CATHETER ASSEMBLY, CATHETER EXTENSION LEG SECURITY DEVICE, AND METHOD OF USE OF CATHETER

JP2024541636A5Pending Publication Date: 2025-11-10BARD ACCESS SYSTEMS INC
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Patent Information

Application Number
JP2024532734
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-12-01
Filing Date
2022-11-30
Publication Date
2025-11-10

AI Technical Summary

Technical Problem

The insertion site for catheters can become crowded with extension legs and associated connectors, leading to obstruction and potential dislodgment during placement, affecting patient comfort and accuracy.

Method used

A catheter assembly with extension leg fixation devices that include organizers and rings to secure and organize extension legs, using channels, snap fits, and bendable wires to maintain position and orientation.

Benefits of technology

Enhances patient comfort and improves catheter placement accuracy by reducing obstruction and movement of extension legs, eliminating the need for tape, and ensuring secure fixation.

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Abstract

An assembly including a catheter and an extension leg fixation device. The catheter includes a hub distally coupled to a catheter tube having two or more lumens. The hub is proximally coupled to two or more extension legs, each extension leg in fluid communication with one lumen. The extension leg fixation device includes an extension leg organizer configured to be removably coupled to the two or more extension legs. The extension leg organizer can include a wire opening and two or more channels arranged in a channel configuration, each channel configured to receive one extension leg.
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Description

[Background technology]

[0001] An insertion site for a catheter can become crowded with extension legs and associated connectors. For example, a common insertion site for inserting a central venous catheter (CVC) can be in the neck. The insertion site during placement of a CVC can become crowded and the extension legs and associated connectors can obscure the patient's face or the insertion site. If the patient moves during placement of the catheter, the catheter can move or become dislodged during placement. Having a fixation system that organizes and secures the extension legs during placement is beneficial to the patient and clinician, resulting in improved patient comfort during use of the catheter and more accurate placement of the catheter. Disclosed herein is an extension leg fixation system and method of use that addresses the above. Summary of the Invention

[0002] Disclosed herein is a catheter assembly, according to some embodiments, that includes: (i) a catheter having two or more extension legs, each extension leg in fluid communication with at least one lumen extending along the catheter tube; and an extension leg fixation device attached to each of the two or more extension legs, the extension leg fixation device including an extension leg organizer having two or more channels configured to individually receive the two or more extension legs therein.

[0003] In some embodiments, each channel is coupled to one of the two or more extension legs by a press fit, a snap fit, or an interference fit, and in some embodiments, each channel is configured to prevent longitudinal displacement of one of the two or more extension legs coupled to the channel.

[0004] In some embodiments, the extension leg organizer is configured to (i) be bent into a curved shape by a clinician during use, and (ii) thereafter maintain the curved shape. In some embodiments, the extended leg fixation device further comprises an extended leg ring coupled to the extended leg organizer, the extended leg ring extending around two or more extended legs as a group, hi some embodiments, the extended leg ring is disposed distal to the extended leg organizer.

[0005] In some embodiments, the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough, and in some embodiments, the slots define a width that is less than a diameter of each of the two or more extension legs.

[0006] In some embodiments, the extended leg ring includes a first arm extending along a first partial circumference of the extended leg ring and a second arm extending along a second partial circumference disposed opposite the first partial circumference, and at least one of the first arm or the second arm is deflectable to increase a width of the slot.

[0007] In some embodiments, the extended leg fixation device further includes a bendable wire coupled between the extended leg ring and the extended leg organizer, and in some embodiments, the bendable wire is configured to (i) bend by a clinician during use to define a position and orientation of the extended leg organizer relative to the extended leg ring, and (ii) maintain the position and orientation of the extended leg organizer relative to the extended leg ring.

[0008] In some embodiments, the extension leg fixation device further includes a second extension leg organizer coupled to the extension leg organizer, the second extension leg organizer having two or more channels configured to individually receive the two or more extension legs therein. In some embodiments, the second extension leg organizer is disposed distal to the extension leg organizer.

[0009] In some embodiments, the extended leg fixation device further includes a bendable wire coupled between the second extended leg organizer and the extended leg organizer, and in some embodiments, the bendable wire is configured to (i) bend by a clinician during use to define a position and orientation of the extended leg organizer relative to the second extended leg organizer, and (ii) maintain the position and orientation of the extended leg organizer relative to the second extended leg organizer.

[0010] Also disclosed herein is a catheter extension leg securement device, according to some embodiments, that includes an extension leg organizer having two or more channels configured to individually receive two or more extension legs of a catheter therein.

[0011] In some embodiments of the device, each channel is configured to couple with one of the two or more extension legs via a press fit, a snap fit, or an interference fit, and in some embodiments of the device, each channel is configured to prevent longitudinal displacement of one of the two or more extension legs coupled to it.

[0012] In some embodiments of the device, the extension leg organizer is configured to (i) be bent into a curved shape by a clinician during use, and (ii) thereafter maintain the curved shape.

[0013] In some embodiments, the apparatus further includes an extension leg ring coupled with the extension leg organizer, the extension leg ring configured to extend around two or more extension legs as a group.

[0014] In some embodiments of the device, the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough, and in some embodiments, the slots define a width that is less than a diameter of each of the two or more extension legs.

[0015] In some embodiments of the device, the extended leg ring includes a first arm extending along a first partial circumference of the extended leg ring and a second arm extending along a second partial circumference of the extended leg ring, the second partial circumference being disposed opposite the first partial circumference, and at least one of the first arm or the second arm being deflectable to increase a width of the slot.

[0016] In some embodiments, the device further includes a bendable wire coupled between the extended leg ring and the extended leg organizer, and in some embodiments, the bendable wire is configured to (i) bend by a clinician during use to define a position and orientation of the extended leg organizer relative to the extended leg ring, and (ii) maintain the position and orientation of the extended leg organizer relative to the extended leg ring.

[0017] In some embodiments, the device further includes a second extension leg organizer coupled to the extension leg organizer, the second extension leg organizer having two or more channels configured to individually receive two or more extension legs therein.

[0018] In some embodiments, the device further includes a bendable wire coupled between the second extended leg organizer and the extended leg organizer, and in some embodiments, the bendable wire is configured to (i) bend by a clinician during use to define a position and orientation of the extended leg organizer relative to the second extended leg organizer, and (ii) maintain the position and orientation of the extended leg organizer relative to the second extended leg organizer.

[0019] Also disclosed herein is a method of using a catheter that, according to some embodiments, includes: (i) coupling two or more extension legs of the catheter to an extension leg organizer that includes two or more channels configured to receive the two or more extension legs therein; and (ii) placing the two or more extension legs within an extension leg ring coupled to the extension leg organizer.

[0020] In some embodiments of the method, the extended leg organizer is coupled to the extended leg ring via a bendable wire, and the method further includes bending the bendable wire to define a position and orientation of the extended leg organizer relative to the extended leg ring.

[0021] In some embodiments of the method, the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough, the slots defining a width that is less than a diameter of each of the two or more extension legs, and disposing the two or more extension legs within the extension leg ring includes displacing the two or more extension legs through the slots.

[0022] In some embodiments of the method, the extended leg ring includes a first arm extending along a first partial circumference of the extended leg ring and a second arm extending along a second partial circumference of the extended leg ring, the second partial circumference being disposed opposite the first partial circumference, at least one of the first arm or the second arm being deflectable to increase a width of the slot, and displacing the two or more extended legs through the slot includes deflecting at least one of the first arm or the second arm.

[0023] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the following description and the accompanying drawings, which describe in more detail certain embodiments of such concepts. A more particular description of the present disclosure will be made by reference to certain embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 is a perspective view of a catheter assembly including an extended leg fixation device, according to some embodiments. [Figure 2A] FIG. 13 is a perspective view of an extension leg anchor coupled to an extension leg of a catheter, according to some embodiments. [Figure 2B] FIG. 2 is a detailed end view of the extension leg organizer of FIG. 1 according to some embodiments. [Figure 2C] FIG. 13 is a detailed end view of another embodiment of an extension leg stationary organizer, according to some embodiments. [Figure 2D] 2 is a detailed end view of the extension leg ring of FIG. 1 in accordance with some embodiments. [Figure 2E] 1 is an exploded side cross-sectional view of an extension leg fixation device according to some embodiments. [Figure 3A]2D is a perspective view of another embodiment of an extended leg fixation device including a pair of extended leg organizers of FIG. 2C, according to some embodiments. [Figure 3B] 2C is a perspective view of another embodiment of an extended leg fixation device including a pair of extended leg organizers of FIG. 2B, according to some embodiments. [Figure 4A] 13 is a perspective view of another embodiment of an extension leg fixation device in an unflexed configuration, according to some embodiments. [Figure 4B] 4B is a perspective view of the extension leg fixation device of FIG. 4A in a bent configuration, according to some embodiments. [Figure 5A] 2A-2D are various views of the catheter assembly of FIG. 1 illustrating an exemplary method of using an extended leg fixation device, according to some embodiments. [Figure 5B] 2A-2D are various views of the catheter assembly of FIG. 1 illustrating an exemplary method of using an extended leg fixation device, according to some embodiments. [Figure 5C] 2A-2D are various views of the catheter assembly of FIG. 1 illustrating an exemplary method of using an extended leg fixation device, according to some embodiments. [Figure 5D] 2A-2D are various views of the catheter assembly of FIG. 1 illustrating an exemplary method of using an extended leg fixation device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0026] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0027] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0028] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0029] The phrases "connected," "coupled," and "in communication" refer to any form of interaction between two or more entities, including, but not limited to, mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0030] Any method disclosed herein includes one or more steps or acts of carrying out the described method. The steps and / or acts of the method may be interchanged with one another. In other words, the order and / or use of certain steps and / or acts may be modified unless a certain order of steps or acts is required for proper operation of an embodiment.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1 shows a perspective view of a catheter assembly 100 including an extension leg securement device 120 and a catheter 102 having several (e.g., two, three, four, or more) extension legs 110, according to some embodiments. The extension leg securement device (device) 120 is generally configured to organize the extension legs 110 of the catheter 102 during use of the catheter 102. In some embodiments, the device 120 is configured to define the direction or orientation of the extension legs 110. In some embodiments, the device 120 is configured to define the arrangement of the extension legs 110, i.e., the position of each extension leg relative to the other extension legs.

[0032] In some embodiments, the catheter 102 may include a central venous catheter (CVC), although it can be understood that other multi-lumen catheters (e.g., peripherally inserted central catheters (PICC), central venous catheters (CVC), midline catheters, etc.) may be used under the scope of the present disclosure. In some embodiments, the catheter 102 may include a hub 104 coupled between a catheter tube 106 having several (e.g., one, two, three, four, or more) lumens 108 therein and extension legs 110. Each extension leg 110 is in fluid communication with at least one of the lumens 108. In some embodiments, the extension legs 110 may each include a connector 112. In some embodiments, the connectors 112 may include a luer lock connector. In some embodiments, the catheter assembly 100 includes a device 120 coupled to the catheter 102 for organizing and / or securing the extension legs 110 together, as described in more detail herein. In some embodiments, the device 120 can be configured to removably couple to the extension legs 110.

[0033] In the illustrated embodiment, the device 120 may generally include an extended leg organizer 122 coupled to an extended leg ring 130 via a bendable wire 150. In some embodiments, either the extended leg organizer 122 or the extended leg ring 130 may be omitted. In some embodiments, the device 120 may include more than one extended leg organizer 122 and / or more than one extended leg ring 130.

[0034] Following placement of the catheter 102, an insertion site 114 on the patient 50 can be identified and accessed, and the insertion site 114 can be used to access the patient's vasculature. In some embodiments, the insertion site 114 can be in the patient's subclavian region. The catheter 102 can be slidably inserted through the insertion site 114 into the vasculature. The extension legs 110 can be organized and secured using the device 120 before, after, or during insertion of the catheter 102. In some embodiments, organizing and securing the extension legs 110 using the device 120 can reduce obstruction around the insertion site, thereby providing increased patient comfort and improved catheter placement by reducing movement of the catheter 102 by reducing movement of the extension legs 110 during and / or after placement of the catheter 102. In some cases, after the catheter 102 is properly placed, the clinician or patient can use the device 120 to keep the extension legs 110 organized. Use of device 120 can eliminate the need to apply tape to the patient or other methods of organizing and / or securing extension legs 110. In some embodiments, device 120 can be configured for single use. In other embodiments, device 120 can be configured for reuse.

[0035] FIG. 2A shows a perspective view of the device 120 including an extension leg organizer 122 coupled with an extension leg ring 130 via a bendable wire 150, according to some embodiments. The extension leg organizer 122 can be configured to secure each of the extension legs 110 individually thereto, and the extension leg ring 130 can be configured to extend around the extension legs 110, or may otherwise organize the extension legs 110 as a group. In some embodiments, the bendable wire 150 can be configured to be bent into any shape consistent with a desired position and / or orientation of the extension legs 110. For example, in FIG. 2A, the bendable wire 150 is bent defining a 180 degree curve such that the extension legs 110 follow the 180 degree curve. In some embodiments, the device 120 can be oriented with respect to the catheter 102 such that the extension leg ring 130 is disposed distal to the extension leg organizer 122. In some cases, the extended leg organizer 122 may be deployed without deploying the extended leg ring 130, or vice versa.

[0036] 2B shows an end view of the extension leg organizer 122, according to some embodiments. In some embodiments, the extension leg organizer 122 can include several (e.g., two, three, four, or more) channels, such as three channels 124A-124C in the illustrated embodiment, each of the channels 124A-124C configured to secure one extension leg 110 therein. Each of the channels 124A-124C can include a channel opening, such as a corresponding channel opening 126A-126C, configured to receive the extension leg 110 therethrough. In some embodiments, the channels 124A-124C can be arranged in various channel configurations on the extension leg organizer 122 to present the extension legs 110 to a user such that each extension leg 110 can be easily accessed and identified.

[0037] In some embodiments, the three channels 124A-124C can be arranged in a channel configuration with a central channel 124B and each remaining channel 124A, 124C disposed laterally adjacent to the central channel 124B. This configuration allows the extension legs 110 located within the central channel 124B to be separated and easily accessible by a user. In some embodiments, the channel openings 126A-126C can face the same direction as shown in FIG. 2B or can face different directions. In some embodiments, the channel openings 126A-126C can be equal. In other embodiments, two or more of the channel openings 126A-126C can be unequal. In some embodiments, the leg extension organizer 122 can include a wire aperture 123 configured to receive and couple with the bendable wire 150 therein.

[0038] In some embodiments, each of the channels 124A-124C can have a channel diameter 128 that is equal to or greater than the channel openings 126A-126C. In some embodiments, the channel diameter 128 can be greater than the diameter of the extension leg 110 such that longitudinal displacement of the extension leg 110 relative to the leg extension organizer 122 is freely permitted. In some embodiments, friction between each channel 124A-124C of each channel and each extension leg 110 can be configured to prevent longitudinal displacement of the extension leg organizer 122 relative to the leg extension organizer 122. In some embodiments, the channel openings 126A-126C can be less than the diameter of the extension leg 110 to define a snap fit, press fit, interference fit, or the like.

[0039] FIG. 2C illustrates another embodiment of an extension leg organizer 222 configured to couple with and organize four extension legs 110. Thus, the extension leg organizer 222 includes four channels 124A-124D. In some embodiments, the channel configuration of the extension leg organizer 222 may be symmetric, such that the channels 124A-124D are evenly spaced along the circumference of the extension leg organizer 222, as shown in FIG. 2C. In other embodiments, the channels 124A-124D may be unevenly spaced along the circumference of the extension leg organizer 222, i.e., the channel configuration may be asymmetric. In some embodiments, the number of channels 124A-124D may correspond to the number of extension legs 110 of the catheter 102.

[0040] In some embodiments, the channel diameter 128 of each of the channels 124A-124D may be the same, or the channel diameter 128 may be different for each of the channels 124A-124D. In some embodiments, the extension leg organizer 122 may be configured to have four channels 124A-124D, and the four channels 124A-124D may have a channel configuration of the four channels 124A-124D organized into a first pair 125A of channels 124A, 124C and a second pair 125B of channels 124B, 124D. In some embodiments, the channel openings 126A, 126C of the first pair 125A may be in opposite directions, and the channel openings 126B, 126D of the second pair 125B may be in opposite directions, as shown in FIG. 2B. In some embodiments, the first pair 125A of channels 124A, 124C may be adjacent to the second pair 125B of channels 124B, 124D, and each channel opening 126A, 126C of the first pair 125A of channels 124A, 124C is positioned 90° from each channel opening 126B, 126D of the second pair 125B of channels 124B, 124D. In some embodiments, the extension leg organizer 122 may be extruded, 3D printed, injection molded, pressed, or stamped from a sheet of material or the like. In some embodiments, the extension leg organizer 122 may be constructed from a polymer, an elastomer, or a metal such as aluminum, stainless steel, or the like.

[0041] 2D shows an end view of the extended leg ring 130. In some embodiments, the extended leg ring 130 can be used with the extended leg organizer 122 to gather the extended legs 110 closely together. In some embodiments, the extended leg ring 130 can include an extended leg ring body 132 having a first arm 134 that defines a first partial circumference of the extended leg ring 130 and a second arm 136 that defines a second partial circumference of the extended leg ring 130, the second arm 136 being disposed opposite the first arm 134. A slot 138 disposed between the first arm 134 and the second arm 136 is configured to individually receive the extended legs 110 therethrough, the slot 138 defining a width that is less than a diameter of each extended leg 110 such that each extended leg 110 is prevented from passing freely through the slot 138. One or both of the arms 134, 136 may be deflectable to allow passage of the extension leg 110 upon the discretion of the clinician. In some embodiments, the extension leg ring 130 may include a wire aperture 135 configured to receive and couple with a bendable wire 150. Like the extension leg organizer 122, the extension leg ring 130 may be extruded, 3D printed, injection molded, pressed, or stamped from a sheet of material or the like. In some embodiments, the extension leg organizer 122 may be constructed from a polymer, an elastomer, or a metal such as aluminum, stainless steel, or the like.

[0042] 2E shows a cross-sectional exploded side view of device 120 including extended leg organizer 122, extended leg ring 130, and bendable wire 150, according to some embodiments. As described above, extended leg ring 130 may be coupled to extended leg organizer 122 via bendable wire 150. During manufacturing of device 120, both ends of bendable wire 150 may be inserted into wire aperture 123 of extended leg organizer 122 and wire aperture 135 of extended leg ring 130.

[0043] The bendable wire 150 is configured to maintain a desired shape after being bent by a clinician. In some embodiments, a portion of the bendable wire 150 may be more bendable than other portions of the bendable wire 150. For example, the end portions of the bendable wire 150 coupled to the wire aperture 123 of the extension leg organizer 122 and the wire aperture 135 of the extension leg ring 130 may be stiffer (i.e., less bendable) than a central portion of the bendable wire 150 extending between the end portions. In some embodiments, the bendable wire 150 may be pre-bent into a particular shape, such as the 180 degree shape shown in FIG. 2E or any other shape.

[0044] 3A shows a perspective view of another embodiment of an extended leg fixation device. The extended leg fixation device 320 includes a first extended leg organizer 322A and a second extended leg organizer 322B coupled to each other via a bendable wire 150, each of which may be similar in some respects to the extended leg organizer 222 of FIG. 2C. In some embodiments, the pair of extended leg organizers 322A, 322B may organize and fix the extended legs 110 more securely than the extended leg fixation device 120. In some embodiments, the first extended leg organizer 322A may have a channel configuration similar to the second extended leg organizer 322B, or the first extended leg organizer 322A may have a channel configuration different from the second extended leg organizer 322B. In some embodiments, the extended leg fixation device 320 may be pre-assembled or may include individual components (e.g., extended leg organizers 322A, 322B, and bendable wire 150) that are disassembled so that a clinician can assemble the extended leg fixation device 320 in a desired configuration at the time of use. In one embodiment, when the extended leg fixation device 320 is pre-assembled, the bendable wire 150 can define a first length 352 that separates the first extended leg organizer 322A from the second extended leg organizer 322B. In one embodiment, when the extended leg fixation device 320 has individual components disassembled, a user can determine the first length 352 of the bendable wire 150 and the respective channel configurations of the first extended leg organizer 322A and the second extended leg organizer 322B. In some embodiments, the bendable wire 150 may be removably coupled to the wire aperture 323A of the first extension leg organizer 322A and the wire aperture 323B of the second extension leg organizer 322B. In some embodiments, the bendable wire 150 may be removably coupled to each of the wire apertures 323A, 323B of the extension leg organizers 322A, 322B with a press fit, a snap fit, an interference fit, or the like.

[0045] 3B shows a perspective view of an embodiment of a device 340 including an extension leg organizer 342, each of which may be similar in some respects to the extension leg organizer 122 of FIG. 2B. In some embodiments, the first extension leg organizer 342A may be oriented in the same direction as the second extension leg organizer 342B. In some embodiments, orienting the first extension leg organizer 342A in the same direction as the second extension leg organizer 342B allows the extension leg 110 to remain in the same configuration when the bendable wire 150 is bent. In some embodiments, the bendable wire 150 allows the extension leg 110 to follow the bend of the bendable wire 150, which may reduce stress on the extension leg 110 and / or the catheter tube 106. Furthermore, the first extension leg organizer 342A and the second extension leg organizer 342B provide a simplified interface for a clinician to easily access each extension leg 110 by removing the desired extension leg 110 from either of the extension leg organizers 342A, 342B.

[0046] 4A shows a perspective view of another embodiment of an extended leg fixation device. According to some embodiments, the extended leg fixation device 420 includes an elongated extended leg organizer 422. The extended leg organizer 422 can have an elongated body 429 extending along a length 423. The elongated body 429 extends between a proximal end 425 and a distal end 427. The elongated extended leg organizer 422 includes several (e.g., two, three, four, or more) channels 424. In some embodiments, each channel 424 can extend along a first length 423. In some embodiments, the extended leg organizer 422 can be constructed from one or more materials that are flexible, allowing the entire extended leg organizer 222 to transition between a non-flexed orientation and a bent orientation.

[0047] 4B shows a perspective view of the extended leg fixation device 420 in a bent configuration, according to some embodiments. In some embodiments, the extended leg organizer 422 may be disposed in a bent orientation. In some embodiments, when disposed in a bent orientation, one or both of the proximal end 425 and the distal end 427 may be bent away from the first midpoint 428. In some embodiments, the material that comprises the extended leg organizer 422 may be configured to allow the extended leg organizer 422 to remain in the bent orientation until a user transitions the extended leg organizer 422 to a non-bent orientation. In some embodiments, the material at the midpoint 428 may be different than the material at the proximal end 425 and / or the distal end 427. For example, the material at the proximal end 425 and / or the distal end 427 may be stiffer than the material at the midpoint 428. In other embodiments, the material at the proximal end 425 and / or the distal end 427 may be more flexible than the material at the midpoint 428.

[0048] 5A-5D show various perspective views of the catheter assembly 100 and an exemplary method of securing and organizing the extension leg 110 of the catheter 102. FIG. 5A shows the catheter assembly 100 in a detached state, i.e., the extension leg securing device 120 is detached from the catheter 102. The catheter 102 includes a catheter tube 106 and a hub 104 coupled between (i) a first extension leg 110A in fluid communication with a first lumen 108A, (ii) a second extension leg 110B in fluid communication with a second lumen 108B, and (iii) a third extension leg 110C in fluid communication with a third lumen 108C. The extension leg securing device 120 includes an extension leg ring 130 and an extension leg organizer 122 having a first channel 124A, a second channel 124B, and a third channel 124C.

[0049] 5B shows the catheter assembly 100 in a partially coupled state. The extension leg ring 130 is coupled to the extension legs 110A-110C. In some cases, the clinician inserts each of the extension legs 110A-110C individually through the openings 118 in the extension leg ring 130 such that the extension leg ring 130 constrains the position of the extension legs 110A-110C as a group. In some cases, the extension leg ring 130 may be used to constrain the extension legs 110A-110C adjacent to the hub 104.

[0050] 5C shows the catheter assembly 100 in a fully coupled state. The extension leg organizer 122 is individually coupled to the extension legs 110A-110C at a location proximal to the extension leg ring 130. In some embodiments, the first channel 124A may be coupled to the first extension leg 110A, the second channel 124B may be coupled to the second extension leg 110B, and the third channel 124C may be coupled to the third extension leg 110C. In some embodiments, the clinician may couple the extension legs 110A-110C to the extension leg organizer 122 after coupling the extension leg ring 130 to the extension legs 110A-110C. In some embodiments, the clinician may couple the extension legs 110A-110C, the extension leg organizer 122, and / or the extension leg ring 130 before inserting the catheter 102 into the patient.

[0051] 5D shows the catheter assembly 100 in a fully coupled state, with the extended leg locking device 120 positioned in a bent configuration. More specifically, the extended leg organizer 122 and the extended leg ring 130 are coupled to the extended legs 110A-110C, and the bendable wires 150 are bent by the clinician into a curved configuration away from the straight configuration of FIGS. 5A-5C. In some embodiments, bending the extended leg organizer 122 away from the extended leg ring 130 can position the extended legs 110A-110B for easy access by the clinician. It can be appreciated that these steps can be performed in any order. For example, the bendable wire 150 may be bent into a desired configuration before the extension legs 110A-110C are coupled to the channels 124A-124C, and / or the extension leg organizer 122 may be coupled to the extension legs 110A-110C before the extension leg ring 130 is coupled to the extension legs 110A-110C.

[0052] A method of using a catheter, according to some embodiments, may include all or any subset of the following steps or processes: The method may include coupling two or more extension legs of the catheter to an extension leg organizer, such as inserting the extension legs into two or more channels of the extension leg organizer. The method may further include placing the two or more extension legs within an extension leg ring, the extension leg ring being coupled to the extension leg organizer.

[0053] In some embodiments of the method, the extended leg organizer may be coupled to the extended leg ring via a bendable wire, and thus the method may further comprise bending the bendable wire to define a position and orientation of the extended leg organizer relative to the extended leg ring.

[0054] In some embodiments of the method, the extension leg ring may include slots configured to individually receive the two or more extension legs therethrough, and the slots may define a width that is less than a diameter of each of the two or more extension legs. According to such embodiments, disposing the two or more extension legs within the extension leg ring includes displacing the two or more extension legs through the slots.

[0055] In some embodiments of the method, the extension leg ring may include a first arm extending along a first partial circumference of the extension leg ring and a second arm extending along a second partial circumference of the extension leg ring. In such embodiments, the second partial circumference is disposed opposite the first partial circumference. In such embodiments, at least one of the first arm or the second arm is deflectable to increase the width of the slot. Thus, displacing the two or more extension legs through the slot includes deflecting at least one of the first arm or the second arm.

[0056] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter assembly comprising: a catheter having two or more extension legs, each extension leg in fluid communication with at least one lumen extending along the catheter tube; an extension leg fastening device attached to each of the two or more extension legs, the extension leg fastening device including an extension leg organizer having two or more channels configured to individually receive the two or more extension legs therein; A catheter assembly comprising:

2. The assembly of claim 1 , wherein each channel is coupled to one of the two or more extension legs by a press fit, a snap fit, or an interference fit.

3. The assembly of claim 1 , wherein each channel is configured to prevent longitudinal displacement of one of two or more extension legs coupled to the channel.

4. 4. The assembly of claim 1, wherein the extension leg organizer comprises: configured to be bent into a curved shape by a clinician during use; the assembly being configured to thereafter maintain said curved shape.

5. 4. The assembly of claim 1, wherein the extension leg fixation device further comprises an extension leg ring coupled to the extension leg organizer, the extension leg ring extending around two or more extension legs as a group.

6. The assembly of claim 5 , wherein the extension leg ring is disposed distally of the extension leg organizer.

7. The assembly of claim 5 , wherein the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough.

8. The assembly of claim 7 , wherein the slot defines a width that is less than a diameter of each of the two or more extension legs.

9. 9. The assembly of claim 8, the extension leg ring includes a first arm extending along a first partial circumference of the extension leg ring and a second arm extending along a second partial circumference of the extension leg ring, the second partial circumference being disposed opposite the first partial circumference; An assembly wherein at least one of the first arm or the second arm is deflectable to increase a width of the slot.

10. The assembly of claim 5 , wherein the extension leg fixation device further comprises a bendable wire coupled between the extension leg ring and the extension leg organizer.

11. 11. The assembly of claim 10, wherein the bendable wire comprises: configured to be bent by a clinician during use to define a position and orientation of the extension leg organizer relative to the extension leg ring; An assembly configured to maintain the position and orientation of the extension leg organizer relative to the extension leg ring.

12. 4. The assembly of claim 1, wherein the extension leg fixation device further comprises a second extension leg organizer coupled to the extension leg organizer, the second extension leg organizer having two or more channels configured to individually receive the two or more extension legs therein.

13. The assembly of claim 12, wherein the extension leg fixation device further comprises a bendable wire coupled between the second extension leg organizer and the extension leg organizer.

14. 14. The assembly of claim 13, wherein the bendable wire comprises: configured to be bent by a clinician during use to define a position and orientation of the extension leg organizer relative to the second extension leg organizer; and An assembly configured to maintain the position and the orientation of the extension leg organizer relative to the second extension leg organizer.

15. A catheter extension leg fixation device, comprising: A catheter extension leg securement device comprising an extension leg organizer having two or more channels configured to individually receive two or more extension legs of a catheter therein.

16. 16. The device of claim 15, wherein each channel is coupled to one of the two or more extension legs by a press fit, a snap fit, or an interference fit.

17. 16. The device of claim 15, wherein each channel is configured to inhibit longitudinal displacement of one of two or more extension legs coupled to the channel.

18. 16. The device of claim 15, wherein the extension leg organizer comprises: configured to be bent into a curved shape by a clinician during use; The device is configured to thereafter maintain the curved shape.

19. The device according to claim 15, The apparatus further includes an extension leg ring coupled to the extension leg organizer, the extension leg ring configured to extend around two or more extension legs as a group.

20. 20. The device of claim 19, wherein the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough.

21. 21. The apparatus of claim 20, wherein the slot defines a width that is less than a diameter of each of the two or more extension legs.

22. 22. The apparatus of claim 21, the extension leg ring includes a first arm extending along a first partial circumference of the extension leg ring and a second arm extending along a second partial circumference of the extension leg ring, the second partial circumference being disposed opposite the first partial circumference; At least one of the first arm or the second arm is deflectable to increase a width of the slot.

23. The device according to claim 19, The device further comprises a bendable wire coupled between the extension leg ring and the extension leg organizer.

24. 24. The device of claim 23, wherein the bendable wire comprises: configured to be bent by a clinician during use to define a position and orientation of the extension leg organizer relative to the extension leg ring; An apparatus configured to maintain the position and orientation of the extension leg organizer relative to the extension leg ring.

25. The device according to claim 15, The apparatus further includes a second extension leg organizer coupled to the extension leg organizer, the second extension leg organizer having two or more channels configured to individually receive the two or more extension legs therein.

26. The device according to claim 25, The apparatus further comprises a bendable wire coupled between the second extension leg organizer and the extension leg organizer.

27. 27. The device of claim 26, wherein the bendable wire comprises: configured to be bent by a clinician during use to define a position and orientation of the extension leg organizer relative to the second extension leg organizer; and An apparatus configured to maintain the position and the orientation of the extension leg organizer relative to the second extension leg organizer.

28. A method of using a catheter, comprising: coupling two or more extension legs of the catheter to an extension leg organizer including two or more channels configured to receive the two or more extension legs therein; placing the two or more extension legs within an extension leg ring coupled to the extension leg organizer; A method comprising:

29. 30. The method of claim 28, wherein the extension leg organizer is coupled to the extension leg ring via a bendable wire, the method further comprising bending the bendable wire to define a position and orientation of the extension leg organizer relative to the extension leg ring.

30. 29. The method of claim 28, the extension leg ring includes slots configured to individually receive the two or more extension legs therethrough; the slot defines a width that is less than a diameter of each of the two or more extension legs; The method, wherein placing the two or more extension legs within the extension leg ring includes displacing the two or more extension legs through the slot.

31. 31. The method of claim 30, the extension leg ring includes a first arm extending along a first partial circumference of the extension leg ring and a second arm extending along a second partial circumference disposed opposite the first partial circumference; at least one of the first arm or the second arm is deflectable to increase a width of the slot; The method, wherein displacing the two or more extension legs through the slot includes deflecting at least one of the first arm or the second arm.