Catheter with variable-length extension legs

Abstract

This provides a catheter assembly for organizing a catheter system. [Solution] The catheter assembly 300 includes a molded hub 302, a catheter tube 308 connected to the distal end of the molded hub 302, a plurality of extension legs 312 having distal ends coupled to the molded hub 302, and a fixation mechanism. The molded hub 302 includes a pair of hub lumens that form the hub portion of a pair of fluid paths passing through the catheter assembly 300. The catheter tube 308 includes a pair of catheter tube lumens. The fixation mechanism is configured to fix the plurality of extension legs 312 together. The fixation mechanism may be in the form of a sliding collar 316 having a proximal opening and a distal opening, the sliding collar 316 being positioned on the plurality of extension legs 312.

Description

Background Art

[0001] In current catheters, the extension legs are only fixed to the hub and can move freely proximal to the hub. Since the extension legs include clamps and luer locks, they are bulky and often difficult to fix together. This can be frustrating for medical professionals and patients who need to change the dressing at the catheter site, and may lead to inappropriate sealing at the catheter site. Currently, there is no solution to assist in fixing the extension legs together proximal to the hub so that medical professionals can focus on dressing changes.

[0002] This specification discloses a catheter assembly for organizing and fixing a plurality of extension legs, and a method of manufacturing the catheter assembly for organizing and fixing a plurality of extension legs.

Summary of the Invention

[0003] This specification discloses a catheter assembly system, as well as methods of using and manufacturing it. Embodiments of the disclosed catheter assembly system provide several advantages over conventional catheter assembly systems. In particular, embodiments of the present disclosure enable medical personnel to easily fix a plurality of extension legs of the catheter assembly system. Such is beneficial as it provides comfort and convenience to the patient during attempts to create a sealed closure at the catheter insertion site and during its general use.

[0004] In some embodiments, a catheter assembly for organizing a catheter system is shown, comprising: a molded hub including at least a pair of hub lumens; a catheter tube connected to the distal end of the molded hub, each including a catheter tube containing at least a pair of catheter tube lumens; a plurality of extension legs, each including a distal end connected to the proximal end of the molded hub, wherein a fluid path is formed between the plurality of extension legs and the catheter tube via a pair of hub lumens; and a fixing mechanism configured to fix the plurality of extension legs together, the fixing mechanism being a sliding collar positioned relative to the plurality of extension legs.

[0005] In some embodiments, the sliding collar is a permanent sliding collar having length, width, and height, the permanent sliding collar having a proximal end with a proximal opening, a distal end with a distal opening, an outer surface, and an inner surface.

[0006] In some embodiments, the length is greater than or equal to the width, and the width is greater than or equal to the height. In some embodiments, the outer surface is inclined toward the inner surface at the midpoint in the longitudinal direction and inclined toward the end point in the longitudinal direction toward the inner surface. In some embodiments, the inner surface is configured to produce friction with the outer surface of the extension leg, and when no external force is applied to the sliding collar, this friction resists the movement of the sliding collar. In some embodiments, the proximal and distal openings have an elliptical shape configuration.

[0007] In some embodiments, a catheter assembly for organizing a catheter system comprises: a molded hub including at least one pair of hub lumens, the hub lumens forming the hub portion of a pair of fluid paths through the catheter assembly; a catheter tube connected to the distal end of the molded hub, the catheter tube including at least one pair of catheter tube lumens; a plurality of extension legs, each including a proximal and distal end, the distal end of each extension leg connected to the molded hub; and a fixing mechanism configured to fix the plurality of extension legs together, the fixing mechanism including one or more adhesive joints between the plurality of extension legs, or attachable sliding collars, or permanent sliding collars. The fixing mechanism may include adhesive joints between the plurality of extension legs. In some embodiments, the fixing mechanism is an attachable sliding collar.

[0008] In some embodiments, the attachable sliding collar is removably connected to the molded hub. In some embodiments, the attachable sliding collar or the permanent sliding collar is positioned relative to a plurality of extension legs. In some embodiments, the fixing mechanism is either the attachable sliding collar or the permanent sliding collar, and the fixing mechanism has length, width, and height, and has a proximal end with a proximal opening, a distal end with a distal opening, a longitudinal midpoint, a longitudinal endpoint, an outer surface, and an inner surface.

[0009] In some embodiments, the length is greater than or equal to the width, and the width is greater than or equal to the height. In some embodiments, the outer surface is inclined toward the inner surface at the midpoint in the longitudinal direction, and then inclined toward the end point in the longitudinal direction toward the inner surface. In some embodiments, the inner surface is configured to produce friction with the outer surface of the extension leg, and when no external force is applied to the attachable sliding collar, this friction resists the movement of the attachable sliding collar. In some embodiments, the proximal and distal openings are elliptical in shape.

[0010] In some embodiments, the fastening mechanism can be axially separated into two distinct parts. In some embodiments, the fastening mechanisms are joined at a longitudinal midpoint. In some embodiments, the fastening mechanisms are joined to each other by a first hinge and a first snap opposite the first hinge. In some embodiments, the fastening mechanisms are joined to each other by a first fastener and a second fastener opposite the first fastener. In some embodiments, the fastening mechanisms are joined to each other by a first pair of magnets and a second pair of magnets opposite the first pair of magnets.

[0011] In some embodiments, a method for manufacturing a catheter assembly for organizing a catheter system is disclosed. This method may include the operations of: obtaining a molded hub comprising at least one pair of hub lumens, each of which has an inlet point adjacent to or substantially adjacent to another inlet point; obtaining a catheter tube comprising at least one pair of catheter tube lumens; obtaining a plurality of extension legs; obtaining a fixation mechanism for fixing the plurality of extension legs together, selected from the group consisting of adhesive joints, permanent sliding collars, and attachable sliding collars; connecting the catheter tube to the distal end of the molded hub; connecting the distal end of each of the plurality of extension legs to the proximal end of the molded hub, such that a fluid path is formed between the plurality of extension legs and the catheter tube via the pair of hub lumens; fixing the plurality of extension legs together using the fixation mechanism; and packaging the catheter assembly in a single-use package.

[0012] In some embodiments, securing multiple extension legs together using a fastening mechanism further includes forming an adhesive joint by curing the multiple extension legs together with heat. In some embodiments, securing multiple extension legs together using a fastening mechanism further includes forming an adhesive joint by coating the multiple extension legs with an adhesive and curing it by heat, pressure, or a combination thereof.

[0013] In some embodiments, securing multiple extension legs using a fixing mechanism further includes attaching permanent sliding collars. In some embodiments, securing multiple extension legs using a fixing mechanism further includes attaching mountable sliding collars.

[0014] Such and other features of the concepts provided herein will become more apparent to those skilled in the art in consideration of the accompanying drawings and the following description illustrating in more detail specific embodiments of such concepts.

[0015] Embodiments of the present invention are shown as examples, not as limitations, in the drawings of the accompanying drawings, where similar reference numerals indicate similar elements. [Brief explanation of the drawing]

[0016] [Figure 1] The diagrams show exemplary catheter assemblies according to several embodiments. [Figure 2A] The diagrams illustrate the catheter assemblies for organizing catheter systems that include a fixation mechanism further comprising adhesive joints, according to several embodiments. [Figure 2B] The diagrams illustrate the catheter assemblies for organizing catheter systems that include a fixation mechanism further comprising adhesive joints, according to several embodiments. [Figure 3A] The diagrams illustrate the catheter assemblies for organizing a catheter system that includes a fixation mechanism further comprising a permanent sliding collar, according to several embodiments. [Figure 3B] The diagrams illustrate the catheter assemblies for organizing a catheter system that includes a fixation mechanism further comprising a permanent sliding collar, according to several embodiments. [Figure 4A] The diagram shows an exemplary catheter assembly for organizing a catheter system that includes a fixing mechanism further comprising a mountable sliding collar, according to several embodiments. [Figure 4B] The diagram shows an exemplary catheter assembly for organizing a catheter system that includes a fixing mechanism further comprising a mountable sliding collar, according to several embodiments. [Figure 5A] The following describes a method of use for organizing multiple extension legs according to several embodiments. [Figure 5B] The following describes a method of use for organizing multiple extension legs according to several embodiments. [Figure 6A] Another embodiment of the sliding collar in several embodiments is shown. [Figure 6B] Another embodiment of the sliding collar in several embodiments is shown. [Figure 7] A flowchart illustrating a method for manufacturing a catheter assembly for organizing catheters according to several embodiments. The system is shown. [Figure 8] This is a diagram of a catheter assembly, including a sliding collar that is secured to the patient using a dressing, according to several embodiments. [Figure 9A] This is a perspective view of a fixed system according to several embodiments. [Figure 9B] This is a perspective view of a fixed system according to several embodiments. [Modes for carrying out the invention]

[0017] 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. The specific embodiments disclosed herein can be easily separated from the specific embodiments and can optionally have features that can be combined with or substituted for the features of any of the many other embodiments disclosed herein.

[0018] Regarding the terms used herein, it should also be understood that the terms are for the purpose of explaining some specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or multiple steps and do not provide consecutive limitations or numerical restrictions. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a specific embodiment including such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly dictates otherwise.

[0019] Regarding "proximal", for example, the "proximal portion" or "proximal end portion" of the catheter disclosed in this specification 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 the 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 the 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 the catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of the catheter does not necessarily include the proximal end of the catheter. That is, unless otherwise suggested by the context, the proximal portion, proximal end portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

[0020] Regarding "distal", for example, the "distal portion" or "distal end portion" of the catheter disclosed in this specification includes the portion of the catheter intended to be near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter intended to be near or within the patient when the catheter is used on a patient. For example, the "distal end" of the needle includes the end of the catheter intended to be near or within the patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of the catheter can include the distal end of the catheter, but the distal portion, distal end portion, or distal length of the catheter does not necessarily include the distal end of the catheter. That is, unless otherwise suggested by the context, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0021] Unless otherwise defined, all scientific and technical terms used in this specification have the same meaning as commonly understood by those skilled in the art. Figure 1 shows a molded hub 102 that receives multiple extension legs 106, a clamp 114, and a Luer connector 112, the clamp 114 and Luer connector 112 connected to the multiple extension legs 106. A catheter tube 104, including the catheter tip 110, is connected to the molded hub 102. The multiple extension legs 106 are not connected to each other along their length 108, allowing the clamp 114 and Luer connector 112 to move laterally along each of the multiple extension legs 106. When performing a dressing change, medical professionals often need to secure the multiple extension legs 106, clamp 114, and Luer connector 112 proximal to the catheter entry site while attempting to create a tight seal at the catheter entry site. Forming a tight seal is important in maintaining sterility and ensuring that the catheter entry site does not become infected. Furthermore, organizing and securing multiple extension legs 106, clamps 114, and Luer connectors 112 can also improve patient comfort.

[0022] Catheter assembly with adhesive joint Figure 2A shows an exemplary diagram of a catheter assembly for organizing a catheter system 200 having extension legs connected via adhesive joints. In Figure 2A, a molding hub 202 is connected to a catheter tube 208 containing a catheter tip 210. Multiple extension legs 212, on which clamps 204 and Luer connectors 206 are positioned, are connected to the molding hub 202. A fixing mechanism 214, such as an adhesive joint, fixes and organizes the multiple extension legs 106 along the length 216 of the multiple extension legs proximal to the molding hub 102.

[0023] The molded hub 202 may include at least one pair of hub lumens, in one example including an arterial lumen and a venous lumen. However, this embodiment is not intended to be limited to such examples. Furthermore, the catheter tube 208 may include at least one pair of catheter tube lumens and can be connected to the distal end of the molded hub 202. The distal ends of each of the multiple extension legs 212 can be connected to the proximal end of the molded hub 202, in which case a fluid path is formed between the multiple extension legs 212 and the catheter tube 208 via the pair of hub lumens.

[0024] Referring here to Figure 2B, the catheter assembly 200 of Figure 2A is shown, in which at least a portion of the adhesive joint is torn so that at least a portion of the extension legs is separated. In some embodiments, the adhesive joint can be torn by applying a force that pulls two or more of the extension legs 212 apart. The adhesive joint 214 can be installed at various lengths along multiple extension legs 212. For example, in some embodiments, the adhesive joint 214 can bond multiple extension legs 212 to each other from the molded hub 202 to at least half of the length of the extension legs 214.

[0025] In some embodiments, the adhesive joint 214 allows for the separation of at least one of a plurality of extension legs 212 by removably bonding at least one extension leg to another extension leg. The adhesive joint 214 between the plurality of extension legs 212 can be removed by external force. For example, in some embodiments, a medical professional can pull a Luer connector 204 connected to an extension leg 212 distally toward the molding hub 202 (otherwise toward the remaining extension legs 212) while securing the other Luer connectors 204 connected to the remaining extension legs 212 proximal toward the other extension legs 204. In some examples, at least one extension leg can be removed. In other examples, only one extension leg can be removed. In some examples, one or more extension legs can be removed to separate the plurality of extension legs 212. For example, in some embodiments, the catheter assembly 200 may include a plurality of extension legs 212, including, but not limited to, at least three extension legs. In some embodiments, but not limited to them, multiple extension legs 212 can be separated into two separate extension legs 212 by pulling distally toward the molding hub 202, while securing one Luer connector 204 connected to one extension leg 212 and two further Luer connectors 204 connected to two extension legs 204. It should be understood that any number of extension legs that may be included in various embodiments of the catheter assembly 200, and the description presented herein, are not intended to be limiting.

[0026] Catheter assembly with collar Figure 3A shows a catheter assembly 300, which includes a molded hub 302 connected to a catheter tube 308 containing a catheter tip 310. In some embodiments, the molded hub 302 is connected to a plurality of extension legs 312, on which clamps 306 and Luer connectors 304 are located. In some embodiments, the catheter assembly 300 optionally further includes a fixation mechanism, which includes an adhesive joint 314 between the plurality of extension legs 312 that fixes the plurality of extension legs 312 together proximal to the molded hub 302. In some embodiments, the fixation mechanism includes the adhesive joint 314, a permanent sliding collar 316, or a combination thereof.

[0027] Figure 3B shows the permanent sliding collar 316 of Figure 3A, including a length 318, a width 320, a height 322, a proximal end, a proximal opening 324, a distal end, a distal opening 326, a longitudinal midpoint 332, a longitudinal endpoint 334, an outer surface 328, and an inner surface 330. In some embodiments, the length 318 can be in the range of 6 to 30 millimeters (mm). In some embodiments, the width 320 can be in the range of 6 to 30 mm. In different embodiments, the width 320 can be modified to accommodate multiple extension legs 312 according to a particular embodiment. The height 322 can be in the range of 6 to 30 mm. In some embodiments, the height 322 can be modified to accommodate multiple extension legs 312. The proximal opening 324 and the distal opening 326 can have an elliptical shape, but are not limited to these. In some embodiments, the proximal opening 324 and the distal opening 326 may have geometric configurations including circular, rectangular, square, and, in some embodiments, polygons including hexagons, heptagons, octagons, nonagons, or decagons. The proximal opening 324 may have the same geometric configuration as the distal opening 326. In some cases, the proximal opening 324 may have a different geometric configuration than the distal opening 326. In some embodiments, the longitudinal midpoint 332 is located in the middle of the length 318 of the permanent sliding collar 316. As shown in Figure 3B, the longitudinal endpoint 334 is located at the distal end of the permanent sliding collar 316.

[0028] In some embodiments, the outer surface 328 is inclined from the proximal end toward the longitudinal midpoint 332 toward the inner surface 330. In some embodiments, the outer surface 328 is inclined away from the direction of the inner surface 330 toward the longitudinal endpoint 334 located at the distal end. In some embodiments, the permanent sliding collar 316 is formed having a continuous curved surface between the proximal and distal ends. For example, the outer surface 328 is inclined from the proximal end 324 toward the position of the longitudinal midpoint 332 toward the inner surface 330, and then from that position toward the longitudinal endpoint 334 located at the distal end toward the direction of the inner surface 330.

[0029] In some embodiments, the inner surface 330 extends along the length 318 to a longitudinal endpoint 334 located at the distal end. The inner surface 330 is configured to contact the outer surfaces of the multiple extension legs 312. In some embodiments, the inner surface 330 is configured to create friction with the outer surfaces of the extension legs 312. This friction prevents the permanent sliding collar 316 from moving distally without external force being applied.

[0030] In an alternative embodiment not shown in the figure, the outer surface 328 extends along the length 318 to the longitudinal endpoint 334 located at the distal end, without being sloped up to the longitudinal midpoint 332. In other words, the outer surface 328 of the permanent sliding collar 316 is flat from the proximal end to the distal end.

[0031] In yet another embodiment, the bottom surface of the collar 316 may include an adhesive placed on the bottom surface for adhesion to the patient's skin. In such an embodiment, the bottom surface of the collar 316 may further include a removable liner initially placed over the adhesive. The liner may include a pull tab that allows a medical professional to remove the liner to expose the adhesive. For example, the liner may be formed of paper and / or plastic.

[0032] Figure 4A shows a catheter assembly 400, which in some embodiments includes a molded hub 402 connected to a catheter tube 408 including a catheter tip 410. In some embodiments, the molded hub 402 is connected to a plurality of extension legs 412, which include a clamp 406 and a Luer connector 404. In some embodiments, the catheter assembly 400 further includes a fixation mechanism, which includes an adhesive joint 414 between the plurality of extension legs 412 that fixes the plurality of extension legs 412 together proximal to the molded hub 402. In some embodiments, the fixation mechanism further includes the adhesive joint 414, a detachable sliding collar 416, or a combination thereof.

[0033] Figure 4B shows a mountable sliding collar 416 in several embodiments, including a length 418, a width 420, a height 422, a proximal end, a proximal opening 424, a distal end, a distal opening 426, a longitudinal midpoint 432, a longitudinal endpoint 436, an outer surface 428, and an inner surface 430. The length 418 can be in the range of 6 mm to 30 mm. The width 420 can be in the range of 6 to 30 mm. The width 420 can be modified to accommodate multiple extension legs 412. In some embodiments, the height 422 can be in the range of 6 to 30 mm. In some embodiments, the height 422 can be modified to accommodate multiple extension legs 412 according to a particular embodiment. In some embodiments, the proximal opening 424 and the distal opening 426 may include, but are not limited to, an elliptical shape configuration. In some embodiments, the proximal opening 424 and the distal opening 426 may have a shape configuration that includes circular, rectangular, square, and, in some embodiments, polygons including hexagons, heptagons, octagons, nonagons, or decagons. In some embodiments, the proximal opening 424 may have the same shape configuration as the distal opening 426. In some embodiments, the proximal opening 424 may have a shape configuration different from that of the distal opening 426. As shown in Figure 4B, the longitudinal midpoint 432 is located in the middle of the length 418. In some embodiments, the longitudinal endpoint 436 is located at the distal end.

[0034] In some embodiments, the attachable sliding collar 416 is formed with a continuous curve between its proximal and distal ends. In some embodiments, the outer surface 428 is inclined from the proximal end toward the longitudinal midpoint 432 toward the inner surface 430. In some embodiments, the outer surface 428 is inclined away from the direction of the inner surface 430 toward the longitudinal midpoint 432 toward the longitudinal endpoint 436 located at the distal end of the attachable sliding collar. In some embodiments, the outer surface 428 may be inclined in one or more directions along the entire length 418. For example, the shape of the outer surface 428 may be configured to be inclined in a first direction from either the proximal or distal end toward a point along the entire length 418 (e.g., the midpoint 432).

[0035] As a non-limiting example, the outer surface 428 is inclined toward the inner surface 430 from its proximal end to the position of the longitudinal midpoint 432, and then from the position of the longitudinal midpoint 432 toward the longitudinal endpoint 436 located at the distal end of the attachable sliding collar 416, away from the direction of the inner surface 430. In some embodiments, the outer surface 428 is inclined toward the inner surface 430 from its proximal end, but not inclined toward the position of the longitudinal midpoint 432. Instead, in some embodiments, it gradually inclins toward the longitudinal midpoint 432, and then gradually inclins toward the longitudinal endpoint 436 located at the distal end of the attachable sliding collar 416. In some embodiments, the outer surface 428 does not inclin toward the longitudinal midpoint 432, but extends along the length 418 to the longitudinal endpoint 436 located at the distal end of the attachable sliding collar 416. In other words, the outer surface of the attachable sliding collar 416 is flat from the proximal end to the distal end. In some embodiments, the inner surface 430 extends along the length 418 to a longitudinal endpoint 436 located at the distal end 426 of the attachable sliding collar 416. In some embodiments, the inner surface 430 can physically contact the outer surfaces of a plurality of extension legs 412. In some embodiments, the inner surface 430 is configured to create friction with the outer surfaces of the extension legs 412, so that this friction prevents the permanent sliding collar 416 from moving distally without external force being applied.

[0036] In some embodiments, the attachable sliding collar 416 can be further separated axially into two parts 416A and 416B, which are configured to be attached to each other at a longitudinal midpoint 432 by a fastening mechanism 434, which may include, for example, but not limited to, a fastener, hinge, snap, magnet, or a combination thereof. In some embodiments, as shown in Figure 4B, the fastening mechanism 434 located on part 416A may be a static fastener including a snap hook 435 at its distal end, in which case the snap hook 435 is configured to be received by a groove 437 located on part 416B. In some embodiments, a first fastening mechanism 434 may be located at the longitudinal midpoint 432 on the first side, and a second fastening mechanism 434 may be located at the longitudinal midpoint 432 on the second side (not shown).

[0037] In some embodiments, the sliding collar 416 may include a bottom surface on which adhesive and a liner are placed, as described above with respect to the sliding collar 316. Figure 5A provides a diagram illustrating how a permanent sliding collar 314 can be used in some embodiments to organize a plurality of extension legs 312 in the proximal direction of a molded hub 302. In some embodiments, the plurality of extension legs 312 are housed in an inner cavity of a permanent collar 316, as shown in Figure 3B, and are axially positioned. The permanent sliding collar 316 can move proximal from position A to position B when an external force is applied to the permanent sliding collar, which may have the advantage of gathering the plurality of extension legs 312, clamp 306, and luer connector 304.

[0038] Figure 5B illustrates how a permanent sliding collar 316 can be used in some embodiments to allow the separation of multiple extension legs 312 from one another. In some embodiments, the permanent sliding collar 316 can move distally from position C to position D when an external force is applied to the permanent sliding collar, thereby allowing the separation of the multiple extension legs 312, clamp 306, and luer connector 304 in the absence of adhesive joints such as adhesive joints 314. In some embodiments, position A may correspond to position D, and position B may correspond to position C. However, this is not mandatory. The permanent sliding collar 316 can be moved proximal or distal along the multiple extension legs 312. In some embodiments, the permanent sliding collar 316 can be detachably connected to the molded hub 302. Regarding Figures 5A and 5B, the permanently installed sliding collar 316 is described above, but please note that the same description applies equally to the attachable sliding collar 416.

[0039] Figures 6A and 6B show alternative embodiments of the sliding collar according to several embodiments. In some embodiments, the width 420 of the attachable sliding collar 416 may vary depending on the number of extension legs 412. For example, in some embodiments shown in Figure 6A, the catheter assembly 400 has three extension legs 412. The width 420 of the attachable sliding collar 416 for the catheter assembly 400 having three extension legs 412 will be different from the width 420 shown in Figure 6B, which has two extension legs 412, in some embodiments. Furthermore, the width 420 can be configured according to the sizing of the extension legs (e.g., the diameter of each extension leg). Note that while the attachable sliding collar 416 has been described above with respect to Figures 6A and 6B, the same description applies equally to the permanent sliding collar 316.

[0040] Manufacturing logic flow Figure 7 is a flowchart showing a method for manufacturing a catheter assembly for organizing extension legs in several embodiments 700. In some embodiments, the method begins by obtaining a catheter assembly including a molded hub, a catheter tube, a plurality of extension legs, and a fixing mechanism (block 702). In some embodiments, the method includes connecting the catheter tube to the molded hub and connecting the extension legs to the molded hub (block 704). In some embodiments, the method 700 further includes fixing the plurality of extension legs together by, for example, bonding the plurality of extension legs to each other to form an adhesive joint (block 708), attaching a detachable sliding collar (block 710), attaching a permanent sliding collar (block 712), or a combination thereof. In some embodiments, bonding the plurality of extension legs to each other to form an adhesive joint (block 712) may be done by a process including extrusion, co-extrusion, or other commonly used manufacturing process, but is not limited to these. In some embodiments, multiple extension legs can be bonded together after extrusion to form an adhesive joint, for example, by curing the multiple extension legs together by applying heat. In some embodiments, the adhesive joint may include, but is not limited to, industrial glue, spray adhesive, ultraviolet (UV) curing adhesive, etc.

[0041] In some embodiments, the curing process involves heating the extension legs to a temperature at which the plastic outer coating begins to melt, and then the extension legs are installed together. By cooling the plastic outer coating, an adhesive joint is formed between the extension legs. In some examples, the extension legs to be bonded together to form an adhesive joint may undergo a cooling process (e.g., application of cooling air) before the installation of the attachable sliding collar or the permanent sliding collar. In some examples, the extension legs may be configured with a barrier to prevent the attachable sliding collar or the permanent sliding collar from moving distally beyond a set point. This barrier is positioned perpendicular to the direction of movement of the attachable sliding collar or the permanent sliding collar and may have a height ranging from 3 to 15 mm.

[0042] In some embodiments, when attaching a detachable sliding collar (block 710) or a permanent sliding collar (712), an external force is required to be applied to the detachable or permanent sliding collar in order to move it proximal to the molded hub. Therefore, the detachable or permanent sliding collar can be configured to be initially joined to the molded hub. In some embodiments, when attaching a detachable sliding collar (block 710) or a permanent sliding collar (712), an external force is required to be applied to the detachable or permanent sliding collar in order to move it distally from the proximal end of the multiple extension legs. Therefore, the detachable or permanent sliding collar can be configured to be initially positioned at the proximal end of the multiple extension legs. In some embodiments, by attaching a mountable collar (block 710) or a permanent collar (712), the mountable sliding collar or the permanent sliding collar can be initially attached to any location along the multiple extension legs.

[0043] In some embodiments, the method for manufacturing a catheter assembly includes manufacturing and attaching a permanent sliding collar (block 708) or manufacturing and attaching a detachable sliding collar (block 710). In some embodiments, in manufacturing a permanent sliding collar (block 708) or a detachable sliding collar (block 710), the permanent sliding collar or the detachable sliding collar can be manufactured from, but are not limited to, acrylonitrile butadiene styrene, polyethylene, polycarbonate, nylon, silicone, polytetrafluoroethylene, acetal, polyphthalamine, polyphenylene sulfide, polyetheretherketone, impact-resistant polystyrene, polypropylene, thermoplastic polyurethane, thermoplastic rubber, combinations thereof, or other commonly used thermoplastic materials and thermoplastic derivatives used in the art.

[0044] In some embodiments, the method for manufacturing a permanent sliding collar 708, or a method for manufacturing a attachable sliding collar (block 710), may further include the outer surface being composed of a different material from the inner surface. For example, the inner surface may contain acetal while the outer surface contains polyethylene. In some embodiments, the method for manufacturing a permanent sliding collar (block 708), or a method for manufacturing a attachable sliding collar (block 710), may further include the outer surface being composed of the same material as the inner surface. For example, the inner surface may contain acetal, and the outer surface may also contain acetal. In some embodiments, the method for manufacturing a permanent sliding collar (block 708), or a method for manufacturing a attachable sliding collar (block 710), may be manufactured by processes of injection molding, 3D printing, urethane casting, thermoforming, or other commonly used manufacturing techniques, but are not limited to these. In some embodiments, the attachment of the attachable collar may be performed when the catheter assembly is being used by a patient. In some embodiments, the catheter assembly is packaged in a single-use package once the multiple extension legs have been bonded together to form an adhesive joint (block 714).

[0045] Exemplary application of a catheter assembly embodiment Referring to Figure 8, diagrams of catheter assemblies including a sliding collar, secured to a patient using a dressing, are shown according to several embodiments. Figure 8 shows an exemplary catheter assembly, such as the catheter assembly 300 of Figure 3, secured to the patient's arm with a dressing 800. As shown, the dressing 800 may include an adhesive base that adheres to the patient's arm. The procedure may involve positioning the catheter assembly 300 on the patient's arm so that the catheter tip 310 is inserted into the patient at the percutaneous insertion site (marked "X" in Figure 8). Following the insertion of the catheter tip 310, the catheter assembly 300 may be secured to the patient's arm by placing the dressing 800 directly over the catheter tube 308 and the insertion site "X". In some cases, the dressing 800 may also be positioned to cover at least a portion of the molded hub 302. As shown in the figure, the sliding collar 316 can be positioned around a plurality of extension legs 312 proximal to the molded hub 302 (where proximal is the relationship to the molded hub 102, with the catheter tip 310 pointing to the distal tip). The sliding collar 316 is shown to be operably positioned on the plurality of extension legs 312 proximal to the molded hub 302 and the dressing 800. A catheter assembly 300 is shown in Figure 8, but a catheter assembly 400 can also be used with the dressing 800. Furthermore, although the dressing 800 is merely an illustrative figure of one dressing, the disclosure is not intended to be limited in that way, and any dressing known to those skilled in the art can be used in place of the illustrated dressing 800.

[0046] Referring to Figures 9A and 9B, perspective views of two embodiments of the anchoring system are shown. Referring to Figure 9A, the anchoring system 900 is configured in association with an embodiment of the present invention. The anchoring system 900 comprises a fixing device 908, which includes an anchor pad 910 on which a retainer 914 is mounted. The base of the retainer 914 supports a plurality of posts and clips. Two covers 920A, 920B also extend from the retainer 914 and can move between an open position and a closed position to facilitate connection with a medical device such as a molded hub 902. The retainer 914 is configured to receive, hold, and fix one or both catheter attachments (e.g., flanges extending laterally from the body of the hub 902) into the fixing device 908.

[0047] As shown in the figure, multiple extension legs 906 extend proximal to the molded hub 902, and the slidable collar 907 can be positioned proximal to the molded hub 902 and around the multiple extension legs 906 (where proximal is the relationship to the molded hub 902 when the catheter tube 904 extends distally from the molded hub 902). The slidable collar 907 can take the form and characteristics of either the slidable collar 316 or the slidable collar 416 as described above.

[0048] When the hub 902 is in the first insertion position, the mounting fixture can be connected to the base of the retainer 914, and together the covers 916A and 916B extend in a closed position over at least a portion of the mounting fixture. When in the closed position over the mounting fixture, the covers 916A and 916B prevent lateral movement of the mounting fixture and, consequently, of the hub 902.

[0049] In some embodiments, a secondary cover 922 including a flange clip 924 can be positioned on the rear 918. The secondary cover 922 is configured to rotate between an open position and a closed position, in which case the flange clip 924 holds the secondary cover 922 in the closed position by connecting with a latch 926. A clinician can apply force to separate the flange clip 924 and the latch 926 (which operate in the same manner as the covers 916A, 916B, and their corresponding flange clips and latches).

[0050] The anchor pad 910 is securely attached to the patient's skin by its lower surface 912, and the retainer 914 is securely attached to the upper surface of the anchor pad 910. The anchor pad 910 may include a laminated structure having an upper layer of plastic (e.g., polyester fabric), paper, or foam (e.g., closed-cell polyethylene foam) and a lower adhesive layer. The lower adhesive layer constitutes the lower surface 912 of the anchor pad. The lower surface 912 is preferably a medical-grade adhesive and can be either sweat-wicking or non-sweat-wicking depending on the specific application.

[0051] Referring to Figure 9B, exemplary embodiments of the anchoring system 900, having projections 920A, 920B for securing the sliding collar 907, are shown according to several embodiments. As a fixing device for the sliding collar 907, replacing the cover 922, the retainer 914 may include projections 920A, 920B. In embodiments in which the retainer 914 is configured to mate (connect) with the sliding collar 907, the rear portion 918 of the retainer 914 may include projections 920A, 920B that releasely grip the sides of the sliding collar 907 when downward pressure is applied to the sliding collar 907. The sliding collar 907, gripped by projections 920A, 920B, can be removed by a clinician applying tensile force to the sliding collar 907 (or, optionally, to a plurality of extension legs 906).

[0052] While several specific embodiments are disclosed herein, and these specific embodiments are disclosed in some degree of detail, they are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may be apparent to those skilled in the art, and these adaptations and / or modifications are also encompassed in broader embodiments. Thus, it is possible to carry out developments from specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter assembly for organizing a catheter system, A molded hub including at least one pair of hub tubular lumens, A catheter tube connected to the distal end of the molded hub, comprising a catheter tube including at least one pair of catheter tube lumens, A plurality of extension legs, each extension leg including a distal end connected to the proximal end of the molded hub, wherein a fluid path is formed between the plurality of extension legs and the catheter tube via the pair of hub lumens, A fixing mechanism configured to fix the plurality of extension legs together, wherein the fixing mechanism is a sliding collar disposed on the plurality of extension legs. A catheter assembly comprising the following features.

2. The catheter assembly according to claim 1, wherein the sliding collar is a permanent collar having length, width, and height, and the permanent collar has a proximal end having a proximal opening, a distal end having a distal opening, an outer surface, and an inner surface.

3. The catheter assembly according to claim 2, wherein the length is greater than or equal to the width, and the width is greater than or equal to the height.

4. The catheter assembly according to claim 2 or 3, wherein the outer surface is inclined toward the inner surface at the midpoint in the longitudinal direction and is inclined toward the end point in the longitudinal direction toward the inner surface.

5. The catheter assembly according to any one of claims 2 to 4, wherein the inner surface is configured to produce friction with the outer surface of the extension leg, and when no external force is applied to the sliding collar, the friction resists the movement of the sliding collar.

6. The catheter assembly according to any one of claims 2 to 5, wherein the proximal opening and the distal opening have an elliptical shape configuration.

7. A catheter assembly for organizing a catheter system, A molded hub including at least one pair of hub tubular lumens, A catheter tube connected to the distal end of the molded hub, comprising a catheter tube including at least one pair of catheter tube lumens, A plurality of extension legs, each extension leg including a proximal end and a distal end, the distal end of each extension leg connected to the proximal end of the molded hub, and a fluid path formed between the plurality of extension legs and the catheter tube via the pair of hub lumens, A fixing mechanism configured to fix the plurality of extension legs together A catheter assembly comprising, wherein the fixing mechanism is selected from the group consisting of adhesive joints between the plurality of extension legs, attachable sliding collars, and permanent sliding collars.

8. The catheter assembly according to claim 7, wherein the fixing mechanism includes adhesive joints between the plurality of extension legs.

9. The catheter assembly according to claim 7 or 8, wherein the fixing mechanism is the attachable sliding collar.

10. The catheter assembly according to claim 9, wherein the attachable sliding collar is detachably connected to the molded hub.

11. The catheter assembly according to any one of claims 7 to 10, wherein the attachable sliding collar or the permanent sliding collar is positioned on the plurality of extension legs.

12. The catheter assembly according to any one of claims 7 to 11, wherein the fixing mechanism is either the attachable sliding collar or the permanent sliding collar, and the fixing mechanism has length, width, and height, and has a proximal end having a proximal opening, a distal end having a distal opening, a longitudinal midpoint, a longitudinal endpoint, an outer surface, and an inner surface.

13. The catheter assembly according to claim 12, wherein the length is greater than or equal to the width, and the width is greater than or equal to the height.

14. The catheter assembly according to claim 12 or 13, wherein the outer surface is inclined toward the inner surface at the midpoint of the longitudinal direction and is inclined toward the end of the longitudinal direction toward the inner surface.

15. The catheter assembly according to any one of claims 12 to 14, wherein the inner surface is configured to produce friction with the outer surface of the extension leg, and when no external force is applied to the attachable sliding collar, the friction resists the movement of the attachable sliding collar.

16. The catheter assembly according to any one of claims 12 to 15, wherein the proximal opening and the distal opening are elliptical in shape.

17. The catheter assembly according to any one of claims 12 to 16, wherein the fixing mechanism is axially separable into two separate parts.

18. The catheter assembly according to claim 17, wherein the fixing mechanism is joined at the midpoint in the longitudinal direction.

19. The catheter assembly according to claim 18, wherein the fixing mechanism is joined together by a fastening mechanism.

20. The catheter assembly according to claim 19, wherein the fastening mechanism includes a fastener having a snap hook positioned on a first portion and a groove on a second portion, the groove being configured to receive the snap hook.

21. The catheter assembly according to claim 18, wherein the fixing mechanism is joined together by a first pair of magnets and a second pair of magnets facing the first pair of magnets.

22. A method for manufacturing a catheter assembly for organizing a catheter system, To obtain a molded hub including at least one pair of hub lumens, wherein each of the hub lumens has an inlet adjacent to or substantially adjacent to another inlet point, To obtain a catheter tube, wherein the catheter tube includes at least one pair of catheter tube lumens, Obtaining multiple extension legs, The present invention provides a fixing mechanism for securing the multiple extension legs together, wherein the fixing mechanism is selected from the group consisting of an adhesive joint, a permanently installed sliding collar, and an attachable sliding collar. The catheter tube is connected to the distal end of the molded hub, The distal end of each of the plurality of extension legs is connected to the proximal end of the molded hub, and a fluid path is formed between the plurality of extension legs and the catheter tube via the pair of hub lumens. The fixing mechanism is used to fix the multiple extension legs together, The catheter assembly is packaged in a single-use package. A method for manufacturing a catheter assembly that includes [the specified component].

23. The method for manufacturing a catheter assembly according to claim 22, wherein fixing the plurality of extension legs together using the fixing mechanism further comprises heat curing the plurality of extension legs together to form the adhesive joint.

24. The method for manufacturing a catheter assembly according to claim 22, further comprising fixing the plurality of extension legs together using the fixing mechanism, coating the plurality of extension legs with an adhesive to form the adhesive joint, and curing it by heat, pressure, or a combination thereof.

25. The method for manufacturing a catheter assembly according to claim 22, wherein fixing the plurality of extension legs using the fixing mechanism further includes attaching the permanent sliding collar.

26. The method for manufacturing a catheter assembly according to claim 22, wherein fixing the plurality of extension legs using the fixing mechanism further includes attaching the attachable sliding collar.

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