Fluid connection kit system and method

The connection kit system addresses the challenge of securely connecting catheters of various French sizes to a standard port by using a standardized coupling system with adjustable connectors and a snap-fit sleeve mechanism, achieving a secure, efficient, and cost-effective solution.

WO2025042393A1PCT designated stage expired Publication Date: 2025-02-27BARD PERIPHERAL VASCULAR INC
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Patent Information

Application Number
PCT/US2023/030967
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-08-23
Publication Date
2025-02-27

AI Technical Summary

Technical Problem

Existing systems face challenges in securely and efficiently connecting proximally trimmable catheters of various French sizes to a standard-sized subcutaneous port, particularly in the confined and wetted environment of a subcutaneous access site, leading to potential leaks, trauma, and misplacement of the catheter distal tip.

Method used

A connection kit system that includes a port, a catheter locking mechanism, and a tool, which allows for the secure coupling of catheters with different French sizes to a standard-sized port using a standardized coupling system. The system features connectors with adjustable stems and fingers that deform radially to secure the catheter, and a sleeve that engages the connector in a snap-fit mechanism to ensure a leak-proof connection.

Benefits of technology

The system provides a secure, leak-proof, and efficient method for connecting catheters of various sizes to a standard port, reducing the risk of misplacement and trauma, and simplifying manufacturing and inventory management by using standardized components.

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Abstract

A connection kit system for fluidly coupling a catheter to a port may include a port having a port socket, a cathlock system including a sleeve slidably engageable with one or more connectors, a tool including a handle socket, and one or more catheters. The catheters can define different French sizes and each connector includes a stem configured to engage at least one of the catheters in an interference fit. Each connector further includes a nozzle configured to couple with either the port socket or the handle socket. Each connector includes a plurality of fingers disposed radially about the stem. The sleeve slidably engages the connector to deflect the fingers radially inwards and secure the cathlock system to the catheter. A tool facilitates coupling the cathlock system to the catheter in a confined wetted environment.
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Description

FLUID CONNECTION KIT SYSTEM AND METHODBACKGROUND

[0001] Briefly summarized, embodiments of the present disclosure are directed to fluid connections for proximally trimmable catheters that may be used, for example, with a surgically implanted port for administering medicaments and / or drawing blood from a patient. Proximally trimmable catheters allow for post-placement sizing of the catheter. When placing a catheter and port assembly subcutaneously, the position of the distal tip of the catheter can be important for the efficacy of the treatment. For example, when placing a catheter tip within the superior vena cava, if the distal tip of the catheter falls short of the target area, the efficacy of the medicament is reduced. If the distal tip is advanced too far, the distal tip can cause arrhythmia. The distance between the distal tip of the catheter and the port can vary since the distances between the target location, insertion site to the vasculature, and the location of the port can vary between patients and procedures. Estimating the catheter length before placement can lead to errors that result in misplacement of the catheter distal tip.

[0002] Proximally trimmable catheters allow for placement of the catheter distal tip at the target location before trimming a proximal portion of the catheter to the correct length. The clinician can then attach the catheter to a subcutaneous port, or similar access device. However, securing the catheter to the port can be challenging. The connection must be leak-proof, especially for use with high-pressure infusion. Further, manipulating the catheter and port within the confined, wetted environment of a subcutaneous access site can lead to slippage, undue trauma to the access site, or misplacement of the catheter distal tip.

[0003] Moreover, the different French sizes of catheters require correspondingly different sized attachment systems and port sizes to ensure correct coupling. However, this leads to increased complexity in manufacturing, complex inventory control, and increased associated costs.

[0004] What is needed therefore is a system and method for coupling various Frenchsized catheters to a standard sized access site (e.g., port) using a standardized coupling system. The coupling system can facilitate a secure connection within the confined, wetted environment of a subcutaneous access site. Disclosed herein are systems and methods that address the foregoing.SUMMARY

[0005] In some aspects, the components and techniques described herein relate to a connection kit for fluidly coupling a port to a catheter, the catheter selected from a first catheter defining a first lumen diameter, and a second catheter defining a second lumen diameter, larger than the first lumen diameter, the connection kit including, a port having a body defining a port socket, a tool including a handle defining a handle socket at a first end and a shaft extending axially from a center of the handle socket, a first connector having a body defining a lumen and including, a first nozzle configured to engage either of the port socket and the handle socket, a first stem defining a first outer diameter, and a first set of fingers arranged radially about the first stem and flexibly deformable radially inwards, each finger of the first set of fingers including a head extending radially inwards by a first width (Hwl), a second connector having a body defining a lumen and including, a second nozzle configured to engage either of the port socket and the handle socket, a second stem defining a second outer diameter, larger than the first outer diameter of the first stem, and a second set of fingers arranged radially about the second stem and flexibly deformable radially inwards, each finger of the second set of fingers including a head extending radially inwards by a second width (Hw2), shorter than the first width (Hwl and a sleeve configured to slidably engage an outer surface of either of the first set of fingers and the second set of fingers.

[0006] In some aspects, the techniques described herein relate to a connection kit, wherein the first stem is configured to slidably engage the lumen of the first catheter in an interference fit and the second stem is configured to slidably engage the lumen of the second catheter in an interference fit.

[0007] In some aspects, the techniques described herein relate to a connection kit, wherein the shaft of the tool is configured to extend through the lumen of the first connector, or the lumen of the second connector.

[0008] In some aspects, the techniques described herein relate to a connection kit, wherein nozzle of the first connector and the nozzle of the second connector engages either of the port socket and the handle socket in an interference fit.

[0009] In some aspects, the techniques described herein relate to a connection kit, wherein the sleeve includes a rim configured to engage a first notch of the first set of fingers,or a first notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector and the second connector in an unlocked position.

[0010] In some aspects, the techniques described herein relate to a connection kit, wherein the rim of the sleeve is configured to engage a second notch of the first set of fingers, or a second notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector and the second connector in a locked position.

[0011] In some aspects, the techniques described herein relate to a connection kit, wherein the sleeve engaged with the first connector in the locked position deflects the first set of fingers radially inwards so that the head compresses a portion of the first catheter on to the first stem, and wherein the sleeve engaged with the second connector in the locked position deflects the second set of fingers radially inwards so that the head compresses a portion of the second catheter on to the second stem.

[0012] In some aspects, the techniques described herein relate to a connection kit, wherein the sleeve includes a clip configured to engage the port body in a snap fit engagement.

[0013] In some aspects, the techniques described herein relate to a method of connecting a port to a catheter, the catheter selected from a group consisting of a first catheter defining a lumen having a first diameter, and a second catheter defining a lumen having a second diameter, the method including, slidably engaging a shaft of a tool with one of a first connector lumen defined by a first connector stem, or a second connector lumen defined by a second connector stem, the shaft extending axially from a handle socket disposed at a first end of a handle of the tool, engaging one of a first connector nozzle or a second connector nozzle with the handle socket in an interference fit, urging either the first connector stem into the lumen of the first catheter, or the second connector stem into the lumen of the second catheter, the first connector stem defines a first outer diameter that is smaller than a second outer diameter of the second connector stem, slidably engaging a sleeve with either of a first set of fingers of the first connector or a second set of fingers of the second connector, to a locked position, a finger of the first set of fingers having a head defining a first width (Hwl) and a finger of the second set of fingers having a head defining a second width (Hw2), the first width (Hwl being greater than the second width (Hw2). disengaging the tool from either the first connector or the second connector, and urging the first connector nozzle into a port socket of the port, or urging the second connector nozzle into the port socket of the port.

[0014] In some aspects, the techniques described herein relate to a method, further including deflecting the first set of fingers radially inwards so that the head compresses a portion of the first catheter onto the first connector stem when the sleeve is in the locked position with the first connector, or deflecting the second set of fingers radially inwards so that the head compresses a portion of the second catheter onto the second connector stem when the sleeve in the locked position with the second connector.

[0015] In some aspects, the techniques described herein relate to a method, wherein a tip of the shaft extends through the lumen of the first connector to a point beyond a tip of the first connector stem, and wherein a tip of the shaft extends through the lumen of the second connector to a point beyond a tip of the second connector stem.

[0016] In some aspects, the techniques described herein relate to a method, further including engaging a rim of the sleeve with either a first notch of the first set of fingers, or a first notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector or to the second connector in an unlocked position.

[0017] In some aspects, the techniques described herein relate to a method, further including engaging the rim of the sleeve with a second notch of the first set of fingers, or a second notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector or to the second connector in a locked position.

[0018] In some aspects, the techniques described herein relate to a method, further including engaging a clip extending from the sleeve, with the port body to secure the sleeve to the port.DRAWINGS

[0019] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. Example embodiments of the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0020] FIG. 1 shows a plan view of connection kit system, in accordance with embodiments disclosed herein.

[0021] FIG. 2 shows a perspective view of a cathlock system coupled to a catheter, and a port 110, in accordance with embodiments disclosed herein.

[0022] FIG. 3 shows a longitudinal cross-section view of a cathlock system coupled to a catheter, and a port, in accordance with embodiments disclosed herein.

[0023] FIG. 4 shows a longitudinal cross-section view of a cathlock system coupled to a catheter and engaged with a port, in accordance with embodiments disclosed herein.

[0024] FIG. 5 shows a perspective underside view of a cathlock system coupled to a catheter and engaged with a port, in accordance with embodiments disclosed herein.

[0025] FIG. 6 shows a lateral cross section view of a cathlock system engaged with a catheter, in accordance with embodiments disclosed herein.

[0026] FIG. 7 shows a cathlock system engaged with a tool of the connection kit system of FIG. 1, in accordance with embodiments disclosed herein.

[0027] FIGS. 8A-8D show an exemplary method of use for the cathlock system and tool of the connection kit system of FIG. 1, in accordance with embodiments disclosed herein.

[0028] FIG. 9A shows a longitudinal cross-section view of the cathlock system engaged with the tool in an unlocked position, in accordance with embodiments disclosed herein.

[0029] FIG. 9B shows a longitudinal cross-section view of the cathlock system engaged with the tool in a locked position, in accordance with embodiments disclosed herein.

[0030] FIG. 10 shows a cross-section view of a first connector and a first catheter engaged with a sleeve and a port in a locked position, in accordance with embodiments disclosed herein.

[0031] FIG. 11 shows a cross-section view of a second connector and a second catheter engaged with a sleeve and a port in a locked position, in accordance with embodiments disclosed herein.

[0032] FIG. 12 shows a cross-section view of a first connector and a first catheter engaged with a sleeve and a tool in an unlocked position, in accordance with embodiments disclosed herein.

[0033] FIG. 13 shows a cross-section view of a second connector and a second catheter engaged with a sleeve and a tool in an unlocked position, in accordance with embodiments disclosed herein.DESCRIPTION

[0034] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the disclosure, and are neither limiting nor necessarily drawn to scale.

[0035] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0036] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, Band C ” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0037] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

[0038] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

[0039] To assist in the description of embodiments described herein, as shown in FIG. 2, a longitudinal axis extends substantially parallel to an axial length of the catheter. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0041] FIG. 1 shows a connection kit system (“system”) 100 for fluidly coupling a catheter to a port and generally including a port 110, a catheter locking mechanism or system (“cathlock system”) 120 having a sleeve 140 slidably engageable with one or more connectors 122, a connection tool (“tool”) 150, and one or more catheters 190. The system 100 can facilitate fluidly coupling a port 110 to a proximally trimmable catheter 190 to provide fluid communication therebetween where the catheter 190 is selected from a group of one or more catheters having different French sizes.

[0042] The port 110 generally includes a body 112 having a port socket 114. Optionally, the port body 112 defines a reservoir 116 and includes a needle-penetrable septum 118 disposed thereover. It will be appreciated, however, that the port 110 shown is exemplary and other types or configurations of vascular access sites are contemplated to fall within the scope of the present disclosure. Exemplary ports can include adult port, intermediate port, pediatric port, low-profile ports, ultra-low-profile ports, or the like.

[0043] The catheter 190 includes a flexible tube formed of a plastic, polymer, elastomer or similar material, and defining a catheter lumen 192. In an embodiment, the system 100 includes two or more catheters 190 defining different French sizes. For example, the system 100 can include a first catheter 190A having a first French size (e.g., 5 Fr.), a second catheter 190B having a second French size (e.g., 6 Fr.), and a third catheter 190C having a third French size (e.g., 8 Fr.). However, it will be appreciated that the system 100 can include greater or less numbers of catheters 190, each being the same or different French sizes from each other. Further, for ease of illustration the catheters 190 shown are single lumen catheters, however, it will be appreciated that dual lumen, or multi-lumen catheters are also contemplated. These and other combinations of catheter numbers, sizes, or configurations are contemplated to fall within the scope of the present disclosure.

[0044] The system 100 includes a catheter locking system (“cathlock”) 120 including a sleeve 140 and one or more connectors 122. Each connector of the one or more connectors 122 are sized to fit a catheter of the one or more catheters 190. In an embodiment, the different connectors 122A, 122B, 122C and the different catheters 190A, 190B, 190C can be color coded to facilitate matching the correct connector to the correct catheter. As shown in more detail in FIGS. 3-4, the connector 122 includes a stem 130 sized to engage a lumen 192 of a catheter 190 in an interference fit, and includes a nozzle 132 configured to engage one or both of the port socket 114 and the handle socket 154. The sleeve 140 is configured to slidably engageeach of the one or more connectors 122 in a snap-fit engagement and configured to transition the connector 122 between an open, or unlocked, position and a closed, or locked, position. In an embodiment, the sleeve 140 further includes a sleeve clip 162 configured to engage the port body 112 in a snap fit engagement and further secures the cathlock system 120 in the locked position, mitigating failure of the fluid connection. To note, the sleeve clip 162 and port body 112 co-operate to provide a smooth outer surface. Advantageously, the cathlock system 120 can be configured to engage a range of different French sized catheters 190, while utilizing standard sized sleeves 140 and ports 110. Further, the snap-fit engagement of the cathlock system 120 to the catheter 190, and again between the clip 162 and the port 110 provides an audible “click” indicating to the clinician that the cathlock system 120 is in the locked position and the cathlock system is locked to the port 110 successfully.

[0045] With continued reference to FIG. 1, the system 100 further includes a tool 150 configured to facilitate coupling the cathlock system 120 to an end of the catheter 190, as described in more detail herein. The tool 150 generally includes a handle 152, a handle socket 154 disposed at a first end of the handle 152, and a shaft 156 extending axially from a center of the socket 154.

[0046] FIGS. 2-6 show further details of the port 110, catheter 190, and cathlock system 120 assembly. FIG. 2 shows a perspective view of a cathlock system 120 coupled to a catheter 190, and a port 110. FIG. 3 shows a longitudinal cross-section view of the cathlock system 120 coupled to the catheter 190, and the port 110. FIG. 4 shows a longitudinal cross-section view of the cathlock system 120 coupled to the catheter 190, and engaged with the port 110. FIG. 5 shows a perspective underside view of the cathlock system 120 coupled to the catheter 190, and engaged with the port 110. To note the sleeve 140 is shown in wire frame for ease of illustration. FIG. 6 shows a lateral cross section view of the cathlock system 120 engaged with the catheter 190.

[0047] In an embodiment, the connector 122 generally includes a body 126 defining a connector lumen 128 extending along a longitudinal axis. The connector body 126 includes a stem 130 extending longitudinally in a first direction towards the catheter 190, and a nozzle 132 extending longitudinally in a second direction towards the port 110. The stem 130, connector body 126, and nozzle 132 co-operate to define the connector lumen 128 extending between a tip of the nozzle 132 to a tip of the stem 130. The nozzle 132 is configured to engagea port socket 114 to place the connector lumen 128 in fluid communication with the port 110, e.g., a reservoir 116.

[0048] The connector 122 further includes one or more fingers 134 extending from the connector body 126 and extending in a first direction towards the catheter 190. As shown in FIG. 6, the one or more fingers 134 are arranged radially about the stem 130. Each finger of the one or more fingers 134 includes a head 136 disposed at a tip thereof and defining an abutment surface 138. In an embodiment, each finger of the one or more fingers 134 can be elastically deformed radially inwards such that an abutment surface 138 of the head 136 of each finger 134 impinges against an outer surface of the catheter 190 which is disposed on an outer surface of the stem 130.

[0049] In an embodiment, the sleeve 140 defines a sleeve lumen 142 configured to receive a portion of the catheter 190 therethrough and configured to receive a portion of the connector 122. The sleeve 140 is configured to slidably engage an outer surface of the one or more fingers 134 of the connector 122. The sleeve 140 includes a rim 144 extending annularly about an inner surface of the sleeve lumen 142. Each finger of the one or more fingers 134 includes a first notch 146 disposed towards the first end of the finger 134, adjacent the head 136, and a second notch 148 disposed towards the second end of the finger 134, adjacent the connector body 126.

[0050] In an embodiment, as shown in FIGS. 9A-9B, the rim 144 of the sleeve 140 engages the first notch 146 in a snap-fit engagement to secure the sleeve 140 to the connector 122 in an open, or unlocked, position (FIG. 9A). Further, the rim 144 of the sleeve 140 engages the second notch 148 in a snap-fit engagement to secure the sleeve 140 to the connector 122 in a closed, or locked, position (FIG. 9B).

[0051] In an embodiment, as shown in FIGS. 4-5, the sleeve 140 further includes a clip 162 extending from the sleeve 140 in a second direction towards the port 110. The clip 162 can be configured to engage the port body 112 in a snap-fit engagement to secure the sleeve 140 in the locked position.

[0052] FIGS. 7-9B show an exemplary method of coupling a catheter 190 with the cathlock system 120. FIG. 7 shows a perspective view of the cathlock system 120 engaged with the tool 150. FIGS. 8A-8D show a close-up perspective view of the cathlock system 120 and the handle socket 154 of the tool 150. To note, the sleeve 140 is shown in wire frame forease of illustration. In an embodiment, the sleeve 140 is formed of a transparent material to facilitate observing the catheter 190 disposed therein. In an embodiment, the sleeve 140 is formed of an opaque material. FIGS. 9A-9B show a cross-section view of the cathlock system 120 and the handle socket 154.

[0053] Initially, a catheter, e.g., a first catheter 190 A, of the one or more catheters 190 is selected and advanced through the vasculature until a distal tip is located at a target location. A connector 122, e.g., a first connector 122A which is configured to fit the first catheter 190A is selected. As shown in FIGS. 7, 8A, and 9A, the first connector 122A is slidably engaged with the tool 150, such that the shaft 156 of the tool 150 slidably engages the connector lumen 128. The connector nozzle 132 is advanced in a second direction, towards the handle 152 until the connector nozzle 132 engages the handle socket 154. The nozzle 132 engages the handle socket 154 in one of an interference fit, press-fit, or snap fit engagement. In an embodiment, the nozzle 132 further includes one or more O-rings 158 disposed thereon to facilitate one of an interference fit, press-fit, or snap fit engagement with the handle socket 154. Advantageously, the one or more O-rings 158 provide a fluid-tight seal between the nozzle 132 and the port socket 114, as described in more detail herein.

[0054] The shaft 156 extends through the connector lumen 128 such that a tip of the shaft 156 extends through the nozzle 132 and through the stem 130 to a point that is beyond the tip of the stem 130 in a first direction towards the catheter 190. Advantageously, the shaft 156 supports the connector 122 and aligns the stem 130 with a longitudinal axis of the handle socket 154.

[0055] As shown in FIGS. 8A-8B, the first catheter 190A can then be advanced over the stem 130 of the first connector 122 A. In an embodiment, the inner diameter of the catheter lumen 192 is equal to, or less than an outer-most diameter of the stem 130. In an embodiment, the inner diameter of the catheter lumen is equal to, or greater than the outer diameter of the shaft 156. As such, the tip of the shaft 156 can facilitate aligning the first catheter 190A with the stem 130. The beveled tip and / or tapered outer of the shaft 156 can also facilitate aligning the catheter 190 with stem 130. The tip of the catheter 190 can be urged over the stem 130 to engage the stem 130 in an interference fit, or friction fit. To note, the outer diameter of the stem tip can be equal to, or less than, the inner diameter of the catheter lumen 192. The outer profile of the stem 130 can provide a beveled or tapered shape to elastically deform the catheter 190 radially outwards as the catheter 190 is urged over the stem 130.

[0056] In an embodiment, the sleeve 140 can be slidably engaged with the catheter 190 prior to a tip of the catheter 190 engaging the stem 130. Worded differently, after the catheter 190 has been trimmed to a preferred length, the trimmed end of the catheter 190 is passed through the sleeve lumen 142 prior to engaging the shaft 156 and stem 130 in an interference fit, as described herein.

[0057] In an embodiment, the sleeve 140 engages the connector 122 in a snap-fit engagement prior to the catheter 190 engaging the stem 130. The sleeve lumen 142 can be aligned with the longitudinal axis of the shaft 156 and can slidably engage the one or more fingers 134 until the rim 144 engages the first notch of the one or more fingers to engage the first connector 122A in a snap-fit engagement in an open position (FIG. 9A). The trimmed end of the catheter 190 can then be slid over the shaft 156, fed through the sleeve lumen 142, and over the stem 130 (FIGS. 8A-8B).

[0058] In an embodiment, as shown in FIG. 8B, a portion of the catheter 190 can be observed between two or more fingers of the one or more fingers 134, and between a second end of the sleeve 140, adjacent the handle 152, and the connector body 126. Advantageously, the user can observe the trimmed end of the catheter 190 to ensure that it is fully engaged with the stem 130 prior to transitioning the sleeve 140 to the locked position. In an embodiment, the sleeve 140 can be formed of a transparent or translucent material to facilitate observing the catheter 190 engage the stem 130. Further, the catheter 190 and the connector 122 can be formed of a material having contrasting colors to facilitate observing the trimmed end of the catheter 190 fully engaging the stem 130.

[0059] As shown in FIGS. 8C-8D, once the catheter 190 is fully engaged with the stem 130, the sleeve 140 can be urged to the locked position. The sleeve 140 can be urged towards the handle 152 so that rim 144 engages the second notch 148 on the one or more fingers 134 in a snap-fit engagement. Advantageously, the snap-fit engagement provides an audible “click” to indicate that the sleeve 140 is successfully positioned in the locked position. As shown in FIG. 9B, the profile of the sleeve lumen 142 is tapered such that as the sleeve 140 is urged towards locked position, the head 136 portion of the fingers 134 abuts against the inner surface of the sleeve lumen 142 and is urged radially inwards towards the stem 130. Once the sleeve 140 is in the locked position, the abutment surface 138 of the head 136 impinges on an outer surface of the catheter 190 compressing a portion of the catheter between the head 136 and the stem 130 gripping the catheter 190 and securing the catheter 190 in place.

[0060] As shown in FIG. 8D, the catheter 190 and cathlock system 120 assembly can be disengaged from the tool 150 by urging the catheter 190 and cathlock system 120 assembly in a first direction to disengage the nozzle 132 from the handle socket 154 and sliding the shaft 156 out of the connector lumen 128. Advantageously, the tool 150 facilitates stabilizing and manipulating the cathlock system 120 while coupling the cathlock system 120 to the catheter 190.

[0061] As shown in FIGS. 2 and 4-5, with the cathlock system 120 engaged with the catheter 190, the cathlock system 120 / catheter 190 assembly can then engage the port 110 in an interference fit, press fit, or snap fit engagement, or a combination thereof. The nozzle 132 is urged into the port socket 114 to provide fluid communication between the catheter lumen 192 and the port 110 by way of the connector lumen 128. The O-rings 158 can form a fluid tight seal between nozzle 132 and the port body 112. Further, the sleeve clip 162 can engage the port body 112 to further secure the cathlock system 120 to the port 110. Advantageously, the snap-fit engagement of the sleeve clip 162 with the port body 112 provides an audible “click” to indicate that the sleeve 140 is successfully positioned in the locked position.

[0062] As noted, the system 100 can include one or more catheters 190 having different French sizes and one or more connectors 122 configured to engage a catheter of the one or more catheters 190. For example, FIGS. 10-13 show two different combinations of connector 122 and catheter 190 engaged with the sleeve 140 and port 110. FIGS. 10 and 12 show a first catheter 190 A engaged with a first connector 122 A, and FIGS. 11 and 13 show a second catheter 190B engaged with a second connector 122B. FIGS. 10-11 show the cathlock system 120 in a locked position and engaged with a port 110. FIGS. 12-13 show the cathlock system 120 in an unlocked position and engaged with a tool 150.

[0063] As shown in FIG. 10, the first catheter 190A (e.g., 5 Fr.) defines a relatively smaller inner lumen diameter. As such, the outer diameter (Sdl) of the stem 130 of the first connector 112A is sized to engage the lumen 192 of the first catheter 190 A in an interference fit. Similarly, as shown in FIG. 11, the second catheter 190B (e.g., 6 Fr.) defines a relatively larger inner lumen diameter. As such, the outer diameter (Sd2) of the stem 130 of the second connector 122B is sized to engage the lumen 192 of the second catheter 190B in an interference fit and is relatively larger than the outer diameter (Sdl of the stem 130 of the first connector

[0064] As shown in FIG. 10, the first connector 122 A includes one or more fingers 134, each finger of the one or more fingers including a head 136. The width of the head 136 extends radially inwards, perpendicular to the longitudinal axis, by a first head width (Hw 1) in order to impinge on the outer surface of the first catheter 190 A when in the locked position. Similarly, as shown in FIG. 11, the second connector 122B includes one or more fingers 134, each finger of the one or more fingers including a head 136. The width of the head 136 of the second connector 122B extends radially inwards by second head width (Hw2) in order to impinge on the outer surface of the second catheter 190B when in the locked position. The second head width (Hw2) being relatively smaller than the first head width (Hwl) since the outer diameter of the second catheter 190B is greater than the outer diameter of the first catheter 190A.

[0065] Worded differently, the first connector 122 A that is sized to engage the relatively smaller diameter first catheter 190A, defines a relatively smaller stem diameter (Sdl) and a relatively larger head width (Hwl compared to the second connector 122B that is sized to engage the relatively larger diameter second catheter 190B and defines a relatively larger stem diameter ( d2) and a relatively smaller head width (Hw2). As such, each of the first connector 122 A and the second connector 122B maintain constant outer diameters a point A and points B such that the same sized sleeve 140 can engage both of the first connector 122 A and the second connector 122B. As will be appreciated, the system 100 can include additional connectors 122 sized to engage larger or smaller sized catheters 190 and each with differing stem diameters and head widths in order to engage the same sized sleeve 140. For example, where a third catheter 190C defines a larger French size (e.g., 8 Fr.) than the second catheter 190B, a third connector 122C defines a stem diameter that is larger than the second stem diameter ( d2) and a head width that is less than the second head width (Hw2).

[0066] Advantageously, the sleeve 140 of the cathlock system 120 can engage either combination of the first catheter 190A and the first connector 122A, or the second catheter 190B and the second connector 122B. This simplifies manufacturing, reduces inventory, and reduces associated costs. Advantageously, the interaction between the sleeve 140 sliding longitudinally and urging the fingers 134 radially inwards mitigates the formation of catheter tube “bunching”. Since the abutment surface 138 of the head 136 transitions along an axis extending perpendicular to the longitudinal axis, the impinging force is applied to the catheter 190 with little or no longitudinal movement. By contrast, where other cathlock system mechanisms include a sleeve sliding longitudinally and contacting the catheter directly,portions of the flexible catheter 190 can be stretched and distorted along the longitudinal axis as the cathlock is transitioned to the locked position, termed “bunching”. The bunching effect can lead to uneven contact between catheter and the stem leading to fluid leakage and failure of the catheter / port fluid connection, especially when under relatively high fluid pressures.

[0067] Advantageously, the nozzle 132 is configured to fit a standard sized port socket 114 which can be included on various types of port (e.g., adult, intermediate, low-profile, ultralow profile, etc.). As such, the connection kit 100 can be used to fit a range of catheter sizes to a range of different port designs without requiring each port design to be French size specific. This reduces the manufacturing complexities, and reduces the amount of inventory required to be stored by a facility, as well as reducing associated costs.

[0068] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A connection kit for fluidly coupling a port to a catheter, the catheter selected from a first catheter defining a first lumen diameter, and a second catheter defining a second lumen diameter, larger than the first lumen diameter, the connection kit comprising: a port having a body defining a port socket; a tool including a handle defining a handle socket at a first end and a shaft extending axially from a center of the handle socket; a first connector having a body defining a lumen and comprising: a first nozzle configured to engage either of the port socket and the handle socket; a first stem defining a first outer diameter; and a first set of fingers arranged radially about the first stem and flexibly deformable radially inwards, each finger of the first set of fingers including a head extending radially inwards by a first width Hwiy, a second connector having a body defining a lumen and comprising: a second nozzle configured to engage either of the port socket and the handle socket; a second stem defining a second outer diameter, larger than the first outer diameter of the first stem; and a second set of fingers arranged radially about the second stem and flexibly deformable radially inwards, each finger of the second set of fingers including a head extending radially inwards by a second width (Hw2), shorter than the first width Hwiy, and a sleeve configured to slidably engage an outer surface of either of the first set of fingers and the second set of fingers.

2. The connection kit according to claim 1, wherein the first stem is configured to slidably engage the lumen of the first catheter in an interference fit and the second stem is configured to slidably engage the lumen of the second catheter in an interference fit.

3. The connection kit according to claim 1, wherein the shaft of the tool is configured to extend through the lumen of the first connector, or the lumen of the second connector.

4. The connection kit according to claim 1, wherein nozzle of the first connector and the nozzle of the second connector engages either of the port socket and the handle socket in an interference fit.

5. The connection kit according to claim 1, wherein the sleeve includes a rim configured to engage a first notch of the first set of fingers, or a first notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector and the second connector in an unlocked position.

6. The connection kit according to claim 5, wherein the rim of the sleeve is configured to engage a second notch of the first set of fingers, or a second notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector and the second connector in a locked position.

7. The connection kit according to claim 6, wherein the sleeve engaged with the first connector in the locked position deflects the first set of fingers radially inwards so that the head compresses a portion of the first catheter on to the first stem, and wherein the sleeve engaged with the second connector in the locked position deflects the second set of fingers radially inwards so that the head compresses a portion of the second catheter on to the second stem.

8. The connection kit according to claim 1, wherein the sleeve includes a clip configured to engage the port body in a snap fit engagement.

9. A method of connecting a port to a catheter, the catheter selected from a group consisting of a first catheter defining a lumen having a first diameter, and a second catheter defining a lumen having a second diameter, the method comprising: slidably engaging a shaft of a tool with one of a lumen of a first connector defined by a first connector stem, or a lumen of a second connector defined by a second connector stem, the shaft extending axially from a handle socket disposed at a first end of a handle of the tool;engaging one of a first connector nozzle or a second connector nozzle with the handle socket in an interference fit; urging either the first connector stem into the lumen of the first catheter, or the second connector stem into the lumen of the second catheter, the first connector stem defines a first outer diameter that is smaller than a second outer diameter of the second connector stem; slidably engaging a sleeve with either of a first set of fingers of the first connector or a second set of fingers of the second connector, to a locked position, a finger of the first set of fingers having a head defining a first width (Hw ) and a finger of the second set of fingers having a head defining a second width (Hw2), the first width ( wl) being greater than the second width (Hw2) disengaging the tool from either the first connector or the second connector; and urging the first connector nozzle into a port socket of the port, or urging the second connector nozzle into the port socket of the port.

10. The method according to claim 9, further including deflecting the first set of fingers radially inwards so that the head compresses a portion of the first catheter onto the first connector stem when the sleeve is in the locked position with the first connector, or deflecting the second set of fingers radially inwards so that the head compresses a portion of the second catheter onto the second connector stem when the sleeve in the locked position with the second connector.

11. The method according to claim 9, wherein a tip of the shaft extends through the lumen of the first connector to a point beyond a tip of the first connector stem, and wherein a tip of the shaft extends through the lumen of the second connector to a point beyond a tip of the second connector stem.

12. The method according to claim 9, further including engaging a rim of the sleeve with either a first notch of the first set of fingers, or a first notch of the second set of fingers in a snap fit engagement to secure the sleeve to either of the first connector or to the second connector in an unlocked position.

13. The method according to claim 12, further including engaging the rim of the sleeve with a second notch of the first set of fingers, or a second notch of the second set offingers in a snap fit engagement to secure the sleeve to either of the first connector or to the second connector in a locked position.

14. The method according to claim 9, further including engaging a clip extending from the sleeve, with a body of the port to secure the sleeve to the port.

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