may not be numerically greater than the second or third durometer hardness in terms of the different scales. However, because each different scale ranging from 0 to 100 is intended to characterize different materials within a group of materials having similar hardnesses, the hardness of the second or third polymeric material may still be less than the hardness of the first polymeric material, or the hardness of the first polymeric material may still be greater than the hardness of the second or third polymeric material.

[0054] Notwithstanding the above, the first portion 142 of the catheter tube 114, the second portion 144 of the catheter tube 114, and the joint 146 can be formed from the same or different polymeric materials having substantially equal durometer hardness, provided that the column buckling strength of the catheter tube 114 is sufficient to prevent buckling of the catheter tube 114 when inserted into an insertion site formed by a percutaneous puncture, and the compliance of the catheter tube 114 is sufficient to advance the catheter tube 114 through the patient's vasculature to a target location.

[0055] Each extension leg of the one or more extension legs 108 is coupled at its distal end portion to the proximal catheter hub component 104. Thus, each of the one or more proximal catheter hub lumens 118 continues as one or more extension leg lumens.

[0056] Each extension leg of the one or more extension legs 108 typically includes a luer connector coupled thereto, through which the extension leg and its extension leg lumen can be connected to another medical device.

[0057] Whether the two-piece catheter 100 is a single-lumen catheter having one lumen or a multi-lumen catheter having multiple lumens, the two-piece catheter 100 includes at least a primary lumen 150 (e.g., a distal lumen) in a connected state of the two-piece catheter 100, in which one or more catheter tube lumens in the distal catheter component 110 are each fluidly connected to one or more extension leg lumens in the proximal catheter component 102 across the two-piece catheter hub 106. The primary lumen 150 typically extends from the proximal end of the two-piece catheter 100 to the distal end of the two-piece catheter 100, e.g., from the opening of a corresponding Luer connector to a primary lumen opening 152 (e.g., a distal lumen opening) at the distal end of the two-piece catheter 100. If the two-piece catheter 100 has more than one lumens, the two-piece catheter 100 further includes at least a secondary lumen 154 (e.g., an intermediate lumen). The secondary lumen 154 typically extends from the proximal end of the two-piece catheter 100 to the distal end portion of the two-piece catheter 100, e.g., from the opening of a corresponding Luer connector, to a secondary lumen opening 156 (e.g., an intermediate lumen opening) in the distal end portion of the catheter tubing 114 proximal to the primary lumen opening 152. If the two-piece catheter 100 has three or more lumens, the two-piece catheter 100 further includes at least a tertiary lumen 158 (e.g., a proximal opening). The tertiary lumen 158 typically extends from the proximal end of the two-piece catheter 100 to the distal end portion of the two-piece catheter 100, e.g., from the opening of a corresponding Luer connector, to a tertiary lumen opening 160 (e.g., a proximal lumen opening) in the distal end portion of the catheter tubing 114 proximal to the secondary lumen opening 156. Notwithstanding the above, the secondary lumen 154 and the tertiary lumen 158 may extend slightly distally beyond the secondary lumen opening 156 and the tertiary lumen opening 160, respectively, due to different manufacturing methods. However, as noted above, the flat-faced proximal end of the junction 146 is fixedly bonded (e.g., solvent bonded, welded, adhesively, etc.) to the flat-faced distal end of the second section 144 of the catheter tube 114, and when bonded, effectively terminates the lumens, such as the secondary lumen 154 and the tertiary lumen 158, so as not to pass through the junction 146.

[0058] As discussed above, it can be difficult to timely identify if blood flashback has occurred and access the established vascular lumen during RICC introduction with a 30-40 cm introducer needle. Thus, a two-piece catheter configured as a RICC as provided herein advantageously allows a clinician to use a shorter, more manageable introducer needle with the distal catheter component 110, which further enables the clinician to quickly identify if flashback has occurred and access the established vascular lumen during any given RICC introduction.

[0059] In particular, the existing catheters mentioned above (see "Background Art") are inserted using the Seldinger technique. Such catheters would not benefit in the same way as the RICC provided herein if the existing catheter is a two-piece catheter. In fact, since one of the reasons RICC is currently being developed is to reduce the overall number of components and steps used in the Seldinger technique of existing catheters, it would be disadvantageous to increase the number of catheter parts of the existing catheter. method Methods of the two-piece catheter 100 include methods of using the two-piece catheter 100. Such methods include the steps of catheter acquisition, needle path establishment, needle withdrawal, and catheter hub clipping.

[0060] The catheter obtaining step includes obtaining a two-piece catheter 100 including a distal catheter component 110 and a proximal catheter component 102. As described above, the distal catheter component 110 includes a catheter tube 114 coupled to a distal catheter hub component 112 at a proximal end portion of the catheter tube 114.

[0061] The needle path establishment step involves establishing a needle path from the area of ​​the patient's skin to the lumen of the blood vessel using an introducer needle positioned within an introducer lumen of the distal catheter component 110. The introducer lumen is the combination of the distal catheter hub lumen and the catheter tube lumen that constitutes part of the primary lumen 150 of the two-piece catheter 100, particularly in the unconnected state of the two-piece catheter 100. During the needle path establishment step, the introducer needle is positioned within the distal catheter component 110 such that its needle tip extends from an introducer lumen opening (e.g., primary lumen opening 152) of the introducer lumen.

[0062] The needle withdrawal step involves withdrawing the introducer needle from the introducer lumen. The catheter hub clipping step involves clipping the distal catheter hub component 112 and the proximal catheter hub component 104 together. As shown in Figures 1 and 3, if the integral clip is part of the distal catheter hub component 112, the catheter hub clipping step involves clipping the integral clip of the distal catheter hub component 112 to the proximal catheter hub component 104, with the tabs 128 of the tabbed arms 124 of the integral clip received in the surface recesses 126 of the major or minor surface of the proximal catheter hub component 104. However, if the integral clip is part of the proximal catheter hub component 104, the catheter hub clipping step involves clipping the integral clip of the proximal catheter hub component 104 to the distal catheter hub component 112, with the tabs 128 of the tabbed arms 124 of the integral clip received in the surface recesses 126 of the major or minor surface of the distal catheter hub component 112. In any event, when the distal catheter hub component 112 and the proximal catheter hub component 104 are clipped together, one or more catheter tube lumens of the catheter tube 114 are each fluidly connected to one or more extension leg lumens of one or more extension legs 108 coupled to the proximal catheter hub component 104 of the proximal catheter component 102.

[0063] The method may further include an access guidewire advancement step, a first catheter advancement step, and an access guidewire retraction step. The access guidewire advancement step includes advancing an access guidewire disposed within the needle lumen of the introducer needle past the needle tip and into the blood vessel lumen. The first catheter advancement step includes initially advancing the two-piece catheter 100 over the access guidewire into the blood vessel lumen. If the two-piece catheter 100 is a RICC, the first catheter advancement step includes advancing the distal end portion of the first section 142 of the catheter tube 114 over the introducer needle into the blood vessel lumen using the access guidewire as a guide. The access guidewire retraction step includes withdrawing the access guidewire together with the introducer needle when withdrawing the introducer needle from the introducing lumen.

[0064] The method may further include a steering guidewire advancement step, a second catheter advancement step, and a steering guidewire retraction step. The steering guidewire advancement step involves advancing a steering guidewire through the primary lumen 150 of the two-piece catheter 100, into the vessel lumen and to the target location. Again, the primary lumen 150 is established by clipping the distal catheter hub component 112 and the proximal catheter hub component 104 together. The second catheter advancement step involves advancing the two-piece catheter 100 further over the steering guidewire into the vessel lumen. If the two-piece catheter 100 is a RICC, the second catheter advancement step involves advancing the remainder of the distal end portion of the first section 142 of the catheter tube 114 into the vessel lumen, up to the proximal end portion of the second section 144 of the catheter tube 114, using the steering guidewire as a guide. Advancing the catheter according to the second catheter advancement step is stopped when the distal end of the two-piece catheter 100 reaches the target location. The steering guidewire withdrawal step involves withdrawing the steering guidewire, leaving the two-piece catheter 100 in place within the patient.

[0065] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A two-piece catheter, A proximal catheter component comprising: a proximal catheter hub component of a two-piece catheter hub; a proximal catheter component having one or more extension legs, each extension leg having one or more extension leg lumens, each extension leg of the one or more extension legs being coupled at a distal end portion thereof to the proximal catheter hub component; A distal catheter component comprising: a distal catheter hub component of a two-piece catheter hub; a catheter tube having one or more catheter tube lumens, the catheter tube being coupled to a distal catheter hub component at a proximal end portion of the catheter tube; and a distal catheter component having The two-piece catheter has a connection configuration in which a proximal catheter hub component is connected to a distal catheter hub component such that one or more catheter tube lumens are fluidly connected to one or more extension leg lumens, respectively, across the two-piece catheter hub; the distal catheter hub component includes an integral clip having tabbed arms extending proximally therefrom, the arms including tabs projecting inwardly therefrom and chamfered tips extending further proximally from the tabs, the proximal catheter hub component includes a surface recess configured to receive the tabs of the arms in the connected state of the two-piece catheter, and the proximal catheter hub component further includes a surface undercut groove configured to receive the chamfered tips of the arms without receiving the tabs in the connected state of the two-piece catheter. Or, a two-piece catheter, wherein the proximal catheter hub piece includes an integral clip having tabbed arms extending distally therefrom, the arms including tabs projecting inwardly therefrom and chamfered tips extending further distally therefrom; the distal catheter hub piece includes a surface recess configured to receive the tabs of the arms in a connected state of the two-piece catheter; and the distal catheter hub piece further includes a surface undercut groove configured to receive the chamfered tips of the arms but not the tabs in a connected state of the two-piece catheter.

2. 10. The two-piece catheter of claim 1, wherein the proximal catheter hub component includes one or more rigid tubes disposed within one or more proximal catheter hub lumens, respectively, the one or more rigid tubes extending from a distal end of the proximal catheter hub component.

3. 3. The two-piece catheter of claim 2, wherein the distal catheter hub component includes one or more seals disposed within one or more distal catheter hub lumens, respectively, the one or more seals configured to be located between the one or more rigid tubes and the one or more distal catheter hub lumens, respectively, in a connected state of the two-piece catheter.

4. 10. The two-piece catheter of claim 1, wherein the distal catheter hub component includes one or more rigid tubes disposed within one or more distal catheter hub lumens, respectively, the one or more rigid tubes extending from a proximal end of the distal catheter hub component.

5. 5. The two-piece catheter of claim 4, wherein the proximal catheter hub component includes one or more seals disposed within one or more proximal catheter hub lumens, respectively, the one or more seals configured to be located between the one or more rigid tubes and the one or more proximal catheter hub lumens, respectively, in a connected state of the two-piece catheter.

6. A two-piece catheter as described in claim 1, wherein when the distal catheter hub part includes an integral clip having the tabbed arm, the arm extends from a long side of the distal catheter hub part and the surface recess is on a main surface of the proximal catheter hub part that is continuous with the long side of the distal catheter hub part when the two-piece catheter is in a connected state.

7. A two-piece catheter as described in claim 1, wherein when the distal catheter hub part includes an integral clip having the tabbed arm, the arm extends from a short side of the distal catheter hub part and the surface recess is on a minor surface of the proximal catheter hub part that is continuous with the short side of the distal catheter hub part when the two-piece catheter is in a connected state.

8. A two-piece catheter as described in claim 1, wherein when the proximal catheter hub part includes an integral clip having the tabbed arm, the arm extends from a long side of the proximal catheter hub part and the surface recess is on a main surface of the distal catheter hub part that is continuous with the long side of the proximal catheter hub part when the two-piece catheter is in a connected state.

9. A two-piece catheter as described in claim 1, wherein when the proximal catheter hub part includes an integral clip having the tabbed arm, the arm extends from a short side of the proximal catheter hub part and the surface recess is on a minor surface of the distal catheter hub part that is continuous with the short side of the proximal catheter hub part when the two-piece catheter is in a connected state.

10. 10. The two-piece catheter of any one of claims 1 to 9, wherein the two-piece catheter comprises a set of three lumens in a connected state of the two-piece catheter, the set of three lumens comprising a primary lumen, a secondary lumen, and a tertiary lumen.

11. 11. The two-piece catheter of claim 10, wherein the primary lumen has a primary lumen opening at a distal end of the two-piece catheter, the secondary lumen has a secondary lumen opening in a side of the catheter tube proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening in a side of the catheter tube proximal to the secondary lumen opening.

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