Catheter fixing device

Abstract

Described herein are auxiliary catheter securement devices configured to retain a catheter or catheter extension line adjacent to a primary catheter securement device during retention time and / or dressing replacement. Each auxiliary catheter fixture secures the catheter in place such that the primary catheter fixture can be removed and replaced, and / or the auxiliary fixture itself acts as the primary fixture and such that site cleaning can be performed during dressing replacement without increasing the risk of catheter movement.

Description

Technical Field

[0001] The present invention relates to medical devices, and particularly to devices for catheter fixation. Background Technology

[0002] A catheter is a medical device that can be inserted into the body to treat diseases or perform surgical procedures. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic procedures. In most uses, catheters are thin, flexible tubes (soft catheters), but depending on the application, catheters of different rigidity grades are available. Catheters can be inserted into body cavities, delivery vessels, blood vessels, the brain, skin, or adipose tissue. Functionally, they allow the drainage or administration of fluids or gases through surgical instruments and also perform a variety of other tasks depending on the type of catheter.

[0003] Referring to Figures 1 through 4E, when catheter 12 remains in place in a patient's body for an extended period, fixation techniques are typically employed to secure catheter 12 in its position. This is especially true for central venous catheters (CVCs) that are typically inserted into the superior vena cava via the patient's neck / chest. Solutions for securing the catheter include sutures 11 (Figure 1) and catheter fixation devices 20, such as the STATLOCK™ fixation device (Figure 3) available from Becton Dickinson, Inc. (1 Becton Avenue, Franklin Lake, NJ). Using any of these techniques, the dressing 25, typically associated with the insertion site IS of catheter 12, should ideally be changed every 7 days. As can be seen in Figures 2A through 2C, cleaning around catheter 12 secured by sutures 11 can result in incomplete (and therefore inadequate) cleaning (e.g., uncleaned area A of the patient's skin S below catheter hub 14), which may in turn increase the risk of central line-associated bloodstream infection (CLABSI).

[0004] When a catheter is secured using an adhesive-based fixation device 20 (Figure 3), the fixation device 20 is typically changed along with the dressing. During dressing changes, replacement of the fixation device 20, and cleaning of the insertion site area, for example, using a sterile applicator 30 (Figure 2A), caregivers should avoid improper catheter movement (e.g., catheter tip migration, dislodgement, or "piston-like" movement at the insertion site can occur, causing the catheter to shift to a point where it is no longer correctly positioned within the vein or other structure into which it is inserted). This is particularly important for certain catheters and insertion sites, such as the CVC.

[0005] Different techniques are currently used for changing dressings around catheters. In one technique illustrated in Figure 4A, a caregiver may attempt to hold catheter 12 in place using their finger F; however, this technique is inconsistent with aseptic non-contact technique (ANTT) protocols. In an alternative technique illustrated in Figure 4B, a rolled-up dressing 25 may be used to temporarily hold catheter 12 when the fixation device 20 is replaced. However, the use of the rolled-up dressing 25 can be inconsistent (e.g., the amount of dressing used). In a third technique illustrated in Figures 4C-4E, an auxiliary fixation component (such as adhesive tape 15) may be used to temporarily hold catheter 12 in place during removal and replacement of fixation device 20. This technique requires caregivers to have the knowledge to do so and to follow the protocols for using adhesive tape 15. Experience shows that this protocol is often overlooked. In addition, removing adhesive tape 15 can be difficult and / or allow catheter 12 to move, and in some cases, adhesive tape 15 leaves residue on the catheter lumen after removal that can attract contaminants.

[0006] It is expected that technologies can be provided to improve adherence to protocols, which in turn can improve patient outcomes. Summary of the Invention

[0007] According to some embodiments of the invention, a catheter fixation device includes: an adjustable-length frame having opposing first and second end portions. The first end portion is configured to be movably secured to a patient's skin at a catheter insertion site, and the second end portion is configured to grip and hold a catheter inserted into the patient's body at the catheter insertion site and prevent accidental 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 fork (e.g., a pair of adjacent spaced forks, etc.) configured to hook the patient's skin at the catheter insertion site. The skin engagement member has a movable hinge configuration that allows the frame to pivot relative to the patient's skin without disengaging the at least one fork from the patient's skin. A clamp is attached to the second end portion and configured to securely receive the catheter or catheter hub therein and prevent unwanted forward and backward movement (i.e., piston-like movement) of the catheter relative to the clamp.

[0008] In some embodiments, the frame includes a first segment slidably coupled to a second segment, such that the frame has a telescopically adjustable length. A locking mechanism is operatively associated with the first and second segments and configured to restrict movement of the first and second segments relative to each other when the frame is at a selected length. The skin-attaching member is attached to the first segment, and the clamp is attached to the second segment.

[0009] In some embodiments, one or more portions of the outer surface of the frame have a material coating that inhibits fibroblast adhesion thereto, and one or more portions of the outer surface of the skin-attaching member have a material coating that inhibits fibroblast adhesion thereto.

[0010] According to other embodiments of the invention, a catheter fixation device includes: an inflatable sheath surrounding a portion of a catheter; and a fitting in fluid communication with the inflatable sheath, the fitting being configured to supply fluid or gas (e.g., saline or air) to the inflatable sheath. The inflatable sheath is configured to expand in response to receiving the fluid or gas from the fitting and to create an interference fit at the catheter insertion site sufficient to prevent unintended forward and backward movement (i.e., piston movement) of the catheter at the insertion site. The fitting is configured to remove the gas or liquid from the inflatable sheath in its expanded configuration to allow the inflatable sheath to contract. The inflatable sheath may have more than one portion configured to expand and contract. For example, in some embodiments, the inflatable sheath may include two inflatable portions spaced apart from each other.

[0011] In some embodiments, the fitting includes an expandable portion that provides indication and reduces the risk of over-inflation when the expandable sleeve is sufficiently expanded to form the interference fit at the conduit insertion site.

[0012] In some embodiments, at least a portion of the fitting includes visual markings that distinguish the fitting from the conduit.

[0013] In some embodiments, the outer surface of the cannula includes one or more grooves configured to allow effluent to flow from the catheter insertion site. In some embodiments, one or more portions of the outer surface of the inflatable cannula have a material coating that inhibits fibroblast adhesion thereto.

[0014] According to another embodiment of the invention, a catheter fixation device includes: an inflatable sheath movable along an outer surface of a catheter and configured to be positioned at a catheter insertion site. The inflatable sheath is configured to expand and create an interference fit at the catheter insertion site sufficient to prevent accidental forward and backward movement (i.e., piston-like movement) of the catheter at the insertion site. The inflatable sheath has an annular body having a first portion configured to be positioned within the catheter insertion site and a second portion configured to circumferentially adjacent to a region of the catheter insertion site. The second portion includes a port through which fluid or gas (e.g., saline or air) can be supplied via a fitting to the inflatable sheath to cause expansion of the inflatable sheath, and through the port, the fluid or gas can be removed from the inflatable sheath to allow the inflatable sheath to contract.

[0015] In some embodiments, the outer surface of the inflatable cannula includes one or more grooves configured to allow effluent to flow from the catheter insertion site. In some embodiments, one or more portions of the outer surface of the inflatable cannula have a material coating that inhibits fibroblast adhesion thereto.

[0016] According to other embodiments of the invention, a catheter fixation device includes: an anchor configured to be secured to a patient's skin adjacent to a catheter insertion site; and a sleeve movably secured to the anchor, for example by a flexible connecting member. The sleeve includes a catheter receiving channel configured to tightly hold a portion of a catheter inserted into the patient's body at the catheter insertion site. The anchor and the sleeve are configured to prevent accidental forward and backward movement (i.e., piston-like movement) of the catheter at the catheter insertion site. The anchor includes a plurality of microneedles configured to be inserted into the patient's skin. In some embodiments, the plurality of microneedles are angled relative to the surface of the anchor.

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

[0018] According to other embodiments of the present invention, a catheter fixation device includes: a cannula configured to surround a portion of a catheter at a catheter insertion site; and a sliding device. The cannula is movable along an outer surface of the catheter and configured to be positioned at the catheter insertion site by the sliding device. In some embodiments, the cannula may be integrated within the catheter. For example, the cannula surrounds and is movable along an outer surface of the catheter, and the cannula and the catheter are surrounded by an outer sheath. The cannula includes an expandable and retractable end portion. For example, the end portion of the cannula may include expandable and retractable flaps. The sliding device includes a flexible tube configured to surround the cannula and hold the end portion of the flexible cannula in a retracted state. The sliding device is configured to move the cannula along the catheter and insert the retracted end portion into the catheter insertion site. When the sliding device retracts along the catheter from the catheter insertion site, the end portion of the cannula expands and engages the patient's skin at the catheter insertion site.

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

[0020] In some embodiments, one or more portions of the outer surface of the cannula have a material coating that inhibits fibroblast adhesion thereto. In some embodiments, the outer surface of the cannula includes one or more grooves configured to allow effluent to flow from the catheter insertion site.

[0021] In some embodiments, the cannula may include a second portion that is deployable and retractable and spaced apart from the deployable and retractable end portions. The flexible tube of the sliding device is configured to surround the cannula and hold the end portions of the cannula and the second portion in a retracted state. The sliding device is configured to move the cannula along the catheter and insert the retracted end portions into the catheter insertion site. As the sliding device retracts along the catheter from the catheter insertion site, the end portions of the cannula deploy and engage the patient's skin at the catheter insertion site, and the second portion of the cannula contacts the outer portion of the patient's skin.

[0022] According to other embodiments of the invention, a catheter fixation device includes: an anchor configured to surround a portion of a catheter at a catheter insertion site and configured to change shape in response to an external force applied to the catheter and prevent accidental forward and backward movement (i.e., piston movement) of the catheter at the catheter insertion site. In some embodiments, the anchor device includes axially aligned opposing first and second collars supported by at least one member in a spaced-apart relationship. A locking strip is associated with the first collar and configured to secure the first collar tightly 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 an external force applied to the catheter.

[0023] In some embodiments, the first collar includes a groove configured to allow the catheter to be received within the first collar, and the second collar includes a groove configured to allow the catheter to be received within the second collar. The at least one member includes a first end fixed to the first collar, an opposite second end pivotally fixed to the second collar, and at least two portions of the at least one member located between the first and second ends, having reduced material that allows the portions of the at least one member located between the first and second ends to articulate outward movement in response to an external force applied to the catheter. In some embodiments, the at least one member includes a thin, elongated structure having opposing inward and outward surfaces. A first notch is formed adjacent to the first end in the inward surface, and a second notch is formed at an intermediate location between the first and second ends in the outward surface.

[0024] In some embodiments, the at least one component comprises a pair of components that are diametrically opposed.

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

[0026] It should be noted that aspects of the inventive concept described with respect to one embodiment may be incorporated into different embodiments, although not specifically described herein. That is, all embodiments and / or features of any embodiment may be combined in any manner and / or combination. Embodiments of the inventive concept can also be used for "in-device" sample preparation for subsequent analytical procedures. The applicant reserves the right to amend any originally filed claim or accordingly file any new claim, including the right to modify any originally filed claim to rely on and / or combine any feature of any other claim, although not originally claimed in this way. These and other objects and / or aspects of the inventive concept will be explained in detail below. Attached Figure Description

[0027] The accompanying drawings, which form part of this specification, illustrate various embodiments of the inventive concept. Together with the description, the drawings serve to fully explain embodiments of the inventive concept.

[0028] Figure 1 illustrates the use of sutures to secure a central venous catheter to a patient.

[0029] Figures 2A to 2C illustrate insufficient site cleaning when using sutures to secure a central venous catheter line as shown in Figure 1.

[0030] Figure 3 illustrates the main known catheter fixation devices (adhesive-based).

[0031] Figures 4A to 4E illustrate current techniques for temporarily securing catheters during dressing changes.

[0032] Figure 5 This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0033] Figure 6A Examples Figure 5 The adjustable frame of the auxiliary catheter fixation device in the retracted position.

[0034] Figure 6B Examples Figure 5 The adjustable frame of the auxiliary catheter fixation device in the extended position.

[0035] Figure 6C yes Figure 5 Exploded view of the adjustable frame of the auxiliary catheter fixation device.

[0036] Figure 6D yes Figure 5 Side view of the adjustable frame of the auxiliary catheter fixation device.

[0037] Figure 7 In use Figure 5 Side view of the auxiliary catheter fixation device.

[0038] Figures 8A to 8D An example is shown for installation at the catheter insertion site. Figure 5 The steps of the auxiliary catheter fixation device.

[0039] Figure 9 Examples are shown during site cleaning. Figure 5 Auxiliary catheter fixation device.

[0040] Figures 10A to 10D Examples are shown for using Figure 5 The procedure for removing the auxiliary catheter fixation device from the patient.

[0041] Figures 11A to 11B This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention. Figure 11A In this configuration, an expandable sheath is integrated within the catheter. Figure 11B In this context, the inflatable sheath is an additional device for the catheter.

[0042] Figure 12 Examples are shown for structures in a contraction phase (top) and structures in an expansion phase (bottom). Figure 11A The inflatable sleeve of the auxiliary catheter fixation device.

[0043] Figure 13 This illustrates a groove in an expandable sleeve that facilitates the drainage of effluent from the conduit insertion site. Figure 11A Bottom perspective view of the auxiliary catheter fixation device.

[0044] Figure 14 yes Figure 12 A cross-sectional view of the inflatable sleeve in a contractile configuration of the auxiliary catheter fixation device.

[0045] Figure 15 yes Figure 12 A side view of the auxiliary catheter fixation device in the expandable sleeve of the expansion structure.

[0046] Figures 16A to 16D An example is shown for installation at the catheter insertion site. Figure 11A The steps of the auxiliary catheter fixation device.

[0047] Figures 17A to 17B Examples are shown during dressing changes. Figure 11A Auxiliary catheter fixation device.

[0048] Figures 18A to 18B Examples are shown for using Figure 11A The procedure for removing the auxiliary catheter fixation device from the patient.

[0049] Figure 19This is a top perspective view of an auxiliary catheter fixation device that is movably fixed to a catheter according to some embodiments of the present invention.

[0050] Figure 20 yes Figure 19 An enlarged perspective view of the auxiliary catheter fixation device.

[0051] Figure 21 An example is shown at the catheter insertion site. Figure 19 Auxiliary catheter fixation device.

[0052] Figure 22A It is a section taken along line 22A-22A and is in a contracting structure. Figure 21 A cross-sectional view of the auxiliary catheter fixation device.

[0053] Figure 22B It is a section taken along line 22A-22A and is located in an expansion structure. Figure 21 A cross-sectional view of the auxiliary catheter fixation device.

[0054] Figure 22C This illustrates a groove that helps drain discharge from the catheter insertion site. Figure 21 Top perspective view of the auxiliary catheter fixation device.

[0055] Figure 23 This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0056] Figure 24A This is a top perspective view of the anchoring device of the auxiliary conduit fixing device in Figure 22.

[0057] Figure 24B It is attached to the patient's skin. Figure 24A Side view of the anchoring device.

[0058] Figure 25A This is a top perspective view of the catheter retaining sleeve of the auxiliary catheter fixation device in Figure 24.

[0059] Figure 25B Examples of fixing in Figure 25A The catheter is held in place within the catheter sleeve.

[0060] Figure 26 yes Figure 23 A top perspective view of the flexible joint of the auxiliary catheter fixation device, which movably secures the catheter retaining sleeve to the anchoring device.

[0061] Figure 27 Examples of attachments to conduit retaining sleeves and anchoring devices are shown. Figure 26 Flexible joint.

[0062] Figures 28A to 28C This illustrates the situation where the catheter and... Figure 23 The movement of the auxiliary catheter fixation device.

[0063] Figure 29 This is an exploded view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0064] Figure 30 Examples Figure 29 The auxiliary catheter fixation device includes a sliding component and a deployable sleeve, wherein the sliding component and the deployable sleeve are engaged and the deployable sleeve is in a collapsed configuration.

[0065] Figure 31 It is an enlarged partial perspective view of the sliding device and the deployable sleeve, wherein the deployable sleeve is in a collapsed structure.

[0066] Figure 32 yes Figure 29 Top perspective view of the auxiliary catheter fixation device at the catheter insertion site.

[0067] Figure 33 This is an enlarged bottom perspective view of the expandable inner cannula within the patient's skin and in the expandable structure.

[0068] Figures 34A to 34D An example is shown for installation at the catheter insertion site. Figure 29 The steps of the auxiliary catheter fixation device.

[0069] Figures 35A to 35C Examples are shown during dressing changes. Figure 29 Auxiliary catheter fixation device.

[0070] Figures 36A to 36D Examples are shown for using Figure 29 The procedure for removing the auxiliary catheter fixation device from the patient.

[0071] Figure 37 This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0072] Figure 38 This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0073] Figure 39 yes Figure 38 Side view of the deployable cannula of the auxiliary catheter fixation device.

[0074] Figure 40 This is a top perspective view of an auxiliary catheter fixation device according to some embodiments of the present invention.

[0075] Figure 41 yes Figure 40 The auxiliary catheter fixation device is positioned within the catheter insertion site in a side view of the anchor, and for clarity, parts of the catheter and anchor have been removed.

[0076] Figure 42 It is installed at the catheter insertion site. Figure 40 Top perspective view of the auxiliary catheter fixation device.

[0077] Figure 43A It is in a non-articular structure. Figure 40 A perspective view of the anchor.

[0078] Figure 43B It is in a joint-like structure. Figure 40 A perspective view of the anchoring device.

[0079] Figure 44A It is a notch in a non-articular structure, exemplified by an anchor, that facilitates the articulated movement of the anchor. Figure 40 Side view of the anchor.

[0080] Figure 44B It is in a joint-like structure. Figure 44A Side view of the anchor.

[0081] Figures 45A to 45F An example is shown for installation at the catheter insertion site. Figure 40 The steps of the auxiliary catheter fixation device.

[0082] Figure 46 Examples are shown during site cleaning. Figure 40 Auxiliary catheter fixation device.

[0083] Figures 47A to 47D Examples are shown for using Figure 40 The procedure for removing the auxiliary catheter fixation device from the patient. Detailed Implementation

[0084] Embodiments of the present invention relate to catheter fixation solutions that help minimize catheter migration and dislodgement during dressing changes without increasing other clinical burdens such as microbial growth, patient pain, and significant workflow disruptions. Embodiments of the present invention provide an auxiliary catheter fixation device configured to retain the catheter or catheter hub near the insertion site in the patient's skin. The auxiliary catheter fixation device allows for 360° site cleaning without increasing the risk of catheter movement during dressing changes for catheters such as long-term indwelling IV catheters, e.g., peripherally inserted central catheter (PICC) lines and central venous catheter (CVC) lines. Embodiments of the present invention will now be described in more detail with reference to the accompanying drawings.

[0085] refer to Figure 5 , Figures 6A to 6D and Figure 7 This illustration shows an auxiliary catheter fixation device 100 according to some embodiments of the present invention. The auxiliary catheter fixation device 100 includes an adjustable-length frame 110 having: a skin-attaching member 120 configured to be secured to the patient's skin at the catheter insertion site IS; and a clamp 130 for securely receiving the catheter hub 14 therein. The skin-attaching member 120 is secured to a first end portion 110a of the frame 110, and the clamp 130 is secured adjacent to a second end portion 110b of the frame 110. The first end portion 110a includes the skin-attaching member 120 configured to be secured to the patient's skin at the catheter insertion site IS and allow the frame 110 to move or pivot at the catheter insertion site IS. The second end portion 110b of the frame 110 includes the clamp 130 configured to grip and hold the catheter hub 14 and prevent accidental movement of the catheter 12 at the catheter insertion site IS.

[0086] Figure 5 An auxiliary catheter fixation device 100 in an installation configuration is illustrated, wherein a skin engagement member 120 is fixed to the patient’s skin at the catheter insertion site IS, and a portion of the catheter hub 14 is received within a clamp 130, thereby securing the catheter hub 14 and the catheter 12 tightly to the frame 110. Figure 7 This is a side view of the auxiliary catheter fixation device 100 in its installation configuration, illustrating a skin engagement member 120 that is fixed to the patient's skin S at the catheter insertion site IS. The catheter hub 14 is configured to be fixed to a primary catheter fixation device, such as the STATLOCK™ fixation device (FIG. 3), and the frame 110 is positioned close to the patient's skin S. When the catheter hub 14 is detached from the primary catheter fixation device, for example during dressing changes and cleaning of the area around the catheter insertion site IS, the frame 110 and the attached catheter 12 can pivot 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 thin construction, and the first end portion 110a has an arcuate or rounded shape, as illustrated in the figure. The rounded shape of the first end portion 110a allows the frame 110 to pivot relative to the patient's skin during catheter site cleaning without interference, as will be described below.

[0088] The illustrated frame 110 includes a first segment 112 slidably coupled to a second segment 114, such that the frame has a telescopically adjustable length. In the illustrated embodiment, the second segment 114 is inserted within the first segment 112. However, in other embodiments, this may be reversed, and the first segment 112 may be inserted within the second segment 114. In the illustrated embodiment, the first segment 112 has a generally thin rectangular construction 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 segment 114 has a generally thin rectangular construction with opposite first end portions 118a and second end portions 118b. The first segment 112 includes a top wall 112a, opposing 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 a plurality of surfaces 117a, 117b, 117c that are angled relative to each other to form an arcuate or rounded shape. However, embodiments of the inventive concept are not limited to three surfaces angled relative to each other. In other embodiments, more than three surfaces angled relative to each other may be used, and even two surfaces angled relative to each other. Furthermore, in some embodiments, the first end portion 116a may be a continuous, smooth surface.

[0089] The illustrated first segment 112 of the frame also includes inwardly extending lower walls 112e, 112f forming a channel 113 for slidably receiving a second segment 114 of the frame therein. The second segment 114 of the frame includes a top wall 114a, opposing side walls 114b, 114c extending downward from the top wall 114a, and inwardly extending lower walls 114d, 114e. The first segment 112 and the second segment 114 can be formed of various materials, including but not limited to various types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof. The skin-bonding member 120 can be formed of various types of plastic and elastomeric materials.

[0090] Figure 6A An example is shown in which the first segment 112 and the second segment 114 are in the retracted frame 110, and Figure 6BAn illustrated frame in which first segment 112 and second segment 114 are in an extended configuration is shown. A locking mechanism 140 is operatively associated with first segment 112 and second segment 114 and configured to restrict movement of first segment 112 and second segment 114 relative to each other when frame 110 is at a selected length. The illustrated locking mechanism 140 includes two buttons 142a, 142b that can be pressed together by a user to release the mechanism (not shown) restricting movement of first segment 112 and second segment 114 relative to each other.

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

[0092] The skin engagement member 120 is attached to a first end portion 116a of a first segment 112 of the frame 110 and includes a pair of adjacent spaced-apart forks 122a, 122b configured to hook onto the patient’s skin at the catheter insertion site S. The skin engagement member 120 is also configured as a movable hinge, allowing the frame 110 to pivot relative to the patient’s skin S without disengaging the forks 122a, 122b from the patient’s skin S.

[0093] The clamp 130 is attached adjacent to the end portion 118b of the second section 114 to the top wall 114a of the second section and is configured to tightly receive the conduit hub 14 therein and prevent the conduit 12 from moving forward and backward relative to the clamp 130 (i.e., piston movement). In other embodiments, the clamp 130 may be configured to receive the conduit 12 therein.

[0094] One or more portions of the outer surfaces of the forks 122a, 122b may have a material coating that inhibits fibroblast adhesion thereto. Similarly, one or more portions of the outer surfaces of the various walls 112a-114f of the first segment 112 and one or more portions of the outer surfaces of the various walls 114a-114e of the second segment 114 may have a material coating that inhibits fibroblast adhesion thereto.

[0095] Figures 8A to 8D An example is shown for installation at the catheter insertion site IS. Figure 5 , Figures 6A to 6D and Figure 7 The steps of the auxiliary catheter fixation device 100. Figure 8A In this configuration, the frame 110 is held substantially perpendicular to the patient's skin S at the catheter insertion site IS, and the forks 122a, 122b of the skin engagement member 120 are advanced into the skin S at the catheter insertion site IS. Figure 8B Place the hemostatic bandage 25a at the catheter insertion site IS. Then tilt the frame 110 downwards toward the patient's skin S. Figure 8C The catheter hub 14 is attached to the clamp 130 using a snap-fit ​​mechanism. Once the frame 110 is positioned horizontally, the movable hinge configuration of the skin engagement member 120 allows the skin engagement member 120 to bend and lock under the surface of the patient's skin S. Figure 7 and Figure 8D A transparent dressing may be applied to the catheter insertion site IS, the auxiliary catheter fixation device 100, and the catheter hub 14.

[0096] Figure 9 Examples are shown during dressing changes. Figure 5 , Figures 6A to 6D and Figure 7 The auxiliary catheter fixation device 100 is then used. The hemostatic bandage 25a and any other dressings are removed, the catheter hub 14 is released from the main catheter fixation device (not shown), the main catheter fixation device is removed from the patient, and then the frame 110, together with the catheter hub 14 and catheter 12 to which it is fixed, is pivoted upwards to allow access to the area around the catheter insertion site IS and the location where the main catheter fixation device was previously located. These areas can be cleaned, for example, using a sterile cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension line 12e can also be cleaned at this time.

[0097] Figures 10A to 10D Examples are shown for using Figure 5 , Figures 6A to 6D and Figure 7 The steps for removing the auxiliary catheter fixation device 100 from the patient include: removing the transparent dressing (not shown) surrounding the catheter insertion site IS from the patient, releasing the catheter hub 14 from the main catheter fixation device (not shown), and releasing the catheter hub 14 from the clamp 130 of the auxiliary catheter fixation device 100. The hemostatic bandage 25a is then removed. Figure 10C The frame 110 is tilted upwards to a generally vertical orientation and moves outwards from the patient's skin S. The movable hinge configuration of the skin engagement member 120 allows the forks 122a, 122b to detach and be removed from the skin S.

[0098] refer to Figures 11A to 11B and Figure 12This illustration shows an auxiliary catheter fixation device 200 according to some embodiments of the present invention. The catheter fixation device 200 includes an inflatable sleeve 210 that surrounds a portion of the catheter 12 at the catheter insertion site IS; and a channel or fitting 220 in fluid communication with the inflatable sleeve 210, configured to supply fluid or gas to the inflatable sleeve 210. The channel or fitting 220 is a separate channel independent of the catheter lumen. The inflatable sleeve 210 may be a separate device surrounding the catheter 12, such as... Figure 11A As illustrated, it may also be integrated within catheter 12, such as Figure 11B As illustrated, the inflatable sleeve 210 can be formed from various elastomeric materials (such as rubber).

[0099] The inflatable cannula 210 is configured to inflate like a balloon in response to the receipt of fluid or gas (e.g., saline or air) from the fitting 220, and to create an interference fit at the catheter insertion site IS sufficient to prevent accidental movement of the catheter 12 at the insertion site IS. The fitting 220 is also configured to remove fluid or gas from the inflatable cannula 210 in its inflatable configuration to allow the inflatable cannula 210 to contract, thereby enabling the catheter 12 to be removed from the patient.

[0100] The inflatable cannula 210 may have more than one portion configured to expand at the catheter insertion site IS and subsequently contract. Embodiments of the inventive concept are not limited to cannulas with only a single portion that expands and contracts. For example, and as... Figure 12 , Figure 14 and Figure 15 As illustrated, according to an embodiment of the invention, the inflatable sleeve 210 may include two inflatable portions 212a, 212b that are spaced apart and adjacent to each other. Figure 12 , Figure 14 and Figure 15 The construction of the inflatable cannula 200 allows the patient's skin S at the catheter insertion site IS to be "clamped" between the two inflatable portions 212a, 212b, thereby providing additional resistance to accidental movement of the catheter 12.

[0101] exist Figure 11A In an exemplary embodiment, fitting 220 includes an expandable portion 224 configured to provide indication and reduce the risk of over-inflation of the sleeve 210 when it has fully expanded to form an interference fit at the catheter insertion site IS. Furthermore, the port 222 of fitting 220 and / or fitting 220 may be provided with visual markings 225 (e.g., color coding) to distinguish it from the port associated with catheter 12 to avoid any port identification errors. When not in use, port 222 of fitting 220 may be closed by a cap 226.

[0102] In some embodiments, such as Figure 13 As illustrated, the outer surface 210a of the cannula 210 may include one or more grooves 228 (e.g., microchannels) extending in the axial direction of the cannula 210 and the catheter 12. These grooves are configured to allow effluent EX to flow from the catheter insertion site IS and be absorbed by a hemostatic bandage or other dressing located at the catheter insertion site IS. The grooves 228 act as capillaries to assist in the drainage of effluent EX and prevent effluent EX from clogging the catheter insertion site IS. Furthermore, one or more portions of the outer surface 210a of the inflatable cannula 210 may have a material coating that inhibits fibroblast adhesion thereto.

[0103] Figures 16A to 16D An example is shown for installation at the catheter insertion site IS. Figure 11A The steps of the auxiliary catheter fixation device 200. Figure 16A In accordance with health facility guidelines, catheter 12 and inflatable cannula 210 are inserted into the patient at the catheter insertion site IS. Figure 16B In this process, a syringe SY containing liquid or gas F / G is attached to port 222 of fitting 220, and then the inflatable sleeve 210 is inflated with liquid or gas F / G from syringe SY to form an interference fit at catheter insertion site IS sufficient to prevent accidental movement of catheter 12 at catheter insertion site IS. Figure 16C A hemostatic bandage 25a is then applied to the catheter insertion site IS, and a transparent dressing 25b is applied over the catheter insertion site IS and the catheter hub 14. Figure 16D In addition, such as Figure 16D As illustrated, the expandable portion 224 of the fitting provides an indication that the expandable sleeve 210 can be fully expanded to form an interference fit at the conduit insertion point IS.

[0104] Figures 17A to 17B Examples are shown during dressing changes. Figure 11A 200 auxiliary catheter fixation device. 25b transparent dressing ( Figure 16D ) and hemostatic bandage 25a ( Figure 16D The catheter hub 14 is removed, releasing the catheter from the main catheter fixation device (such as the STATLOCK™ fixation device (Figure 3)). The main catheter fixation device is removed, and the catheter 12 and the sleeve 14 are lifted away from the patient's skin. Figure 17AThis allows access to the area surrounding the catheter insertion site IS and the location where the main catheter fixation device was previously located. For example, these areas can be cleaned using a sterile cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension line 12e can also be cleaned at this time. The inflated cannula 210 holds the catheter 12 in place at the catheter insertion site IS during cleaning. A new main catheter fixation device (such as the STATLOCK™ fixation device (Figure 3)) is attached to the patient, the catheter hub 14 is attached to the main catheter fixation device, a new hemostatic bandage 25a is applied to the catheter insertion site IS, and a new transparent bandage 25b is applied to the patient to cover the catheter insertion site IS, the auxiliary fixation device 200, and the main fixation device (…). Figure 17B ).

[0105] Figures 18A to 18B Examples are shown for using Figure 11A The procedure for removing the auxiliary catheter fixation device 200 from the patient. A transparent dressing 25b is applied at the catheter insertion site IS. Figure 17B ) and hemostatic bandage 25a ( Figure 17B The syringe SY is attached to port 222 of fitting 220, and fluid or gas F / G is drawn from the expanded sleeve 210 through syringe SY, thereby venting the sleeve 210 at the catheter insertion site IS. Figure 18A Then the catheter 12, together with the inflatable cannula 210, can be removed from the patient. Figure 18B ).

[0106] refer to Figures 19 to 21 and Figures 22A to 22C An auxiliary catheter fixation device 300 according to some embodiments of the present invention is illustrated. The auxiliary catheter fixation device 300 is an inflatable sleeve 310 movable along the outer surface of the catheter 12 and configured to be positioned at the catheter insertion site IS. The inflatable sleeve 310 is configured to expand and create an interference fit at the catheter insertion site IS sufficient to prevent accidental forward and backward movement (i.e., piston movement) of the catheter 12 at the catheter insertion site IS. The inflatable sleeve 310 has an annular body 312 ( Figure 20 The annular body defines a passage 313 through which the 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 having a diameter larger than the first portion 314, such that the second portion can abut a region circumferentially adjacent to the catheter insertion site IS. The annular body 312 includes a port 318 through which passage, for example via a fitting (e.g., fitting 220), is made possible. Figure 11AFluid or gas may be supplied to the inflatable sleeve 310 to cause the inflatable sleeve 310 to expand. Similarly, fluid or gas may be removed from the inflatable sleeve 310 via port 318 to cause the inflatable sleeve 310 to contract, so that the sleeve 310 and the conduit 12 can be removed from the conduit insertion site IS.

[0107] Figure 22A It is a section taken along line 22A-22A. Figure 21 A cross-sectional view of the auxiliary catheter fixation device 300, showing an inflatable cannula 310 in its unexpanded (i.e., contracted) configuration and positioned within the patient's skin S at the catheter insertion site IS. When fluid or gas is supplied to the annular body 312 via port 318, the annular body 312 expands, as indicated by arrow A3. Figure 22B An example is illustrated by an interference fit at the catheter insertion site IS, which is in an expanded configuration and provides sufficient protection against accidental movement of the catheter 12 at the insertion site IS. Figure 22A 310 refillable expansion sleeve.

[0108] In some embodiments, such as Figure 22C As illustrated, the outer surface 310a of the cannula 310 may include one or more grooves 328 (e.g., microchannels) extending in the axial direction of the cannula 310. These grooves are configured to allow effluent EX to flow from the catheter insertion site IS and be absorbed by a hemostatic bandage or other dressing located at the catheter insertion site IS. The grooves 328 act as capillaries to assist in the drainage of effluent EX and prevent effluent EX from clogging the catheter insertion site IS. Furthermore, one or more portions of the outer surface 310a of the inflatable cannula 310 may have a material coating that inhibits fibroblast adhesion thereto.

[0109] refer to Figure 23 The illustration shows an auxiliary catheter fixation device 400 according to some embodiments of the present invention. The catheter fixation device 400 includes an anchor 410 configured to be fixed to the patient's skin adjacent to the catheter insertion site IS; and a catheter holding sleeve 420 movably fixed 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 patient's skin S adjacent to the catheter insertion site IS and configured to resist movement of the anchor 410 in the X, Y, and Z directions.

[0110] The illustrated catheter retaining sleeve 420 is a semi-elastic component in which a catheter receiving groove or channel 422 is formed, the groove or channel being configured to tightly retain a portion of the catheter 12 therein. The catheter retaining sleeve 420 substantially holds the catheter 12 in place by forming a frictional connection with the catheter 12. In the illustrated embodiment, opposing 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, embodiments of the opposing edge portions 422a, 422b are not limited thereto. For example, only the first opposing edge portion 422a may extend toward the second opposing edge portion 422b; or only the second opposing edge portion 422b may extend toward the first opposing edge portion 422a. The protruding construction of one or both of the opposing edge portions 422a and 422b of the catheter receiving channel 422 secures the catheter 12 within the catheter receiving channel 422 and helps prevent the catheter 12 from accidentally dislodging from the sleeve 420. Furthermore, the tight fit of the catheter 12 within the catheter receiving channel 422 prevents piston-like movement of the catheter at the catheter insertion site IS. The catheter retaining sleeve 420 can be formed of various materials, including but not limited to various types of plastic materials, ceramic materials, metals, elastomer materials, or combinations thereof.

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

[0112] In the illustrated embodiment, a plurality of microneedles 416 are angled relative to the lower surface 412a of the first member 412 and the lower surface 414a of the second member 414. A third member 418 is positioned between and connected to the first member 412 and the second member 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 patient's skin S, such that the catheter insertion site IS is located between the first member 412 and the second member 414, as illustrated. Embodiments of the inventive concept are not limited to the illustrated configuration of the anchor 410. The first member 412 and the second member 414 may have various shapes and configurations.

[0113] The catheter retaining sleeve 420 is movably secured to the third member 418 of the anchor 410 via a connecting member 430. The connecting member 430 includes a first end portion 432 configured to attach to the catheter retaining sleeve 420; and a opposite second end portion 434 including a hook portion 436 configured to receive the third member 418 of the anchor 410 therein and allow pivotal movement of the connecting member 430.

[0114] Figures 28A to 28C Examples Figure 23 The movement of the auxiliary catheter fixation device 400. Figure 28A In this configuration, the anchor 410 of the auxiliary catheter fixation device 400 is attached to the patient's skin S, and the catheter 12 is secured within the catheter receiving channel 422 of the catheter retaining sleeve 420, and the catheter retaining sleeve 420 is positioned such that the catheter hub 14 can be secured to the primary catheter fixation device, such as the STATLOCK™ fixation device (Figure 3). Figures 28B to 28C The example illustrates the separation of the catheter hub 14 from the main catheter fixation device and the upward pivoting of the catheter retaining sleeve 420 and the catheter 12 away from the patient's skin S to allow access to the area around the catheter insertion site IS, so that the area can be cleaned, for example, using a disinfection and cleaning applicator.

[0115] refer to Figure 29 An auxiliary catheter fixation device 500 according to some embodiments of the present invention is illustrated. The catheter fixation device 500 includes a sleeve 510 configured to surround a portion of a catheter 12; and a sliding device 520. The sleeve 510 is formed of a flexible material and includes an inner cavity 511 configured to receive the catheter 12 passing through it and allow the sleeve 510 to move along the outer surface of the catheter 12. The sleeve 510 includes a deployable and retractable distal end portion 512. In the illustrated example, the end portion 512 of the sleeve 510 includes a plurality of deployable wings or flaps 514. The flaps 514 collapse when the sliding device 520 is pushed over the flaps, and deploy once the sliding device 520 is pulled back away from the flaps 514. When the end portion 512 of the cannula 510 is positioned at the catheter insertion site IS and the sliding device 520 is pulled back, the flap 514 is configured to unfold and clamp the patient's skin S, as... Figure 33 As illustrated, this anchors the cannula 510 at the catheter insertion site IS.

[0116] The cannula 510 can be formed from various elastomeric materials. In addition, the cannula 510 can be reinforced with a more rigid material at a selected location to provide the selected stiffness to ensure that the cannula 510 remains within the skin at the catheter insertion site IS.

[0117] The sliding device 520 includes a tube 522 configured to surround the sleeve 510 and hold the flap 514 at the end portion 512 of the sleeve in a retracted state, such as... Figure 31 As illustrated, the sliding device 520 is configured to move the cannula 510 along the catheter 12 and insert the end portion 512 of the cannula 510 into the catheter insertion site IS in a retracted state. As the sliding device 520 retracts along the catheter 12 from the catheter insertion site IS, the end portion 512 of the cannula unfolds and engages with the patient's skin S at the catheter insertion site IS. The tube 522 of the sliding device 520 may be configured to be flexible so that it can be inserted into the patient's skin S at the catheter insertion site IS, but then return to its original unflexed shape once retracted. For example, Figure 29 , Figure 31 , Figure 32 and Figure 34B Example 522 is shown in its normal, unflexed shape. Figure 30 and Figure 34C An example is a tube 522 of a sliding device 520 that is in a flexed or bent shape during insertion into the patient's skin S at the catheter insertion site IS (together with cannula 410).

[0118] The sliding device 520 may be an integral part of the catheter system during the insertion of the catheter 12 into the catheter insertion portion IS, or the sliding device 520 may be configured to attach to the catheter 12, such as... Figure 34B As illustrated. For example, the sliding device fitting 522 may include a longitudinally extending groove 523 that allows the sliding device 520 to be mounted around the conduit 12.

[0119] The sliding device 520 includes a fitting 526 configured to be secured to the main catheter fixation device 20. For example, in some embodiments, the fitting 526 of the sliding device 520 includes a pair of opposing wings 528a, 528b, and each wing 528a, 528b is configured to engage and be secured to the main catheter fixation device 20. The sliding device 520 is configured to overlap the catheter hub 14 such that the wings 528a, 528b of the fitting overlap the wings 14a, 14b of the catheter hub 14. Each wing 528a, 528b of the fitting includes a corresponding opening 529 configured to align with a corresponding opening 19 of the corresponding wing 14a, 14b of the catheter hub and engage with a corresponding post P associated with the main catheter fixation device 20, such as... Figure 32 exemplified.

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

[0121] Figures 34A to 34D An example is shown for installation at the catheter insertion site IS. Figure 29 The steps of the auxiliary catheter fixation device 500. During or after the insertion of the catheter 12 into the patient's body, the cannula 510 and the sliding device 520 are placed on the catheter 12. Figure 34A As described above, the sliding device 520 can be configured to be pushed onto the conduit 12. Figure 34B Alternatively, the sliding device 520 may be part of the catheter assembly. The sliding device 520 is then used to push the cannula 510, having a constricted end portion 512, into the insertion site IS like a dilator, and then pull the sliding device 520 back to allow the end portion 512 of the cannula 510 to expand within the skin S. Figure 34C The accessory 526 of the sliding device 520 is then secured to the main catheter fixation 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 auxiliary catheter fixation device 500, and the main catheter fixation device 20. Figure 34D ).

[0122] Figures 35A to 35C Examples are shown during dressing changes. Figure 29 500 auxiliary catheter fixation device. During dressing changes, transparent dressing 25b ( Figure 34D ) and hemostatic bandage 25a ( Figure 35A The primary catheter fixation device 20 is removed, leaving the secondary catheter fixation device 500 to secure the catheter 12 to the patient. Figure 35B ).like Figure 35B As illustrated, catheter 12 can be raised relative to the patient, and the area around the catheter insertion site IS and the location where the main catheter fixation device 20 was previously located can be cleaned, for example, using a disinfection and cleaning applicator CA. Catheter 12, catheter hub 14, and catheter extension line 12e can also be cleaned at this time.

[0123] The new main catheter fixation device 20 can be fixed to the patient's skin S, the hub 14 and accessory 526 can be fixed within the new main catheter fixation device 20, the new hemostatic bandage 25a can be applied to the insertion site IS, and the new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and the hemostatic bandage 25a, the auxiliary catheter fixation device 500 and the main catheter fixation device 20. Figure 35C ).

[0124] Figures 36A to 36D Examples are shown for using Figure 29 The procedure for removing the auxiliary catheter fixation device 500 from the patient. A transparent dressing 25b is applied at the catheter insertion site IS. Figure 35C ) and hemostatic bandage 25a ( Figure 35C ) was removed ( Figure 36A The sliding device 520 disengages from the main catheter fixing device 20 and moves toward the catheter insertion site IS, causing the distal end portion 512 of the sleeve 510 at the insertion site IS to collapse. Figure 36B , Figure 36C Then the catheter 12, cannula 510, and sliding device 520 can be removed from the patient. Figure 36D ).

[0125] refer to Figure 37 The cannula 510 can be integrated into the catheter assembly. Once inserted into the insertion site, the deployable cannula 510 can remain in place (due to the locking feature or integration into the catheter assembly). Therefore, there is no retraction of the cannula 510 along with the sliding device 520, and once the sliding device 520 is pulled out, the end portion 512 of the cannula 510' will deploy.

[0126] refer to Figure 38 and Figure 39 In some embodiments, the cannula 510 may include a second portion 516 that is deployable and retractable and spaced apart from the deployable / retractable end portion 512. The second portion 516 may include a plurality of deployable flaps 514' similar to the flaps 514 at the end portion 512. The flexible tube 522 of the sliding device 520 is configured to surround the cannula 510 and hold the end portion 512 and the second portion 516 of the cannula in a retracted state. The sliding device 520 is configured to move the cannula 510 along the catheter 12 and insert the end portion 512 into the catheter insertion site IS in a retracted state. As the sliding device 520 retracts along the catheter 12 from the catheter insertion site IS, the end portion 512 of the cannula deploys and engages with the patient's skin at the catheter insertion site IS, and the second portion 516 of the flexible cannula deploys and contacts the outer portion of the patient's skin S.

[0127] In each of the above embodiments, the sliding device 520 can be discarded after the catheter at the insertion site has been secured using the deployable sleeve 510. A new sliding device 520 can be used during catheter 12 removal to maintain sterility, thus reducing the risk of infection.

[0128] refer to Figure 40An auxiliary catheter fixation device 600 according to some embodiments of the present invention is illustrated. The catheter fixation device 600 includes an anchor 610 configured to surround a portion of the catheter 12 at the catheter insertion site IS. The anchor 610 is configured to change shape in response to an external force applied to the catheter 12 and to prevent accidental movement (e.g., piston-like movement) of the catheter 12 at the catheter insertion site IS. For example, the anchor 610 may horizontally collapse relative to the catheter insertion site IS in response to an external force. The anchor 610 may be formed of a variety of materials, including but not limited to various types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.

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

[0130] In the illustrated embodiment, the anchor 610 includes opposing first collars 620 and second collars 630 that are axially aligned and supported by a pair of pins or members 640, 642 in a spaced-apart relationship. Figures 43A to 43B Locking strip 650 ( Figure 42 The locking strip 650 is associated with and configured to secure the first loop 620 tightly to the conduit 12. Thus, once the conduit 12 is secured within the anchor 610, the locking strip 650 can be tightened to hold the conduit 12 in place during the conduit indwelling process.

[0131] Each of the members 640, 642 of the anchor 610 is 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 conduit 12 and the first collar 620. This outwardly extending articulated configuration of the first member 640 and the second member 642 applies pressure to the skin at the conduit insertion site IS and creates a hooking action. Although a pair of members 640, 642 is illustrated, in some embodiments more than two members may be used, and even a single member may be used.

[0132] In the illustrated embodiment, the first collar 620 includes a groove 622 configured to allow the conduit 12 to be received within the first collar 620, and the second collar 630 includes a groove 632 configured to allow the conduit 12 to be received within the second collar 630. Therefore, the anchor 610 can attach to the conduit 12 by pressing each collar 620, 630 onto the conduit 12 such that the conduit passes through each corresponding groove and enters each collar 620, 630, as... Figure 45B and Figure 45CAs illustrated. Each collar 620, 630 is configured to extend around the conduit 12 and clamp the conduit tightly therein.

[0133] In the illustrated embodiment, each member 640, 642 has a thin, elongated structure. The first member 640 includes opposing first end portions 640a and 640b, and opposing inward surfaces 640c and 640d. Similarly, the second member 642 includes opposing first end portions 642a and 642b, and opposing inward surfaces 642c and 642d. The first end portions 640a of the first member 640 and 642a of the second member 642 are fixed to a first collar 620. The second end portions 640b of the first member 640 and 642b of the second member 642 are movably fixed to a second collar 630, such that the first member 640 and the second member 642 can pivot relative to the second collar 630 at their respective second end portions 640b, 642b, as... Figure 41 , Figure 42 , Figure 43B and Figure 44B exemplified.

[0134] In the illustrated embodiment, the first member 640 includes two portions 643a, 643b with reduced material, which allows a portion of the first member 640 to articulate outward in response to an external force applied to the first collar 620 (arrow A4). Figure 44B Part 643a is a notch formed in the outward surface 640d of the first member 640, and part 643b is a notch formed in the inward surface 640c of the first member 640. Similarly, the second member 642 includes two parts 645a, 645b with reduced material, which allows a portion of the second member 642 to articulate outward in response to an external force applied to the first collar 620 (arrow A5). Figure 44B Part 645a is a recess formed in the outward surface 642d of the second member 642, and part 645b is a recess formed in the inward surface 642c of the second member 640. Figure 41 An anchor 610 is illustrated within the catheter insertion site IS, wherein the catheter is not shown for clarity. The first member 640 and the second member 642 each have a portion that can move laterally articulately due to the force applied to the anchor 610. Each laterally articulated portion extends into the patient's skin S at the catheter insertion site IS and restricts movement of the anchor 610 at the insertion site IS. Therefore, the catheter 12, tightly received within the anchor 610, is restricted from movement.

[0135] Figures 45A to 45FExamples are shown for using Figure 40 The step of attaching the anchor 610 of the auxiliary catheter fixation device 600 to the catheter at the catheter insertion site IS. Once the catheter 12 is inserted into the patient, the second ring 630 of the anchor 610 is attached to the catheter 12, as... Figures 45A to 45B As illustrated, a hemostatic bandage 25a (not shown) is then applied to the insertion site IS, and the anchor 610 is pushed downward along the catheter 12 such that the first loop 620 then engages the catheter 12 and receives the catheter therein. Figure 45C The force applied to the catheter 12 and thus to the first ring 620 causes the members 640, 642 to collapse into an articulated configuration to engage with the skin S at the catheter insertion site IS. Figure 45D Then the locking strip 650 is tightened around the conduit 12 to secure the anchor 610 and the conduit 12 at the conduit insertion site IS. Figure 45E The catheter hub 14 is then secured to the main fixation device 20, and a transparent adhesive bandage may be applied to cover the catheter insertion site IS, the hemostatic bandage 25a, the auxiliary catheter fixation device 600, the catheter 12, and the main catheter fixation device 20.

[0136] Figure 46 Examples are shown during dressing changes. Figure 40 The auxiliary catheter fixation device 600 is used. During dressing changes, the transparent dressing 25b and hemostatic bandage 25a are removed, and then the main catheter fixation device 20 is removed, leaving the auxiliary catheter fixation device 600 to secure the catheter 12 to the patient. The catheter 12 can be raised relative to the patient, and the area around the catheter insertion site IS and the location where the main catheter fixation device 20 was previously located can be cleaned, for example, using a sterile cleaning applicator CA. The catheter 12, catheter hub 14, and catheter extension line 12e can also be cleaned at this time. A new main catheter fixation device 20 can be fixed to the patient's skin S, the catheter hub 14 can be fixed within the new main catheter fixation 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, the hemostatic bandage 25a, the auxiliary catheter fixation device 600, and the main catheter fixation device 20.

[0137] Figures 47A to 47D Examples are shown for using Figure 40 The auxiliary catheter fixation device 600 is removed from the patient. The transparent dressing and hemostatic bandage (not shown) at the catheter insertion site IS are removed, and the catheter hub 14 is removed from the main fixation device 20. The locking strip 650 is unlocked and removed. Figure 47B ), and apply a force (e.g., a horizontal force) to the first ring 620 so that members 640, 642 move from an articulated position to a non-articulated position. Figure 47C Then, the anchor 610 is moved upward out of the insertion portion IS, causing the first collar 620 to disengage from the conduit 12. Figure 47D Then, the second ring 630 is disengaged from the catheter 12, and the catheter 12 is removed from the insertion site IS.

[0138] It should 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 used only to distinguish one element from another. For example, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element, without departing from the scope of the invention. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0139] It should be understood that when an element is referred to as being "on" another element, the element may be directly on the other element, or there may be intermediate elements. Conversely, when an element is referred to as being "directly on" another element, there are no intermediate elements. Furthermore, it should be understood that when an element is referred to as being "connected" or "linked" to another element, the element may be directly "connected" or "linked" to the other element, or there may be intermediate elements. Conversely, when an element is referred to as being "directly connected" or "directly linked" to another element, there are no intermediate elements. Other terms used to describe relationships between elements should be interpreted in a similar manner (i.e., "between" and "directly between," "adjacent" and "directly adjacent," etc.).

[0140] This document may use relative terms such as “below” or “above” or “upper” or “lower” or “horizontal” or “vertical” to describe the relationship between one element, layer, or region and another element, layer, or region illustrated in the figures. It should be understood that these terms are intended to cover different orientations of the device, in addition to those depicted in the figures.

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

[0142] The term "approximately," as used herein to refer to measurable values, such as quantity or concentration, is intended to cover variations of ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the specified value, as well as the specified value itself. For example, "approximately X" (where X is a measurable value) is intended to include X and variations of X of ±10%, ±5%, ±1%, ±0.5%, or even ±0.1%. The ranges of measurable values ​​provided herein may include any other ranges and / or individual values ​​thereof.

[0143] All aspects and elements of the embodiments disclosed above can be combined in any way and / or combined with aspects or elements of other embodiments to provide multiple additional embodiments.

Claims

1. A catheter fixation device, comprising: An adjustable length frame having opposite first end portions and second end portions, wherein the first end portions are configured to be movably secured to the patient’s skin at the catheter insertion site, and wherein the second end portions are configured to grasp and hold the catheter inserted into the patient’s body at the catheter insertion site and prevent accidental movement of the catheter at the catheter insertion site.

2. The apparatus according to claim 1, further comprising: A skin-attaching member attached to the first end portion of the frame, wherein the skin-attaching member includes at least one fork configured to hook the patient’s skin at the catheter insertion site, and wherein the skin-attaching member has an active hinge configuration that allows the frame to pivot relative to the patient’s skin without disengaging the at least one fork from the patient’s skin.

3. The apparatus of claim 2, wherein the at least one fork tooth comprises a pair of adjacent, spaced-apart fork teeth.

4. The apparatus according to claim 2, further comprising: A clamp, the clamp being attached to the second end portion, wherein the clamp is configured to tightly receive the catheter or catheter hub therein and To prevent the catheter from moving forward and backward relative to the clamp.

5. The apparatus of claim 1, wherein the frame includes a first segment slidably connected to the second segment, such that the frame has a telescopically adjustable length.

6. The apparatus according to claim 5, further comprising: A locking mechanism operatively associated with the first segment and the second segment, wherein the locking mechanism is configured to restrict movement of the first segment and the second segment relative to each other when the frame is at a selected length.

7. The apparatus according to claim 5, further comprising: A skin-attaching member attached to the first section, wherein the skin-attaching member includes at least one fork configured to hook the patient’s skin at the catheter insertion site, and wherein the skin-attaching member has a movable hinge configuration that allows the frame to pivot relative to the patient’s skin without disengaging the at least one fork from the patient’s skin; as well as A clamp is attached to the second section, wherein the clamp is configured to tightly receive the catheter or catheter hub therein and prevent the catheter from moving forward and backward relative to the clamp.

8. The device of claim 7, wherein one or more portions of the outer surface of the frame include a material coating that inhibits fibroblast adhesion thereto, and wherein one or more portions of the outer surface of the skin-adhesive member include a material coating that inhibits fibroblast adhesion thereto.

9. A catheter fixation device, comprising: A frame, the frame including a first segment slidably connected to a second segment, such that the frame has a telescopically adjustable length; A locking mechanism operatively associated with the first segment and the second segment, wherein the locking mechanism is configured to restrict movement of the first segment and the second segment relative to each other when the frame is at a selected length; A skin-attaching member attached to the first section, wherein the skin-attaching member includes at least one fork configured to hook onto the patient’s skin at the catheter insertion site, and wherein the skin-attaching member has a movable hinge configuration that allows the frame to pivot relative to the patient’s skin without disengaging the at least one fork from the patient’s skin. as well as A clamp is attached to the second section, wherein the clamp is configured to securely receive the catheter therein and prevent accidental movement of the catheter at the catheter insertion site.

10. The apparatus of claim 9, wherein the at least one fork tooth comprises a pair of adjacent, spaced-apart fork teeth.

11. The device of claim 9, wherein one or more portions of the outer surface of the frame include a material coating that inhibits fibroblast adhesion thereto, and wherein one or more portions of the outer surface of the skin-adhesive member include a material coating that inhibits fibroblast adhesion thereto.

12. A catheter fixation 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 the catheter insertion site sufficient to prevent accidental movement of the catheter at the catheter insertion site; and A fitting in fluid communication with the expandable sleeve, wherein the fitting is configured to supply gas or liquid to the expandable sleeve to cause the expandable sleeve to expand, and wherein the fitting is configured to remove the gas or liquid from the expandable sleeve to cause the expandable sleeve to contract.

13. The apparatus of claim 12, wherein the tubing includes an expandable portion configured to provide indication when the sleeve is sufficiently expanded to form the interference fit at the catheter insertion site.

14. The apparatus of claim 12, wherein at least a portion of the tubing includes a visual marker distinguishing the tubing from the conduit.

15. The apparatus of claim 12, wherein the outer surface of the sleeve includes one or more grooves configured to allow effluent to flow from the catheter insertion site.

16. The apparatus of claim 12, wherein one or more portions of the outer surface of the inflatable sleeve comprise a material coating that inhibits fibroblast adhesion thereto.

17. The apparatus of claim 12, wherein the inflatable sleeve comprises two inflatable portions spaced apart from each other.

18. A catheter fixation device, comprising: An inflatable sleeve, movable along the outer 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 sufficient to prevent accidental movement of the catheter at the catheter insertion site.

19. The apparatus of claim 18, wherein the inflatable sheath comprises an annular body having a first portion configured to be positioned within the catheter insertion site and a second portion configured to adjoin a region circumferentially adjacent to the catheter insertion site.

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

21. The apparatus of claim 20, further comprising: A fitting, which is in fluid communication with the port and configured to supply the gas or liquid to the expandable sleeve to cause the expandable sleeve to expand, and wherein the fitting is configured to remove the gas or liquid from the expandable sleeve to cause the expandable sleeve to contract.

22. The apparatus of claim 18, wherein the outer surface of the sleeve includes one or more grooves configured to allow effluent to flow from the catheter insertion site.

23. The apparatus of claim 18, wherein one or more portions of the outer surface of the inflatable sleeve comprise a material coating that inhibits fibroblast adhesion thereto.

24. A catheter fixation device, comprising: An anchor, the anchor being configured to be secured to the patient’s skin adjacent to the catheter insertion site; as well as A sleeve, the sleeve being movably secured to the anchor, wherein the sleeve includes a catheter receiving channel configured to be tightly held at the catheter insertion site as part of the catheter inserted into the patient's body; The anchor and the sleeve are configured to prevent accidental movement of the conduit at the conduit insertion site.

25. The device of claim 24, wherein the anchor comprises a plurality of microneedles configured to be inserted into the patient’s skin.

26. The apparatus of claim 25, wherein the plurality of microneedles are angled relative to the surface of the anchor.

27. The apparatus of claim 24, wherein the sleeve is movably secured to the anchor by a flexible connecting member.

28. The apparatus of claim 24, wherein the anchor comprises a first member and a second member spaced apart from each other, wherein the first member comprises a plurality of microneedles and the second member comprises a plurality of microneedles.

29. The apparatus of claim 28, wherein the anchor further comprises a third member positioned between the first member and the second member and connected to the first member and the second member, and wherein the sleeve 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 patient’s skin such that the catheter insertion site is located between the first member and the second member.

31. A catheter fixation device, comprising: An anchor, the anchor being configured to be secured to the patient’s skin adjacent to the catheter insertion site, wherein the anchor includes a first member, a second member, and a third member, the third member being positioned between and connected to the first and second members such that the first and second members are adjacent and spaced apart, and wherein each of the first and second members includes a plurality of microneedles configured to be inserted into the patient’s skin; as well as A sleeve, the sleeve being movably secured to the third member of the anchor, wherein the sleeve includes a catheter receiving channel configured to be tightly held at the catheter insertion site into the patient's body; The anchor and the sleeve are configured to prevent accidental movement of the conduit at the conduit insertion site.

32. The apparatus of claim 31, wherein the plurality of microneedles are angled relative to the respective surfaces of the first member and the second member.

33. The apparatus of claim 31, wherein the sleeve is movably fixed 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 patient’s skin such that the catheter insertion site is located between the first member and the second member.

35. A catheter fixation device, comprising: A cannula configured to surround a portion of a catheter inserted into a patient at a catheter insertion site, wherein the cannula is movable along the outer surface of the catheter and configured to be positioned at the catheter insertion site, and wherein the cannula includes an expandable and retractable end portion. as well as The sliding component device includes: A flexible tubing configured to surround the cannula and hold the end portion of the cannula in a retracted state, wherein a sliding device is configured to move the cannula along the catheter and insert the retracted end portion into the catheter insertion site, and wherein the sliding device is configured to retract along the catheter from the catheter insertion site such that the end portion of the cannula unfolds and engages with the patient's skin at the catheter insertion site. The accessory is configured to be fixed to the main conduit fixation device.

36. The device of claim 35, wherein the end portion of the sleeve includes deployable and retractable flaps.

37. The device of claim 35, wherein the accessory of the sliding device comprises a pair of opposing wings, each wing including an opening configured to engage with a corresponding post of the main conduit fixing device.

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

39. The apparatus of claim 35, wherein the outer surface of the sleeve includes one or more grooves configured to allow effluent to flow from the catheter insertion site.

40. The device of claim 35, wherein the flexible sheath is integrated within the catheter.

41. The device of claim 35, wherein the flexible cannula further comprises an expandable and retractable second portion, wherein the second portion is spaced apart from the end portion, wherein the flexible tube of the sliding device is configured to surround the flexible cannula and hold the end portion of the flexible cannula and the second portion in a retracted state, wherein the sliding device is configured to move the flexible cannula along the catheter and insert the retracted end portion into the catheter insertion site, and wherein the sliding device is configured to retract along the catheter from the catheter insertion site such that the end portion of the flexible cannula expands and engages the patient's skin at the catheter insertion site, and such that the second portion of the flexible cannula contacts the outer portion of the patient's skin.

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

43. The apparatus of claim 42, wherein the anchoring device comprises opposing first and second collars that are axially aligned and supported by at least one member in a spaced-apart relationship, wherein the at least one member is configured to move from an elongated configuration to an outwardly extending articulated configuration in response to an external force applied to the conduit.

44. The apparatus of claim 43, wherein the first collar includes a groove configured to allow the catheter to be received within the first collar, and wherein the second collar includes a groove configured to allow the catheter to be received within the second collar.

45. The apparatus of claim 43, wherein the at least one component comprises a pair of components in a diameter-opposite relationship.

46. ​​The apparatus of claim 43, wherein the at least one member comprises a first end fixed to the first collar, an opposite second end pivotally fixed to the second collar, and at least two portions of the at least one member located between the first end and the second end having reduced material, the reduced material allowing the portion of the at least one member located between the first end and the second end to articulate outward movement in response to the external force applied to the conduit.

47. The apparatus of claim 46, wherein the at least one member comprises a thin, elongated structure having opposing inward and outward surfaces, wherein a first notch is formed adjacent to the first end in the inward surface and a second notch is formed at an intermediate position between the first end and the second end in the outward surface.

48. The apparatus of claim 43, further comprising: A locking strip associated with the first collar, the locking strip being configured to secure the first collar tightly to the conduit.

49. The apparatus of claim 42, wherein one or more portions of the outer surface of the anchor comprise a material coating that inhibits fibroblast adhesion thereto.

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