Catheter system with integrated stabilization anchor fixation

Abstract

A catheter system including a catheter and associated catheter devices is provided herein, the catheter devices including a side port for fluid communication with the catheter. An extension tube is provided for fluid communication with the side port, the extension tube having a proximal access port. A stabilizing anchor platform is spaced apart from the catheter device and integrated with a component or tube of the catheter system, the stabilizing anchor platform being configured to hold the component or tube in place relative to the patient's skin surface. The stabilizing anchor platform may be integrated with the patient-proximal access port, intermediate tube, extension tube, proximal access port, or force-controlled release connector of the catheter system.

Description

Technical Field

[0001] This disclosure relates to a catheter system having an integrated stabilization anchor that provides high strength fixation.

Background Art

[0002] Cross-reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 459,303, filed on April 14, 2023, titled "Catheter System with Integrated Stabilization Anchor Fixation", the entire disclosure of which is incorporated herein by reference.

[0003] Catheters are generally used to administer liquids that enter and exit the body. Patients in various situations, including hospitals and home care, receive liquids, medications, and blood products via a vascular access device (VAD) that includes such a catheter inserted into the patient's vasculature. Common VADs include plastic catheters inserted into a patient's vein, and the length of the catheter can vary, for example, from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to many centimeters when the VAD is a central venous catheter (CVC). The VAD can be for short-term (days), moderate-term (weeks), or long-term (months to years) indwelling.

[0004] In some examples, the VAD is part of a larger catheter system, and the tube or intravenous line extends from an adapter or connector of the VAD, providing additional flexibility to medical personnel in administering and / or withdrawing fluid from the VAD. According to various embodiments, the tube can be integrated with the VAD (integrated catheter system) or part of an extension set provided separately from the VAD (non-integrated catheter system).

[0005] While current VADs, and therefore extension sets or tubing, may be manually operated to allow blood sampling or fluid introduction, doing so in an uncontrolled manner can increase the incidence of VAD dislodgement from the vascular system and thus shorten the lifespan of the catheter. Retaining devices may exist and be used to attach the extension set or tubing to the patient's skin, but such devices may not provide sufficient fixation strength to ensure the VAD remains in place. For example, the fixation strength provided by a retaining device may be less than the release strength of a controlled release connection provided at the proximal end of the extension set.

[0006] Therefore, there is a need in the art for improved devices and methods for securing the extension set or tubing of the catheter system to the patient in order to prevent accidental detachment of the VAD. [Overview of the Initiative]

[0007] Provided herein is an integrated catheter system comprising: a catheter adapter including a side port for receiving a catheter and for fluid communication with the catheter; a patient-near-access port coupled to the side port via an intermediate tube and for fluid communication with the side port, and a patient-near-access port including a secondary port thereon; an extension tube coupled to the secondary port and for fluid communication with the side port of the catheter device via the patient-near-access port, and an extension tube having a proximal access port coupled to its proximal end; and a stabilizing anchor platform integrated with the components of the integrated catheter system and configured to hold the components in place relative to the patient's skin surface, the components including one of the patient-near-access port, intermediate tube, extension tube, or proximal access port.

[0008] In some embodiments, the stabilizing anchor platform is formed integrally with the component.

[0009] In some embodiments, the stabilizing anchor platform and components are co-molded.

[0010] In some embodiments, the component into which the stabilizing anchor platform is integrated includes a first join feature, and the stabilizing anchor platform includes a second join feature configured to mate with the first join feature in order to integrate the stabilizing anchor platform with the component.

[0011] In some embodiments, the stabilizing anchor platform is integrated with the extension tube.

[0012] In some embodiments, the extension tube includes a clamp positioned on it, and the stabilizing anchor platform is integrated with the clamp.

[0013] In some embodiments, the stabilizing anchor platform is integrated with the intermediate tube.

[0014] In some embodiments, the stabilization anchor platform is integrated with the patient-near-access port.

[0015] In some embodiments, the stabilization anchor platform is integrated with the proximal access port.

[0016] In some embodiments, the upper surface of the stabilizing anchor platform is angled away from the patient-near-patient access port or proximal access port into which it is integrated.

[0017] In some embodiments, the integrated catheter system includes a mounting member for securing a stabilizing anchor platform to the patient's skin surface, the mounting member including one or more of the following: an upper mounting member positioned on the stabilizing anchor platform and having an adhesive on its bottom surface; an external stabilizing device including a cutout formed therein configured to receive the stabilizing anchor platform; and a pattern or layer of adhesive for directly bonding the stabilizing anchor platform to the skin surface.

[0018] In some embodiments, the integrated catheter system includes a force-controlled release connector coupled to a proximal access port, wherein at least a portion of the force-controlled release connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled release connector, and the mounting member holds the stabilizing anchor platform in place relative to the skin surface with a fixing force greater than the predetermined separation force that separates the force-controlled release connector from the proximal access port.

[0019] Furthermore, this specification provides a non-integrated catheter system comprising a catheter hub for receiving a catheter, a side port having a catheter connector coupled to the catheter hub and having fluid communication with the catheter, and a non-integrated extension set comprising an extension tube coupled to the side port and having fluid communication with the catheter hub, wherein the extension tube has a proximal access port coupled to its proximal end portion. The non-integrated catheter system also comprises a stabilizing anchor platform integrated with the components of the non-integrated catheter system and configured to hold the components in place relative to the patient's skin surface, wherein the components comprise either an extension tube or a proximal access port.

[0020] In some embodiments, the stabilizing anchor platform is formed integrally with the component.

[0021] In some embodiments, the component into which the stabilizing anchor platform is integrated includes a first join feature, and the stabilizing anchor platform includes a second join feature configured to mate with the first join feature in order to integrate the stabilizing anchor platform with the component.

[0022] In some embodiments, the stabilizing anchor platform is integrated with the extension tube.

[0023] In some embodiments, the stabilization anchor platform is integrated with the proximal access port.

[0024] In some embodiments, the non-integrated catheter system includes a mounting member for securing a stabilizing anchor platform to the patient's skin surface, the mounting member including one or more of the following: an upper mounting member positioned on the stabilizing anchor platform and having an adhesive on its bottom surface; an external stabilizing device including a cutout formed therein configured to receive the stabilizing anchor platform; and a pattern or layer of adhesive for directly bonding the stabilizing anchor platform to the skin surface.

[0025] In some embodiments, the non-integrated catheter system includes a force-controlled discharge connector coupled to a proximal access port, wherein at least a portion of the force-controlled discharge connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled discharge connector, and the mounting member holds the stabilizing anchor platform in place relative to the skin surface with a fixing force greater than the predetermined separation force that separates the force-controlled discharge connector from the proximal access port.

[0026] Also provided herein is a catheter system that includes a catheter device for receiving a catheter and having a side port in fluid communication with the catheter, the catheter device being a catheter adapter or a catheter connector. The catheter system also includes an extension tube in fluid communication with the side port of the catheter device, the extension tube having a proximal access port coupled to its proximal end portion, the proximal access port comprising a needleless connector. The catheter system further includes a force-controlled release connector coupled to the proximal access port, at least a portion of the force-controlled release connector being configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled release connector. The catheter system further includes a stabilization anchor platform integrated with the force-controlled release connector and an attachment member for securing the stabilization anchor platform to the patient's skin surface, the attachment member holding the stabilization anchor platform in a predetermined position relative to the skin surface with a fixing force greater than the predetermined separation force for separating the force-controlled release connector from the proximal access port.

[0027] In some embodiments, the force-controlled release connector includes a breakaway connector and a release feature coupled to the needleless connector of the proximal access port, the release feature engaging the breakaway connector and being configured to disengage from the breakaway connector when a predetermined separation force is applied to the breakaway connector or the needleless connector of the proximal access port, and the stabilization anchor platform is integrated with the release feature.

Brief Description of the Drawings

[0028] [Figure 1] FIG. 1 is a top view of an integrated catheter system according to one aspect or embodiment of the present application. [Figure 2] FIG. 2 is a top view of a non-integrated catheter system according to one aspect or embodiment of the present application. [Figure 3] FIG. 3 is a top view of a force-controlled release connection included in the system of FIG. 1 and / or FIG. 2 according to a further aspect or embodiment of the present application. [Figure 4] Figure 4 is a cross-sectional view of the force-controlled release connection of Figure 3, in a disconnected state, according to a further aspect or embodiment of the present application. [Figure 5] Figure 5 is a perspective view of a stabilizing anchor platform and mounting member included in the system of Figure 1 and / or Figure 2, according to one aspect or embodiment of the present application. [Figure 6] Figure 6 is a perspective view of a stabilizing anchor platform and mounting member included in the system of Figure 1 and / or Figure 2, according to one aspect or embodiment of the present application. [Figure 7] Figure 7 is a perspective view of a stabilizing anchor platform and mounting member included in the system of Figure 1 and / or Figure 2, according to one aspect or embodiment of the present application. [Figure 8] Figure 8 is a perspective view of a stabilizing anchor platform and mounting member included in the system of Figure 1 and / or Figure 2, according to one aspect or embodiment of the present application. [Figure 9] Figure 9 is a perspective view of a stabilizing anchor platform and mounting member included in the system of Figure 1 and / or Figure 2, according to one aspect or embodiment of the present application. [Figure 10A] Figure 10A is a top view of an integrated catheter system having a first clip feature provided on its extension tube, according to one aspect or embodiment of the present application. [Figure 10B] Figure 10B shows the integrated catheter system of Figure 10A, having a stabilizing anchor platform including a second clip feature coupled to a first clip feature, according to one aspect or embodiment of the present application. [Figure 11] Figure 11 is a top view of an integrated catheter system having an intermediate tube and an integrated stabilizing anchor platform according to one aspect or embodiment of the present application. [Figure 12] Figure 12 is a top view of an integrated catheter system having an extension tube and an integrated stabilizing anchor platform according to one aspect or embodiment of the present application. [Figure 13] Figure 13 is a top view of an integrated catheter system having a patient-proximal access port and an integrated stabilizing anchor platform according to one aspect or embodiment of the present application. [Figure 14] Figure 14 is a top view of an integrated catheter system having a clamp on its extension tube and an integrated stabilizing anchor platform, according to one aspect or embodiment of the present application. [Figure 15] Figure 15 is a top view of an integrated catheter system having a proximal access port and an integrated stabilizing anchor platform according to one aspect or embodiment of the present application. [Figure 16] Figure 16 is a top view of an integrated catheter system having a force-controlled release connection and an integrated stabilizing anchor platform according to one aspect or embodiment of the present application. [Modes for carrying out the invention]

[0029] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain immediately obvious to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure.

[0030] Hereinafter, for the purpose of explanation, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “topmost,” “bottommost,” “horizontal,” “vertical,” and their derivatives shall be considered as relating to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless explicitly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0031] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the catheter insertion device in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “distally” and “distally” mean the direction toward the distal tip of the needle or catheter of the system, and the terms “proximal” and “proximal” mean the direction opposite to the direction toward the distal tip of the needle or catheter.

[0032] Referring to Figure 1, an integrated catheter system 10 is shown, which is one embodiment or part of an embodiment in which an embodiment of the present invention may be implemented. The integrated catheter system 10 includes a catheter device 12 in the form of a catheter adapter (hereinafter, "catheter adapter 12") together with an integrated extension set 14 (including an extension tube 16). The catheter adapter 12 includes a catheter 18, a body 20 that receives the catheter 18, and a side port 22 that is in fluid communication with the catheter 18. The integrated extension set 14 includes a proximal access port 24 coupled to the proximal end portion of the extension tube 16, and the extension tube 16 is in fluid communication with the side port 22 of the catheter adapter 12 (via an intermediate port 32 and tube 30, as described below).

[0033] In some embodiments or aspects, the system 10 may include a patient-near-access port 26 that fluidly communicates with a side port 22 of a catheter adapter 12, the patient-near-access port 26 including a connector portion 28 configured to be coupled to a peripheral probe device. The patient-near-access port 26 is configured to provide catheter access to a peripheral device such as a blood collection device (e.g., PIVO® from Becton, Dickinson and Inc.) or a vascular access probe (VAP) for intravenous digital measurement of patient data such as temperature, pH, lactate level, and / or other blood-based measurements. In some embodiments, the patient-near-access port 26 is coupled to the side port 22 of the catheter adapter 12 via the length of an intermediate tube 30. However, in other embodiments, the patient-near-access port 26 may be directly coupled to the side port 22 or connected via another intermediate member.

[0034] The patient-near-access port 26 includes a connector portion 28, which in some embodiments is configured to be compatible with peripheral devices such as blood collection devices and / or vascular access probes. In some embodiments, the connector portion 28 is configured as a needleless connector (NFC) configured to accept the blunt entry portion of a blood collection device. More specifically, the connector portion 28 may be configured as a segmented septum NFC with direct probe access, such as a Q-Syte® or SmartSite® NFC from Becton, Dickinson and Co., or any other suitable segmented septum NFC. Alternatively, in other embodiments, the connector portion 28 may be formed from a non-septum type NFC. Furthermore, in some embodiments, the patient-near-access port 26 may include antimicrobial and / or flush-promoting functions. For example, the patient-near-access port 26 may include one or more of the following: vortex-generating function of the offset tube port, proximal fluid bypass function, antimicrobial NFC lubricant, antimicrobial eluting surface coating or insert. Using a patient-near-access port 26 fluidly coupled to the catheter adapter 12 via a side port 22, the system 10 provides probe (or tube) access from a peripheral probe device via an indwelling catheter 18. The patient-near-access port 26 further includes a secondary port 32 located near its distal end. In some embodiments, the secondary port 32 is coupled to an extension tube 16 of an integrated extension set 14. A clamp 34 may be provided on the integrated extension set 14 and is configured to selectively restrict flow through the extension tube 16 of the integrated extension set 14.

[0035] In other embodiments or designs, the extension tube 16 of the integrated extension set 14 may extend directly from the side port 22 of the catheter, with the system 10 not including a nearby patient-presiding access port 26. In such embodiments, the system 10 may incorporate, as a non-limiting example, a BD Nexiva® closed peripheral IV catheter system or a BD Nexiva® Diffusics® closed IV catheter system.

[0036] Referring to Figure 2, a non-integrated catheter system 40 is shown according to another aspect or embodiment in which embodiments of the present invention may be implemented. The non-integrated catheter system 40 includes a catheter hub 42 and a non-integrated extension set 44 which includes a catheter device 46 in the form of a catheter stabilizing catheter connector (hereinafter, "catheter connector 46") together with an extension tube 48. The catheter hub 42 receives a catheter 50 and connects to the catheter connector 46. In one aspect or embodiment, the catheter hub 42 is the AccuCath® catheter system, commercially available from Becton, Dickinson and Company.

[0037] The catheter connector 46 is configured to be positioned to contact the patient's skin surface at or near the insertion site of the catheter 50. The catheter connector 46 may be any suitable shape, size, and / or configuration. In the non-limiting embodiments shown, the catheter connector 46 has a connector portion 52 and a stabilizing portion 54. The connector portion 52 has a proximal port with a coupler 56 and a distal port with a distal coupler 58, defining at least one lumen (not shown) extending through or otherwise in fluid communication with the couplers 56 and 58. The proximal coupler 56 and / or distal coupler 58 may be, for example, male or female Luer locks and / or any other suitable couplers. The proximal coupler 56 can be configured as an NFC, for example, and can be physically and fluidly coupled to peripheral devices such as a blood collection device (e.g., PIVO® from Becton, Dickinson and Company) or a vascular access probe (VAP) for intravenous digital measurement of patient data such as temperature, pH, lactate, and / or other blood-based measurements. The distal coupler 58 can be physically and fluidly coupled to the catheter hub 42 such that the lumen of the connector portion 52 is at least selectively in fluid communication with the catheter 50. In some embodiments, the inner surface of the connector portion 52 may be configured to provide alignment, guidance, centering, etc., to an object or device advancing through it (e.g., a blood collection catheter as described above).

[0038] The connector portion 52 also includes and / or defines one or more additional ports, such as a side port 60. The side port 60 may be included in and / or part of the connector portion 52, the proximal coupler 56, the distal coupler 58, and / or a combination thereof. For example, the side port 60 may be distal to the proximal coupler 56. However, in other embodiments, the connector portion 52 may include and / or define a side port 60 formed by a structure or mechanism forming the proximal coupler. In some examples, positioning the side port 60 at a desired location along the length of the connector portion 52 between couplers 56 and 58 may allow for a reduction in the length of the connector portion 52 and / or facilitate flushing and / or fluid transfer through the side port 60.

[0039] The side port 60 defines a lumen (not shown) that is in fluid communication with the lumen between the distal coupler 58 and the proximal coupler 56. In other words, the connector portion 52 and / or the side port 60 include and / or can include a first lumen (e.g., between the distal coupler 58 and the proximal coupler 56) and a second lumen (e.g., a lumen defined by the side port 60 and the extension tube 48). Thus, the side port 60 can provide access to the lumen between the distal coupler 58 and the proximal coupler 56, which can then provide access to a device (e.g., a VAD) coupled to the distal coupler 58, and / or access to a portion of the body in which the VAD is at least partially located.

[0040] In some embodiments, the arrangement of the side ports 60 may be such that the connector portion 52 forms, for example, a Y-connector or a T-connector. More specifically, the side ports 60 may be positioned substantially perpendicular (e.g., about 90 degrees) to the lumen of the connector portion 52 and near or adjacent to the proximal coupler 56. In non-limiting embodiments, the side ports 60 extend from the connector portion 52 at an angle other than 90 degrees with respect to the lumen between the distal coupler 58 and the proximal coupler 56 (for example, the side ports 60 extend at an angle of, for example, 15 to 165 degrees, including all values ​​and subranges in between). In non-limiting embodiments, a plurality of side ports 60 are included in the connector portion 52.

[0041] As shown in Figure 2, the side port 60 may be coupled to the extension tube 48 so that the extension tube 48 is in fluid communication with the lumen of the side port 60. In some embodiments, the side port 60 and / or the extension tube 48 may be at least part of and / or form part of a fluid line that can be used to deliver fluid, remove fluid, flush fluid, etc. In such embodiments, for example, a configuration in which the side port 60 is positioned adjacent to the proximal coupler 56 may allow flushing of the space between the proximal coupler 56, any valve contained therein, and / or any valve and the inner surface of the connector portion 52 (e.g., defining at least part of the lumen).

[0042] As shown in the figure, the extension set 44 includes a proximal access port 62 coupled to the proximal end portion of the extension tube 48, and the extension tube 48 is in fluid communication with the side port 60 of the catheter connector 46. A clamp 64 may be provided on the extension tube 48 and is configured to selectively restrict the flow through the extension tube 48.

[0043] In each of the systems shown in Figures 1 and 2, the force-controlled release connector 66 can be coupled to the proximal access ports 24, 62. At least a portion of the force-controlled release connector 66 is configured to detach from the proximal access ports 24, 62 when a predetermined detachment force is applied to the force-controlled release connector 66. In some embodiments, the predetermined detachment force that detaches the force-controlled release connector 66 from the proximal access ports 24, 62 is, as a non-limiting example, about 5 pounds, but it is recognized that the force-controlled release connector 66 may have a greater or lesser detachment force. Therefore, at least a portion of the force-controlled release connector 66 is configured to detach from the proximal access ports 24, 62 to prevent excessive force from being transmitted to the catheter adapter 12 (Figure 1) or catheter connector 46 (Figure 2) via the extension tubes 16, 48. For example, the line from the IV bag may be connected to the extension tubes 16, 48 via the force-controlled release connector 66 so that excessive movement of the IV bag and line does not transfer that movement to the extension tubes 16, 48 and interfere with the placement of the catheters 18, 50, but rather simply disconnects the connection between the proximal access port 24, 62 and the force-controlled release connector 66.

[0044] Referring to Figures 3 and 4, one embodiment shows a force-controlled release connector 66 in more detail. The force-controlled release connector 66 includes a cutting connector 68 and a release feature 70 coupled to a needleless connector 72 of the proximal access ports 24, 62. The release feature 70 engages with the cutting connector 68 and is configured to detach from the cutting connector 68 when a predetermined separation force is applied to the cutting connector 68 or the needleless connector 72 of the proximal access ports 24, 62. The cutting connector 68 includes a valve member 74, which is configured to seal the cutting connector 68 when it is detached from the needleless connector 72. In one aspect or embodiment, the release feature 70 is configured to be biased radially outward when a predetermined distinct force is reached. The release feature 70 and the cutting connector 68 may form a cam arrangement in which an axial force moves the release feature 70 radially outward, thereby releasing the cutting connector 68 from the release feature 70. The release feature 70 may be formed integrally with the needleless connector 72, or it may be a separate component attached to or coupled to the needleless connector 72 or the proximal access ports 24, 62.

[0045] Referring again to Figures 1 and 2, in each of the systems 10 and 40, a stabilizing anchor platform 100 is provided, spaced apart from the catheter adapter 12 (Figure 1) or catheter connector 46 (Figure 2) and positioned along the extension tubes 16 and 48. The stabilizing anchor platform 100 provides a primary fixation point on the patient's skin surface and is configured to minimize catheter dislocation, infiltration, or catheter movement that could cause the tip of the catheter 18, 50 to be drawn out of the vein or artery. The stabilizing anchor platform 100 is configured to isolate forces applied externally from the catheter adapter 12 or catheter connector 46 and the insertion site to limit the movement of the catheter 18, 50 and / or the movement of the catheter 18, 50 due to forces applied to the intravenous line or extension set.

[0046] According to embodiments, the stabilizing anchor platform 100 may be of any size or shape that provides the ability to secure the anchor platform 100 to components to which it is attached, such as extension tubes 16, 48. According to embodiments, the stabilizing anchor platform 100 may be elliptical, triangular, circular, square, rectangular, trapezoidal, or another suitable shape, and may also be flat, angled, or tapered. The stabilizing anchor platform 100 may be formed of a flexible, soft, semi-rigid, or rigid material and may include features or living hinges to facilitate flexibility for patient comfort. The stabilizing anchor platform 100 may also include one or more colors or visual markings to provide catheter gauge, length, type, or procedure-related information.

[0047] In embodiments where the stabilizing anchor platform 100 is configured to be positioned along extension tubes 16, 48, the stabilizing anchor platform 100 may generally consist of a substantially flat or planar body 104 and a retaining section 106 (e.g., a cylindrical passage) configured to secure the extension tubes 16, 48 therein. The retaining section 106 may be configured such that the stabilizing anchor platform 100 is not removable from the extension tubes 16, 48. In some embodiments, the retaining section 106 may allow the stabilizing anchor platform 100 to slide along the extension tubes 16, 48 so that the fixed position of the stabilizing anchor platform 100 can be selected by a clinician. In other embodiments, the retaining section 106 may fix the stabilizing anchor platform 100 to one position on the extension tubes 16, 48, and the retaining section 106 is fixed to the extension tubes 16, 48 via adhesive, welding, or solvent bonding, etc. In some embodiments, the body 104 of the stabilizing anchor platform 100 includes a pair of stabilizing wings 108, 110 with a holding section 106 positioned in the center, but other suitable arrangements may be utilized, including the body 104 of the stabilizing anchor platform 100 being elliptical, triangular, circular, square, rectangular, trapezoidal, or another suitable shape.

[0048] In some embodiments or situations, as shown in Figures 1 and 2, the stabilizing anchor platform 100 is positioned distal to the proximal access ports 24, 62 and proximal to the clamps 34, 64. In other embodiments or situations, as shown by dashed lines in Figures 1 and 2, the stabilizing anchor platform 100 is positioned distal to the clamps 34, 64. In yet another embodiment or situation, the stabilizing anchor platform 100 may be positioned proximal to the access ports 24, 62 and the force control release connector 66.

[0049] In aspects of this disclosure, mounting members 102 are provided that can be used to fix the stabilizing anchor platform 100 in place against the skin surface of a patient (indicated by 112), in relation to the stabilizing anchor platform 100. The mounting members 102 are generally shown by dashed lines in Figures 1 and 2, but it is recognized that the mounting members 102 can take several different forms, including fixing tapes, external stabilization devices (ESDs), bandages, anchor platform adhesives with paper backings, and / or skin adhesives. Figures 5 to 9 show various embodiments of mounting members 102 that can be used to fix the stabilizing anchor platform 100 in place against the skin surface.

[0050] Referring first to Figure 5, an attachment member 102 for securing the stabilizing anchor platform 100 in place to the patient's skin surface is provided according to one aspect or embodiment. The attachment member 102 is provided as an upper fixing member 102a applied on top of the stabilizing anchor platform 100, with the stabilizing anchor platform 100 positioned between the skin surface 112 and the upper fixing member 102a. The upper fixing member 102a may be configured as an upper dressing or adhesive tape for fixation. In one embodiment, the upper fixing member 102a may include a transparent dressing portion 114 and a fabric boundary portion 116. The upper fixing member 102a can be of various shapes and sizes, and in the illustrated embodiment, it has a shape generally similar to the shape of the stabilizing anchor platform 100 (i.e., a pair of wings), but has a larger perimeter and surface area than the stabilizing anchor platform 100. The upper fixing member 102a contains adhesive 118 on its bottom surface, so that at least a first portion of the upper fixing member 102a (i.e., around the periphery such as the fabric boundary portion 116) adheres to the skin surface 112, and optionally a second portion of the upper fixing member 102a (i.e., part of the transparent bandage portion 114) adheres to the upper surface of the stabilizing anchor platform 100.

[0051] In some embodiments, the upper fixing member 102a includes one or more slots 120 that allow extension tubes 16, 48 to pass through. That is, if the stabilizing anchor platform 100 is covered by the upper fixing member 102a, the upper fixing member 102a needs to accommodate the wiring of the extension tubes 16, 48 through the slots 120 in order to allow the extension tubes 16, 48 to enter and exit the area covered by the upper fixing member 102a.

[0052] Referring here to Figure 6, a mounting member 102 for securing the stabilizing anchor platform 100 in place against the patient's skin surface 112 is provided according to another aspect or embodiment. In some embodiments, the mounting member 102 is provided as a bottom fixing member 102b, which is an external stabilizing device (hereinafter, "external stabilizing device 102b"). The external stabilizing device 102b includes, for example, a tricot base pad 122 having an adhesive 124 attached to its bottom surface for attachment to the patient's skin surface 112. A notch 126 is formed within the base pad 124 having a shape and circumference / area that matches the shape and circumference / area of ​​the stabilizing anchor platform 100. Adhesive 128 is applied to the area of ​​the notch 126 to secure the stabilizing anchor platform 100 within the notch 126 and to secure the stabilizing anchor platform 100 against the external stabilizing device 102b and the skin surface 112. The adhesive 128 within the area of ​​the notch 126 can fix the periphery of the stabilizing anchor platform 100 within the notch 126, and optionally, the bottom (adjacent to its periphery) of the stabilizing anchor platform 100 can be fixed to the skin surface 112.

[0053] Referring here to Figure 7, mounting members 102 for securing the stabilization anchor platform 100 in place to the patient's skin surface 112 are provided according to another aspect or embodiment. The mounting members 102 are provided as both an upper fixing member 102a and a bottom fixing member 102b (i.e., an external stabilization device 102b). As previously stated, the upper fixing member 102a may be configured as an upper bandage or adhesive tape, and in one embodiment, the upper fixing member 102a may include a transparent bandage portion 114 and a fabric boundary portion 116. The external stabilization device 102b may include a base pad 124 having a shape and circumference / area that matches the shape and circumference / area of ​​the stabilization anchor platform 100, and having a notch 126 formed therein.

[0054] When positioning the upper fixing member 102a and the bottom fixing member 102b relative to the stabilizing anchor platform 100, and when fixing the fixing members and the stabilizing anchor platform 100 to the patient, the bottom fixing member 102b (external stabilization device 102b) is attached to the patient's skin surface 112 via adhesive 124 applied to the bottom surface of the external stabilization device 102b. The stabilizing anchor platform 100 is positioned within a notch 126 in the base pad 124 of the external stabilization device 102b, and adhesive 128 is applied to the area of ​​the notch 126 to fix the stabilizing anchor platform 100 within the notch 126. Once the external stabilization device 102b and the stabilizing anchor platform 100 are positioned and fixed relative to the skin surface 112, the upper fixing member 102a is applied over the external stabilization device 102b and the stabilizing anchor platform 100. As shown in Figure 6, the upper fixing member 102a is sized such that its circumference extends beyond the circumference of the external stabilization device 102b. The upper fixing member 102a contains adhesive 118 on its bottom surface, so that at least a first portion of the upper fixing member 102a (i.e., around the fabric boundary portion 116, etc.) adheres to the skin surface 112, and optionally a second portion of the upper fixing member 102a adheres to the upper surface of the external stabilization device 102b and / or stabilization anchor platform 100. Thus, the upper fixing member 102a further secures the stabilization anchor platform 100 (and external stabilization device 102b) to the skin surface 112 in a predetermined position.

[0055] Referring here to Figure 8, a mounting member 102 for securing the stabilizing anchor platform 100 in place to the patient's skin surface 112 is provided according to another aspect or embodiment. The mounting member 102 is provided as a pattern or layer of skin adhesive 102c that directly secures the stabilizing anchor platform 100 to the skin surface 112. According to one embodiment, the stabilizing anchor platform 100 is a skin adhesive compatible platform that may include a feature 130 (i.e., a "through" feature) on its surface that allows for the distribution of skin adhesive 102c to the top of the stabilizing anchor platform 100 so that the bottom surface of the stabilizing anchor platform 100 can be securely attached to the skin surface 112, and facilitates the distribution of skin adhesive 102c to the bottom surface of the stabilizing anchor platform 100. In another embodiment, the skin adhesive 102c may be applied directly to the bottom of the stabilizing anchor platform 100 and / or to the skin surface 112. In any of the embodiments described above, the stabilizing anchor platform 100 is pressed onto the skin surface 112 (for example, by a clinician or by tape or bandage) and allowed to dry to ensure the formation of a strong adhesive bond.

[0056] In some embodiments, as shown in Figure 9, the stabilizing anchor platform 100 can be fixed in place relative to the skin surface 112 via a combination of a skin adhesive 102c between the stabilizing anchor platform 100 and the skin surface 112 and an upper fixing member 102a applied on the stabilizing anchor platform 100. As previously stated, the upper fixing member 102a may be configured as an upper bandage or adhesive tape, and in one embodiment, the upper fixing member 102a may include a transparent bandage portion 114 and a fabric boundary portion 116.

[0057] When positioning and securing the stabilizing anchor platform 100 and the upper fixing member 102a to the patient, the skin adhesive 102c is first applied to the stabilizing anchor platform 100. According to the embodiment, the skin adhesive 102c may be applied to the upper through feature 130 of the stabilizing anchor platform 100 which distributes the adhesive to the bottom surface of the stabilizing anchor platform 100, or the skin adhesive 102c may be applied directly to the bottom surface of the stabilizing anchor platform 100 and / or to the skin surface 112. Once the stabilizing anchor platform 100 is secured in place against the skin surface 112, the upper fixing member 102a is applied over the stabilizing anchor platform 100. As shown in Figure 9, the upper fixing member 102a is sized such that its circumference extends beyond the circumference of the stabilizing anchor platform 100. The upper fixing member 102a includes adhesive 118 on its bottom surface, so that at least a first portion of the upper fixing member 102a (i.e., the peripheral portion such as the fabric boundary portion 116) adheres to the skin surface 112, and optionally a second portion of the upper fixing member 102a adheres to the upper surface of the stabilizing anchor platform 100. Thus, the upper fixing member 102a further fixes the stabilizing anchor platform 100 in a predetermined position relative to the skin surface 112.

[0058] In aspects of the present disclosure, in each of the embodiments described in Figures 5-9, the mounting member 102 may be configured to apply a fixing force (securing the stabilizing anchor platform 100 in place) greater than a predetermined separation force that separates the force-controlled release connector 66 from the proximal access ports 24, 62 (Figures 1 and 2). In some embodiments, the fixing force is an adhesive force at least 0.25 pounds greater than the predetermined separation force that separates the force-controlled release connector 66 from the proximal access ports 24, 62. Thus, in a non-limiting example where the predetermined separation force of the force-controlled release connector 66 is 5 pounds, the adhesive force of the mounting member 102 should be 5.25 pounds or greater. According to non-limiting embodiments and based on the predetermined separation force of the particular force-controlled release connector 66 used, the adhesive force of the mounting member 102 may be greater than 7 pounds, greater than 5 pounds, greater than 3 pounds, etc. By applying a fixing force to the mounting member 102 that is greater than the predetermined separation force of the force-controlled release connector 66, it is ensured that the stabilizing anchor platform 100 is held in place until the force-controlled release connector 66 is released, thereby preventing excessive movement or removal of the catheters 18, 50.

[0059] While various embodiments in Figures 1 and 2 and Figures 5–9 illustrate the stabilizing anchor platform 100 being positioned on extension tubes 16, 48 and secured (in a non-removable manner) via its retaining section 106, it is recognized that in other embodiments, the stabilizing anchor platform 100 may be connected to and / or integrated with the extension tubes 16, 48 in alternative ways. In yet another embodiment, the stabilizing anchor platform 100 may be connected to and / or integrated with another component of the catheter system 10, 40.

[0060] Referring here to Figures 10A and 10B, a stabilizing anchor platform 100 is provided on an extension tube 16 according to one embodiment of the present disclosure. Figures 10A and 10B show a stabilizing anchor platform 100 used to secure an extension tube 16 in an integrated catheter system 10, but it is recognized that the stabilizing anchor platform 100 may be used to secure an extension tube 48 in a non-integrated catheter system 40. The stabilizing anchor platform 100 may be secured to the extension tube 16 via coupling or “clip” features (hereinafter, “clip features”) provided on the stabilizing anchor platform 100 and the extension tube 16. A first clip feature 134 may be provided on the extension tube 16 from which it cannot be removed (Figure 10A), and a second clip feature 136 may be provided on the stabilizing anchor platform 100 configured to mate with the first clip feature 134 (Figure 10B). In some non-limiting embodiments, the first clip feature 134 may include a plurality of ridges or projections 138 configured to engage and mat with a plurality of corresponding grooves or cavities 140 formed in the second clip feature 136, such as via a snap-fit ​​connection or a crimp-fit ​​connection, as an example of non-limiting embodiments. The first clip feature 134 may be provided anywhere along the extension tube 16 where it is desirable to attach the stabilizing anchor platform 100 to the skin surface 112 and to fix the stabilizing anchor platform 100, as shown in Figures 10A and 10B, which show the first clip feature 134 provided on the distal extension tube 16 of the clamp 34 (and the stabilizing anchor platform 100 connected to it via the second clip feature 136). Thus, with the first clip feature 134 coupled to the extension tube 16 and the stabilizing anchor platform 100 coupled to the extension tube 16 via the engagement of the second clip feature 136 with the first clip feature 134, the stabilizing anchor platform 100 may be considered “integrated” with the extension tube 16 of the catheter system 10.

[0061] Once the stabilizing anchor platform 100 is connected to the extension tube 16 via the engagement of the first and second clip features 134, 136, the stabilizing anchor platform 100 can be fixed in place against the skin surface 112 via one of several mounting members 102. That is, as described above with respect to Figures 5-9, the stabilizing anchor platform 100 can be fixed in place against the skin surface 112 using one or more mounting members 102 in the form of fixing tape, external stabilization devices (ESDs), bandages, anchor platform adhesives with paper backing, and / or skin adhesives.

[0062] Referring here to Figures 11 and 12, the stabilizing anchor platform 100 is integrated with the tubing of the catheter system 10, according to additional embodiments of the present disclosure. According to embodiments, the stabilizing anchor platform 100 may be formed integrally with the tubing, for example, through a molding process, and the stabilizing anchor platform 100 and the tubing may be formed from a common moldable material, which may be flexible, soft, semi-rigid, or rigid material, according to embodiments. The stabilizing anchor platform 100 may be centered on the tubing such that its wings 108 extend to either side of the tubing. Referring first to Figure 11, the stabilizing anchor platform 100 is shown for use in an integrated catheter system 10, and the stabilizing anchor platform 100 is formed integrally with an intermediate tubing 30 that connects the access port 26 to the side port 22 of the catheter adapter 12. The stabilizing anchor platform 100 may be sized to occupy a large portion of the length of the intermediate tubing 30. Referring next to Figure 12, the stabilizing anchor platform 100 is shown for use in an integrated catheter system 10, and the stabilizing anchor platform 100 is integrally formed with an extension tube 16 extending from the secondary port 32 of the patient-proximal access port 26. The stabilizing anchor platform 100 is formed on the distal extension tube 16 from the proximal access port 24. Again, the stabilizing anchor platform 100 can be sized to occupy most of the length of the extension tube 16 so as to leave little space between the secondary port 32 and the proximal access port 24.

[0063] According to the embodiment, the stabilizing anchor platform 100, integrated with the tubes 30 and 16 of the catheter system 10, may be fixed in place relative to the skin surface 112 via one of several mounting members 102, as shown in Figures 11 and 12. That is, as described above with respect to Figures 5-9, the stabilizing anchor platform 100 can be fixed in place relative to the skin surface 112 using one or more mounting members 102 in the form of fixing tape, an external stabilization device (ESD), a bandage, an anchor platform adhesive with a paper backing, and / or a skin adhesive.

[0064] Referring here to Figures 13 to 15, the stabilizing anchor platform 100 is shown to be integrated with one of several components of the catheter system 10 according to embodiments of the present disclosure. As defined herein, the stabilizing anchor platform 100 may be "integrated" with the components of the catheter system 10 either through integral molding (e.g., co-molding with the component) of the entire stabilizing anchor platform 100 with the component, or through integral molding of engagement features (e.g., co-molding with the component) with the component to which the stabilizing anchor platform 100 can be coupled. If engagement features are formed with the component, the engagement features may include a first clip feature 134, which includes a second clip feature 136 that mates with a first clip feature 134 to secure the stabilizing anchor platform 100 to the component, as previously described in Figure 10. As shown in Figures 13-15, exemplary components are shown in which the stabilizing anchor platform 100 is incorporated as part of the integrated catheter system 10; however, it is recognized that the stabilizing anchor platform 100 can also be integrated with components of a non-integrated catheter system 40 (see, for example, Figure 2) according to other embodiments.

[0065] As shown in Figure 13, in one embodiment, the stabilizing anchor platform 100 is integrated with the patient-proximal access port 26 of the catheter system 10 (i.e., its connector portion 28 which may be configured as a needleless connector). As shown in Figure 14, in another embodiment, the stabilizing anchor platform 100 is integrated with a clamp 34 provided on the extension tube 16. As shown in Figure 15, in yet another embodiment, the stabilizing anchor platform 100 is integrated with the proximal access port 24 which may be configured as a Luer connector, as described above. In some of these integrated configurations illustrated in Figures 13-15, the upper surface of the stabilizing anchor platform 100 may be flat or angled, allowing for some space or offset between the skin surface 112 and the component into which the stabilizing anchor platform 100 is integrated. For example, if the stabilization anchor platform 100 is integrated into the connector portion 28 of the patient-proximal access port 26 or the proximal access port 24, it may be desirable to tilt the upper surface of the stabilization anchor platform 100 downward to improve access to the port / connector, which may be, for example, a Luer connection, thereby providing easy connection and disconnection to the Luer connection.

[0066] According to the embodiment, when integrated with the components of the catheter system 10 as shown in Figures 13-15, the stabilizing anchor platform 100 may be fixed in place relative to the skin surface 112 via one of several mounting members 102. That is, as described above with respect to Figures 5-9, the stabilizing anchor platform 100 can be fixed in place relative to the skin surface 112 using one or more mounting members 102 in the form of fixing tape, external stabilization devices (ESDs), bandages, anchor platform adhesives with paper backing, and / or skin adhesives. However, it is recognized that it may be desirable for the mounting members 102 to be provided in such a way as not to interfere with the operation / use of the component on which they are formed, and therefore it may be preferable for the mounting members 102 to be provided as a pattern or layer of skin adhesive applied to the bottom surface of the stabilizing anchor platform 100.

[0067] Referring here to Figure 16, the stabilizing anchor platform 100 is shown to be integrated with the force-controlled release connector 66 of the catheter system 10. According to the embodiment, the stabilizing anchor platform 100 is integrated with the patient-side half of the force-controlled release connector 66, i.e., the release feature 70 of the force-controlled release connector 66, as shown in detail in Figures 3 and 4. As previously stated, the release feature 70 may be provided as part of a needleless connector 72 connected to the proximal access ports 24, 62, or it may be a separate component attached to or coupled to the needleless connector 72 or the proximal access ports 24, 62, with the stabilizing anchor platform 100 formed integrally with the release feature 70. During operation, when the force-controlled release connector 66 is activated, the stabilizing anchor platform 100 holds the release feature 70 in contact with the patient's skin while the cutting connector 68 of the force-controlled release connector 66 detaches.

[0068] According to the embodiment, the stabilizing anchor platform 100 integrated with the force-controlled release connector 66 can be fixed in place against the skin surface 112 via one of several mounting members 102. That is, as described above with respect to Figures 5-9, the stabilizing anchor platform 100 can be fixed in place against the skin surface 112 using one or more mounting members 102 in the form of fixing tape, external stabilization devices (ESDs), bandages, anchor platform adhesives with paper backing, and / or skin adhesives. However, it is recognized that it may be desirable for the mounting members 102 to be provided so as not to interfere with the operation / use of the force-controlled release connector 66, and therefore it may be preferable for the mounting members 102 to be provided as a pattern or layer of skin adhesive applied to the bottom surface of the stabilizing anchor platform 100.

[0069] Beneficially, embodiments of the present disclosure provide a stabilization anchor platform and associated mounting components that can be integrated with a catheter system, the stabilization anchor platform providing a fixed point on the patient's skin surface and configured to minimize catheter detachment, infiltration, or movement of the catheter, which could result in the catheter tip being drawn out of a vein or artery. The stabilization anchor platform is configured to isolate external forces applied from a device (i.e., a catheter adapter or catheter connector) coupled to the catheter (or catheter hub) at the insertion site, thereby limiting catheter movement and / or movement of the catheter due to forces applied to an intravenous line or extension set. The stabilization anchor platform can be integrated with components of the catheter system, such as a patient-near-access port, proximal access port, or force-controlled release connector, by being formed integrally with it or by being formed via clip features on the component and platform. Alternatively, the stabilization anchor platform can be integrated with tubing of the catheter system, such as an extension tube or intermediate tube connecting the catheter adapter to the patient-near-access port.

[0070] This disclosure has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, this disclosure is intended to be, wherever possible, to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. An integrated catheter system, A catheter adapter for receiving a catheter and including a side port for fluid communication with the catheter, A patient-near-port access port connected to the side port via an intermediate tube and in fluid communication with the side port, wherein the patient-near-port access port includes a secondary port thereon, An extension tube connected to the secondary port and in fluid communication with the side port of the catheter device via the patient-proximal access port, wherein the extension tube has a proximal access port connected to its proximal end portion, A stabilizing anchor platform integrated with the components of the integrated catheter system and configured to hold the components in a predetermined position relative to the patient's skin surface, wherein the components comprise one of the patient-proximal access port, the intermediate tube, the extension tube, or the proximal access port, An integrated catheter system equipped with [specific features / features].

2. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform is formed integrally with the component.

3. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform and the components are co-molded.

4. The component into which the stabilization anchor platform is integrated comprises a first coupling feature, The integrated catheter system according to claim 1, wherein the stabilizing anchor platform comprises a second coupling feature configured to engage with the first coupling feature, and the stabilizing anchor platform is integrated with the component.

5. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform is integrated with the extension tube.

6. The integrated catheter system according to claim 5, wherein the extension tube comprises a clamp positioned thereon, and the stabilizing anchor platform is integrated with the clamp.

7. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform is integrated with the intermediate tube extending between the side port and the patient-proximal access port of the catheter adapter.

8. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform is integrated with the patient-proximal access port.

9. The integrated catheter system according to claim 1, wherein the stabilizing anchor platform is integrated with the proximal access port.

10. The integrated catheter system according to claim 8, wherein the upper surface of the stabilizing anchor platform is angled away from the patient-near access port or the proximal access port into which it is integrated.

11. The integrated catheter system according to claim 1, further comprising a mounting member for fixing a stabilizing anchor platform to the skin surface of a patient, the mounting member further comprising one or more of the following: an upper fixing member positioned on the stabilizing anchor platform and having an adhesive on its bottom surface; an external stabilizing device having a notch formed therein configured to receive the stabilizing anchor platform; and a pattern or layer of adhesive for directly bonding the stabilizing anchor platform to the skin surface.

12. The integrated catheter system according to claim 11, further comprising a force-controlled release connector coupled to the proximal access port, wherein at least a portion of the force-controlled release connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled release connector, and the mounting member holds the stabilizing anchor platform in a predetermined position relative to the skin surface with a fixing force greater than the predetermined separation force that separates the force-controlled release connector from the proximal access port.

13. It is a non-integrated catheter system, A catheter hub for receiving the catheter, It is a non-integrated expansion set, A catheter connector, which is connected to the catheter hub and includes a side port that communicates fluidly with the catheter, An extension tube connected to the side port and in fluid communication with the catheter hub, wherein the extension tube has a proximal access port connected to its proximal end portion, A non-integrated expansion set comprising, A non-integrated catheter system comprising a stabilizing anchor platform integrated with the components of the non-integrated catheter system and configured to hold the components in place relative to the patient's skin surface, wherein the components comprise one of an extension tube or a proximal access port.

14. The non-integrated catheter system according to claim 13, wherein the stabilizing anchor platform is formed integrally with the component.

15. The component into which the stabilization anchor platform is integrated comprises a first coupling feature, The non-integrated catheter system according to claim 13, wherein the stabilizing anchor platform comprises a second coupling feature configured to engage with the first coupling feature, and the stabilizing anchor platform integrates with the component.

16. The non-integrated catheter system according to claim 14, wherein the stabilizing anchor platform is integrated with the extension tube.

17. The non-integrated catheter system according to claim 14, wherein the stabilizing anchor platform is integrated with the proximal access port.

18. The non-integrated catheter system according to claim 13, further comprising a mounting member for fixing the stabilizing anchor platform to the skin surface of the patient, the mounting member further comprising one or more of the following: an upper fixing member positioned on the stabilizing anchor platform and having an adhesive on its bottom surface; an external stabilizing device having a notch formed therein configured to receive the stabilizing anchor platform; and a pattern or layer of adhesive for directly bonding the stabilizing anchor platform to the skin surface.

19. The non-integrated catheter system according to claim 18, further comprising a force-controlled release connector coupled to the proximal access port, wherein at least a portion of the force-controlled release connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled release connector, and the mounting member holds the stabilizing anchor platform in a predetermined position relative to the skin surface with a fixing force greater than the predetermined separation force that separates the force-controlled release connector from the proximal access port.

20. It is a catheter system, A catheter device comprising a catheter receiving side port for fluid communication with the catheter, wherein the catheter device comprises a catheter adapter or catheter connector, An extension tube that communicates fluidly with the side port of the catheter device, wherein the extension tube has a proximal access port coupled to its proximal end, and the proximal access port is equipped with a needleless connector, A force-controlled release connector coupled to the proximal access port, wherein at least a portion of the force-controlled release connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force-controlled release connector, A stabilization anchor platform integrated with the aforementioned force control release connector, Mounting member for fixing the stabilizing anchor platform to the patient's skin surface, Equipped with, A catheter system wherein the mounting member holds the stabilizing anchor platform in a predetermined position relative to the skin surface with a fixing force greater than the predetermined separation force that separates the force-controlled release connector from the proximal access port.

21. The catheter system according to claim 20, wherein the force-controlled release connector comprises a cutting connector and a release feature coupled to the needleless connector of the proximal access port, the release feature engaging with the cutting connector and configured to detach from the cutting connector when a predetermined separation force is applied to the cutting connector or the needleless connector of the proximal access port, and the stabilizing anchor platform is integrated with the release feature.

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