Catheter system with high-strength stabilizing anchor fixation

Abstract

Provided herein is a catheter system including a catheter and an associated catheter device, the catheter device including a side port in fluid communication with the catheter. An extension tube is provided in fluid communication with the side port, the extension tube having a proximal access port. A force control release connector is coupled to the proximal access port and is separable therefrom when a predetermined separation force is applied. A stabilizing anchor platform is spaced from the catheter device and disposed along the extension tube distal to the force control release connector, the stabilizing anchor platform including an attachment member for securing the stabilizing anchor platform against the patient's skin surface. The attachment member holds the stabilizing anchor platform in position against the skin surface with a securing force greater than the predetermined separation force of the force control release connector.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 63 / 480,025, entitled "Catheter System with High-Strength Stabilizing Anchor Fixation," filed January 16, 2023, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to a catheter system having high strength fixation of a stabilizing anchor. [Background technology]

[0003] Catheters are commonly used to administer fluids into and out of the body. Patients in various settings, including hospitals and home care, receive fluids, medications, and blood products via vascular access devices (VADs), which contain such catheters inserted into the patient's vascular system. A typical VAD includes a plastic catheter inserted into a patient's vein, and the length of the catheter varies, for example, from a few centimeters if the VAD is a peripheral intravenous catheter (PIVC) to several centimeters if the VAD is a central venous catheter (CVC). VADs can be indwelling for short-term (days), medium-term (weeks), or long-term (months to years).

[0004] In some instances, the VAD is part of a larger catheter system, and tubing or an intravenous line extends from an adapter or connector on the VAD to provide additional flexibility to the healthcare professional in administering and / or withdrawing fluids from the VAD. According to various embodiments, the tubing can be integrated with the VAD (an integrated catheter system) or part of an extension set provided separately from the VAD (a non-integrated catheter system).

[0005] Current VADs, and thus extension sets or tubing, may be manually manipulated to allow for blood withdrawal or fluid introduction; however, doing so in an uncontrolled manner can increase the incidence of VAD dislodgement from the vasculature and therefore shorten the lifespan of the catheter. While fixation devices exist and may be used to attach the extension set or tubing to the patient's skin, such fixation devices may not provide sufficient fixation strength necessary to ensure the VAD is held in place. For example, the fixation strength provided by the fixation device may be less than the release strength of the control-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 a catheter system to a patient to prevent accidental dislodgement of the VAD. Summary of the Invention

[0007] Provided herein is a catheter system including a catheter device including a side port that receives a catheter and is in fluid communication with the catheter, the catheter device including a catheter adapter or 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 catheter system further includes a force control release connector coupled to the proximal access port, at least a portion of the force control release connector configured to separate from the proximal access port when a predetermined separation force is applied to the force control release connector. The catheter system further includes a stabilizing anchor platform spaced from the catheter device, disposed along the extension tube, and distal to the force control release connector, and an attachment member for securing the stabilizing anchor platform against the patient's skin surface. The attachment member holds the stabilizing anchor platform in place against the skin surface with a securing force greater than the predetermined separation force that separates the force control release connector from the proximal access port.

[0008] In some embodiments, the stabilizing anchor platform includes a body that substantially defines a perimeter of the stabilizing anchor platform, and a retainer portion provided on the body and configured to retain the extension tube therein.

[0009] In some embodiments, the body includes a pair of stabilizing wings, and the retaining portion is disposed between the pair of stabilizing wings.

[0010] In some embodiments, the attachment member is an upper fixation member having adhesive on at least a portion of its bottom surface, the upper fixation member being positioned over the stabilizing anchor platform such that the stabilizing anchor platform is positioned between the skin surface and the upper fixation member, the perimeter of the upper fixation member being greater than the perimeter of the stabilizing anchor platform, and a first portion of the upper fixation member being adhered to the skin surface and a second portion of the upper fixation member being adhered to the stabilizing anchor platform.

[0011] In some embodiments, the second portion of the upper fixation member is adhered to the upper surface of the stabilizing anchor platform via adhesive on the bottom surface of the upper fixation member.

[0012] In some embodiments, the upper fixation member includes a slot formed therein through which the extension tube is disposed.

[0013] In some embodiments, the attachment member is an external stabilizing device having an adhesive on a bottom surface thereof that adheres to the skin surface, the external stabilizing device including a cutout portion therein configured to receive the stabilizing anchor platform, and the external stabilizing device including another adhesive that secures the stabilizing anchor platform within the cutout portion.

[0014] In some embodiments, the shape of the cutout portion matches the shape of the stabilizing anchor platform.

[0015] In some embodiments, the attachment member includes both an upper fixation member and an external stabilization device.

[0016] In some embodiments, the attachment member is a pattern or layer of adhesive that adheres the stabilizing anchor platform directly to the skin surface.

[0017] In some embodiments, the stabilizing anchor platform includes one or more pass-through mechanisms that pass through the stabilizing anchor platform from a front surface of the stabilizing anchor platform to a rear surface of the stabilizing anchor platform, the one or more pass-through mechanisms configured to transfer and distribute adhesive applied thereto from the front surface to the rear surface.

[0018] In some embodiments, the attachment member includes both an upper fixation member and a pattern or layer of adhesive that adheres the stabilizing anchor platform directly to the skin surface.

[0019] In some embodiments, the securing force is greater than 7 pounds, greater than 5 pounds, or greater than 3 pounds of adhesive force.

[0020] In some embodiments, the catheter system includes a clamp disposed along the extension tube, and the stabilizing anchor platform is disposed distal to the proximal access port and proximal to the clamp.

[0021] In some embodiments, the proximal access port is a needleless connector.

[0022] In some embodiments, the force control release connector includes a disconnection connector and a release mechanism coupled to the needleless connector of the proximal access port, the release mechanism configured to engage with the disconnection connector and to decouple from the disconnection connector when a predetermined separation force is applied to the disconnection connector or the needleless connector of the proximal access port.

[0023] In some embodiments, the catheter system includes a secondary stabilization anchor platform configured to stabilize the catheter device.

[0024] In some embodiments, the extension tube is integral with the catheter adapter as part of an integrated catheter system.

[0025] In some embodiments, the extension tube and catheter connector are connectable to a catheter hub connected to the catheter as part of a non-integrated catheter system.

[0026] Also provided herein is a method for securing a catheter system to a patient's skin surface, the method comprising adhering a stabilizing anchor platform in a predetermined position relative to the skin surface via an attachment member, the attachment member being adhered to the skin surface with a securing force greater than a predetermined separation force that separates the force control release connector from the proximal access port. [Brief explanation of the drawings]

[0027] [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 control 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] FIG. 4 is a cross-sectional view of the force control release connection of FIG. 3, with the connection in a disconnected state, according to a further aspect or embodiment of the present application. [Figure 5] FIG. 5 is a perspective view of a stabilizing anchor platform and attachment member included in the system of FIG. 1 and / or FIG. 2 according to one aspect or embodiment of the present application. [Figure 6]FIG. 6 is a perspective view of a stabilizing anchor platform and attachment member included in the system of FIG. 1 and / or FIG. 2 according to one aspect or embodiment of the present application. [Figure 7] FIG. 7 is a perspective view of a stabilizing anchor platform and attachment member included in the system of FIG. 1 and / or FIG. 2 according to one aspect or embodiment of the present application. [Figure 8] FIG. 8 is a perspective view of a stabilizing anchor platform and attachment member included in the system of FIG. 1 and / or FIG. 2 according to one aspect or embodiment of the present application. [Figure 9] FIG. 9 is a perspective view of a stabilizing anchor platform and attachment member included in the system of FIG. 1 and / or FIG. 2 according to one aspect or embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0028] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0029] For purposes of explanation hereinafter, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, shall refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered limiting.

[0030] In this disclosure, the distal end of a component or device means the end farthest from the user's hand when the component or device is in the use position, 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 "proximally" and "proximally" mean the direction opposite to the direction of the distal tip of the needle or catheter.

[0031] Referring to FIG. 1 , an integrated catheter system 10 is shown according to one aspect or embodiment in which embodiments 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”) along with an integrated extension set 14 (including extension tube 16). The catheter adapter 12 includes a catheter 18, a body 20 that receives the catheter 18, and a side port 22 in fluid communication with the catheter 18. The integrated extension set 14 includes a proximal access port 24 coupled to a proximal end portion of the extension tube 16, which is in fluid communication with the side port 22 of the catheter adapter 12.

[0032] In some aspects or embodiments, the system 10 may include a patient-proximal access port 26 in fluid communication with the side port 22 of the catheter adapter 12, the patient-proximal access port 26 including a connector portion 28 configured to be coupled to a peripheral probe device. The patient-proximal access port 26 is configured to provide catheter access to a peripheral device, such as, for example, 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. In some embodiments, the patient-proximal access port 26 is coupled to the side port 22 of the catheter adapter 12 via a length of intermediate tubing 30. However, in other embodiments, the patient-proximal access port 26 may be directly coupled to the side port 22 or may be connected via another intermediate member.

[0033] The near-patient 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 a blunt introducer of a blood collection device. More specifically, the connector portion 28 may be configured as a split-septum NFC with direct probe access, such as a Becton, Dickinson and Co. Q-Syte™ or SmartSite™ NFC, or any other suitable split-septum NFC. Alternatively, in other embodiments, the connector portion 28 may be formed from a non-split-septum NFC. Furthermore, in some embodiments, the near-patient access port 26 may include antimicrobial and / or flush-facilitating features. For example, the near-patient access port 26 may include one or more of an offset tubing port vortex-generating feature, a proximal fluid bypass feature, an antimicrobial NFC lubricant, an antimicrobial-eluting surface coating or insert, or the like. Using a proximal patient access port 26 fluidly coupled to the catheter adapter 12 via the side port 22, the system 10 provides probe (or tubing) access from a peripheral probe device via the indwelling catheter 18. The proximal patient access port 26 further includes a secondary port 32 disposed near its distal end. In some embodiments, the secondary port 32 is coupled to the extension tubing 16 of the integrated extension set 14. A clamp 34 may be provided on the integrated extension set 14, the clamp 34 configured to selectively restrict flow through the extension tubing 16 of the integrated extension set 14.

[0034] In other aspects or embodiments, the extension tubing 16 of the integrated extension set 14 may extend directly from the catheter's side port 22, with the system 10 not including a nearby patient access port 26. In such embodiments, the system 10 may incorporate, by way of non-limiting example, a BD Nexiva™ closed peripheral IV catheter system or a BD Nexiva™ Diffusics™ closed IV catheter system.

[0035] 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 including a catheter device 46 in the form of a catheter stabilizing catheter connector (hereinafter "catheter connector 46") along with an extension tube 48. The catheter hub 42 receives a catheter 50 and is coupled to the catheter connector 46. In one aspect or embodiment, the catheter hub 42 is an AccuCath™ catheter system commercially available from Becton, Dickinson and Company.

[0036] The catheter connector 46 is configured to be placed in contact with a patient's skin surface at or near the insertion site of the catheter 50. The catheter connector 46 may be of any suitable shape, size, and / or configuration. In the illustrated non-limiting embodiment, 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, and defines 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 the distal coupler 58 may be, for example, a male or female Luer lock and / or any other suitable coupler. The proximal coupler 56 can be configured as an NFC or the like and can physically and fluidly couple to a peripheral device such as, for example, 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 can be configured to provide alignment, guidance, centering, etc., for an object or device (e.g., a blood collection catheter, as described above, etc.) being advanced therethrough.

[0037] Connector portion 52 also includes and / or defines one or more additional ports, such as a side port 60. Side port 60 may be included in and / or be part of connector portion 52, proximal coupler 56, distal coupler 58, and / or combinations thereof. For example, side port 60 may be distal to proximal coupler 56. However, in other embodiments, connector portion 52 may include and / or define side port 60 formed by structures or features forming the proximal coupler. In some examples, locating side port 60 at a desired location along the length of connector portion 52 between couplers 56 and 58 may allow for shortening the length of connector portion 52 and / or may facilitate flushing and / or fluid transfer via side port 60.

[0038] 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 can include and / or define a first lumen (e.g., between the distal coupler 58 and the proximal coupler 56) and a second lumen (e.g., the 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 in turn can provide access to a device (e.g., a VAD) coupled to the distal coupler 58 and / or can provide access to a portion of the body in which the VAD is at least partially disposed.

[0039] In some embodiments, the arrangement of the side port 60 can be such that the connector portion 52 forms, for example, a Y-connector or a T-connector. More specifically, the side port 60 can be positioned substantially perpendicular (e.g., at about 90 degrees) to the lumen of the connector portion 52 and positioned near or adjacent to the proximal coupler 56. In non-limiting embodiments, the side port 60 extends from the connector portion 52 at an angle other than 90 degrees relative to the lumen between the distal coupler 58 and the proximal coupler 56 (e.g., the side port 60 extends at an angle between, for example, but not limited to, 15 and 165 degrees, including all values ​​and subranges therebetween). In non-limiting embodiments, multiple side ports 60 are included in the connector portion 52.

[0040] 2, the side port 60 may be coupled to the extension tube 48 such 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 a fluid line that may be used to deliver fluids, remove fluids, flush fluids, etc. In such embodiments, for example, a configuration in which the side port 60 is positioned adjacent the proximal coupler 56 may enable flushing of the proximal coupler 56, any valves contained therein, and / or the space between any valves and the inner surface of the connector portion 52 (e.g., defining at least a portion of the lumen).

[0041] As shown, the extension set 44 includes a proximal access port 62 coupled to a proximal end portion of the extension tube 48, which 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, the clamp 64 being configured to selectively restrict flow through the extension tube 48.

[0042] 1 and 2, a force control release connector 66 may be coupled to the proximal access port 24, 62. At least a portion of the force control release connector 66 is configured to separate from the proximal access port 24, 62 when a predetermined separation force is applied to the force control release connector 66. In some embodiments, the predetermined separation force that separates the force control release connector 66 from the proximal access port 24, 62 is, by way of non-limiting example, approximately 5 pounds of force, although it will be recognized that the force control release connector 66 can have a greater or lesser separation force. Thus, at least a portion of the force control release connector 66 is configured to detach from the proximal access port 24, 62 to prevent excessive force from being transmitted to the catheter adapter 12 (FIG. 1) or catheter connector 46 (FIG. 2) via the extension tube 16, 48. For example, the line from the IV bag may be connected to the extension tube 16, 48 via the force control release connector 66 such that excessive movement of the IV bag and line simply disconnects the connection between the proximal access port 24, 62 and the force control release connector 66 rather than transferring that movement to the extension tube 16, 48 and interfering with the placement of the catheter 18, 50.

[0043] 3 and 4, the force control release connector 66 is shown in more detail, according to one embodiment. The force control release connector 66 includes a disconnecting connector 68 and a release feature 70 coupled to a needleless connector 72 of the proximal access port 24, 62. The release feature 70 is configured to engage with the disconnecting connector 68 and to be disconnected from the disconnecting connector 68 when a predetermined separation force is applied to the disconnecting connector 68 or the needleless connector 72 of the proximal access port 24, 62. The disconnecting connector 68 includes a valve member 74 configured to seal the disconnecting connector 68 when separated from the needleless connector 72. In one aspect or embodiment, the release mechanism 70 is configured to be biased radially outward when a predetermined separate force is reached. The release mechanism 70 and the disconnecting connector 68 may form a cam arrangement in which an axial force moves the release mechanism 70 radially outward, thereby disengaging the disconnecting connector 68 from the release mechanism 70. The release mechanism 70 may be integrally formed with the needleless connector 72 or may be a separate component attached or coupled to the needleless connector 72 or the proximal access port 24,62.

[0044] 1 and 2, each of the systems 10, 40 provides a stabilizing anchor platform 100 spaced apart from the catheter adapter 12 (FIG. 1) or catheter connector 46 (FIG. 2) and positioned along the extension tube 16, 48. The stabilizing anchor platform 100, along with an associated attachment member 102 (generally shown in phantom in FIGS. 1 and 2, but the configuration of which may vary according to various embodiments, as described below), provides a primary fixation point at the patient's skin surface and is configured to minimize catheter dislodgement, infiltration, or catheter migration, which could result in the tip of the catheter 18, 50 being pulled out of the vein or artery. The stabilizing anchor platform 100 is configured to isolate externally applied forces from the catheter adapter 12 or catheter connector 46 and insertion site to limit catheter 18, 50 migration and / or catheter 18, 50 movement due to forces applied to the intravenous line or extension set.

[0045] According to embodiments, the stabilization anchor platform 100 generally comprises a substantially flat or planar body 104 and a retaining section 106 (e.g., a cylindrical passageway) configured to secure the extension tube 16, 48 therein. In some embodiments, the body 104 includes a pair of stabilizing wings 108, 110 centrally disposed within the retaining section 106, although other suitable configurations may be utilized, including the body 104 of the stabilization anchor platform 100 being oval, triangular, circular, square, rectangular, trapezoidal, or another suitable shape. The stabilization anchor platform 100 may be flexible, pliable, semi-rigid, or rigid and may include mechanisms or living hinges to promote flexibility for patient comfort. The stabilization anchor platform 100 may also include one or more features to improve attachment to the attachment member 102, such as protrusions, surface roughness, pockets, etc. The stabilization anchor platform 100 may include one or more color or visual markings to provide catheter gauge, length, type, or procedure-related information.

[0046] In some aspects or embodiments, the stabilizing anchor platform 100 is positioned distal to the proximal access port 24, 62 and proximal to the clamp 34, 64. In other aspects or embodiments, the stabilizing anchor platform 100 is positioned distal to the clamp 34, 64.

[0047] 5-9 illustrate various embodiments of attachment members 102 that can be used to secure the stabilizing anchor platform 100 in place relative to a patient's skin surface (indicated by 112). According to aspects of the present invention, the attachment members 102 are configured to apply a securing force (a force that secures the stabilizing anchor platform 100 in place) that is greater than a predetermined separation force that separates the force control release connector 66 from the proximal access port 24, 62. In some embodiments, the securing force is an adhesive force that is at least 0.25 pounds greater than the predetermined separation force that separates the force control release connector 66 from the proximal access port 24, 62. Thus, in a non-limiting example where the predetermined separation force of the force control release connector 66 is 5 pounds, the adhesive force of the attachment members 102 should be 5.25 pounds or greater. According to non-limiting embodiments, the adhesive force of the attachment members 102 can be greater than 7 pounds, greater than 5 pounds, greater than 3 pounds, etc., depending on the predetermined separation force of the particular force control release connector 66 used. By applying a securing force to the attachment member 102 that is sufficiently greater than the predetermined force separation of the force control release connector 66, it is ensured that the stabilizing anchor platform 100 is held in place until the force control release connector 66 is released, thereby preventing excessive movement or removal of the catheters 18, 50.

[0048] Referring initially to FIG. 5 , an attachment member 102 for securing a stabilizing anchor platform 100 in place relative to a patient's skin surface is provided according to one aspect or embodiment. The attachment member 102 is provided as an upper fixation member 102a that is applied over the stabilizing anchor platform 100, with the stabilizing anchor platform 100 being disposed between the skin surface 112 and the upper fixation member 102a. The upper fixation member 102a may be configured as a top dressing or adhesive tape for fixation. In one embodiment, the upper fixation member 102a may include a transparent dressing portion 114 and a fabric border portion 116. The upper fixation member 102a may be of various shapes and sizes, and in the illustrated embodiment, has a shape generally similar to that of the stabilizing anchor platform 100 (i.e., a pair of wings), but has a perimeter and surface area greater than that of the stabilizing anchor platform 100. The upper fixation member 102a includes adhesive 118 on its bottom surface such that at least a first portion of the upper fixation member 102a (i.e., the periphery thereof, such as the fabric border portion 116) adheres to the skin surface 112, and optionally a second portion of the upper fixation member 102a (i.e., a portion of the transparent bandage portion 114) adheres to the top surface of the stabilizing anchor platform 100.

[0049] In some embodiments, the upper fixation member 102a includes one or more slots 120 that allow for the passage of the extension tubes 16, 48. That is, when the stabilizing anchor platform 100 is covered by the upper fixation member 102a, the upper fixation member 102a must accommodate the routing of the extension tubes 16, 48 through the slots 120 to allow the extension tubes 16, 48 to enter and exit the area covered by the upper fixation member 102a.

[0050] 6 , an attachment member 102 for securing a stabilizing anchor platform 100 in place relative to a patient's skin surface 112 is provided according to another aspect or embodiment. The attachment member 102, in some embodiments, is provided as a bottom fixation member 102b that is an external stabilizing device (hereinafter, “external stabilizing device 102b”). The external stabilizing device 102b includes, for example, a tricot base pad 122 having adhesive 124 affixed to its bottom surface for attachment to the patient's skin surface 112. A cutout 126 is formed in the base pad 124 having a shape and perimeter / area that matches the shape and perimeter / area of ​​the stabilizing anchor platform 100. Adhesive 128 is applied in the area of ​​the cutout 126 to secure the stabilizing anchor platform 100 within the cutout 126 and secure the stabilizing anchor platform 100 relative to the external stabilizing device 102b and the skin surface 112. Adhesive 128 in the area of ​​the cutout 126 can secure the periphery of the stabilizing anchor platform 100 within the cutout 126 and, optionally, can secure the bottom of the stabilizing anchor platform 100 (adjacent its periphery) to the skin surface 112.

[0051] 7 , an attachment member 102 for securing a stabilizing anchor platform 100 in place relative to a patient's skin surface 112 is provided according to another aspect or embodiment. The attachment member 102 is provided as both a top attachment member 102a and a bottom attachment member 102b (i.e., external stabilizing device 102b). As previously mentioned, the top attachment member 102a may be configured as a top bandage or adhesive tape, and in one embodiment, the top attachment member 102a may include a transparent bandage portion 114 and a fabric border portion 116. The external stabilizing device 102b may include a base pad 124 having a cutout 126 formed therein having a shape and perimeter / area that matches the shape and perimeter / area of ​​the stabilizing anchor platform 100.

[0052] When positioning the top and bottom fixation members 102a, 102b relative to the stabilizing anchor platform 100 and securing the fixation members and stabilizing anchor platform 100 to the patient, the bottom fixation member 102b (external stabilizing device 102b) is attached to the patient's skin surface 112 via adhesive 124 applied to the bottom surface of the external stabilizing device 102b. The stabilizing anchor platform 100 is placed within a notch 126 in the base pad 124 of the external stabilizing device 102b, and adhesive 128 is applied in the area of ​​the cutout 126 to secure the stabilizing anchor platform 100 within the notch 126. Once the external stabilizing device 102b and stabilizing anchor platform 100 are positioned and secured in place relative to the skin surface 112, the top fixation member 102a is applied over the external stabilizing device 102b and stabilizing anchor platform 100. As shown in FIG. 6 , the top fixation member 102a is sized such that its perimeter extends beyond the perimeter of the external stabilizing device 102b. The upper fixation member 102a includes an adhesive 118 on its bottom surface such that at least a first portion of the upper fixation member 102a (i.e., a perimeter such as the fabric border portion 116) adheres to the skin surface 112, and optionally a second portion of the upper fixation member 102a adheres to the top surface of the external stabilizing device 102b and / or the stabilizing anchor platform 100. Thus, the upper fixation member 102a further secures the stabilizing anchor platform 100 (and the external stabilizing device 102b) in place relative to the skin surface 112.

[0053] 8 , an attachment member 102 for securing the stabilizing anchor platform 100 in place relative to a patient's skin surface 112 is provided according to another aspect or embodiment. The attachment member 102 is provided as a pattern or layer of skin adhesive 102c that secures the stabilizing anchor platform 100 directly to the skin surface 112. According to an embodiment, the stabilizing anchor platform 100 is a skin adhesive compatible platform and may include a mechanism 130 (i.e., a “pass-through” mechanism) that allows the skin adhesive 102c to be dispensed onto the top of the stabilizing anchor platform 100 and facilitates distribution of the skin adhesive 102c to the bottom surface of the stabilizing anchor platform 100 so that the bottom surface of the stabilizing anchor platform 100 may be securely attached to the skin surface 112. In other embodiments, 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 above embodiments, the stabilizing anchor platform 100 is pressed against the skin surface 112 (e.g., by a clinician or by tape or a bandage) and allowed to dry to ensure the formation of a strong adhesive bond.

[0054] 9, the stabilizing anchor platform 100 may be secured 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 securing member 102a applied over the stabilizing anchor platform 100. As previously mentioned, the upper securing member 102a may be configured as an upper bandage or adhesive tape, and in one embodiment, the upper securing member 102a may include a transparent bandage portion 114 and a fabric border portion 116.

[0055] When positioning and securing the stabilizing anchor platform 100 and upper fixation member 102a to a patient, the skin adhesive 102c is first applied to the stabilizing anchor platform 100. According to embodiments, the skin adhesive 102c may be applied to a pass-through mechanism 130 on the top of the stabilizing anchor platform 100 that dispenses the adhesive onto 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 the skin surface 112. Once the stabilizing anchor platform 100 is secured in place relative to the skin surface 112, the upper fixation member 102a is applied atop the stabilizing anchor platform 100. As shown in FIG. 9 , the upper fixation member 102a is sized such that its perimeter extends beyond the perimeter of the stabilizing anchor platform 100. The upper fixation member 102a includes an adhesive 118 on its bottom surface such that at least a first portion of the upper fixation member 102a (i.e., a peripheral portion such as the fabric border portion 116) adheres to the skin surface 112, and optionally a second portion of the upper fixation member 102a adheres to the top surface of the stabilizing anchor platform 100. Thus, the upper fixation member 102a further secures the stabilizing anchor platform 100 in place relative to the skin surface 112.

[0056] 5-9, the attachment member 102 is configured to apply a fixation force (a force that secures the stabilizing anchor platform 100 in place) that is greater than a predetermined separation force that separates the force control release connector 66 from the proximal access port 24, 62 (FIGS. 1 and 2). Applying a fixation force to the attachment member 102 that is greater than the predetermined separation force of the force control release connector 66 ensures that the stabilizing anchor platform 100 is held in place until the force control release connector 66 is released, thereby preventing excessive movement or removal of the catheter 18, 50.

[0057] Beneficially, embodiments of the present disclosure provide a stabilization anchor platform and associated attachment member(s) positionable on an extension tube of a catheter system, where the stabilization anchor platform is configured to provide a fixation point at a patient's skin surface and minimize catheter dislodgement, infiltration, or catheter migration, which could result in the catheter tip being pulled out of a vein or artery. The stabilization anchor platform is configured to isolate externally applied forces from a device (i.e., a catheter adapter or catheter connector) coupled to the catheter (or catheter hub) at the insertion site to limit catheter migration and / or catheter movement due to forces applied to an intravenous line or extension set. In the case of a catheter system having a force control release connector coupled to the proximal access port of the extension tube, the attachment member is configured to hold the stabilization anchor platform in place against the skin surface with a fixation force greater than a predetermined separation force that separates the force control release connector from the proximal access port.

[0058] While the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

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