Catheter equipped with variable length extension leg

Abstract

A catheter assembly for a tissue catheter system is disclosed. The catheter assembly can include a molded hub, a catheter tube coupled to a distal end of the molded hub, a plurality of extension legs having a fixation mechanism coupled to a distal end of the molded hub. The molded hub can include a pair of hub lumens that form a pair of hub portions of a pair of fluid channels through the catheter assembly. The catheter tube can include a pair of catheter tube lumens. The fixation mechanism can be configured to secure the plurality of extension legs together. The fixation mechanism can be in the form of a slidable collar including a proximal opening and a distal opening, wherein the slidable collar is positioned over the plurality of extension legs.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 036,899, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to catheters having extendable legs of variable length. Background Technology

[0004] In current catheters, the extension leg is simply secured to the hub and moves freely proximally to the hub. The extension leg includes clamps and Luer locks, which are typically bulky and difficult to secure together. This can be frustrating for both healthcare professionals and patients needing to perform dressing changes at the catheter site and can result in inadequate closure at the catheter site. Currently, there is no solution to help healthcare professionals secure the extension leg proximally from the hub, allowing them to focus on dressing changes.

[0005] This article discloses a catheter assembly for organizing and securing several extension legs, and a method for manufacturing a catheter assembly for organizing and securing several extension legs. Summary of the Invention

[0006] This document discloses a catheter assembly system and a method for using and manufacturing the catheter assembly system. The disclosed catheter assembly system offers several advantages over conventional catheter assembly systems. Specifically, the disclosed embodiment allows healthcare professionals to easily secure several extension legs of the catheter assembly system. Such an embodiment is advantageous when attempting to create a closed seal at the catheter entry site and during general use, as it provides patient comfort and convenience.

[0007] In some embodiments, a catheter assembly for a tissue catheter system is shown, comprising: a molded bushing including at least a pair of bushing lumens; a catheter fitting coupled to a distal end of the molded bushing, the catheter fitting including at least a pair of catheter fitting lumens; a plurality of extension legs, each including a distal end coupled to a proximal end of the molded bushing, wherein a fluid passage is formed between the plurality of extension legs and the catheter fitting through the pair of bushing lumens; and a fixation mechanism configured to secure the plurality of extension legs together, wherein the fixation mechanism is a slidable collar above the plurality of extension legs.

[0008] In some embodiments, the sliding collar is a permanently sliding collar including length, width and height, having a proximal end with a proximal opening and a distal end with a distal opening, and having 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 slopes toward the inner surface at its longitudinal midpoint and slopes toward the longitudinal endpoints away from the inner surface. In some embodiments, the inner surface is configured to generate friction with the exterior of the extension leg, wherein friction resists movement of the sliding collar in the absence of an external force applied to it. In some embodiments, the proximal and distal openings have an elliptical shape.

[0010] In some embodiments, a catheter assembly for a tissue catheter system includes: a molded bushing including at least a pair of bushing lumens forming a bushing portion through a pair of fluid channels of the catheter assembly; a catheter fitting coupled to a distal end of the molded bushing, the catheter fitting including at least a pair of catheter fitting lumens; a plurality of extension legs, each including a proximal end and a distal end, wherein the distal end of each extension leg is coupled to the molded bushing; and a fixation mechanism configured to secure the plurality of extension legs together, wherein the fixation mechanism includes one or more adhesion bonds, or attachable slidable collars or permanent slidable collars, between the plurality of extension legs. The fixation mechanism may include an adhesion bond between the plurality of extension legs. In some embodiments, the fixation mechanism is an attachable slidable collar.

[0011] In some embodiments, the attachable sliding collar is detachably coupled to the molded bushing. In some embodiments, the attachable sliding collar or a permanent sliding collar is positioned above several extension legs. In some embodiments, the fixing mechanism is either the attachable sliding collar or the permanent sliding collar, and wherein the fixing mechanism includes length, width, and height, has a proximal end with a proximal opening, a distal end with a distal opening, a longitudinal midpoint, and a longitudinal end point, and is equipped with an outer surface and an inner surface.

[0012] 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 slopes toward the inner surface at its longitudinal midpoint and then slopes toward the longitudinal endpoints away from the inner surface. In some embodiments, the inner surface is configured to generate friction with the exterior of the extension leg, wherein friction resists movement of the attachable sliding collar in the absence of an external force applied to it. In some embodiments, the proximal and distal openings are elliptical.

[0013] In some embodiments, the fixing mechanism may be axially divided into two separate parts. In some embodiments, the fixing mechanism is engaged at the longitudinal midpoint. In some embodiments, the fixing mechanism is engaged together by a first hinge and a first snap opposite the first hinge. In some embodiments, the fixing mechanism is engaged together by a first clasp and a second clasp opposite the first clasp. In some embodiments, the fixing mechanism is engaged together by a first pair of magnets and a second pair of magnets opposite the first pair of magnets.

[0014] In some embodiments, a method of manufacturing a catheter assembly for a tissue catheter system is disclosed. The method may include operations comprising: obtaining a molded bushing including at least a pair of bushing lumens, each bushing lumen having an access point adjacent to or substantially adjacent to another access point; obtaining a catheter fitting including at least a pair of catheter fitting lumens; obtaining a plurality of extension legs; obtaining a securing mechanism for securing the plurality of extension legs together, wherein the securing mechanism is selected from the group consisting of: adhesive joints, permanently slidable collars, and attachable slidable collars; coupling the catheter fitting to a distal end of the molded bushing; coupling the distal end of each of the plurality of extension legs to a proximal end of the molded bushing, wherein a fluid passage is formed between the plurality of extension legs and the catheter fitting through a pair of bushing lumens; securing the plurality of extension legs together using the securing mechanism; and packaging the catheter assembly into a single-use package.

[0015] In some embodiments, securing the extension legs together using a fixing mechanism further includes heating to cure the extension legs together to create an adhesive bond. In some embodiments, securing the extension legs together using a fixing mechanism further includes applying an adhesive to the extension legs and curing them using heat, pressure, or a combination thereof to create an adhesive bond.

[0016] In some embodiments, securing the extension legs together using a fixing mechanism further includes attaching a permanently sliding collar. In some embodiments, securing the extension legs together using a fixing mechanism further includes attaching an attachable sliding collar.

[0017] These and other features of the concepts provided herein will become apparent to those skilled in the art in light of the accompanying drawings and the following description, which further details specific embodiments of these concepts. Attached Figure Description

[0018] Embodiments of the invention are illustrated by way of example rather than limitation of the various images in the accompanying drawings, wherein similar reference numerals denote similar elements, wherein:

[0019] Figure 1An exemplary view of a conduit assembly according to some embodiments is shown;

[0020] Figure 2A-2B An exemplary view of a catheter assembly for a tissue catheter system according to some embodiments is shown, the catheter system including a fixation mechanism that further includes an adhesive joint;

[0021] Figures 3A-3B An exemplary view of a catheter assembly for a tissue catheter system according to some embodiments is shown, the catheter system including a fixation mechanism that further includes a permanent slidable collar;

[0022] Figures 4A-4B An exemplary view of a catheter assembly for a tissue catheter system according to some embodiments is shown, the catheter system including a fixation mechanism that further includes an attachable, slidable collar;

[0023] Figures 5A-5B A method for organizing several extension legs according to some embodiments is shown;

[0024] Figures 6A-6B An alternative embodiment of a sliding collar according to some implementation schemes is shown;

[0025] Figure 7 A flowchart is shown of a method for manufacturing a catheter assembly for a tissue catheter system according to some embodiments;

[0026] Figure 8 This is an illustration of a catheter assembly according to some embodiments, the catheter assembly including a slidable collar secured to the patient using a dressing; and

[0027] Figures 9A-9B It is a perspective view of an anchoring system based on some implementation schemes. Detailed Implementation

[0028] Before disclosing some specific implementation schemes in more detail, it should be understood that the specific implementation schemes disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific implementation schemes disclosed herein can have features that are easily separable from the specific implementation schemes, and these features can be selectively combined with or substituted for any of the features in several other implementation schemes disclosed herein.

[0029] Regarding the terminology used herein, it should be understood that these terms are used to describe specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different components or steps in a group of parts or steps and do not provide for a sequence or quantity limitation. For example, the components or steps “first,” “second,” and “third” do not need to appear in that order, and a specific embodiment including such components or steps is not limited to three components or steps. Labels such as “left,” “right,” “front,” “back,” “top,” and “bottom” are used for convenience and are not intended to imply, for example, any specific fixed position, orientation, or direction. Rather, these labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise.

[0030] As disclosed herein, for example, the terms "proximal," "proximal portion," or "proximal portion" of a catheter include the portion of the catheter intended to be close to the clinician when the catheter is placed on a patient. Similarly, the term "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is placed on a patient. The term "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when the catheter is placed on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal portion, proximal portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless specifically stated herein, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0031] As disclosed herein, for example, the terms "distal," "distal portion," or "distal part" of a catheter include a portion of the catheter intended to be close to or in the patient when the catheter is used on a patient. Similarly, the term "distal length" of a catheter includes the length of the catheter intended to be close to or in the patient when the catheter is used on a patient. The term "distal end" of a catheter includes one end of the catheter intended to be close to or in the patient when the catheter is used on a patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless specifically stated herein, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0032] 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.

[0033] Figure 1A molded bushing 102 is shown, which receives a plurality of extension legs 106, a clamp 114, and a Luer connector 112, wherein the clamp 114 and the Luer connector 112 are connected to the plurality of extension legs 106. A catheter fitting 104, including a catheter tip 110, is coupled to the molded bushing 102. The plurality of extension legs 106 are not connected together along the length 108 of the plurality of extension legs 106, which allows the clamp 114 and the Luer connector 112 to be able to move laterally along each of the plurality of extension legs 106. When changing dressings, healthcare professionals typically need to secure the plurality of extension legs 106, clamp 114, and Luer connector 112 proximal to the catheter entry site while attempting to create a closed seal at the catheter entry site. Creating a closed seal is important for maintaining sterility and ensuring that the catheter entry site is not infected. Organizing and securing the plurality of extension legs 106, clamp 114, and Luer connector 112 can also increase patient comfort.

[0034] catheter assembly with adhesive joint

[0035] Figure 2A An exemplary view of a catheter assembly for a tissue catheter system 200 is shown, the catheter system 200 having extension legs connected via adhesive bonding. Figure 2A In this configuration, a molded bushing 202 is coupled to a catheter fitting 208 including a catheter tip 210. Several extension legs 212 (each having a clamp 204 and a Luer connector 206 disposed thereon) are attached to the molded bushing 202. A securing mechanism 214 (e.g., an adhesive joint) secures and organizes the extension legs 106 proximally to the molded bushing 102 along the length of the extension legs 212.

[0036] The molded bushing 202 may include at least one pair of bushing lumens, one example of which includes an arterial lumen and a venous lumen. However, the implementation is not intended to be limited to such an example. Furthermore, the catheter fitting 208 may include at least one pair of catheter fitting lumens and be coupled to the distal end of the molded bushing 202. The distal end of each of the plurality of extension legs 212 may be coupled to the proximal end of the molded bushing 202, wherein a fluid passage is formed between the plurality of extension legs 212 and the catheter fitting 208 through a pair of bushing lumens.

[0037] For reference Figure 2B , showed Figure 2AThe conduit assembly 200 includes an adhesive joint 214 in which at least a portion of the adhesive joint has been broken, causing at least a portion of the extension legs to separate. In some embodiments, the adhesive joint can be broken by applying a force that pulls two or more extension legs 212 apart. The adhesive joint 214 can be positioned along various lengths of the extension legs 212. For example, in some embodiments, the adhesive joint 214 can bond the extension legs 212 together from the molded bushing 202 to at least a majority length of the extension legs 214.

[0038] In some embodiments, adhesive joint 214 detachably engages at least one extension leg to another extension leg to allow at least one of the extension legs 212 to separate. Adhesive joint 214 between the extension legs 212 can be detached by external force. For example, in some embodiments, a medical professional can pull a Luer connector 206 connected to an extension leg 212 distally toward the molded bushing 202 while simultaneously securing other Luer connectors 206 proximally connected to the remaining extension legs 212 (or additionally, distally). In some instances, at least one extension leg can be detached. In other instances, no more than one extension leg can be detached. In some instances, one or more extension legs can be detached to separate the extension legs. 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, at least, but not limited to, one Luer connector 206 may be securely connected to one extension leg 212, pulled distally toward the molded bushing 202, while two other Luer connectors 206 are securely connected to two extension legs 212, to divide the plurality of extension legs 212 into two distinct groups of extension legs 212. It should be understood that any number of extension legs and illustrations provided herein that may be included in the various embodiments of the catheter assembly 200 are not intended to be limiting.

[0039] catheter assembly with collar

[0040] Figure 3A A catheter assembly 300 is shown, comprising a molded bushing 302 coupled to a catheter fitting 308 (which includes a catheter tip 310). In some embodiments, the molded bushing 302 is coupled to a plurality of extension legs 312 having clamps 306 and Luer connectors 304 disposed thereon. In some embodiments, the catheter assembly 300 optionally further includes a securing mechanism comprising an adhesive joint 314 between the plurality of extension legs 312, the adhesive joint 314 securing the plurality of extension legs 312 together proximal to the molded bushing 302. In some embodiments, the securing mechanism includes the adhesive joint 314 or a permanently sliding collar 316 or a combination thereof.

[0041] Figure 3B Show Figure 3A A permanent sliding collar 316 includes 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 end point 334, an outer surface 328, and an inner surface 330. In some embodiments, the length 318 may be in the range of 6-30 mm. In some embodiments, the width 320 may be in the range of 6-30 mm. In different embodiments, the width 320 may vary depending on the specific embodiment to accommodate several extension legs 312. The height 322 may be in the range of 6-30 mm. In some embodiments, the height 322 may vary to accommodate several extension legs 312. The proximal opening 324 and the distal opening 326 may be, but are not limited to, elliptical shapes. In some embodiments, the proximal opening 324 and the distal opening 326 may include shapes including circles, rectangles, squares, and polygons, with the polygons including hexagons, heptagons, octagons, nonagons, or decagons in some embodiments. The proximal opening 324 may include the same shape and construction as the distal opening 326. In some examples, the proximal opening 324 may include a different shape and construction than the distal opening 326. In some embodiments, the longitudinal midpoint 332 is located at the middle of the length 318 of the permanently sliding collar 316. Figure 3B As shown, the longitudinal endpoint 334 is located at the distal end of the permanent sliding collar 316.

[0042] In some embodiments, the outer surface 328 slopes from the proximal end toward the longitudinal midpoint 332, in a direction from the inner surface 330. In some embodiments, the outer surface 328 slopes away from the inner surface 330 from the longitudinal midpoint 332 toward the longitudinal endpoint 334 at the distal end. In some embodiments, the permanently sliding collar 316 is formed with a continuous curve between the proximal and distal ends. For example, the outer surface 328 slopes from the proximal end 324, in a direction from the inner surface 330, to a point at the longitudinal midpoint 332, and then slopes away from the inner surface 330 toward the longitudinal endpoint 334 at the distal end, away from the longitudinal midpoint 332.

[0043] In some embodiments, the inner surface 330 extends along length 318 to a longitudinal end point 334 located at the distal end. The inner surface 330 is configured to contact the outer surfaces of a plurality of extension legs 312. In some embodiments, the inner surface 330 is configured to generate friction with the exterior of the extension legs 312. Friction prevents the permanently slidable collar 316 from moving distally without an external force applied thereto.

[0044] In an optional embodiment not shown in the accompanying drawings, the outer surface 328 does not slope to the longitudinal midpoint 332, but extends along the length 318 to the longitudinal endpoint 334 at the distal end. In other words, the outer surface 328 of the permanent sliding collar 316 is flat from the proximal end to the distal end.

[0045] In other embodiments, the underside of the collar 316 may include an adhesive disposed thereon for adhesion to the patient's skin. In such embodiments, the underside of the collar 316 may also include a removable pad initially disposed over the adhesive. The pad may include a pull tab, allowing a medical professional to remove the pad and expose the adhesive. For example, the pad may be formed of paper and / or plastic.

[0046] Figure 4A A catheter assembly 400 is shown, which in some embodiments includes a molded bushing 402 coupled to a catheter fitting 408 (which includes a catheter tip 410). In some embodiments, the molded bushing 402 is coupled to a plurality of extension legs 412, the extension legs 412 including a clamp 406 and a Luer connector 404. In some embodiments, the catheter assembly 400 also includes a securing mechanism including an adhesive engagement 414 between the plurality of extension legs 412, which secures the plurality of extension legs 412 together proximal to the molded bushing 402. In some embodiments, the securing mechanism further includes the adhesive engagement 414 or an attachable sliding collar 416 or a combination thereof.

[0047] Figure 4BAn attachable, sliding collar 416 is shown, which in some embodiments includes a length 418, a width 420, a height 422, a proximal end, a proximal opening 424, a distal end, a distal opening 326, a longitudinal midpoint 432, a longitudinal end point 436, an outer surface 428, and an inner surface 430. The length 418 can range from 6 to 30 mm. The width 420 can range from 6 to 30 mm. The width 420 can vary to accommodate several extension legs 412. In some embodiments, the height 422 can range from 6 to 30 mm. In some embodiments, the height 422 can vary depending on the specific embodiment to accommodate several extension legs 412. In some embodiments, the proximal opening 424 and the distal opening 426 can include, but are not limited to, elliptical shapes. In some embodiments, the proximal opening 424 and the distal opening 426 can include shapes including circles, rectangles, squares, and polygons, the polygons including, in some embodiments, hexagons, heptagons, octagons, nonagons, or decagons. In some embodiments, the proximal opening 424 may include the same shape and configuration as the distal opening 426. In some embodiments, the proximal opening 424 may include a different shape and configuration than the distal opening 426. For example... Figure 4B As shown, the longitudinal midpoint 432 is located in the middle of length 418. In some embodiments, the longitudinal endpoint 436 is located at the far end.

[0048] 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 slopes from the proximal end toward the longitudinal midpoint 432 in a direction from the inner surface 430. In some embodiments, the outer surface 428 slopes away from the inner surface 430 from 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 slope along the length 418 in one or more directions. For example, the shape of the outer surface 428 may be configured to slope in a first direction from either the proximal or distal end to a point (e.g., the midpoint 432) along the length 418.

[0049] As a non-limiting example, the outer surface 428 slopes from the proximal end 324 in the direction of the inner surface 430 to a point located at the longitudinal midpoint 432, and then slopes away from the inner surface 430 toward the longitudinal endpoint 436 located at the distal end of the attachable sliding collar 416, away from the point located at the longitudinal midpoint 432. In some embodiments, the outer surface 428 slopes from the proximal end in the direction of the inner surface 430 but does not slope to the point located at the longitudinal midpoint 432; instead, in some embodiments, it slopes gradually toward the longitudinal midpoint 432 and gradually slopes away from the longitudinal midpoint 432 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 slope 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 length 418 to a longitudinal end point 436 located at the distal end 426 of the attachable sliding collar 416. In some embodiments, the inner surface 430 may physically contact the outer surfaces of a plurality of extension legs 412. In some embodiments, the inner surface 430 is configured to generate friction with the exterior of the extension legs 412 such that friction prevents the permanently sliding collar 416 from moving distally without an external force applied thereto.

[0050] In some embodiments, the attachable sliding collar 416 can also be axially divided into two parts 416A, 416B, which are configured to be attached together at a longitudinal midpoint 432 by means of, but not limited to, a fastening mechanism 434 (which includes any one of a fastening portion, a hinge portion, an engaging portion, a magnet, etc., or a combination thereof). In some embodiments, such as Figure 4B As shown, the fastening mechanism 434 disposed on part 416A may be a static fastening portion including a snap hook 435 at the distal end, wherein the snap hook 435 is configured to be received by a slot 437 disposed on part 416B. In some embodiments, the first fastening mechanism 434 may reside at the longitudinal midpoint 432 on a first side, while the second fastening mechanism 434 may reside at the longitudinal midpoint 432 on a second side (not shown).

[0051] In some embodiments, the sliding collar 416 may include an underside and have an adhesive and a gasket disposed thereon, as discussed above with respect to the sliding collar 316.

[0052] Figure 5AThe illustrations show how, in some embodiments, a permanent sliding collar 314 can be used to organize several extension legs 312 proximally to a molded bushing 302. In some embodiments, the extension legs 312 are axially positioned and contained within the cavity of the permanent collar 316, as... Figure 3B As shown. Due to the external force applied to the permanent sliding collar, the permanent sliding collar 316 can move from position A to position B proximally, which may help to bring together several extension legs 312, clamps 306 and Luer connectors 304.

[0053] Figure 5B This illustrates how, in some embodiments, a permanent sliding collar 316 can be used to allow the extension legs 312 to be separated from each other. In some embodiments, due to the presence of an external force applied to the permanent sliding collar, the permanent sliding collar 316 can be moved distally from position C to position D, which may allow the extension legs 312, clamp 306, and Luer connector 304 to be separated without an adhesive joint (such as adhesive joint 314). In some embodiments, position A may be equivalent to position D, and position B may be equivalent to position C. However, this is not necessary. The permanent sliding collar 316 can be moved proximally or distally along the extension legs 312. In some embodiments, the permanent sliding collar 316 can be detachably coupled to the molded bushing 302. It should be noted that although the above relates to... Figures 5A-5B The permanent sliding collar 316 has been discussed, but the same discussion applies equally to the attachable sliding collar 416.

[0054] Figures 6A-6B Alternative embodiments of a sliding collar according to some implementations are shown. 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, such as Figure 6A As shown, the catheter assembly 400 has three extension legs 412. The width 420 of the attachable sliding collar 416 of the catheter assembly 400 with three extension legs 412 will differ in some embodiments from that shown. Figure 6B The width 420 shown has two extending legs 412. Further, the width 420 can be configured according to the dimensions of the extending legs (e.g., the diameter of each extending leg). It should be noted that although the above relates to... Figures 6A-6B The attachable sliding collar 416 has been discussed, but the same discussion applies equally to the permanent sliding collar 316.

[0055] Manufacturing logic process

[0056] Figure 7This is a flowchart of a method 700 for manufacturing a catheter assembly for tissue extension legs according to some embodiments. In some embodiments, the method includes obtaining a catheter assembly including a molded bushing, a catheter fitting, a plurality of extension legs, and a fixation mechanism (block 702). In some embodiments, the method includes attaching the catheter fitting to the molded bushing and attaching the extension legs to the molded bushing (block 704). In some embodiments, method 700 further includes securing the plurality of extension legs together by, for example, adhering the plurality of extension legs together to create an adhesive bond (block 708), attaching an attachable slidable collar (block 710), attaching a permanent slidable collar (block 712), or a combination thereof. In some embodiments, adhering the plurality of extension legs together to create an adhesive bond (block 712) can be achieved by, but is not limited to, processes including, extrusion, co-extrusion, or other commonly used manufacturing processes. In some embodiments, the plurality of extension legs can be adhered together after extrusion to form an adhesive bond, for example, by curing the plurality of extension legs together by heating them. In some implementations, the adhesive bond may include, but is not limited to, industrial adhesives, spray adhesives, ultraviolet (UV) curing adhesives, etc.

[0057] In some embodiments, the curing process includes heating the extension legs to a temperature at which the plastic outer coating begins to melt, and then placing the extension legs together. Cooling the plastic outer coating creates an adhesive bond between the extension legs. In some instances, the extension legs bonded together to create the adhesive bond may undergo a cooling step (e.g., applying cold air) before undergoing attachment of an attachable sliding collar or a permanent sliding collar. In some instances, the extension legs may be configured with a barrier to prevent distal movement of the attachable sliding collar or permanent sliding collar beyond a set point. The barrier may be positioned perpendicular to the direction of movement of the attachable sliding collar or permanent sliding collar and have a height ranging from 3 to 15 mm.

[0058] In some embodiments, in attaching the attachable sliding collar (block 710) or in attaching the permanent sliding collar (712), the attachable sliding collar or permanent sliding collar may be configured to be initially engaged to the molded bushing, such that an external force must be applied to the attachable collar or permanent collar for any proximal movement of the molded bushing. In some embodiments, in attaching the attachable sliding collar (block 710) or in attaching the permanent sliding collar (712), the attachable sliding collar or permanent sliding collar may be configured to be initially positioned at the proximal end of a plurality of extension legs, such that an external force must be applied to the attachable sliding collar or permanent sliding collar for any distal movement at the proximal end of the plurality of extension legs. In some embodiments, an attachable collar (block 710) or a permanent collar (712) is attached, the attachable or permanent slidable collar being initially attached at any position along several extension legs.

[0059] In some embodiments, the method of manufacturing the conduit assembly includes manufacturing and attaching a permanent sliding collar (box 708) or manufacturing and attaching an attachable sliding collar (box 710). In some embodiments, the manufacturing of the permanent sliding collar (box 708) or the manufacturing of the attachable sliding collar (box 710) may be made of (but not limited to) acrylonitrile-butadiene-styrene, polyethylene, polycarbonate, nylon, silicone, polytetrafluoroethylene, acetal, polytrans-phenylenecyclopropane, polyphenylene sulfide, polyetheretherketone, high-impact polystyrene, polypropylene, thermoplastic polyurethane, thermoplastic rubber, combinations thereof, or other commonly used thermoplastic plastics and thermoplastic derivatives in the art.

[0060] In some embodiments, the method of manufacturing a permanent sliding collar 708 or an attachable sliding collar (box 710) may further include constructing the outer surface of a material different from the inner surface. For example, the inner surface may include acetal, while the outer surface may include polyethylene. In some embodiments, the method of manufacturing a permanent sliding collar (box 708) or an attachable sliding collar (box 710) may further include constructing the outer surface of the same material as the inner surface. For example, the inner surface may include acetal, and the outer surface may also include acetal. In some embodiments, the method of manufacturing a permanent sliding collar (box 708) or an attachable sliding collar (box 710) may be made by processes including, but not limited to, injection molding, 3D printing, polyurethane casting, thermoforming, or other commonly used manufacturing techniques. In some embodiments, attachment of the attachable collar may occur once the catheter assembly is used by a patient. In some embodiments, once several extension legs are adhered together to create an adhesive bond, the catheter assembly is packaged in a single-use package (box 714).

[0061] Exemplary applications of catheter assembly implementation schemes

[0062] refer to Figure 8 The illustration shows a catheter assembly according to some embodiments, which includes a sliding collar that is secured to the patient using a dressing. Figure 8 An exemplary catheter assembly, such as one secured to a patient's arm using a dressing 800, is shown. Figure 3A The catheter assembly 300. As shown, the dressing 800 may include an adhesive that adheres to the underside of the patient's arm. Procedurally, the catheter assembly 300 may be positioned on the patient's arm such that the catheter tip 310 is at the percutaneous insertion site ( Figure 8 The catheter is inserted into the patient at the site marked with an 'X'. After insertion of the catheter tip 310, the catheter assembly 300 is secured to the patient's arm by placing the dressing 800 directly on top of the catheter fitting 308 and over the insertion site 'X'. In some examples, the dressing 800 may also be positioned over at least a portion of the molded liner 302. As shown, a sliding collar 316 may be positioned proximally to the molded liner 302 around several extension legs 312 (where proximally relative to the molded liner 302, such that the catheter tip 310 refers to the distal tip). The sliding collar 316 is shown operably positioned proximally to the molded liner 302 and the dressing 800 on several extension legs 312. Although the catheter assembly 300 is in Figure 8 The catheter assembly 400 is shown in the figure, but the catheter assembly 400 can also be used with the dressing 800. Furthermore, the dressing 800 is merely an example of a dressing; however, the disclosed text is not intended to be so limiting, and rather, the dressing 800 shown in the figure can be replaced with any dressing known to those skilled in the art.

[0063] refer to Figures 9A-9B The diagram shows perspective views of two implementation schemes of the anchoring system. (Reference) Figure 9A Anchoring system 900 is configured to connect with embodiments of the present invention. Anchoring system 900 includes a fixation device 908, which includes an anchoring pad 910, on which a retainer 914 is disposed. The base of retainer 914 supports several posts and clips. Two caps 920A, 920B also extend from retainer 914 and are movable between an open position and a closed position to facilitate connection with a medical device such as a molded bushing 902. Retainer 914 is configured to receive, retain, and secure one or two catheter fittings (e.g., flanges extending laterally from the body of bushing 902) within fixation device 908.

[0064] As shown in the figure, a plurality of extension legs 906 extend proximally from the molded bushing 902, wherein a slidable collar 907 may be arranged proximally around the plurality of extension legs 906 to the molded bushing 902 (wherein the proximity relative to the molded bushing 902 causes the conduit fitting 904 to extend distally from the molded bushing 902). The slidable collar 907 may take the form and features of any of the slidable collars 316 or 416 discussed above.

[0065] When bushing 902 is in the first insertion position, the fitting can be engaged with the base of retainer 914, while covers 916A and 916B extend over at least a portion of the fitting in a closed position. When in the closed position over the fitting, covers 916A and 916B restrict lateral movement of the fitting and bushing 902.

[0066] In some embodiments, a second cover 922 may be disposed on a back 918 including a flange clip 924. The second cover 922 is configured to rotate between an open position and a closed position, wherein the flange clip 924 engages with a latch 926 to hold the second cover 922 in the closed position. A clinician may apply force to separate the flange clip 924 and the latch 926 (in the same manner as with covers 916A, 916B and their corresponding flange clips and latches).

[0067] Anchor pad 910 is securely attached to the patient's skin via its lower surface 912, while retainer 914 is securely attached to the upper surface of anchor pad 910. Anchor pad 910 may comprise a layered structure having an upper layer of plastic (e.g., woven polyester), 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, depending on the specific application, may be sweat-inducing or non-sweat-inducing.

[0068] refer to Figure 9B Exemplary embodiments of an anchoring system 900 having pins 920A, 920B for securing a sliding collar 907 are shown according to some implementations. As an optional securing device between the sliding collar 907 and the cover 922, a retainer 914 may include pins 920A, 920B. In embodiments where the retainer 914 is configured to engage (connect) with the sliding collar 907, the back 918 of the retainer 914 may include pins 920A, 920B that releasably clamp the sides of the sliding collar 907 when a downward force is applied to it. The sliding collar 907 can be removed from the clamping of pins 920A, 920B by a clinician applying a pulling force to the sliding collar 907 (or, in some examples, applying a pulling force to several extension legs 906).

[0069] While specific embodiments have been disclosed herein, and these embodiments have been disclosed in detail, this does not mean that these specific embodiments limit the scope of the concepts provided herein. Additional adaptive modifications and / or alterations will be apparent to those skilled in the art, and these adaptive modifications and / or alterations are also encompassed in a broader sense. Therefore, certain modifications can be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter assembly for a tissue catheter system, characterized in that, include: A molded bushing, the molded bushing comprising at least a pair of bushing cavities; A conduit fitting, the conduit fitting being connected to the distal end of the molded bushing, the conduit fitting comprising: At least one pair of conduit fittings lumen; and A catheter tip configured for insertion into a patient via a percutaneous access site; A plurality of extension legs, each extension leg including a distal end coupled to a proximal end of the molded bushing, wherein a fluid passage is formed between the plurality of extension legs and the conduit fitting through the pair of bushing cavities; A fixing mechanism, configured to secure the plurality of extension legs together, wherein the fixing mechanism is a slidable collar positioned above the plurality of extension legs; and Anchoring system, the anchoring system comprising: A base configured for attachment to a patient via an adhesive; A bushing anchoring mechanism configured to selectively anchor the bushing to the base; and A collar anchoring mechanism configured to selectively anchor the slidable collar to the base. The bushing anchoring mechanism and the collar anchoring mechanism are independent of each other.

2. The catheter assembly according to claim 1, characterized in that, The slidable collar is a permanent collar, which includes length, width and height, has a proximal end with a proximal opening and a distal end with a distal opening, and has an outer surface and an inner surface.

3. The catheter assembly according to claim 2, characterized in that, 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, characterized in that, The outer surface slopes toward the inner surface at the midpoint of the longitudinal direction and slopes away from the inner surface toward the longitudinal endpoint.

5. The catheter assembly according to claim 2, characterized in that, The inner surface is configured to generate friction with the outside of the extension leg, wherein the friction resists movement of the sliding collar in the absence of an external force applied to the sliding collar.

6. The catheter assembly according to claim 2, characterized in that: The proximal opening and the distal opening have the same shape. The shape is elliptical, and The slidable collar defines a single elliptical cavity having a consistent shape extending from the proximal opening to the distal opening.

7. A catheter assembly for a tissue catheter system, characterized in that, include: A molded bushing, the molded bushing comprising at least a pair of bushing cavities; A conduit fitting, the conduit fitting being connected to the distal end of the molded bushing, the conduit fitting comprising: At least one pair of conduit fittings lumen; and A catheter tip configured for insertion into a patient via a percutaneous access site; A plurality of extension legs, each extension leg including a proximal end and a distal end, wherein the distal end of each extension leg is coupled to the proximal end of the molded bushing, wherein a fluid passage is formed between the plurality of extension legs and the conduit fitting through the pair of bushing cavities. A fixing mechanism configured to secure the plurality of extension legs together, wherein the fixing mechanism is selected from the group consisting of attachable sliding collars and permanent sliding collars; and Anchoring system, the anchoring system comprising: A base configured for attachment to a patient via an adhesive; A bushing anchoring mechanism configured to selectively anchor the bushing to the base; and A collar anchoring mechanism configured to selectively anchor the slidable collar to the base. The bushing anchoring mechanism and the collar anchoring mechanism are independent of each other.

8. The catheter assembly according to claim 7, characterized in that, The fixing mechanism includes an adhesive joint between the plurality of extension legs.

9. The catheter assembly according to claim 7, characterized in that, The fixing mechanism is the attachable, sliding collar.

10. The catheter assembly according to claim 9, characterized in that, The attachable, sliding collar is detachably attached to the molded bushing.

11. The catheter assembly according to claim 7, characterized in that, The attachable sliding collar or permanent sliding collar is positioned above the plurality of extension legs.

12. The catheter assembly according to claim 7, characterized in that, The fixing mechanism is either the attachable sliding collar or the permanent sliding collar, and the fixing mechanism includes length, width and height, has a proximal end with a proximal opening, a distal end with a distal opening, a longitudinal midpoint, a longitudinal end point, and has an outer surface and an inner surface.

13. The catheter assembly according to claim 12, characterized in that, 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, characterized in that, The outer surface slopes toward the inner surface at the midpoint of the longitudinal direction, and then slopes away from the inner surface toward the longitudinal endpoint.

15. The catheter assembly according to claim 12, characterized in that, The inner surface is configured to generate friction with the outside of the extended leg, wherein the friction resists movement of the attachable sliding collar in the absence of an external force applied to the attachmentable sliding collar.

16. The catheter assembly according to claim 12, characterized in that: The proximal opening and the distal opening have the same shape. The shape is elliptical, and The attachable, slidable collar defines a single elliptical cavity having a consistent shape extending from the proximal opening to the distal opening.

17. The catheter assembly according to claim 12, characterized in that, The fixing mechanism can be axially divided into two separate parts, and the two separate parts are separated from each other.

18. The catheter assembly according to claim 17, characterized in that, The fixing mechanism is engaged at the midpoint of the longitudinal direction.

19. The catheter assembly according to claim 18, characterized in that, The fixing mechanism is engaged together by a fastening mechanism.

20. The catheter assembly according to claim 19, characterized in that, The fastening mechanism includes a fastening portion with a hook arranged on a first section and a groove on a second section, wherein the groove is configured to receive the hook.

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

22. A method for manufacturing a catheter assembly for a tissue catheter system, characterized in that, include: A molded bushing is obtained, the molded bushing comprising at least a pair of bushing cavities, each of the bushing cavities having an entry point adjacent to or substantially adjacent to the other entry point; Obtain a conduit fitting, the conduit fitting comprising: At least one pair of conduit fittings lumen; and A catheter tip configured for insertion into a patient via a percutaneous access site; Gain several extended legs; A fixing mechanism is obtained for securing the plurality of extended legs together, wherein the fixing mechanism is selected from the group consisting of a permanent sliding collar and an attachable sliding collar; Connect the conduit fitting to the distal end of the molded bushing; The distal end of each of the plurality of extension legs is connected to the proximal end of the molded bushing, wherein a fluid passage is formed between the plurality of extension legs and the conduit fitting through the pair of bushing cavities. The fixing mechanism is used to fix the plurality of extension legs together; Obtain an anchoring system, the anchoring system comprising: A base configured for attachment to a patient via an adhesive; A bushing anchoring mechanism configured to selectively anchor the bushing to the base; and A collar anchoring mechanism configured to selectively anchor the slidable collar to the base. The bushing anchoring mechanism and the collar anchoring mechanism are independent of each other; and The conduit assembly and the anchoring system are packaged as single-use packages.

23. The method for manufacturing a catheter assembly according to claim 22, characterized in that, Securing the plurality of extension legs together using the fixing mechanism also includes curing the plurality of extension legs together by heating to create an adhesive bond.

24. The method for manufacturing a catheter assembly according to claim 22, characterized in that, Securing the plurality of extension legs together using the fixing mechanism also includes applying an adhesive to the plurality of extension legs and curing them by heating, pressure, or a combination thereof to create an adhesive bond.

25. The method of manufacturing a catheter assembly according to claim 22, characterized in that, Securing the plurality of extension legs using the fixing mechanism also includes attaching the permanent slidable collar.

26. The method of manufacturing a catheter assembly according to claim 22, characterized in that, The fixing mechanism used to secure the plurality of extension legs also includes attaching the attachable, slidable collar.

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