Catheter securement devices

Abstract

Secondary catheter securement devices are described herein that are configured to hold a catheter or catheter extension line adjacent to a primary catheter securement device during dwell time and / or dressing change. Each secondary catheter securement device secures a catheter in place such that a primary catheter securement device can be removed and replaced and / or the secondary securement device itself acts as a primary securement device, and such that site cleaning can be performed during dressing change without increasing the risk of catheter movement.

Description

CATHETER SECUREMENT DEVICESFIELD OF THE INVENTION

[0001] The present inventive concepts relate to medical devices, and in particular, devices for catheter securement.BACKGROUND OF THE INVENTION

[0002] Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic procedures. In most uses, a catheter is a thin, flexible tube (soft catheter) though catheters are available in varying levels of stiffness depending on the application. Catheters can be inserted into a body cavity, duct, vessel, brain, skin, or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and also perform a wide variety of other tasks depending on the type of catheter.

[0003] Referring to FIGS. 1-4E, when a catheter 12 is left in place in a patient longterm, often a securement technique is employed to secure the catheter 12 in its location. This is particularly true for central venous catheters (CVCs), which are often inserted into the superior vena cava via the patient's neck / chest. Solutions to secure a catheter include sutures 11 (FIG. 1) and catheter securement devices 20, such as the STATLOCK™ securement device (FIG. 3), available from Becton, Dickinson and Company (1 Becton Drive, Franklin Lakes, New Jersey). With either of these techniques, typically a dressing 25 associated with the insertion site IS of the catheter 12 requires changing after every 7 days in a best case scenario. As can be seen in FIGS. 2A-2C, cleaning around a catheter 12 that is secured by sutures 11 may result in incomplete (and therefore inadequate) cleaning (e.g., an area A of the patient’s skin S below the catheter hub 14 that has not been cleaned), which in turn can increase the risk of central line-associated bloodstream infection (CLABSI).

[0004] When a catheter is secured with an adhesive-based securement device 20 (FIG. 3), typically the securement device 20 is changed at the same time as the dressing. During changing of the dressing, replacement of the securement device 20 and cleaning around theinsertion site, for example, with a disinfecting applicator 30 (FIG. 2A), a caretaker should avoid undue movement of the catheter (for example, tip migration, dislodgement or “pistoning” of the catheter in the insertion site may occur, which may result in the catheter shifting to the extent that the catheter is no longer correctly positioned at intended location within the vein or other structure into which it is inserted). This is particularly important for certain catheters and insertion sites, such as CVCs.

[0005] Different techniques for changing the dressing around the catheter are currently used. In one technique illustrated in FIG. 4A, a caretaker may attempt to use a finger F to hold a catheter 12 in place; however, this technique is not aligned with Aseptic Non-Touch Technique (ANTT) protocol. In an alternative technique illustrated in FIG. 4B, a rolled-up dressing 25 may be used to temporarily hold a catheter 12 as a securement device 20 is replaced. However, the use of the rolled-up dressing 25 may present inconsistency (e g., how much dressing to use). In a third technique illustrated in FIGS. 4C-4E, a secondary securement component, such as an adhesive strip 15, may be used to temporarily hold a catheter 12 in position during removal and replacement of the securement device 20. This technique requires that a caretaker have the knowledge to do this and the adherence to protocol to use the adhesive strip 15. Experience has shown that this protocol is often ignored. Also, removal of the adhesive strip 15 may be difficult and / or may cause movement to the catheter 12, and in some instances the adhesive strip 15 leaves an adhesive residue on the catheter lumen after removal that can attract contaminants.

[0006] It may be desirable to provide techniques for improving adherence to protocols, which may in turn improve patient outcomes.SUMMARY

[0007] According to some embodiments of the present inventive concepts, a catheter securement device includes an adjustable length frame having opposite first and second end portions. The first end portion is configured to be movably secured to the skin of a patient at a catheter insertion site, and the second end portion is configured to grasp and hold a catheter inserted into the patient at the catheter insertion site and prevent inadvertent movement of the catheter at the catheter insertion site. A skin engagement member is attached to the first end portion of the frame and includes at least one prong (e.g., a pair of adjacent spaced apart prongs, etc.) that is configured to hook the skin of the patient at the catheter insertion site. The skin engagement member has a living hinge configuration that allows the frame to be pivoted relativeto the skin of the patient without disengaging the at least one prong from the skin of the patient. A clip is attached to the second end portion and is configured to snugly receive the catheter or catheter hub therein and prevent unwanted forward and backward movement (i.e., pistoning) of the catheter relative to the clip.

[0008] In some embodiments, the frame includes a first section slidably coupled to a second section such that the frame has a telescopically adjustable length. A locking mechanism is operably associated with the first and second sections and is configured to restrain movement of the first and second sections relative to each other when the frame is at a selected length. The skin engagement member is attached to the first section, and the clip is attached to the second section.

[0009] In some embodiments, one or more portions of the exterior surface of the frame has a coating of material that inhibits fibroblast cell adhesion thereto, and one or more portions of an exterior surface of the skin engagement member has a coating of material that inhibits fibroblast cell adhesion thereto.

[0010] According to other embodiments of the present inventive concepts, a catheter securement device includes an inflatable sleeve surrounding a portion of a catheter, and a tube in fluid communication with the inflatable sleeve that is configured to supply a fluid or gas (e.g., saline or air, etc.) to the inflatable sleeve. The inflatable sleeve is configured to expand in response to receiving the fluid or gas from the tube and create an interference fit at a catheter insertion site that is sufficient to prevent inadvertent forward and backward movement (i.e., pistoning) of the catheter at the catheter insertion site. The tube is also configured to remove the fluid or gas from the inflatable sleeve when in an expanded configuration in order to allow the inflatable sleeve to contract. The inflatable sleeve may have more than one portion configurated to expand and contract. For example, in some embodiments, the inflatable sleeve may include two inflatable portions in spaced apart relationship.

[0011] In some embodiments, the tube includes an inflatable portion that provides an indication when the inflatable sleeve is sufficiently expanded to form the interference fit at the catheter insertion site, and to reduce the risk of over inflation.

[0012] In some embodiments, at least a portion of the tube includes visual indicia that distinguishes the tube from the catheter.

[0013] In some embodiments, an outer surface of the sleeve includes one or more grooves configured to allow exudate to flow from the catheter insertion site. In someembodiments, one or more portions of an exterior surface of the inflatable sleeve has a coating of material that inhibits fibroblast cell adhesion thereto.

[0014] According to other embodiments of the present inventive concepts, a catheter securement device includes an inflatable sleeve that is movable along an exterior surface of a catheter and is configured to be positioned at a catheter insertion site. The inflatable sleeve is configured to expand and create an interference fit at the catheter insertion site that is sufficient to prevent inadvertent forward and backward movement (i.e., pistoning) of the catheter at the catheter insertion site. The inflatable sleeve has an annular body with a first portion configured to be positioned within the catheter insertion site and a second portion configured to abut an area circumferentially adjacent to the catheter insertion site. The second portion includes a port through which a fluid or gas (e.g., saline or air, etc.) can be supplied via a tube to the inflatable sleeve to cause the inflatable sleeve to expand, and through which the fluid or gas can be removed from the inflatable sleeve to allow the inflatable sleeve to contract.

[0015] In some embodiments, an outer surface of the inflatable sleeve includes one or more grooves configured to allow exudate to flow from the catheter insertion site. In some embodiments, one or more portions of an exterior surface of the inflatable sleeve has a coating of material that inhibits fibroblast cell adhesion thereto.

[0016] According to other embodiments of the present inventive concepts, a catheter securement device includes an anchor configured to be secured to the skin of a patient adjacent a catheter insertion site, and a hub movably secured to the anchor, for example by a flexible connecting member. The hub includes a catheter receiving channel that is configured to snugly hold a portion of a catheter inserted into the patient at the catheter insertion site. The anchor and the hub are configured to prevent inadvertent forward and backward movement (i.e., pistoning) of the catheter at the catheter insertion site. The anchor includes a plurality of microneedles that are configured to be inserted within the skin of the patient. In some embodiments, the plurality of microneedles are angled relative to a surface of the anchor.

[0017] In some embodiments, the anchor includes a first member and a second member in adjacent, spaced-apart relationship. The first member includes a plurality of microneedles and the second member comprises a plurality of microneedles. In some embodiments, the plurality of microneedles are angled relative to a surface of each of the first member and the second member. A third member is positioned between and connected to the first and second members, and the hub is movably secured to the third member. In some embodiments, the anchor has a U-shape and is configured to be secured to the skin of the patient such that the catheter insertion site is between the first and second members.

[0018] According to other embodiments of the present inventive concepts, a catheter securement device includes a sleeve configured to surround a portion of a catheter at a catheter insertion site and a slider device. The sleeve is movable along an exterior surface of the catheter and is configured to be positioned at the catheter insertion site by the slider device. In some embodiments, the sleeve may be integrated within a catheter. For example, the sleeve surrounds and is movable along an exterior surface of a catheter, and the sleeve and catheter are surrounded by an outer sleeve. The sleeve includes an end portion that is expandable and contractable. For example, the end portion of the sleeve may include one or more flaps that are expandable and contractable. The slider device includes a flexible tube that is configured to surround the sleeve and maintain the flexible sleeve end portion in a contracted state. The slider device is configured to move the sleeve along the catheter and insert the end portion in the contracted state into the catheter insertion site. When the slider device is retracted from the catheter insertion site along the catheter, the sleeve end portion expands and engages skin of the patient at the catheter insertion site.

[0019] The slider device includes a fitting that is configured to be secured to a primary catheter securement device, such as the STATLOCK™ securement device (FIG. 3). For example, in some embodiments, the slider device includes a pair of opposing wings, and each wing is configured to engage with and be secured to the primary catheter securement device. For example, in some embodiments, each wing may include an opening configured to engage with a respective post associated with the primary catheter securement device.

[0020] In some embodiments, one or more portions of the exterior surface of the sleeve has a coating of material that inhibits fibroblast cell adhesion thereto. In some embodiments, an outer surface of the sleeve includes one or more grooves configured to allow exudate to flow from the catheter insertion site.

[0021] In some embodiments, the sleeve may include a second portion that is expandable and contractable and that is in adjacent spaced apart relationship with the expandable and contractable end portion. The flexible tube of the slider device is configured to surround the sleeve and maintain the end portion and the second portion of the sleeve in a contracted state. The slider device is configured to move the sleeve along the catheter and insert the end portion in the contracted state into the catheter insertion site. When the slider device is retracted from thecatheter insertion site along the catheter, the sleeve end portion expands and engages the skin of the patient at the catheter insertion site and the sleeve second portion contacts an external portion of the skin of the patient.

[0022] According to other embodiments of the present inventive concepts, a catheter securement device includes an anchor that is configured to surround a portion of a catheter at a catheter insertion site, and that is configured to change shape in response to an external force applied to the catheter and prevent inadvertent forward and backward movement (i.e., pistoning) of the catheter at the catheter insertion site. In some embodiments, the anchor device includes opposing first and second collars in axial alignment that are supported in spaced apart relationship by at least one member. A locking strap is associated with the first collar and is configured to snugly secure the first collar to the catheter. The at least one member is configured to move from an elongated configuration to an outwardly extending articulated configuration in response to the external force applied to the catheter.

[0023] In some embodiments, the first collar includes a slot configured to allow the catheter to be received within the first collar, and the second collar includes a slot configured to allow the catheter to be received within the second collar. The at least one member includes a first end secured to the first collar, an opposite second end pivotably secured to the second collar, and at least two portions of the at least one member between the first and second ends have reduced material that allows a portion of the at least one member between the first and second ends to articulate outwardly in response to the external force applied to the catheter. In some embodiments, the at least one member has a slender elongate configuration with opposite inward and outward surfaces. A first notch is formed within the inward surface adjacent the first end and a second notch is formed within the outward surface at an intermediate location between the first and second ends.

[0024] In some embodiments, the at least one member includes a pair of members in diametrically opposing relationship.

[0025] In some embodiments, one or more portions of an exterior surface of the anchor has a coating of material that inhibits fibroblast cell adhesion thereto.

[0026] It is noted that aspects of the present inventive concepts described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto That is, all embodiments and / or features of any embodiment can be combined in any way and / or combination. Embodiments of the present inventive concepts mayalso be used for “in-device” sample preparation for a subsequent analytical procedure. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and / or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and / or aspects of the present inventive concepts are explained in detail belowBRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which form a part of the specification, illustrate various embodiments of the present inventive concepts. The drawings and description together serve to fully explain embodiments of the present inventive concepts.

[0028] FIG. 1 illustrates using sutures to secure a central venous catheter line on a patient.

[0029] FIGS. 2A-2C illustrate inadequate site-cleaning when sutures are used to secure a central venous catheter line as shown in FIG. 1.

[0030] FIG. 3 illustrates a known primary catheter securement device (adhesive-based).

[0031] FIGS. 4A-4E illustrate current techniques used to temporarily secure a catheter during a dressing change.

[0032] FIG. 5 is a top perspective view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0033] FIG. 6A illustrates the adjustable frame of the secondary catheter securement device of FIG. 5 in a retracted position.

[0034] FIG. 6B illustrates the adjustable frame of the secondary catheter securement device of FIG. 5 in an extended position.

[0035] FIG. 6C is an exploded view of the adjustable frame of the secondary catheter securement device of FIG. 5.

[0036] FIG. 6D is a side view of the adjustable frame of the secondary catheter securement device of FIG. 5.

[0037] FIG. 7 is a side view of the secondary catheter securement device of FIG. 5 in use.

[0038] FIGS. 8A-8D illustrate steps for installing the secondary catheter securement device of FIG. 5 at a catheter insertion site.

[0039] FIG. 9 illustrates the secondary catheter securement device of FIG. 5 during site cleaning.

[0040] FIGS. 10A-10D illustrate steps for removing the secondary catheter securement device of FIG. 5 from a patient.

[0041] FIGS. 11A-1 IB are top perspective views of a secondary catheter securement device, according to some embodiments of the present inventive concepts. In FIG. 11 A, an inflatable sleeve is integrated within a catheter. In FIG. 1 IB, an inflatable sleeve is an add-on device to a catheter.

[0042] FIG. 12 illustrates the inflatable sleeve of the secondary catheter securement device of FIG. 11 A in a contracted configuration (top) and in an expanded configuration (bottom).

[0043] FIG. 13 is a bottom perspective view of the secondary catheter securement device of FIG. 11 A illustrating grooves in the inflatable sleeve that can assist with the egress of exudate from a catheter insertion site.

[0044] FIG. 14 is a cross-sectional view of the inflatable sleeve of the secondary catheter securement device of FIG. 12 in a contracted configuration.

[0045] FIG. 15 is a side view of the inflatable sleeve of the secondary catheter securement device of FIG. 12 in an expanded configuration.

[0046] FIGS. 16A-16D illustrate steps for installing the secondary catheter securement device of FIG. 11 A at a catheter insertion site.

[0047] FIGS. 17A-17B illustrate the secondary catheter securem ent device of FIG. 11A during dressing change.

[0048] FIGS. 18A-18B illustrate steps for removing the secondary catheter securement device of FIG. 11 A from a patient.

[0049] FIG. 19 is top perspective view of a secondary catheter securement device movably secured to a catheter, according to some embodiments of the present inventive concepts.

[0050] FIG. 20 is an enlarged perspective view of the secondary catheter securement device of FIG. 19.

[0051] FIG. 21 illustrates the secondary catheter securement device of FIG. 19 positioned at a catheter insertion site.

[0052] FIG. 22A is a cross-sectional view of the secondary catheter securement device of FIG. 21 taken along line 22A-22A and in a contracted configuration.

[0053] FIG. 22B is a cross-sectional view of the secondary catheter securement device of FIG. 21 taken along line 22A-22A and in an expanded configuration.

[0054] FIG. 22C is a top perspective view of the secondary catheter securement device of FIG. 21 illustrating grooves that can assist with the egress of exudate from the catheter insertion site.

[0055] FIG. 23 is top perspective view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0056] FIG. 24A is top perspective view of the anchoring device of the secondary catheter securement device of FIG. 22.

[0057] FIG. 24B is a side view of the anchoring device of FIG. 24A attached to the skin of a patient.

[0058] FIG. 25A is top perspective view of the catheter retaining hub of the secondary catheter securement device of FIG. 24.

[0059] FIG. 25B illustrates a catheter secured within the catheter retaining hub of FIG. 25A.

[0060] FIG. 26 is top perspective view of the flexible joint of the secondary catheter securement device of FIG. 23 and that movably secures the catheter retaining hub to the anchoring device.

[0061] FIG. 27 illustrates the flexible joint of FIG. 26 attached to the catheter retaining hub and to the anchoring device.

[0062] FIGS. 28A-28C illustrate movement of a catheter and the secondary catheter securement device of FIG. 23 when the catheter is not attached to a primary securement device.

[0063] FIG. 29 is an exploded view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0064] FIG. 30 illustrates the slider device and expandable sleeve of the secondary catheter securement device of FIG. 29, wherein the slider device and expandable sleeve are engaged and the expandable sleeve is in a collapsed configuration.

[0065] FIG. 31 is an enlarged partial perspective view of the slider device and expandable sleeve with the expandable sleeve in a collapsed configuration.

[0066] FIG. 32 is a top perspective view of the secondary catheter securement device of FIG. 29 at a catheter insertion site.

[0067] FIG. 33 is an enlarged bottom perspective view of the expandable inner sleeve inside the skin of a patient and in an expanded configuration.

[0068] FIGS. 34A-34D illustrate steps for installing the secondary catheter securement device of FIG. 29 at a catheter insertion site.

[0069] FIGS. 35A-35C illustrate the secondary catheter securement device of FIG. 29 during dressing change.

[0070] FIGS. 36A-36D illustrate steps for removing the secondary catheter securement device of FIG. 29 from a patient.

[0071] FIG. 37 is a top perspective view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0072] FIG. 38 is a top perspective view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0073] FIG. 39 is a side view of the expandable sleeve of the secondary catheter securement device of FIG. 38.

[0074] FIG. 40 is a top perspective view of a secondary catheter securement device, according to some embodiments of the present inventive concepts.

[0075] FIG. 41 is a side view of the anchor of the secondary catheter securement device of FIG. 40 positioned within a catheter insertion site, and with the catheter and portions of the anchor removed for clarity.

[0076] FIG. 42 is top perspective view of the secondary catheter securement device of FIG. 40 installed at a catheter insertion site.

[0077] FIG. 43 A is a perspective view of the anchor of FIG. 40 in a non-articulated configuration.

[0078] FIG. 43B is a perspective view of the anchor device of FIG. 40 in an articulated configuration.

[0079] FIG. 44A is a side view of the anchor of FIG. 40 in a non-articulated configuration and illustrating notches in the members of the anchor that facilitate articulation thereof.

[0080] FIG. 44B is a side view of the anchor of FIG. 44A in an articulated configuration.

[0081] FIGS. 45A-45F illustrate steps for installing the secondary catheter securement device of FIG. 40 at a catheter insertion site.

[0082] FIG. 46 illustrates the secondary catheter securement device of FIG. 40 during site cleaning.

[0083] FIGS. 47A-47D illustrate steps for removing the secondary catheter securement device of FIG. 40 from a patient.DETAILED DESCRIPTION

[0084] Embodiments of the present inventive concepts are directed to catheter securement solutions that help minimize catheter migration and dislodgement during the dressing change of a catheter, while also not elevating other clinical burden, for example, microbial growth, patient pain, and significant workflow impact. Embodiments of the present inventive concepts provide secondary catheter securement devices that are configured to hold a catheter or catheter hub near the insertion site of the catheter in a patient’s skin. The secondary catheter securement devices allow for 360° site cleaning without increasing the risk of catheter movement during dressing change of the catheter, such as long-dwelling IV catheters, for example, a peripherally inserted central catheter (PICC) line and a central venous catheter (CVC) line. Embodiments of the present inventive concepts will now be described in further detail below with reference to the drawings.

[0085] Referring to FIGS. 5, 6A-6D and 7, a secondary catheter securement device 100 according to some embodiments of the present inventive concepts is illustrated. The secondary catheter securement device 100 includes an adjustable length frame 110 with a skin engagement member 120 that is configured to be secured to the skin of a patient at a catheter insertion site IS and a clip 130 for snugly receiving a catheter hub 14 therein. The skin engagement member 120 is secured to a first end portion 110a of the frame 110 and the clip 130 is secured adjacent an opposite second end portion 110b of the frame 110. The first end portion 110a includes a skin engagement member 120 that is configured to be secured to the skin of a patient at a catheter insertion site IS and that allows the frame 110 to be moved or pivoted at the catheter insertion site IS. The second end portion 110b of the frame 110 includes a clip 130 that is configured to grasp and hold a catheter hub 14 and prevent inadvertent movement of the catheter 12 at the catheter insertion site IS.

[0086] FIG. 5 illustrates the secondary catheter securement device 100 in an installed configuration with the skin engagement member 120 secured to the skin of a patient at a catheter insertion site IS and a portion of a catheter hub 14 received within the clip 130, thereby securing the catheter hub 14 and catheter 12 snugly to the frame 110. FIG. 7 is a side view of the secondary catheter securement device 100 in an installed configuration and illustrates the skin engagement member 120 secured to the skin S of a patient at a catheter insertion site IS. The catheter hub 14 is configured to be secured to a primary catheter securement device, such as the STATLOCK™ securement device (FIG. 3) and the frame 110 is positioned close to the skin S of the patient. When the catheter hub 14 is detached from the primary catheter securement device, for example during dressing change and cleaning of the area around the catheter insertion site IS, the frame 110 and the catheter 12 attached thereto can be pivoted away from the patient to allow access to the area around the catheter insertion site IS, as will be described below.

[0087] The adjustable length frame 110 has a generally slender configuration and the first end portion 110a has an arcuate or rounded shape, as illustrated. The rounded shape of the first end portion 110a allows the frame 110 to be pivoted relative to the skin of a patient during catheter site cleaning without interference, as will be described below.

[0088] The illustrated frame 110 includes a first section 112 slidably coupled to a second section 114 such that the frame has a telescopically adjustable length. In the illustrated embodiment, the second section 114 is inserted within the first section 112. However, in other embodiments, this may be reversed and the first section 112 may be inserted within the second section 114. In the illustrated embodiment, the first section 112 has a generally slender, rectangular configuration with a rounded first end portion 116a and an opposite second end portion 116b. The rounded first end portion 116a is also the rounded first end portion 110a of the frame 110. The second section 114 has a generally slender, rectangular configuration with opposite first and second end portions 118a, 118b. The first section 112 includes a top wall 112a, opposite side walls 112b, 112c extending downward from the top wall 112a, and an arcuate or rounded front wall 112d. In the illustrated embodiment, the first end portion 116a includes multiple surfaces 117a, 117b, 117c that are angled relative to each other to form the arcuate or rounded first end portion. However, embodiments of the present inventive concepts are not limited to three surfaces angled relative to each other. In other embodiments, more than three surfaces that are angled relative to each other and event two surfaces that are angledrelative to each other may be utilized. In addition, the first end portion 116a may be a continuous smooth surface in some embodiments.

[0089] The illustrated frame first section 112 also includes inward extending lower walls 112e, 112f that form a channel 113 for slidably receiving the frame second section 114 therein. The frame second section 114 includes a top wall 114a, opposite side walls 114b, 114c extending downward from the top wall 114a, and inward extending lower walls 114d, 114e. The first and second sections 112, 114 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof. The skin engagement member 120 may be formed from various types of plastic and elastomeric materials.

[0090] FIG. 6A illustrates the frame 110 with the first and second sections 112, 114 in a retracted configuration and FIG. 6B illustrates the frame with the first and second sections 112, 114 in an extended configuration. A locking mechanism 140 is operably associated with the first and second sections 112, 114 and is configured to restrain movement of the first and second sections 112, 114 relative to each other when the frame 110 is at a selected length. The illustrated locking mechanism 140 includes two buttons 142a, 142b that can be squeezed together by a user to release a mechanism (not shown) that restrains movement of the first and second sections 112, 114 relative to each other.

[0091] In some embodiments, the first and second sections 112, 114 of the frame 110 may be moved relative to each other so that the frame has various, user-selected lengths. In other embodiments, the frame may be configured such that the first and second sections 112, 114 of the frame 110 may be moved to only certain pre-selected lengths.

[0092] The skin engagement member 120 is attached to the first end portion 116a of the first section 112 of the frame 110 and includes a pair of adjacent spaced apart prongs 122a, 122b that are configured to hook the skin of the patient at the catheter insertion site IS. The skin engagement member 120 is also configured as a living hinge so that the frame 110 can be pivoted relative to the skin S of the patient without disengaging the prongs 122a, 122b from the skin S of the patient.

[0093] The clip 130 is attached to the second section top wall 114a adjacent the end portion 118b of the second section 114 and is configured to snugly receive the catheter hub 14 therein and prevent forward and backward movement (i .e., pistoning) of the catheter 12 relativeto the clip 130. In other embodiments, the clip 130 may be configured to receive the catheter 12 therein.

[0094] One or more portions of the exterior surface of the prongs 122a, 122b may have a coating of material that inhibits fibroblast cell adhesion thereto. Similarly, one or more portions of the exterior surface of the various walls 112a-l 14f of the first section 112, and one or more portions of the exterior surface of the various walls 114a-l 14e of the second section 114 may have a coating of material that inhibits fibroblast cell adhesion thereto.

[0095] FIGS. 8A-8D illustrate steps for installing the secondary catheter securement device 100 of FIGS. 5, 6A-6D and 7 at a catheter insertion site IS. In FIG. 8A, the frame 110 is held generally perpendicular to the skin S of a patient at a catheter insertion site IS, and the prongs 122a, 122b of the skin engagement member 120 are pushed into the skin S at the catheter insertion site IS. In FIG. 8B, a hemostatic bandage 25a is placed at the catheter insertion site IS. The frame 110 is then tilted downward toward the skin S of the patient (FIG. 8C) and the catheter hub 14 is attached to the clip 130 with a snap fit. Once the frame 110 is placed horizontally, the living hinge configuration of the skin engagement member 120 allows the skin engagement member 120 to bend and lock under the surface of the skin S of the patient (FIGS. 7 and 8D). A transparent dressing may be applied over the catheter insertion site IS, the secondary catheter securement device 100, and the catheter hub 14.

[0096] FIG. 9 illustrates the secondary catheter securement device 100 of FIGS. 5, 6A- 6D and 7 during dressing change. The hemostatic bandage 25a, and any other dressing, is removed, the catheter hub 14 is released from a primary catheter securement device (not shown), the primary catheter securement device is removed from the patient, and then the frame 110 with the catheter hub 14 and catheter 12 secured thereto is pivoted upwardly to provide access to the area around the catheter insertion site IS and where the primary catheter securement device had previously been located. These areas can be cleaned, for example, with an antiseptic cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension lines 12e can be cleaned at this time, as well.

[0097] FIGS. 10A-10D illustrate steps for removing the secondary catheter securement device 100 of FIGS. 5, 6A-6D and 7 from a patient. A transparent dressing (not shown) surrounding the catheter insertion site IS is removed from the patient, the catheter hub 14 is released from a primary catheter securement device (not shown), and the catheter hub 14 is released from the clip 130 of the secondary catheter securement device 100. The hemostaticbandage 25a is removed (FIG. IOC), and the frame 110 is tilted upwardly to a generally vertical orientation and is moved outward from the skin S of the patient. The living hinge configuration of the skin engagement member 120 allows the prongs 122a, 122b to be dislodged and removed from the skin S.

[0098] Referring to FIGS. 11A-1 IB and 12, a secondary catheter securement device 200, according to some embodiments of the present inventive concepts, is illustrated. The catheter securement device 200 includes an inflatable sleeve 210 that surrounds a portion of a catheter 12 at a catheter insertion site IS, and a channel or tube 220 in fluid communication with the inflatable sleeve 210 that is configured to supply a fluid or gas to the inflatable sleeve 210. The channel or tube 220 is a separate channel, independent from the catheter lumen. The inflatable sleeve 210 may be a separate device that surrounds a catheter 12, as illustrated in FIG. 11 A, or may be integrated within a catheter 12, as illustrated in FIG. 1 IB. The inflatable sleeve 210 may be formed from various elastomeric materials, such as rubber, etc.

[0099] The inflatable sleeve 210 is configured to expand like a balloon in response to receiving a fluid or gas (e.g., saline or air, etc.) from the tube 220 and create an interference fit at the catheter insertion site IS that is sufficient to prevent inadvertent movement of the catheter 12 at the catheter insertion site IS. The tube 220 is also configured to remove the fluid or gas from the inflatable sleeve 210 in an expanded configuration to allow the inflatable sleeve 210 to contract such that the catheter 12 can be removed from the patient.

[0100] The inflatable sleeve 210 may have more than one portion that is configurated to expand and subsequently contract at a catheter insertion site IS. Embodiments of the present inventive concepts are not limited to a sleeve that has only a single portion that expands and contracts. For example, and as illustrated in FIGS. 12, 14 and 15, an inflatable sleeve 210, according to embodiments of the present inventive concepts, may include two inflatable portions 212a, 212b in spaced apart, adjacent relationship. The configuration of the inflatable sleeve 200 of FIGS. 12, 14 and 15 allows for the skin S of a patient at a catheter insertion site IS to be “sandwiched” between the two inflatable portions 212a, 212b, thereby providing additional resistance to inadvertent movement of a catheter 12.

[0101] In the illustrated embodiment of FIG. 11 A, the tube 220 includes an inflatable portion 224 that is configured to provide an indication when the inflatable sleeve 210 is sufficiently expanded to form an interference fit at the catheter insertion site IS and to reduce the risk of over-inflation of the sleeve 210. In addition, the port 222 of the tube 220 and / or the tube220 may be provided with visual indicia 225 (e.g., color-coding, etc.) to distinguish it from ports associated with the catheter 12 in order to avoid any port-identification errors. When not in use, the port 222 of the tube 220 can be closed by a cap 226.

[0102] In some embodiments, as illustrated in FIG. 13, an outer surface 210a of the sleeve 210 may include one or more grooves 228 (e.g., micro-channels) extending in an axial direction of the sleeve 210 and catheter 12 that are configured to allow exudate EX to flow from the catheter insertion site IS and be absorbed by a hemostatic bandage or other dressing at the catheter insertion site IS. The grooves 228 act as capillaries to assist in exudate EX egress and to prevent blockage of exudate EX at the catheter insertion site IS. In addition, one or more portions of the outer surface 210a of the inflatable sleeve 210 may have a coating of material that inhibits fibroblast cell adhesion thereto.

[0103] FIGS. 16A-16D illustrate steps for installing the secondary catheter securement device 200 of FIG. 11 A at a catheter insertion site IS. In FIG. 16A, the catheter 12 and inflatable sleeve 210 are inserted into the patient at a catheter insertion site IS according to health facility guidelines. In FIG. 16B, a syringe SY containing a fluid or gas F / G is attached to the port 222 of the tube 220 and then the inflatable sleeve 210 is inflated with the fluid or gas F / G from the syringe SY to create an interference fit at the catheter insertion site IS that is sufficient to prevent inadvertent movement of the catheter 12 at the catheter insertion site IS (FIG. 16C). A hemostatic bandage 25a is then provided at the catheter insertion site IS and a transparent dressing 25b is applied over the catheter insertion site IS and the catheter hub 14 (FIG. 16D). Also, as illustrated in FIG. 16D, the inflatable portion 224 of the tube provides an indication that the inflatable sleeve 210 is sufficiently expanded to form an interference fit at the catheter insertion site IS.

[0104] FIGS. 17A-17B illustrate the secondary catheter securement device 200 of FIG. 11 A during dressing change. The transparent dressing 25b (FIG. 16D) and the hemostatic bandage 25a (FIG. 16D) are removed, the catheter hub 14 is released from a primary catheter securement device, such as the STATLOCK™ securement device (FIG. 3), the primary catheter securement device is removed, and the catheter 12 and hub 14 are lifted away from the skin S of the patient (FIG. 17A) to provide access to the area around the catheter insertion site IS and where the primary catheter securement device had previously been located. These areas can be cleaned, for example, with an antiseptic cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension lines 12e can be cleaned at this time, as well. The inflated sleeve 210retains the catheter 12 in place at the catheter insertion site IS during cleaning. A fresh primary catheter securement device, such as the STATLOCK™ securement device (FIG. 3), is attached to the patient, the catheter hub 14 is attached to the primary catheter securement device, a fresh hemostatic bandage 25a is provided at the catheter insertion site IS, and a fresh transparent bandage 25b is applied to the patient to cover the catheter insertion site IS, the secondary securement device 200, and the primary securement device (FIG. 17B).

[0105] FIGS. 18A-18B illustrate steps for removing the secondary catheter securement device 200 of FIG. 11 A from a patient. The transparent dressing 25b (FIG. 17B) and the hemostatic bandage 25a (FIG. 17B) at the catheter insertion site IS are removed. A syringe SY is attached to the port 222 of the tube 220, and the fluid or gas F / G is drawn out from the expanded sleeve 210 by the syringe SY, thereby deflating the sleeve 210 at the catheter insertion site IS (FIG. 18A). The catheter 12 along with the inflatable sleeve 210 can then be removed from the patient (FIG. 18B).

[0106] Referring to FIGS. 19-21 and 22A-22C, a secondary catheter securement device 300, according to some embodiments of the present inventive concepts, is illustrated. The secondary catheter securement device 300 is an inflatable sleeve 310 that is movable along an exterior surface of a catheter 12 and is configured to be positioned at a catheter insertion site IS. The inflatable sleeve 310 is configured to expand and create an interference fit at the catheter insertion site IS that is sufficient to prevent inadvertent forward and backward movement (i.e., pi stoning) of the catheter 12 at the catheter insertion site IS. The inflatable sleeve 310 has an annular body 312 (FIG. 20) defining a passageway 313 through which a catheter 12 is inserted. The illustrated annular body 312 also includes a first portion 314 configured to be positioned within the catheter insertion site IS and a second portion 316 with a diameter larger than the first portion 314 such that the second portion can abut an area circumferentially adjacent to the catheter insertion site IS. The annular body 312 includes a port 318 through which a fluid or gas can be supplied, for example via a tube (e.g., tube 220, FIG. 11A), to the inflatable sleeve 310 to cause the inflatable sleeve 310 to expand. Similarly, the fluid or gas can be removed from the inflatable sleeve 310 via the port 318 to cause the inflatable sleeve 310 to contract so that the sleeve 310 and catheter 12 can be removed from a catheter insertion site IS.

[0107] FIG. 22A is a cross-sectional view of the secondary catheter securement device 300 of FIG. 21 taken along line 22A-22A showing the inflatable sleeve 310 in an unexpanded (i.e., contracted) configuration and positioned within the skin S of a patient at a catheter insertionsite IS. When a fluid or gas is supplied to the annular body 312 via the port 318, the annular body 312 expands, as indicated by arrows A3. FIG. 22B illustrates the inflatable sleeve 310 of FIG. 22A in an expanded configuration and creating an interference fit at the catheter insertion site IS that is sufficient to prevent inadvertent movement of the catheter 12 at the catheter insertion site IS.

[0108] In some embodiments, as illustrated in FIG. 22C, an outer surface 310a of the sleeve 310 may include one or more grooves 328 (e.g., micro-channels) extending in an axial direction of the sleeve 310 that are configured to allow exudate EX to flow from the catheter insertion site IS and be absorbed by a hemostatic bandage or other dressing at the catheter insertion site IS. The grooves 328 act as capillaries to assist in exudate EX egress and to prevent blockage of exudate EX at the catheter insertion site IS. In addition, one or more portions of the outer surface 310a of the inflatable sleeve 310 may have a coating of material that inhibits fibroblast cell adhesion thereto.

[0109] Referring to FIG. 23, a secondary catheter securement device 400 according to some embodiments of the present inventive concepts is illustrated. The catheter securement device 400 includes an anchor 410 configured to be secured to the skin of a patient adjacent a catheter insertion site IS, and a catheter retaining hub 420 movably secured to the anchor 410, for example, by a connecting member 430. As will be described below, the anchor 410 includes a plurality of microneedles 416 configured to be inserted into the skin S of a patient adjacent to a catheter insertion site IS and that are configured to resist movement of the anchor 410 in X, Y and Z directions.

[0110] The illustrated catheter retaining hub 420 is a semi-elastic component having a catheter receiving groove or channel 422 formed therein that is configured to snugly hold a portion of a catheter 12 therein. The catheter retaining hub 420 essentially holds the catheter 12 in place by forming a friction joint with the catheter 12. In the illustrated embodiment, opposite edge portions 422a, 422b of the catheter receiving channel 422 extend toward each other and, thus, overhang or extend over the catheter receiving channel 422. However, the embodiments of the opposite edge portions 422a, 422b are not limited thereto. For example, only the first opposite edge portion 422a may extend toward the second opposite edge portion 422b; or only the second opposite edge portion 422b may extend toward the first opposite edge portion 422a. This protruding configuration of one or both of the opposite edge portions 422a, 422b of the catheter receiving channel 422 retains the catheter 12 within the catheter receiving channel 422and helps prevent the catheter 12 from becoming unintentionally disengaged from the hub 420. In addition, the snug fit of the catheter 12 within the catheter receiving channel 422 prevents pistoning of the catheter at the catheter insertion site IS. The catheter retaining hub 420 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.

[0111] The illustrated anchor 410 includes an elongate first member 412 and an elongate second member 414 in adjacent, spaced-apart relationship. The first member 412 includes a plurality of microneedles 416 extending downward from a lower surface 412a thereof, and the second member 414 includes a plurality of microneedles 416 extending downward from a lower surface 414a thereof, as illustrated. The anchor 410 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, or combinations thereof.

[0112] In the illustrated embodiment, the plurality of microneedles 416 are angled relative to the lower surfaces 412a, 414a of the first and second members 412, 414. A third member 418 is positioned between and is connected to the first and second members 412, 414 such that the anchor 410 has a U-shape. The U-shape of the anchor 410 allows the anchor to be secured to the skin S of a patient such that the catheter insertion site IS is between the first and second members 412, 414, as illustrated. Embodiments of the present inventive concepts are not limited to the illustrated configuration of the anchor 410. The first and second members 412, 414 may have various shapes and configurations.

[0113] The catheter retaining hub 420 is movably secured to the third member 418 of the anchor 410 via the connecting member 430. The connecting member 430 includes a first end portion 432 that is configured to be attached to the catheter retaining hub 420, and an opposite second end portion 434 that includes a hook portion 436 that is configured to receive the third member 418 of the anchor 410 therein and allow for pivotal movement of the connecting member 430.

[0114] FIGS. 28A-28C illustrate movement of the secondary catheter securement device 400 of FIG. 23. In FIG. 28A, the anchor 410 of the secondary catheter securement device 400 is attached to the skin S of a patient and a catheter 12 is secured within the catheter receiving channel 422 of the catheter retaining hub 420 and the catheter retaining hub 420 is positioned such that the catheter hub 14 can be secured to a primary catheter securement device, such as the STATLOCK™ securement device (FIG. 3). FIGS. 28B-28C illustrate the catheter hub 14 freefrom a primary catheter securement device and the catheter retaining hub 420 and catheter 12 pivoted upwardly away from the skin S of a patient to provide access to the area around the catheter insertion site IS so that the area can be cleaned, for example, with an antiseptic cleaning applicator.

[0115] Referring to FIG. 29, a secondary catheter securement device 500 according to some embodiments of the present inventive concepts is illustrated. The catheter securement device 500 includes a sleeve 510 configured to surround a portion of a catheter 12 and a slider device 520. The sleeve 510 is formed from flexible material and includes a lumen 511 configured to receive a catheter 12 therethrough and allow the sleeve 510 to be moved along an exterior surface of the catheter 12. The sleeve 510 includes a distal end portion 512 that is expandable and contractable. In the illustrated example, the end portion 512 of the sleeve 510 includes multiple expandable wings or flaps 514. The flaps 514 collapse when the slider device 520 is pushed over them and the flaps 514 expand once the slider device 520 is pulled back away from them. When the end portion 512 of the sleeve 510 is positioned at a catheter insertion site IS and the slider device 520 is pulled back, the flaps 514 are configured to expand and grip the skin S of a patient, as illustrated in FIG. 33, and thereby anchor the sleeve 510 at the catheter insertion site IS.

[0116] The sleeve 510 can be formed from various elastomeric materials. In addition, the sleeve 510 can be reinforced with stiffer material at selected locations to provide selected stiffness to the sleeve 510 so as to ensure that the sleeve 510 remains inside the skin S at a catheter insertion site IS.

[0117] The slider device 520 includes a tube 522 that is configured to surround the sleeve 510 and maintain the flaps 514 at the sleeve end portion 512 in a contracted state, as illustrated in FIG. 31. The slider device 520 is configured to move the sleeve 510 along the catheter and insert the end portion 512 of the sleeve 510 in the contracted state into the catheter insertion site IS. When the slider device 520 is retracted from the catheter insertion site IS along the catheter 12, the sleeve end portion 512 expands and engages skin S of the patient at the catheter insertion site IS. The tube 522 of the slider device 520 is configured to flex so it can be inserted into the skin S of a patient at a catheter insertion site IS, but then return to its original, unflexed shape once retracted. For example, FIGS. 29, 31, 32 and 34B illustrate the tube 522 in its normal unflexed shape. FIGS. 30 and 34C illustrate the tube 522 of the slider device 520 in aflexed or curved shape during insertion (with the sleeve 410) into the skin S of a patient at a catheter insertion site IS.

[0118] The slider device 520 can be an integral part of a catheter system during insertion of a catheter 12 into a catheter insertion site IS or the slider device 520 can be configured to be attached to a catheter 12, as illustrated in FIG. 34B. For example, the slider device tube 522 may include a longitudinally extending slot 523 that allows the slider device 520 to be installed around the catheter 12.

[0119] The slider device 520 includes a fitting 526 that is configured to be secured to a primary catheter securement device 20. For example, in some embodiments, the fitting 526 of the slider device 520 includes a pair of opposing wings 528a, 528b, and each wing 528a, 528b is configured to engage with and be secured to the primary catheter securement device 20. The slider device 520 is configured to overlie the catheter hub 14 such that the fitting wings 528a, 528b overlie the respective wings 14a,, 14b of the catheter hub 14. Each fitting wing 528a, 528b includes a respective opening 529 that is configured to align with a respective opening 19 of a respective catheter hub wing 14a, 14b and engage with a respective post P associated with the primary catheter securement device 20, as illustrated in FIG. 32.

[0120] In some embodiments, one or more portions of an outer surface of the sleeve 510 and / or an outer surface of the slider device 520 has a coating of material that inhibits fibroblast cell adhesion thereto. In some embodiments, the outer surface of the sleeve may include one or more grooves configured to allow exudate EX to flow from the catheter insertion site IS.

[0121] FIGS. 34A-34D illustrate steps for installing the secondary catheter securement device 500 of FIG. 29 at a catheter insertion site IS. The sleeve 510 and slider device 520 are placed on a catheter 12 during or after insertion of the catheter 12 into a patient (FIG. 34A). As described above, the slider device 520 may be configured to be pushed onto the catheter 12 (FIG. 34B), or the slider device 520 may be a part of the catheter assembly. The slider device 520 is then used to push the sleeve 510 with the end portion 512 contracted into the insertion site IS like a dilator, and then the slider device 520 is pulled back to allow the end portion 512 of the sleeve 510 to expand inside the skin S (FIG. 34C). The fitting 526 of the slider device 520 is then secured to the primary catheter securement device 20, a hemostatic bandage 25a is placed at the catheter insertion site IS, and a transparent adhesive bandage 25b is applied over the catheter insertion site IS, the secondary catheter securement device 500 and the primary catheter securement device 20 (FIG. 34D).

[0122] FIGS. 35A-35C illustrate the secondary catheter securement device 500 of FIG.29 during dressing change. During dressing change, the transparent dressing 25b (FIG. 34D) and and the hemostatic bandage 25a are removed (FIG. 35 A), and then the primary catheter securement device 20 is removed leaving the secondary catheter securement device 500 securing the catheter 12 to the patient (FIG. 35B). As illustrated in FIG. 35B, the catheter 12 can be lifted relative to the patient and the area around the catheter insertion site IS and where the primary catheter securement device 20 had previously been located can be cleaned, for example, with an antiseptic cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension lines 12e can be cleaned at this time, as well.

[0123] A new primary catheter securement device 20 can be secured to the skin S of the patient, the hub 14 and the fitting 526 can be secured within the new primary catheter securement device 20, a new hemostatic bandage 25a can be applied to the insertion site IS, and a new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, the secondary catheter securement device 500, and the primary catheter securement device 20 (FIG. 35C).

[0124] FIGS. 36A-36D illustrate steps for removing the secondary catheter securement device 500 of FIG. 29 from a patient. The transparent dressing 25b (FIG. 35C) and the hemostatic bandage 25a (FIG. 35C) at the catheter insertion site IS are removed (FIG. 36A). The slider device 520 is disengaged from the primary catheter securement device 20 and moved toward the catheter insertion site IS to collapse the distal end portion 512 of the sleeve 510 at the insertion site IS (FIGS. 36B, 36C). The catheter 12, sleeve 510 and slider device 520 can then be removed from the patient (FIG. 36D).

[0125] Referring to FIG. 37, the sleeve 510 may be integrated into a catheter assembly. Once inserted into the insertion site, the expandable sleeve 510 is configured to stay in place (due to a locking feature or being integrated into the catheter assembly). Thus, there will not be any retraction of the sleeve 510 along with the slider device 520 and the end portion 512 of the sleeve 510’ will expand once the slider device 520 is pulled out.

[0126] Referring to FIGS. 38 and 39, in some embodiments, the sleeve 510 may include a second portion 516 that is expandable and contractable and that is in adjacent spaced apart relationship with the expandable / contractable end portion 512. The second portion 516 may include a plurality of expandable flaps 514’ similar to the flaps 514 at the end portion 512. The flexible tube 522 of the slider device 520 is configured to surround the sleeve 510 and maintainthe end portion 512 and the second portion 516 of the sleeve in a contracted state. The slider device 520 is configured to move the sleeve 510 along the catheter 12 and insert the end portion 512 in the contracted state into the catheter insertion site IS. When the slider device 520 is retracted from the catheter insertion site IS along the catheter 12, the sleeve end portion 512 expands and engages the skin of the patient at the catheter insertion site IS and the flexible sleeve second portion 516 expands and contacts an external portion of the skin S of the patient.

[0127] In each of the embodiments of described above, the slider device 520 can be disposed of after catheter securement at the insertion site is completed with the expandable sleeve 510. A fresh slider device 520 can be used during removal of the catheter 12 to maintain sterility, thus reducing risk of infection.

[0128] Referring to FIG. 40, a secondary catheter securement device 600 according to some embodiments of the present inventive concepts is illustrated. The catheter securement device 600 includes an anchor 610 that is configured to surround a portion of a catheter 12 at a catheter insertion site IS. The anchor 610 is configured to change shape in response to an external force applied to the catheter 12 and prevent inadvertent movement (e.g., pistoning) of the catheter 12 at the catheter insertion site IS. For example, the anchor 610 is collapsible horizontally relative to the catheter insertion site IS in response to an external force. The anchor 610 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.

[0129] In some embodiments, one or more portions of an outer surface of the anchor 610 has a coating of material that inhibits fibroblast cell adhesion thereto. In some embodiments, the outer surface of the anchor 610 may include one or more grooves configured to allow exudate EX to flow from the catheter insertion site IS.

[0130] In the illustrated embodiment, the anchor 610 includes opposing first and second collars 620, 630 (FIGS. 43A-43B) that are in axial alignment and that are supported in spaced apart relationship by a pair of pins or members 640, 642. A locking strap 650 (FIG. 42) is associated with the first collar 620 and is configured to snugly secure the first collar 620 to the catheter 12. Thus, once the catheter 12 is secured within the anchor 610, the locking strap 650 is tightened to hold the catheter 12 in place during the course of catheter dwelling.

[0131] Each of the members 640, 642 of the anchor 610 are configured to move from an elongated configuration to an outwardly extending articulated configuration in response to an external force (e.g., a horizontal force) applied to the catheter 12 and to the first collar 620. Thisoutwardly extended articulated configuration of the first and second members 640, 642 applies pressure to the skin at the catheter insertion site IS and creates a hooking action. Although a pair of members 640, 642 are illustrated, in some embodiments, more than two members may be utilized, and even a single member may be utilized.

[0132] In the illustrated embodiment, the first collar 620 includes a slot 622 configured to allow the catheter 12 to be received within the first collar 620, and the second collar 630 includes a slot 632 configured to allow the catheter 12 to be received within the second collar 630. As such, the anchor 610 can be attached to a catheter 12 by pressing each collar 620, 630 onto the catheter 12 so that the catheter passes through each respective slot and into each collar 620, 630, as illustrated in FIGS. 45B and 45C. Each collar 620, 630 is configured to extend around and snugly grip the catheter 12 therein.

[0133] In the illustrated embodiment, each member 640, 642 has a slender, elongate configuration. The first member 640 includes opposite first and second end portions 640a, 640b and opposing inward and outward surfaces 640c, 640d. Similarly, the second member 642 includes opposite first and second end portions 642a, 642b and opposing inward and outward surfaces 642c, 642d. The first end portions 640a, 642a of the first and second members 640, 642 are secured to the first collar 620. The second end portions 640b, 642b of the first and second members 640, 642 are movably secured to the second collar 630 so that the first and second members 640, 642 can pivot at the respective second ends 640b, 642b relative to the second collar 630, as illustrated in FIGS. 41, 42, 43B and 44B.

[0134] In the illustrated embodiment, the first member 640 has two portions 643a, 643b with reduced material that allows a portion of the first member 640 to articulate outwardly (arrow A4, FIG. 44B) in response to an external force applied to the first collar 620. The portion 643 a is a notch formed in the outward surface 640d of the first member 640, and the portion 643b is a notch formed in the inward surface 640c of the first member 640. Similarly, the second member 642 has two portions 645a, 645b with reduced material that allows a portion of the second member 642 to articulate outwardly (arrow A5, FIG. 44B) in response to an external force applied to the first collar 620. The portion 645a is a notch formed in the outward surface 642d of the second member 642, and the portion 645b is a notch formed in the inward surface 642c of the second member 640. FIG. 41 illustrates the anchor 610 positioned within a catheter insertion site IS and with the catheter not shown for clarity. The first and second members 640, 642 each have a portion that is articulating outwardly as a result of a force applied to the anchor 610. Eachoutward articulating portion extends into the skin S of a patient at the catheter insertion site IS and restrains movement of the anchor 610 at the insertion site IS. Therefore, a catheter 12 snugly received within the anchor 610 is restrained from movement.

[0135] FIGS. 45A-45F illustrate steps for installing the anchor 610 of the secondary catheter securement device 600 of FIG. 40 onto a catheter at a catheter insertion site IS. Once the catheter 12 is inserted into a patient, the second collar 630 of the anchor 610 is attached to the catheter 12, as illustrated in FIGS. 45A-45B. A hemostatic bandage 25a (not shown) is then applied to the insertion site IS and the anchor 610 is pushed down along the catheter 12 such that the first collar 620 then engages and receives the catheter 12 therewithin (FIG. 45C). A force applied to the catheter 12 and, thus, to the first collar 620, causes the members 640, 642 to collapse to an articulated configuration to engage the skin S at the catheter insertion site IS (FIG. 45D). The locking strap 650 is then tightened around the catheter 12 to secure the anchor 610 and catheter 12 at the catheter insertion site IS (FIG. 45E). The catheter hub 14 is then secured to the primary securement device 20 and a transparent adhesive bandage may be applied to cover the catheter insertion site IS, the hemostatic bandage 25a, the secondary catheter securement device 600 and catheter 12, and the primary catheter securement device 20.

[0136] FIG. 46 illustrates the secondary catheter securement device 600 of FIG. 40 during dressing change. During dressing change, a transparent dressing 25b and the hemostatic bandage 25a are removed, and then the primary catheter securement device 20 is removed leaving the secondary catheter securement device 600 securing the catheter 12 to the patient. The catheter 12 can be lifted relative to the patient and the area around the catheter insertion site IS and where the primary catheter securement device 20 had previously been located can be cleaned, for example with an antiseptic cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension lines 12e can be cleaned at this time, as well. A new primary catheter securement device 20 can be secured to the skin S of the patient, the catheter hub 14 can be secured within the new primary catheter securement device 20, a new hemostatic bandage 25a can be applied to the insertion site IS, and a new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, the secondary catheter securement device 600, and the primary catheter securement device 20.

[0137] FIGS. 47A-47D illustrate steps for removing the secondary catheter securement device 600 of FIG. 40 from a patient. A transparent dressing and hemostatic bandage at the catheter insertion site IS (not shown) are removed, and the catheter hub 14 is removed from theprimary securement device 20. The locking strap 650 is unlocked and removed (FIG. 47B), and a force (e.g., a horizontal force) is applied to the first collar 620 to cause the members 640, 642 to move from an articulated position to an unarticulated position (FIG. 47C). The anchor 610 is then moved upwardly out of the insertion site IS so that the first collar 620 disengages from the catheter 12 (FIG. 47D). The second collar 630 is then disengaged from the catheter 12 and the catheter 12 is removed from the insertion site IS.

[0138] It will be understood that, although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present invention. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0139] It will be understood that when an element is referred to as being “on” another element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly on” another element, there are no intervening elements present. It will also be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (i.e., “between” versus “directly between”, “adjacent” versus “directly adjacent”, etc.).

[0140] Relative terms such as “below” or “above” or “upper” or “lower” or “horizontal” or “vertical” may be used herein to describe a relationship of one element, layer or region to another element, layer or region as illustrated in the figures. It will be understood that these terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures.

[0141] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises”, “comprising,” “includes” and / or “including” when used herein, specify the presence of statedfeatures, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, operations, elements, components, and / or groups thereof.

[0142] The term “about,” as used herein when referring to a measurable value such as an amount or concentration and the like, is meant to encompass variations of ± 10%, ± 5%, ± 1%, ± 0.5%, or even ± 0.1% of the specified value as well as the specified value. For example, “about X” where X is the measurable value, is meant to include X as well as variations of ± 10%, ± 5%, ± 1%, ± 0.5%, or even ± 0.1% of X. A range provided herein for a measurable value may include any other range and / or individual value therein.

[0143] Aspects and elements of all of the embodiments disclosed above can be combined in any way and / or combination with aspects or elements of other embodiments to provide a plurality of additional embodiments.

Claims

What is claimed is:

1. A catheter securement device, comprising: an adjustable length frame having opposite first and second end portions, wherein the first end portion is configured to be movably secured to skin of a patient at a catheter insertion site, and wherein the second end portion is configured to grasp and hold a catheter inserted into the patient at the catheter insertion site and prevent inadvertent movement of the catheter at the catheter insertion site.

2. The device of Claim 1, further comprising a skin engagement member attached to the first end portion of the frame, wherein the skin engagement member comprises at least one prong that is configured to hook the skin of the patient at the catheter insertion site, and wherein the skin engagement member has a living hinge configuration that allows the frame to be pivoted relative to the skin of the patient without disengaging the at least one prong from the skin of the patient.

3. The device of Claim 2, wherein the at least one prong comprises a pair of adjacent spaced apart prongs.

4. The device of Claim 2, further comprising a clip attached to the second end portion, wherein the clip is configured to snugly receive the catheter or catheter hub therein and prevent forward and backward movement of the catheter relative to the clip.

5. The device of Claim 1, wherein the frame comprises a first section slidably coupled to a second section such that the frame has a telescopically adjustable length.

6. The device of Claim 5, further comprising a locking mechanism operably associated with the first and second sections, wherein the locking mechanism is configured to restrain movement of the first and second sections relative to each other when the frame is at a selected length.

7. The device of Claim 5, further comprising:a skin engagement member attached to the first section, wherein the skin engagement member comprises at least one prong that is configured to hook the skin of the patient at the catheter insertion site, and wherein the skin engagement member has a living hinge configuration that allows the frame to be pivoted relative to the skin of the patient without disengaging the at least one prong from the skin of the patient; and a clip attached to the second section, wherein the clip is configured to snugly receive the catheter or catheter hub therein and prevent forward and backward movement of the catheter relative to the clip.

8. The device of Claim 7, wherein one or more portions of an exterior surface of the frame comprise a coating of material that inhibits fibroblast cell adhesion thereto, and wherein one or more portions of an exterior surface of the skin engagement member comprise a coating of material that inhibits fibroblast cell adhesion thereto.

9. A catheter securement device, comprising: a frame comprising a first section slidably coupled to a second section such that the frame has a telescopically adjustable length; a locking mechanism operably associated with the first and second sections, wherein the locking mechanism is configured to restrain movement of the first and second sections relative to each other when the frame is at a selected length; a skin engagement member attached to the first section, wherein the skin engagement member comprises at least one prong that is configured to hook skin of a patient at a catheter insertion site, and wherein the skin engagement member has a living hinge configuration that allows the frame to be pivoted relative to the skin of the patient without disengaging the at least one prong from the skin of the patient; and a clip attached to the second section, wherein the clip is configured to snugly receive the catheter therein and prevent inadvertent movement of the catheter at the catheter insertion site.

10. The device of Claim 9, wherein the at least one prong comprises a pair of adjacent spaced apart prongs.11 . The device of Claim 9, wherein one or more portions of an exterior surface of the frame comprise a coating of material that inhibits fibroblast cell adhesion thereto, and wherein one or more portions of an exterior surface of the skin engagement member comprise a coating of material that inhibits fibroblast cell adhesion thereto.

12. A catheter securement device, comprising: an inflatable sleeve surrounding a portion of a catheter, wherein the inflatable sleeve is configured to expand and create an interference fit at a catheter insertion site that is sufficient to prevent inadvertent movement of the catheter at the catheter insertion site; and a tube in fluid communication with the inflatable sleeve, wherein the tube is configured to supply a gas or liquid to the inflatable sleeve to cause the inflatable sleeve to expand, and wherein the tube is configured to remove the gas or liquid from the inflatable sleeve to cause the inflatable sleeve to contract.

13. The device of Claim 12, wherein the tube comprises an inflatable portion configured to provide an indication when the sleeve is sufficiently expanded to form the interference fit at the catheter insertion site.

14. The device of Claim 12, wherein at least a portion of the tube comprises visual indicia that distinguishes the tube from the catheter.

15. The device of Claim 12, wherein an outer surface of the sleeve comprises one or more grooves configured to allow exudate to flow from the catheter insertion site.

16. The device of Claim 12, wherein one or more portions of an exterior surface of the inflatable sleeve comprise a coating of material that inhibits fibroblast cell adhesion thereto.

17. The device of Claim 12, wherein the inflatable sleeve comprises two inflatable portions in spaced apart relationship.

18. A catheter securement device, comprising: an inflatable sleeve movable along an exterior surface of a catheter and configured to be positioned at a catheter insertion site, wherein the inflatable sleeve is configured to expand and create an interference fit at the catheter insertion site that is sufficient to prevent inadvertent movement of the catheter at the catheter insertion site.

19. The device of Claim 18, wherein the inflatable sleeve comprises an annular body having a first portion configured to be positioned within the catheter insertion site and a second portion configured to abut an area circumferentially adjacent to the catheter insertion site.

20. The device of Claim 19, wherein the second portion comprises a port through which a gas or liquid can be supplied to the inflatable sleeve to cause the inflatable sleeve to expand.

21. The device of Claim 20, further comprising a tube in fluid communication with the port and that is configured to supply the gas or liquid to the inflatable sleeve to cause the inflatable sleeve to expand, and wherein the tube is configured to remove the gas or liquid from the inflatable sleeve to cause the inflatable sleeve to contract.

22. The device of Claim 18, wherein an outer surface of the sleeve comprises one or more grooves configured to allow exudate to flow from the catheter insertion site.

23. The device of Claim 18, wherein one or more portions of an exterior surface of the inflatable sleeve comprise a coating of material that inhibits fibroblast cell adhesion thereto.

24. A catheter securement device, comprising: an anchor configured to be secured to the skin of a patient adjacent a catheter insertion site; and a hub movably secured to the anchor, wherein the hub comprises a catheter receiving channel that is configured to snugly hold a portion of a catheter inserted into the patient at the catheter insertion site;wherein the anchor and the hub are configured to prevent inadvertent movement of the catheter at the catheter insertion site.

25. The device of Claim 24, wherein the anchor comprises a plurality of microneedles configured to be inserted within the skin of the patient.

26. The device of Claim 25, wherein the plurality of microneedles are angled relative to a surface of the anchor.

27. The device of Claim 24, wherein the hub is movably secured to the anchor by a flexible connecting member.

28. The device of Claim 24, wherein the anchor comprises a first member and a second member in adjacent, spaced-apart relationship, wherein the first member comprises a plurality of microneedles and the second member comprises a plurality of microneedles.

29. The device of Claim 28, wherein the anchor further comprises a third member positioned between and connected to the first and second members, and wherein the hub is movably secured to the third member.

30. The device of Claim 29, wherein the anchor has a U-shape and is configured to be secured to the skin of the patient such that the catheter insertion site is between the first and second members.

31. A catheter securement device, comprising: an anchor configured to be secured to the skin of a patient adjacent a catheter insertion site, wherein the anchor comprises a first member, a second member, and a third member positioned between and connected to the first and second members such that the first and second members are in adjacent spaced apart relationship, and wherein the first and second members each comprise a plurality of microneedles configured to be inserted into the skin of the patient; anda hub movably secured to the third member of the anchor, wherein the hub comprises a catheter receiving channel that is configured to snugly hold a portion of a catheter inserted into the patient at the catheter insertion site; wherein the anchor and the hub are configured to prevent inadvertent movement of the catheter at the catheter insertion site.

32. The device of Claim 31, wherein the plurality of microneedles are angled relative to a respective surface of the first and second members.

33. The device of Claim 31, wherein the hub is movably secured to the third member of the anchor by a flexible connecting member.

34. The device of Claim 31, wherein the anchor has a U-shape and is configured to be secured to the skin of the patient such that the catheter insertion site is between the first and second members.

35. A catheter securement device, comprising: a sleeve configured to surround a portion of a catheter inserted into a patient at a catheter insertion site, wherein the sleeve is movable along an exterior surface of the catheter and is configured to be positioned at the catheter insertion site, and wherein the sleeve comprises an end portion that is expandable and contractable; and a slider device comprising: a flexible tube that is configured to surround the sleeve and maintain the sleeve end portion in a contracted state, wherein the slider device is configured to move the sleeve along the catheter and insert the end portion in the contracted state into the catheter insertion site, and wherein the slider device is configured to retract from the catheter insertion site along the catheter such that the sleeve end portion expands and engages skin of the patient at the catheter insertion site; and a fitting configured to be secured to a primary catheter securement device.

36. The device of Claim 35, wherein the end portion of the sleeve comprises flaps that are expandable and contractable.

37. The device of Claim 35, wherein the fitting of the slider device comprises a pair of opposing wings, each wing comprising an opening configured to engage with a respective post of the primary catheter securement device.

38. The device of Claim 35, wherein one or more portions of an exterior surface of the sleeve comprise a coating of material that inhibits fibroblast cell adhesion thereto.

39. The device of Claim 35, wherein an outer surface of the sleeve comprises one or more grooves configured to allow exudate to flow from the catheter insertion site.

40. The device of Claim 35, wherein the flexible sleeve is integrated within the catheter.

41. The device of Claim 35, wherein the flexible sleeve further comprises a second portion that is expandable and contractable, wherein the second portion is in adjacent spaced apart relationship with the end portion, wherein the flexible tube of the slider device is configured to surround the flexible sleeve and maintain the end portion and the second portion of the flexible sleeve in a contracted state, wherein the slider device is configured to move the flexible sleeve along the catheter and insert the end portion in the contracted state into the catheter insertion site, and wherein the slider device is configured to retract from the catheter insertion site along the catheter such that the flexible sleeve end portion expands and engages the skin of the patient at the catheter insertion site and such that the flexible sleeve second portion contacts an external portion of the skin of the patient.

42. A catheter securement device, comprising: an anchor configured to surround a portion of a catheter at a catheter insertion site, wherein the anchor is configured to change shape in response to an external force applied to the catheter and prevent inadvertent movement of the catheter at the catheter insertion site.

43. The device of Claim 42, wherein the anchor device comprises opposing first and second collars in axial alignment and that are supported in spaced apart relationship by at leastone member, wherein the at least one member is configured to move from an elongated configuration to an outwardly extending articulated configuration in response to the external force applied to the catheter.

44. The device of Claim 43, wherein the first collar comprises a slot configured to allow the catheter to be received within the first collar, and wherein the second collar comprises a slot configured to allow the catheter to be received within the second collar.

45. The device of Claim 43, wherein the at least one member comprises pair of members in diametrically opposing relationship.

46. The device of Claim 43, wherein the at least one member comprises a first end secured to the first collar, an opposite second end pivotably secured to the second collar, and at least two portions of the at least one member between the first and second ends having reduced material that allows a portion of the at least one member between the first and second ends to articulate outwardly in response to the external force applied to the catheter.

47. The device of Claim 46, wherein the at least one member has a slender elongate configuration with opposite inward and outward surfaces, wherein a first notch is formed within the inward surface adjacent the first end and a second notch is formed within the outward surface at an intermediate location between the first and second ends.

48. The device of Claim 43, further comprising a locking strap associated with the first collar that is configured to snugly secure the first collar to the catheter.

49. The device of Claim 42, wherein one or more portions of an exterior surface of the anchor comprise a coating of material that inhibits fibroblast cell adhesion thereto.

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