Catheter fixation device

Abstract

Secondary catheter fixation devices are described herein, which are configured to hold a catheter or catheter extension line adjacent to a primary catheter fixation device during the indwelling period and / or during dressing changes. Each secondary catheter fixation device is fixed in place so that the primary catheter fixation device can be removed and replaced and / or the secondary fixation device itself can function as a primary fixation device, and so that site irrigation can be performed during dressing changes without increasing the risk of catheter movement.

Description

Technical Field

[0001] The concept of the present invention relates to medical devices, in particular to devices for securing catheters.

Background Art

[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. For most applications, catheters are thin, flexible tubes (soft catheters), but catheters of various hardness levels are available depending on the application. Catheters can be inserted into body cavities, lumens, blood vessels, the brain, skin or adipose tissue. Functionally, catheters enable drainage, administration of fluids or gases, access by surgical instruments, and can also perform a wide variety of other tasks depending on the type of catheter.

[0003] Referring to FIGS. 1 to 4E, when a catheter 12 is indwelled in place in a patient for a long period of time, a fixation technique is often used to fix the catheter 12 in the predetermined position. This is particularly true for central venous catheters (CVCs), each of which is often inserted into the superior vena cava through the patient's neck / chest. Solutions for securing catheters include sutures 11 (FIG. 1) and catheter securing devices 20, such as StatLock available from Becton, Dickinson and Company (1 Becton Drive, Franklin Lakes, New Jersey) 商標This includes a fixation device (Figure 3). In any of these techniques, it is typically necessary that the dressing 25 associated with the insertion site IS of the catheter 12 be changed every 7 days in the best-case scenario. As can be seen in Figures 2A-2C, cleaning around the catheter 12 fixed by sutures 11 may result in incomplete (and therefore insufficient) cleaning (e.g., area A of the patient's skin below the catheter hub 14 is not cleaned), which may in turn increase the risk of central line-associated bloodstream infection (CLABSI).

[0004] When the catheter is secured with an adhesive-based fixation device 20 (Figure 3), the fixation device 20 is typically replaced at the same time as the dressing. During the dressing change, the replacement of the fixation device 20, and cleaning around the insertion site (e.g., cleaning with a disinfectant applicator 30) (Figure 2A), the caregiver must avoid excessive movement of the catheter 12 (e.g., tip displacement, detachment, or "pistoning" of the catheter, which may cause the catheter 12 to shift too much and not be properly positioned in the intended location within the inserted vein or other structure). This is particularly important for certain catheters and insertion sites, such as CVCs.

[0005] Various techniques are currently used for changing the dressing around a catheter. In one technique shown in Figure 4A, the caregiver may attempt to hold the catheter 12 in place using a gloved finger F. However, this technique does not conform to the Aseptic Non-Touch Technique (ANTT) protocol. In an alternative technique shown in Figure 4B, a rolled-up dressing 25 may be used to temporarily hold the catheter 12 when the fixation device 20 is replaced. However, the use of a rolled-up dressing 25 can result in inconsistencies (e.g., the amount of dressing to use). In a third technique shown in Figures 4C-4E, a secondary fixation component, such as adhesive tape 15, may be used to temporarily hold the catheter in place between the removal and replacement of the fixation device 20. This technique requires the caregiver to have the knowledge to perform it and to adhere to the protocol for using the adhesive tape 15. Empirically, this protocol has been found to be frequently ignored. Furthermore, removal of the adhesive tape 15 may be difficult and / or may cause it to move relative to the catheter 12, and in some cases, residue of the adhesive tape 15 may be left on the catheter lumen after removal, thereby potentially causing contamination. [Overview of the project] [Problems that the invention aims to solve]

[0006] It is desirable to provide technologies that improve adherence to protocols, which may improve patient outcomes. [Means for solving the problem]

[0007] According to some embodiments of the concept of the present invention, a catheter fixation device comprises a length-adjustable frame having opposing first and second ends. The first end is configured to be movably fixed to the patient's skin at a catheter insertion site, and the second end is configured to grasp and hold the catheter being inserted into the patient at the catheter insertion site and to prevent inadvertent movement of the catheter at the catheter insertion site. A skin engagement member is attached to the first end of the frame and comprises at least one projection (e.g., a pair of spaced-apart projections) configured to hook onto the patient's skin at the catheter insertion site. The skin engagement member has a living hinge configuration, which allows the frame to pivot relative to the patient's skin without the at least one projection disengaging from the patient's skin. A clip is attached to the second end, and the clip is configured to snugly receive the catheter or catheter hub therein and to prevent unwanted forward and backward movement (i.e., piston motion) of the catheter relative to the clip.

[0008] In some embodiments, the frame comprises a first section slidably connected to a second section, such that the frame has a length adjustable to extendable and retractable lengths. A locking mechanism is operably associated with the first section and the second section and is configured to restrict the movement of the first section and the second section 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 outer surface of the frame are coated with a material, the coating of which inhibits the adhesion of fibroblasts, and one or more portions of the outer surface of the skin engagement member are coated with a material, the coating of which inhibits the adhesion of fibroblasts.

[0010] According to another embodiment of the concept of the present invention, the catheter fixation device comprises an inflatable sleeve surrounding a portion of a catheter and a tube that fluid-communicates with the inflatable sleeve, the tube being configured to supply a fluid or gas (e.g., saline solution or air) to the inflatable sleeve. The inflatable sleeve is configured to expand in response to receiving the fluid or gas from the tube and to form an interference fit at the catheter insertion site that is sufficient to prevent unintended anterior-posterior movement (i.e., piston motion) of the catheter. To allow the inflatable sleeve to deflate, the tube is also configured to remove the fluid or gas from the inflatable sleeve when it is in an expanded configuration. The inflatable sleeve may have multiple portions configured to expand and deflate. For example, in some embodiments, the inflatable sleeve may have two inflatable portions spaced apart from each other.

[0011] In some embodiments, the tube includes an inflatable portion that provides an indication when the inflatable sleeve is fully inflated in order to form the tight 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 is provided with a visual indicia that distinguishes the tube from the catheter.

[0013] In some embodiments, the outer surface of the sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site. In some embodiments, one or more portions of the outer surface of the inflatable sleeve are coated with a material that inhibits the adhesion of fibroblasts thereto.

[0014] According to another embodiment of the concept of the present invention, the catheter fixation device comprises an inflatable sleeve, which is movable along the outer surface of the catheter and is positioned at the catheter insertion site. The inflatable sleeve is configured to form a tight fit at the catheter insertion site that is sufficient to prevent unintended anterior-posterior movement (i.e., piston motion) of the catheter. The inflatable sleeve comprises an annular body, which has a first portion configured to be positioned within the catheter insertion site and a second portion configured to have circumferentially adjacent regions in contact with the catheter insertion site. The second portion comprises a port through which a fluid or gas (e.g., saline solution or air) can be supplied to the inflatable sleeve to inflate it, and the fluid or gas can be removed from the inflatable sleeve through the port to deflate it.

[0015] In some embodiments, the outer surface of the inflatable sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site. In some embodiments, one or more portions of the outer surface of the inflatable sleeve are coated with a material that inhibits the adhesion of fibroblasts thereto.

[0016] According to another embodiment of the concept of the present invention, the catheter fixation device comprises an anchor configured to be fixed to the skin adjacent to the catheter insertion site of a patient, and a hub movably fixed to the anchor, for example by a flexible connecting member. The hub has a catheter receiving channel configured to snugly hold a portion of the catheter to be 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., piston motion) of the catheter at the catheter insertion site. The anchor comprises a plurality of microneedles configured to be inserted into the patient's skin. In some embodiments, the plurality of microneedles are angled with respect to the surface of the anchor.

[0017] In some embodiments, the anchor comprises a first member and a second member in an adjacent, spaced-apart relationship. The first member comprises a plurality of microneedles, and the second member comprises a plurality of microneedles. In some embodiments, the plurality of microneedles are angled with respect to the respective surfaces of the first member and the second member. A third member is positioned between the first member and the second member and connected to the first member and the second member, and the hub is movably fixed to the third member. In some embodiments, the anchor has a U-shape and is configured to be fixed to the patient so as to be located between the first member and the second member at the catheter insertion site.

[0018] According to another embodiment of the concept of the present invention, the catheter fixation device comprises a sleeve configured to surround a portion of the catheter at a catheter insertion site, and a slider device. The sleeve is movable along the outer 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 the catheter. For example, the sleeve surrounds the outer surface of the catheter and is movable along the outer surface of the catheter, and the sleeve and the catheter are surrounded by an outer sleeve. The sleeve has an expandable and contractible end. For example, the end of the sleeve may have one or more expandable and contractible flaps. The slider device comprises a flexible tube, which is configured to surround the sleeve and to maintain the end of the flexible sleeve in a contracted state. The slider device is configured to move along the catheter and to insert the contracted end into the catheter insertion site. As the slider device retracts along the catheter from the catheter insertion site, the sleeve end expands and engages with the patient's skin at the catheter insertion site.

[0019] The slider device is configured to be fixed to a primary catheter fixation device, such as a STATLOCK joint. 商標 The device includes a fixation device (Figure 3). For example, in some embodiments, the slider device comprises a pair of opposing wings, each wing configured to engage with and be fixed to the primary catheter fixation device. For example, in some embodiments, each wing may have an opening configured to engage with individual posts associated with the primary catheter fixation device.

[0020] In some embodiments, one or more portions of the outer surface of the sleeve are coated with a substance, the coating of which inhibits the adhesion of fibroblasts. In some embodiments, the outer surface of the sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site.

[0021] In some embodiments, the sleeve may have a second portion, which is expandable and contractible and is spaced adjacent to the expandable and contractible end. The flexible tube of the slider device is configured to surround the sleeve and to maintain the end and the second portion of the sleeve in a contracted state. The slider device is configured to move the sleeve along the catheter and to insert the contracted end into the catheter insertion site. As the slider device retracts along the catheter from the catheter insertion site, the sleeve end expands and engages with the patient's skin at the catheter insertion site, and the second portion of the sleeve contacts the outer portion of the patient's skin.

[0022] According to another embodiment of the concept of the present invention, a catheter fixation device or anchor is provided, the anchor being configured to surround a portion of the catheter at the catheter insertion site and to change shape in response to an external force applied to the catheter and to prevent unintended anterior-posterior movement (i.e., piston motion) of the catheter at the catheter insertion site. In some embodiments, the anchor device comprises a first collar and a second collar that are aligned laterally and opposed to each other, the first and second collars being supported in a spaced-out relationship by at least one member. A locking strap is associated with the first collar and configured to snugly fix 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 comprises a slot configured to allow the catheter to be received within the first collar, and the second collar comprises a slot configured to allow the catheter to be received within the second collar. The at least one member comprises a first end fixed to the first collar, an opposing second end pivotally fixed to the second collar, and at least two portions of the at least one member between the first end and the second end, the at least two portions having a reduced material, and the reduced material allows a portion of the at least one member between the first end and the second end to articulate outwardly in response to an external force applied to the catheter. In some embodiments, the at least one member has an elongated configuration having opposing inner and outer surfaces. A first notch is formed in the inner surface adjacent the first end, and a second notch is formed in the outer surface at an intermediate position between the first end and the second end.

[0024] In some embodiments, the at least one member comprises a pair of members in diametrically opposed relation.

[0025] In some embodiments, the anchor comprises one or more portions of an outer surface of the anchor, and a coating of the substance on the one or more portions inhibits fibroblast adhesion thereto.

[0026] It should be noted that aspects of the invention 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 may also be used for in-device sample preparation for subsequent analytical procedures. Applicant reserves the right to amend the originally filed claims and / or to file new claims accordingly, including the right to amend the originally filed claims to depend on and / or incorporate features of any other claim or claims even if not originally claimed as such. These and other objects and / or aspects of the present invention are described in detail in the specification set forth below.

[0027] The accompanying drawings, which form a part of the present specification, illustrate various embodiments of the inventive concept. Together with the description, the drawings serve to fully explain embodiments of the inventive concept. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] [Figure 1] Figure 1 illustrates securing a central venous catheter line to a patient using sutures. [Figure 2A] Figure 2A illustrates inadequate site cleaning when a suture is used to secure a central venous catheter line as shown in Figure 1. [Figure 2B] Figure 2B illustrates inadequate site cleaning when a suture is used to secure a central venous catheter line as shown in Figure 1. [Figure 2C] Figure 2C illustrates inadequate site cleaning when a suture is used to secure a central venous catheter line as shown in Figure 1. [Figure 3] Figure 3 shows a known primary catheter securing device (adhesive base). [Figure 4A] Figure 4A shows current techniques used to temporarily secure a catheter during dressing changes. [Figure 4B] Figure 4B shows current techniques used to temporarily secure a catheter during dressing changes. [Figure 4C] Figure 4C shows current techniques used to temporarily secure a catheter during dressing changes. [Figure 4D] Figure 4D shows current techniques used to temporarily secure a catheter during dressing changes. [Figure 4E] Figure 4E shows current techniques used to temporarily secure a catheter during dressing changes. [Figure 5] Figure 5 is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 6A] Figure 6A shows the adjustable frame of the secondary catheter fixation device shown in Figure 5 in the retracted position. [Figure 6B] Figure 6B shows the adjustable frame of the secondary catheter fixation device of Figure 5 in the extended position. [Figure 6C] Figure 6C is an exploded view of the adjustable frame of the secondary catheter fixation device shown in Figure 5. [Figure 6D] Figure 6D is a side view of the adjustable frame of the secondary catheter fixation device shown in Figure 5. [Figure 7] Figure 7 is a side view of the secondary catheter fixation device shown in Figure 5 when in use. [Figure 8A] Figure 8A shows the steps for installing the secondary catheter fixation device shown in Figure 5 at the catheter insertion site. [Figure 8B] Figure 8B shows the steps for installing the secondary catheter fixation device shown in Figure 5 at the catheter insertion site. [Figure 8C]Figure 8C shows the steps for installing the secondary catheter fixation device shown in Figure 5 at the catheter insertion site. [Figure 8D] Figure 8D shows the steps for installing the secondary catheter fixation device shown in Figure 5 at the catheter insertion site. [Figure 9] Figure 9 shows the secondary catheter fixation device from Figure 5 during site irrigation. [Figure 10A] Figure 10A shows the steps for removing the secondary catheter fixation device shown in Figure 5 from the patient. [Figure 10B] Figure 10B shows the steps for removing the secondary catheter fixation device shown in Figure 5 from the patient. [Figure 10C] Figure 10C shows the steps for removing the secondary catheter fixation device shown in Figure 5 from the patient. [Figure 10D] Figure 10D shows the steps for removing the secondary catheter fixation device shown in Figure 5 from the patient. [Figure 11A] Figure 11A is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. In Figure 11A, the inflatable sleeve is integrated within the catheter. [Figure 11B] Figure 11B is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. In Figure 11B, the inflatable sleeve is an add-on device to the catheter. [Figure 12] Figure 12 shows the inflatable sleeve of the secondary catheter fixation device of Figure 11A in a contracted configuration (top) and an expanded configuration (bottom). [Figure 13] Figure 13 is a bottom perspective view of the secondary catheter fixation device of Figure 11A, showing a groove in the inflatable sleeve that can help drain exudate from the catheter insertion site. [Figure 14] Figure 14 is a cross-sectional view of the deflated configuration of the inflatable sleeve of the secondary catheter fixation device shown in Figure 12. [Figure 15] Figure 15 is a cross-sectional view of the inflated configuration of the inflatable sleeve of the secondary catheter fixation device shown in Figure 12. [Figure 16A] Figure 16A shows the steps for installing the secondary catheter fixation device shown in Figure 11A at the catheter insertion site. [Figure 16B] Figure 16B shows the steps for installing the secondary catheter fixation device shown in Figure 11A at the catheter insertion site. [Figure 16C] Figure 16C shows the steps for installing the secondary catheter fixation device shown in Figure 11A at the catheter insertion site. [Figure 16D] Figure 16D shows the steps for installing the secondary catheter fixation device shown in Figure 11A at the catheter insertion site. [Figure 17A] Figure 17A shows the secondary catheter fixation device from Figure 11A during a dressing change. [Figure 17B] Figure 17B shows the secondary catheter fixation device from Figure 11A during a dressing change. [Figure 18A] Figure 18A shows the steps for removing the secondary catheter fixation device shown in Figure 11A from the patient. [Figure 18B] Figure 18B shows the steps for removing the secondary catheter fixation device shown in Figure 11A from the patient. [Figure 19] Figure 19 is a top perspective view of a secondary catheter fixation device movably fixed to a catheter, according to several embodiments of the concept of the present invention. [Figure 20] Figure 20 is an enlarged perspective view of the secondary catheter fixation device shown in Figure 19. [Figure 21] Figure 21 shows the secondary catheter fixation device from Figure 19, positioned at the catheter insertion site. [Figure 22A] Figure 22A is a cross-sectional view of the secondary catheter fixation device of Figure 21, in a contracted configuration along line 22A to line 22A. [Figure 22B]Figure 22B is a cross-sectional view of the secondary catheter fixation device shown in Figure 21, in an expanded configuration along line 22A to line 22A. [Figure 22C] Figure 22C is a top perspective view of the secondary catheter fixation device shown in Figure 21, which shows a groove that can help drain exudate from the catheter insertion site. [Figure 23] Figure 23 is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 24A] Figure 24A is a top perspective view of the anchoring device of the secondary catheter fixation device shown in Figure 22. [Figure 24B] Figure 24B is a side view of the anchoring device shown in Figure 24A, attached to the patient's skin. [Figure 25A] Figure 25A is a top perspective view of the catheter-retaining hub of the secondary catheter fixation device shown in Figure 24. [Figure 25B] Figure 25B shows the catheter fixed within the hub that holds the catheter in Figure 25A. [Figure 26] Figure 26 is a top perspective view of the flexible joint of the secondary catheter fixation device shown in Figure 23, which movably fixes the hub that holds the catheter to the anchoring device. [Figure 27] Figure 27 shows the hub that holds the catheter and the flexible joint of Figure 26 attached to the anchoring device. [Figure 28A] Figure 28A shows the movement of the catheter and the secondary catheter fixation device in Figure 23 when the catheter is not attached to the primary fixation device. [Figure 28B] Figure 28B shows the movement of the catheter and the secondary catheter fixation device in Figure 23 when the catheter is not attached to the primary fixation device. [Figure 28C]Figure 28C shows the movement of the catheter and the secondary catheter fixation device in Figure 23 when the catheter is not attached to the primary fixation device. [Figure 29] Figure 29 is an exploded view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 30] Figure 30 shows the slider device and expandable sleeve of the secondary catheter fixation device of Figure 29, where the slider device and the expandable sleeve are engaged, and the expandable sleeve is in a collapsed configuration. [Figure 31] Figure 31 is a magnified partial perspective view of the slider device and expandable sleeve when the expandable sleeve is in a collapsed configuration. [Figure 32] Figure 32 is a top perspective view of the secondary catheter fixation device shown in Figure 29 at the catheter insertion site. [Figure 33] Figure 33 is an enlarged lower perspective view of an expandable inner sleeve located within the patient's skin and in an expanded configuration. [Figure 34A] Figure 34A shows the steps for installing the secondary catheter fixation device shown in Figure 29 at the catheter insertion site. [Figure 34B] Figure 34B shows the steps for installing the secondary catheter fixation device shown in Figure 29 at the catheter insertion site. [Figure 34C] Figure 34C shows the steps for installing the secondary catheter fixation device shown in Figure 29 at the catheter insertion site. [Figure 34D] Figure 34D shows the steps for installing the secondary catheter fixation device shown in Figure 29 at the catheter insertion site. [Figure 35A] Figure 35A shows the secondary catheter fixation device from Figure 29 during a dressing change. [Figure 35B] Figure 35B shows the secondary catheter fixation device from Figure 29 during a dressing change. [Figure 35C] Figure 35C shows the secondary catheter fixation device from Figure 29 during a dressing change. [Figure 36A] Figure 36A shows the steps for removing the secondary catheter fixation device shown in Figure 29 from the patient. [Figure 36B] Figure 36B shows the steps for removing the secondary catheter fixation device shown in Figure 29 from the patient. [Figure 36C] Figure 36C shows the steps for removing the secondary catheter fixation device shown in Figure 29 from the patient. [Figure 36D] Figure 36D shows the steps for removing the secondary catheter fixation device shown in Figure 29 from the patient. [Figure 37] Figure 37 is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 38] Figure 38 is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 39] Figure 39 is a side view of the expandable sleeve of the secondary catheter fixation device shown in Figure 38. [Figure 40] Figure 40 is a top perspective view of a secondary catheter fixation device according to several embodiments of the concept of the present invention. [Figure 41] Figure 41 is a side view of the anchor of the secondary catheter fixation device shown in Figure 40, positioned within the catheter insertion site. For clarity, parts of the catheter and the anchor have been removed. [Figure 42] Figure 42 is a top perspective view of the secondary catheter fixation device shown in Figure 40, installed at the catheter insertion site. [Figure 43A] Figure 43A is a perspective view of the anchor in Figure 40 in a non-articulated configuration. [Figure 43B] Figure 43B is a perspective view of the anchor in Figure 40 in an articulated configuration. [Figure 44A] Figure 44A is a side view of the anchor in Figure 40 in a non-articulated configuration, showing a notch in the anchor member that facilitates articulation. [Figure 44B] Figure 44B is a side view of the anchor in Figure 44A in an articulated configuration. [Figure 45A] Figure 45A shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 45B] Figure 45B shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 45C] Figure 45C shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 45D] Figure 45D shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 45E] Figure 45E shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 45F] Figure 45F shows the steps for installing the secondary catheter fixation device shown in Figure 40 at the catheter insertion site. [Figure 46] Figure 46 shows the secondary catheter fixation device from Figure 40 during site irrigation. [Figure 47A] Figure 47A shows the process of removing the secondary catheter fixation device from the patient, as shown in Figure 40. [Figure 47B] Figure 47B shows the process of removing the secondary catheter fixation device from the patient, as shown in Figure 40. [Figure 47C] Figure 47C shows the process of removing the secondary catheter fixation device from the patient, as shown in Figure 40. [Figure 47D] Figure 47D shows the process of removing the secondary catheter fixation device from the patient, as shown in Figure 40. [Modes for carrying out the invention]

[0029] The concept of embodiments of the present invention is directed toward a catheter fixation solution that helps minimize catheter migration and dispersion during catheter dressing changes without increasing other clinical burdens, such as microbial growth, patient pain, and significant impact on workflow. The concept of embodiments of the present invention provides a secondary catheter fixation device configured to hold the catheter or catheter hub near the insertion site of the catheter in the patient's skin. The secondary catheter fixation device enables 360° site cleaning without increasing the risk of catheter movement during dressing changes of the catheter, such as long-dwelling IV catheters (e.g., peripherally inserted central catheter (PICC) lines and central venous catheter (CVC) lines). Hereinafter, the concept of embodiments of the present invention will be described in further detail below with reference to the drawings.

[0030] Referring to Figures 5, 6A-6D and 7, a secondary catheter fixation device 100 according to several embodiments of the concept of the present invention is shown. The secondary catheter fixation device 100 comprises a length-adjustable frame 110 with a skin engagement member 120 configured to be fixed to the patient's skin at a catheter insertion site IS, and a clip 130, the clip 130 snugly receiving a catheter hub 14 therein. The skin engagement member 120 is fixed to a first end 110a of the frame 110, and the clip 130 is fixed adjacent to the opposing second end 110b of the frame 110. The first end 110a is equipped with the skin engagement member 120, which is configured to be fixed to the patient's skin at a catheter insertion site IS, and allows the frame 110 to be moved or rotated at the catheter insertion site IS. The second end 110b of the frame 110 is equipped with a clip 130, which is configured to grip and hold the catheter hub 14 and to prevent unintended movement of the catheter 12 at the catheter insertion site IS.

[0031] Figure 5 shows the secondary catheter fixation device 100 in its installed configuration, where the 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 the clip 130, thereby snugly fixing the catheter hub 14 and the catheter 12 to the frame 110. Figure 7 is a side view of the secondary catheter fixation device 100 in its installed configuration and shows the skin engagement member 120 fixed to the patient's skin S at the catheter insertion site IS. The catheter hub 14 is fixed to the primary catheter fixation device, such as STATLOCK. 商標The frame 110 is configured to be fixed to a fixation device (Figure 3), and the frame 110 is positioned near the patient's skin S. As described later, for example, during dressing changes and cleaning around the catheter insertion site IS, when the catheter hub 14 is removed from the primary catheter fixation device, the frame 110 and the catheter 12 attached thereto are rotated away from the patient to allow access to the area around the catheter insertion site IS.

[0032] The length-adjustable frame 110 has a generally slender configuration, and its first end 110a has an arc-shaped or rounded shape as shown in the figure. As will be described later, the rounded shape of the first end 110a allows the frame 110 to rotate without interfering with the patient's skin during catheter site irrigation.

[0033] The illustrated frame 110 includes a first section 112 slidably connected to a second section 114 such that the frame has a length that is adjustable to extend and retract. In the illustrated embodiment, the second section 114 is inserted into the first section 112. However, in other embodiments, this may be reversed, and the first section 112 may be inserted into the second section 114. In the illustrated embodiment, the first section 112 has a generally elongated rectangular configuration and includes a rounded first end 116a and an opposing second end 116b. The rounded first end 116a is also the rounded first end 110a of the frame 110. The second section 114 has a generally elongated rectangular configuration and includes an opposing first end 118a and a second end 118b. The first section 112 comprises 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 116a comprises a plurality of faces 117a, 117b, 117c, which are angled toward each other to form the arcuate or rounded first end. However, the concept of the embodiments of the present invention is not limited to three faces angled toward each other. In other embodiments, three or more faces angled toward each other, or even two faces angled toward each other, may be used. In addition, in some embodiments, the first end 116a may be a continuous smooth surface.

[0034] The first section 112 of the illustrated frame also comprises lower walls 112e, 112f extending inward, the lower walls 112e, 112f forming channels 113 for slidably receiving the second section 114 of the frame. The second section 114 of the frame comprises a top wall 114a, opposing side walls 114b, 114c extending downward from the top wall 114a, and lower walls 114d, 114e extending inward. The first section and the second sections 112, 114 may be formed from a variety of materials, including but not limited to plastics, ceramics, metals, elastomers, or combinations thereof of any kind. The skin engagement member 120 may be formed from various types of plastics and elastomers.

[0035] Figure 6A shows the frame 110 having the first section 112 and the second section 114 in a retracted configuration, and Figure 6B shows the frame 110 having the first section 112 and the second section 114 in an extended configuration. A locking mechanism 140 is operably associated with the first section 112 and the second section 114 and is configured to restrict the movement of the first section 112 and the second section 114 relative to each other when the frame 110 is at a selected length. The illustrated locking mechanism 140 comprises two buttons 142a, 142b which can be pressed by the user to release a mechanism (not shown) that restrains the movement of the first section 112 and the second section 114 relative to each other.

[0036] In some embodiments, the first section 112 and the second section 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 section 112 and the second section 114 of the frame 110 can be moved only to a predetermined length.

[0037] The skin engagement member 120 is attached to the first end 116a of the first section 112 of the frame 110 and comprises a pair of spaced-apart adjacent projections 122a, 122b configured to hook onto the patient's skin 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 swung relative to the patient's skin S without disengaging the projections 122a, 122b from the patient's skin S.

[0038] The clip 130 is attached to the upper wall 114a of the second section 114 adjacent to the end 118b of the second section 114, and is configured to snugly receive the catheter hub 14 therein and to prevent the catheter 12 from moving forward or backward (i.e., piston-like) relative to the clip 130. In other embodiments, the clip 130 may be configured to receive the catheter 12 therein.

[0039] One or more portions of the outer surface of the protrusions 122a, 122b may have a coating of a substance, which inhibits the adhesion of fibroblasts thereto. Similarly, one or more portions of the outer surface of various walls 112a to 114f of the first section 112 and one or more portions of the outer surface of various walls 114a to 114e of the second section 114 may have a coating of a substance, which inhibits the adhesion of fibroblasts thereto.

[0040] Figures 8A to 8D illustrate the steps for installing the secondary catheter fixation device 100 shown in Figures 5, 6A to 6D, and 7 at the catheter insertion site IS. In Figure 8A, the frame 110 is held approximately perpendicular to the patient's skin S at the catheter insertion site IS, and the projections 122a and 122b of the skin engagement member 120 are pushed into the skin S at the catheter insertion site IS. In Figure 8B, a hemostatic bandage 25a is placed at the catheter insertion site IS. Next, the frame 110 is tilted downward toward the patient's skin S (Figure 8C), and the catheter hub 14 is attached to the clip 130 by snap-fit. When the frame 110 is placed horizontally, the living hinge structure of the skin engagement member 120 allows the skin engagement member 120 to bend and lock beneath the surface of the patient's skin S (Figures 7 and 8D). A transparent dressing may be applied over the catheter insertion site IS, the secondary catheter fixation device 100, and the catheter hub 14.

[0041] Figure 9 shows the secondary catheter fixation device 100 in Figures 5, 6A-6D and 7 during a dressing change. The hemostatic bandage 25a and any other dressings are removed, the catheter hub 14 is released from the primary catheter fixation device (not shown), the primary catheter fixation device is removed from the patient, and then the frame 110 having the catheter hub 14 and the catheter 12 fixed to the catheter hub 14 is rotated upward to provide access to the area around the catheter insertion site IS and the area where the primary catheter fixation device was previously positioned. These areas can be cleaned, for example, using a disinfectant cleaning applicator CA. At this time, the catheter 12, catheter hub 14 and catheter extension line 12e can also be cleaned.

[0042] Figures 10A to 10D illustrate the steps for removing the secondary catheter fixation device 100 from the patient, as shown in Figures 5, 6A to 6D, and 7. The transparent dressing (not shown) surrounding the catheter insertion site IS is removed from the patient, the catheter hub 14 is released from the primary catheter fixation device (not shown), and the catheter hub 14 is released from the clip 130 of the secondary catheter fixation device 100. The hemostatic bandage 25a is removed (Figure 10C), and the frame 110 is tilted upward so that it is in a generally vertical orientation and moved outward from the patient's skin S. The living hinge configuration of the skin engagement member 120 allows the projections 122a and 122b to be detached from the skin S and removed.

[0043] Referring to Figures 11A-11B and 12, a secondary catheter fixation device 200 according to several embodiments of the concept of the present invention is shown. The catheter fixation device 200 comprises an inflatable sleeve 210 that surrounds a portion of the catheter 12 at the catheter insertion site IS, and a channel or tube 220 that is in fluid communication with the inflatable sleeve 210 and configured to supply fluid or gas to the inflatable sleeve 210. The channel or tube 220 is a separate channel independent of the catheter lumen. The inflatable sleeve 210 may be a separate device surrounding the catheter 12, as shown in Figure 11A, or it may be integrally formed within the catheter 12, as shown in Figure 11B. The inflatable sleeve 210 may be formed from various elastomer materials, such as rubber.

[0044] The inflatable sleeve 210 is configured to inflate like a balloon in response to receiving a fluid or gas (e.g., saline solution or air) from the tube 220, and to form a sufficient tight fit at the catheter insertion site IS to prevent unintended movement of the catheter 12 at the catheter insertion site IS. The tube 220 is also configured to allow the fluid or gas to be removed from the inflatable sleeve 210 in its inflated state, thereby allowing the inflatable sleeve 210 to deflate.

[0045] The inflatable sleeve 210 may have two or more portions configured to inflate at the catheter insertion site IS and then deflate. The concept of embodiments of the present invention is not limited to sleeves having only a single portion that inflates and deflates. For example, as shown in Figures 12, 14 and 15, an inflatable sleeve 210 according to an embodiment of the concept of the present invention may include two inflatable portions 212a and 212b adjacent to each other and spaced apart. The configuration of the inflatable sleeve 200 in Figures 12, 14 and 15 allows the patient's skin S to be "sandwiched" between the two inflatable portions 212a and 212b at the catheter insertion site IS, thereby providing additional resistance to unintended movement of the catheter 12.

[0046] In the embodiment illustrated in Figure 11A, the tube 220 is provided with an inflatable portion 224, which is configured to provide an indication when the inflatable sleeve 210 is sufficiently inflated to form a tight fit at the catheter insertion site IS and to reduce the risk of over-inflation of the sleeve 210. In addition, to prevent any port-identification errors, the port 222 of the tube 220 and / or the tube 220 may be provided with a visual indication 225 (e.g., color coding) to distinguish it from the port associated with the catheter 12. When not in use, the port 222 of the tube 220 can be closed by a cap 226.

[0047] In some embodiments, as shown in Figure 13, the outer surface 210a of the sleeve 210 may have one or more grooves 228 (e.g., microchannels) extending axially in the sleeve 210 and catheter 12, the one or more grooves being configured to allow exudate EX to flow out of the catheter insertion site IS and to be absorbed by a hemostatic bandage or other dressing at the catheter insertion site IS. The grooves 228 function as capillaries to help drain the exudate EX and to prevent occlusion of the 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 a material, the coating of which inhibits the adhesion of fibroblasts.

[0048] Figures 16A to 16D illustrate the steps for installing the secondary catheter fixation device 200 shown in Figure 11A at the catheter insertion site IS. In Figure 16A, the catheter 12 and the inflatable sleeve 210 are inserted into the patient at the catheter insertion site IS in accordance with the guidelines of the medical facility. In Figure 16B, a syringe SY containing fluid or gas F / G is attached to the port 222 of the tube 220, and then the inflatable sleeve 210 is inflated using the fluid or gas F / G flowing from the syringe SY to form a sufficient tight fit at the catheter insertion site IS to prevent unintended movement of the catheter 12 (Figure 16C). Subsequently, a hemostatic bandage 25a is provided at the catheter insertion site IS, and a clear dressing 25b is provided across the catheter insertion site IS and the catheter hub 14 (Figure 16D). Furthermore, as shown in Figure 16D, the inflatable portion 224 of the tube provides an indication that the inflatable sleeve 210 is sufficiently inflated to form a tight fit at the catheter insertion site IS.

[0049] Figures 17A and 17B show the secondary catheter fixation device 200 of Figure 11A during a dressing change. The transparent dressing 25b (Figure 16D) and the hemostatic bandage 25a (Figure 16D) are removed, and the catheter hub 14 is fixed to the primary catheter fixation device, such as STATLOCK. 商標 The catheter 12 and hub 14 are removed from the fixation device (Figure 3) and lifted from the patient's skin S to provide access to the area around the catheter insertion site IS and the area where the primary catheter fixation device was previously positioned (Figure 17A). These areas can be cleaned, for example, using a disinfectant cleaning applicator CA. During this process, the catheter 12, catheter hub 14, and catheter extension line 12e can be cleaned simultaneously. During cleaning, the inflated sleeve 210 holds the catheter 12 in place at the catheter insertion site IS. A new primary catheter fixation device, such as STATLOCK, is then installed. 商標An immobilization device (Figure 3) is attached to the patient, the catheter hub 14 is attached to the primary catheter immobilization device, a new hemostatic bandage 25a is provided at the catheter insertion site IS, and a new transparent bandage 25b is applied to the patient so as to cover the catheter insertion site IS, the secondary immobilization device 200, and the primary immobilization device (Figure 17B).

[0050] Figures 18A and 18B illustrate the steps for removing the secondary catheter fixation device 200 shown in Figure 11A from the patient. The transparent dressing 25b (Figure 17B) and the hemostatic bandage 25a (Figure 17B) are removed from the catheter insertion site IS. A syringe SY is attached to the port 222 of the tube 220, and the fluid or gas F / G is drawn out of the expanded sleeve 210 by the syringe SY, thereby de-airing the sleeve 210 at the catheter insertion site IS (Figure 18A). The catheter 12 can then be removed from the patient together with the expandable sleeve 210 (Figure 18B).

[0051] Referring to Figures 19–21 and 22A–22C, a secondary catheter fixation device 300 according to several embodiments of the concept of the present invention is shown. The secondary catheter fixation device 300 is an inflatable sleeve 310 that is movable along the outer surface of a catheter 12 and configured to be positioned at a catheter insertion site IS. The inflatable sleeve 310 is configured to form a sufficient tight fit at the catheter insertion site IS to prevent unintended anterior-posterior movement (i.e., piston motion) of the catheter 12 at the catheter insertion site IS. The inflatable sleeve 310 has an annular body 312 (Figure 20) that defines a passage 313 into which the catheter 12 is inserted. The illustrated annular body 312 also comprises a first portion 314 configured to be positioned within the catheter insertion site IS and a second portion 316 having a larger diameter than the first portion 314, the second portion being able to abut against a region circumferentially adjacent to the catheter insertion site IS. The annular body 312 is provided with a port 318 through which a fluid or gas is supplied to the inflatable sleeve 310, for example, via a tube (e.g., tube 220 in Figure 11A), causing the inflatable sleeve 310 to inflate. Similarly, the fluid or gas is removed from the inflatable sleeve 310 via the port 318, causing the inflatable sleeve 310 to deflate, so that the sleeve 310 and the catheter 12 can be removed from the catheter insertion site IS.

[0052] Figure 22A is a cross-sectional view of the secondary catheter fixation device of Figure 21 along line 22A to line 22A, showing the inflatable sleeve 310 in an uninflated (i.e., deflated) 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 through the port 318, the annular body 312 inflates as indicated by arrow A3. Figure 22B shows the inflatable sleeve 310 of Figure 22A in an inflated configuration, forming a sufficient tight fit at the catheter insertion site IS to prevent unintended movement of the catheter 12 at the catheter insertion site IS.

[0053] In some embodiments, as shown in Figure 22C, the outer surface 310a of the sleeve 310 may have one or more grooves 328 (e.g., microchannels) extending axially along the sleeve 310, the one or more grooves 328 allowing exudate EX to flow out of the catheter insertion site IS and be absorbed by a hemostatic bandage or other dressing at the catheter insertion site IS. The grooves 328 function as capillaries to help drain the exudate EX and prevent occlusion of the 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 a material, the coating of which inhibits the adhesion of fibroblasts.

[0054] Referring to Figure 23, a secondary catheter fixation device 400 is shown that conforms to several embodiments of the concept of the present invention. The catheter fixation device 400 comprises an anchor 410 configured to be fixed to the patient's skin IS adjacent to the catheter insertion site, and a hub 420 that holds a catheter movably fixed to the anchor 410, for example by a connecting member 430. As will be described later, the anchor 410 comprises a plurality of microneedles 416, which are configured to be inserted into the patient's skin S adjacent to the catheter insertion site IS, and are configured to resist movement of the anchor 410 in the X, Y, and Z directions.

[0055] The illustrated catheter-holding hub 420 is a semi-elastic component having a catheter-receiving groove or channel 422 formed therein, which is configured to snugly hold a portion of the catheter 12. The catheter-holding hub 420 substantially holds the catheter 12 in place by forming a friction joint with the catheter 12. In the illustrated embodiment, the opposing end portions 422a and 422b of the catheter-receiving channel 422 extend toward each other and thus protrude or extend across the catheter-receiving channel 422. However, embodiments of the opposing end portions 422a and 422b are not limited to these. For example, only the first opposing end portion 422a may extend toward the opposing end portion 422b; or only the second opposing end portion 422b may extend toward the first opposing end portion 422a. The protruding configuration of either or both of the opposing end portions 422a and 422b of the catheter receiving channel 422 helps to hold the catheter 12 within the catheter receiving channel 422 and prevent the catheter 12 from unintentionally dislodging from the hub 420. In addition, the snug 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 hub 420 that holds the catheter may be formed from a variety of materials, including but not limited to plastics, ceramics, metals, elastomers, or combinations thereof.

[0056] The illustrated anchor 410 comprises an elongated first member 412 and an elongated second member 414 adjacent to and spaced apart from it. As shown, the first member 412 has a plurality of microneedles 416 extending downward from its lower surface 412a, and the second member 414 has a plurality of microneedles 416 extending downward from its lower surface 414a. The anchor 410 may be formed from a variety of materials, including but not limited to plastics, ceramics, metals, or combinations thereof of any kind.

[0057] In the illustrated embodiment, the plurality of microneedles 416 are angled with respect to the lower surfaces 412a, 414a of the first member 412 and the second member 414. A third member 418 is positioned between the first member 412 and the second member 414 and connected to the first member 412 and the second member 414 such that the anchor 410 has a U-shape. As illustrated, the U-shape of the anchor 410 allows the anchor to be fixed to the patient's skin S such that the catheter insertion site IS is between the first member 412 and the second member 414. Embodiments of the concept of the present invention are not limited to the illustrated configuration of the anchor 410. The first member 412 and the second member 414 may have a variety of shapes and configurations.

[0058] The hub 420 that holds the catheter is movably fixed to the third member 418 of the anchor 410 via a connecting member 430. The connecting member 430 has a first end 432 configured to be attached to the hub 420 that holds the catheter, and an opposing second end 434, the second end 434 having a hook portion 436, the hook portion 436 configured to receive the third member 418 of the anchor 410 and to allow the connecting member 430 to pivot.

[0059] Figures 28A to 28C show the movement of the secondary catheter fixation device 400 in Figure 23. In Figure 28A, the anchor 410 of the secondary catheter fixation device 400 is attached to the patient's skin S and fixed within the catheter receiving channel 422 of the catheter-holding hub 420, and the catheter-holding hub 420 is a primary catheter fixation device, such as STATLOCK. 商標 The catheter is positioned so that it can be fixed to a fixation device (Figure 3). Figures 28B–28C show the catheter hub 14 released from the primary catheter fixation device, as well as the catheter holding hub 420 and the catheter 12, which are flipped up from the patient's skin S to provide access to the area around the catheter insertion site IS so that the area around the catheter insertion site IS can be cleaned, for example, with a disinfectant cleaning applicator.

[0060] Referring to Figure 29, a secondary catheter fixation device 500 is shown that conforms to several embodiments of the concept of the present invention. The catheter fixation device 500 comprises a sleeve 510 configured to form part of a catheter 12 and a slider device 520. The sleeve 510 is formed of a flexible material and comprises a lumen 511, which is configured to receive the catheter 12 through it and to allow the sleeve 510 to move along the outer surface of the catheter 12. The sleeve 510 comprises an expandable and contractible distal end portion 512. In the illustrated example, the distal end portion 512 of the sleeve 510 comprises a plurality of expandable wings or flaps 514. The flaps 514 fold when the slider device 520 is pushed over them, and the flaps 514 unfold when the slider device 520 is pulled away from them. As the distal end portion 512 of the sleeve 510 is positioned at the catheter insertion site IS and the slider device 520 is pulled away, the flap 514 unfolds to grasp the patient's skin S, as shown in Figure 33, thereby anchoring the sleeve 510 to the catheter insertion site IS.

[0061] The sleeve 510 can be formed from various elastomer materials. In addition, in order to ensure that the sleeve 510 remains within the skin S at the catheter insertion site IS, the sleeve 510 can be reinforced with a highly rigid material at selected locations to provide the sleeve 510 with selected rigidity.

[0062] As shown in Figure 31, the slider device 520 comprises a tube 522 configured to surround the sleeve 510 and maintain the flap 514 of the sleeve end 512 in a contracted state. The slider device 520 is configured to move the sleeve 510 along the catheter and to insert the contracted end 512 of the sleeve 510 into the catheter insertion site IS. As the slider device 520 is retracted along the catheter 12 from the catheter insertion site IS, the sleeve end 512 expands and engages with the patient's skin S at the catheter insertion site IS. The tube 522 of the slider device 520 is configured to bend so that it can be inserted into the patient's skin S at the catheter insertion site IS, but returns to its original unflexed shape when retracted. For example, Figures 29, 31, 32, and 34B show the tube 522 in its normal unflexed shape. Figures 30 and 34C show the tube 522 of the slider device 520, which is bent or curved in shape as it is inserted (together with the sleeve 410) into the patient's skin S at the catheter insertion site IS.

[0063] The slider device 520 may be an integral part of the catheter system during insertion of the catheter 12 into the catheter insertion site IS, or, as shown in Figure 34B, the slider device 520 may be configured to be attached to the catheter 12. For example, the tube 522 of the slider device may have a longitudinally extending slot 523, which allows the slider device 520 to be positioned around the catheter 12.

[0064] The slider device 520 includes a joint 526 configured to be fixed to the primary catheter fixation device 20. For example, in some embodiments, the joint 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 fixed to the primary catheter fixation device 20. The slider device 520 is configured to overlap the catheter hub 14 such that the wings 528a, 528b of the joint overlap with the individual wings 14a, 14b of the catheter hub 14. As shown in Figure 32, each wing 528a, 528b of the joint includes an individual opening 529, the opening 529 is configured to align with the individual openings 19 of the individual wings 14a, 14b of the catheter hub and to engage with the individual posts P associated with the primary catheter fixation device 20.

[0065] In some embodiments, one or more portions of the outer surface of the sleeve 510 and / or the outer surface of the slider device 520 are coated with a material, the coating of which prevents fibroblasts from adhering thereto. In some embodiments, the outer surface of the sleeve may be provided with one or more grooves, the one or more grooves configured to allow exudate EX to flow out of the catheter insertion site IS.

[0066] Figures 34A to 34D illustrate the steps for installing the secondary catheter fixation device 500 of Figure 29 into the catheter insertion site IS. The sleeve 510 and slider device 520 are placed on the catheter 12 during or after insertion into the patient (Figure 34A). As described above, the slider device 520 may be configured to be pushed onto the catheter 12 (Figure 34B), or the slider device 520 may be part of the catheter assembly. Next, the slider device 520 is used to push the sleeve 510, which has a retracted tip 512, into the insertion site IS like a dilator, and then the slider device 520 is pulled back to allow the end 512 of the sleeve 510 to expand inside the skin S (Figure 34C). Next, the joint 526 of the slider device 520 is fixed to the primary catheter fixation device 20, a hemostatic bandage 25a is placed on the catheter insertion site IS, and a transparent adhesive bandage 25b is applied over the catheter insertion site IS, the secondary catheter fixation device 500, and the primary catheter fixation device 20 (Figure 34D).

[0067] Figures 35A–35C show the secondary catheter fixation device 500 of Figure 29 during a dressing change. During the dressing change, the transparent dressing 25b (Figure 34D) and the hemostatic bandage 25a are removed (Figure 35A), and then the primary catheter fixation device 20 is removed, leaving the secondary catheter fixation device 500 in place, to fix the catheter 12 to the patient (Figure 35B). As shown in Figure 35B, the catheter 12 can be lifted relative to the patient, and the area around the catheter insertion site IS and the area where the primary catheter fixation device 20 was previously positioned can be cleaned, for example, using a disinfectant cleaning applicator CA. At this time, the catheter 12, catheter hub 14 and catheter extension line 12e can also be cleaned.

[0068] A new primary catheter fixation device 20 can be fixed to the patient's skin S, the hub 14 and the joint 526 can be fixed within the new primary 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 secondary catheter fixation device 500, and the primary catheter fixation device 20 (Figure 35C).

[0069] Figures 36A to 36D show the steps for removing the secondary catheter fixation device 500 from the patient, as shown in Figure 29. The transparent dressing 25b (Figure 35C) and the hemostatic bandage 25a (Figure 35C) are removed from the catheter insertion site IS (Figure 36A). The slider device 520 is detached from the primary catheter fixation device 20 and moved toward the catheter insertion site IS to crush the distal end portion 512 of the sleeve 510 at the insertion site IS (Figures 36B, 36C). The catheter 12, the sleeve 510, and the slider device 520 can then be removed from the patient (Figure 36D).

[0070] Referring to Figure 37, the expandable sleeve 510 may be integrally formed within the catheter assembly. When inserted into the insertion site, the expandable sleeve 510 is configured to remain in place (either by a locking feature or by being integrally formed within the catheter assembly). Therefore, when the slider device 520 is withdrawn, the sleeve 510 does not retract with the slider device 520, and the end 512 of the sleeve 510' expands.

[0071] Referring to Figures 38 and 39, in some embodiments, the sleeve 510 may include a second portion 516, the second portion 516 being expandable and contractible, and being adjacent to and spaced apart from the expandable / contractible end 512. The second portion 516 may include a plurality of expandable flaps 514' at the end 512, similar to the flap 514. The flexible tube 522 of the slider device 520 is configured to surround the sleeve 510 and to maintain the end 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 to insert the contracted end 512 into the catheter insertion site IS. As the slider device 520 retracts along the catheter 12 from the catheter insertion site IS, the sleeve end 512 expands and engages with the patient's skin at the catheter insertion site IS, and the second portion 516 of the flexible sleeve contacts the outer portion of the patient's skin S.

[0072] In each of the embodiments described above, the slider device 520 can be discarded after catheter fixation at the insertion site IS is completed using the expandable sleeve 510. A new slider device 520 can be used while removing the catheter 12 to maintain sterility, thus reducing the risk of infection.

[0073] Referring to Figure 40, a secondary catheter fixation device 600 is shown that conforms to several embodiments of the concept of the present invention. The catheter fixation device 600 comprises an anchor 610 that surrounds 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 unintended movement of the catheter 12 at the catheter insertion site IS (e.g., piston motion). For example, the anchor 610 is capable of collapsing horizontally relative to the catheter insertion site IS in response to an external force. The anchor 610 may be formed from a variety of materials, including but not limited to plastics, ceramics, metals, elastomers, or combinations thereof of any kind.

[0074] In some embodiments, one or more portions of the outer surface of the anchor 610 are coated with a material, the coating of which inhibits the adhesion of fibroblasts. In some embodiments, the outer surface of the anchor 610 is provided with one or more grooves configured to allow exudate EX to flow out of the catheter insertion site IS.

[0075] In the illustrated embodiment, the anchor 610 comprises a first collar 620 and a second collar 630 (Figures 43A-43B) that are aligned laterally and opposed to each other, and these collars are supported by a pair of pins or members 640, 642 that are spaced apart from each other. A lock strap 650 (Figure 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 lock strap tightens to hold the catheter 12 in place for the duration of catheter placement.

[0076] Each of the members 640 and 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 catheter 12 and the first collar 620. This outwardly extended articulated configuration of the first member 640 and the second member 642 applies pressure to the skin at the catheter insertion site IS and produces a hooking action. Although a pair of members 640 and 642 are shown, in some embodiments three or more members may be used, or even a single member may be used.

[0077] In the illustrated embodiment, the first collar 620 has a slot 622 configured to allow the catheter 12 to be received within the first collar 620, and the second collar 630 has a slot 632 configured to allow the catheter 12 to be received within the second collar 630. Thus, as shown in Figures 45B and 45C, the anchor 610 can be attached to the catheter 12 by pressing each collar 620, 630 onto the catheter 12 so that it is inserted into each collar 620, 630 through the individual slots. Each collar 620, 630 is configured to extend therein around the catheter 12 and snugly grip the catheter 12.

[0078] In the illustrated embodiment, each member 640, 642 has an elongated rectangular configuration. The first member 640 has opposing first ends 640a and second ends 640b, and opposing inner surfaces 640c and outer surfaces 640d. Similarly, the second member 642 has opposing first ends 642a and second ends 642b, and opposing inner surfaces 642c and outer surfaces 642d. The first ends 640a and 642a of the first member 640 and the second member 642 are fixed to the first collar 620. As shown in Figures 41, 42, 43B, and 44B, the second ends 640b and 642b of the first member 640 and the second member 642 are movably fixed to the second collar 630 so that the first member 640 and the second member 642 can pivot at their respective second ends 640b and 642b relative to the second collar 630.

[0079] In the illustrated embodiment, the first member 640 has two portions 643a and 643b, the two portions 643a and 643b having reduced material portions, which allow 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). Portion 643a is a notch formed on the outer surface 640d of the first member 640, and portion 643b is a notch formed on the inner surface 640c of the first member 640. Similarly, the second member 642 has two portions 645a and 645b, the two portions 645a and 645b having reduced material portions, which allow a portion of the second member 642 to articulate outwardly in response to an external force applied to the first collar 620 (arrow A5, Figure 44B). Portion 645 is a notch formed on the outer surface 642d of the second member 642, and portion 645b is a notch formed on the inner surface 642c of the second member 640. Figure 41 shows the anchor 610 positioned within the catheter insertion site IS, and the catheter is not shown for clarity. The first member 640 and the second member 642 each have an articulating outward portion as a result of the force applied to the anchor 610. Each outward articulating portion extends into the patient's skin S at the catheter insertion site IS and restricts the movement of the anchor 610 at the insertion site IS. Therefore, the catheter 12 snugly received by the anchor 610 has its movement restricted.

[0080] Figures 45A to 45F show the process of placing the anchor 610 of the secondary catheter fixation device 600 of Figure 40 onto the catheter at the catheter insertion site IS. As shown in Figures 45A to 45B, when the catheter 12 is inserted into the patient, the second collar 630 of the anchor 610 is attached to the catheter 12. Next, a hemostatic bandage 25a (not shown) is applied to the insertion site IS, and then the anchor 610 is pushed down along the catheter 12 so that the first collar 620 engages with and holds the catheter 12 within it (Figure 45C). The force applied to the catheter 12 and therefore to the first collar 620 causes members 640, 642 to fold into an articulated configuration and engage with the skin S at the catheter insertion site IS (Figure 45D). Next, the lock strap 650 is tightened around the catheter 12 to secure the anchor 610 and the catheter 12 at the catheter insertion site IS (Figure 45E). Then, the catheter hub 14 is secured to the primary fixation device 20, and a transparent adhesive bandage may be applied to cover the catheter insertion site IS, the hemostatic bandage 25a, the secondary catheter fixation device 600 and the catheter 12, and the primary catheter fixation device 20.

[0081] Figure 46 shows the secondary catheter fixation device 600 of Figure 40 during a dressing change. During the dressing change, the clear dressing 25b and the hemostatic bandage 25a are removed, and then the primary catheter fixation device 20 is removed, leaving the secondary catheter fixation device 600 in place, to fix the catheter 12 to the patient. The catheter 12 is lifted relative to the patient, and the area around the catheter insertion site IS and the area where the primary catheter fixation device 20 was previously placed can be cleaned, for example, using a disinfectant cleaning applicator CA. At this time, the catheter 12, the catheter hub 14, and the catheter extension line 12e can also be cleaned. A new primary catheter fixation device 20 can be fixed to the patient's skin S, the catheter hub 14 can be fixed within the new primary 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 secondary catheter fixation device 600, and the primary catheter fixation device 20.

[0082] Figures 47A to 47D show the steps for removing the secondary catheter fixation device 600 from the patient as shown in Figure 40. The clear dressing and hemostatic bandage at the catheter insertion site IS (not shown) are removed from the primary fixation device 20. The lock strap 650 is unlocked and removed (Figure 47B), and a force (e.g., a horizontal force) is applied to the first collar 620, causing the members 640, 642 to move from an articulated position to an unarticulated position (Figure 47C). Next, the anchor 610 is moved upward from the insertion site IS so that the first collar 620 is removed from the catheter 12 (Figure 47D). Next, the second collar 630 is removed from the catheter 12, and the catheter 12 is removed from the insertion site IS.

[0083] In this specification, terms such as "first" and "second" may be used to describe various elements, but it should be understood that these elements are not limited by these terms. These terms are used solely to distinguish one element from another. For example, without departing the scope of the invention, the first element may be called the second element, and similarly, the second element may be called the first element. In this specification, the terms "and / or" encompass any and all combinations of one or more of the associated enumerated items.

[0084] When an element is referred to as being "on top of" another element, it will be understood that the element may be directly on top of the other element, or that other elements may exist between them. In contrast, when an element is referred to as being, for example, "directly on top of" another element, there are no other elements between them. Similarly, when an element is referred to as being "connected" or "linked" to another element, it will be understood that the element may be directly connected or linked to the other element, or that other elements may exist between them. In contrast, when an element is referred to as being "directly connected" or "directly linked" to another element, there are no elements intervening between them. Other terms used to describe relationships between elements should be interpreted in a similar manner (i.e., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.).

[0085] Relative terms, such as "below," "above," "upper," "lower," "horizontal," or "vertical," may be used herein to describe the relationship between one element, layer, or region and another, as shown in the drawings. It will be understood that these terms are intended to encompass different orientations of the device, in addition to the orientation illustrated in the drawings.

[0086] The terms used herein are intended solely to describe specific embodiments and are not intended to limit the invention. Where used herein, the singular “one” (a, an) and “the” are intended to also include the plural unless the context clearly indicates otherwise. Where used herein, the words “equipped with,” “possessing,” “encompassing,” and / or “containing” identify the presence of the described feature, action, element and / or component, but do not exclude the presence or addition of one or more other features, actions, elements, components and / or combinations thereof.

[0087] As used herein, the term "about" when referring to a measurable value, such as quantity or concentration, means to include not only the specified value itself, but also a range of variation of that specified value of ±10%, ±5%, ±1%, ±0.5%, or ±0.1%. For example, if X is a measurable value, "about X" is interpreted to include X, as well as a range of variation of X of ±10%, ±5%, ±1%, ±0.5%, or ±0.1%. The ranges provided herein for measurable values ​​may include any other ranges and / or individual values ​​within them.

[0088] 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 a number of additional embodiments.

Claims

1. A catheter fixation device, A length-adjustable frame having opposing first and second ends, wherein the first end is configured to be movably fixed to the patient's skin at a catheter insertion site, and the second end is configured to grasp and hold a catheter being inserted into the patient at the catheter insertion site and to prevent unintended movement of the catheter at the catheter insertion site. The catheter fixation device comprising the above-mentioned features.

2. The catheter fixation device according to claim 1, further comprising a skin engagement member attached to the first end of the frame, wherein the skin engagement member comprises at least one projection configured to hook onto the patient's skin at the catheter insertion site, and the skin engagement member has a living hinge configuration, the living hinge configuration enabling the frame to pivot relative to the patient's skin without the at least one projection disengaging from the patient's skin.

3. The catheter fixation device according to claim 2, wherein the at least one projection comprises a pair of projections that are spaced apart from each other and adjacent to one another.

4. The catheter fixation device according to claim 2, further comprising a clip attached to the second end, wherein the clip is configured to snugly receive the catheter or catheter hub therein and to prevent the catheter from moving in the anterior-posterior direction relative to the clip.

5. The catheter fixation device according to claim 1, wherein the frame comprises a first section slidably connected to a second section such that the frame has a length that is adjustable to be retractable.

6. The catheter fixation device according to claim 5, further comprising a locking mechanism operably associated with the first section and the second section, wherein the locking mechanism is configured to restrict the movement of the first section and the second section relative to each other when the frame is of a selected length.

7. A skin engagement member attached to the first section, wherein the skin engagement member comprises at least one projection configured to hook onto the patient's skin at the catheter insertion site, and the skin engagement member has a living hinge configuration that allows the frame to pivot relative to the patient's skin without the at least one projection disengaging from the patient's skin; and, A clip attached to the second section, wherein the clip is configured to tightly receive the catheter or catheter hub therein and to prevent the catheter from moving in the anterior-posterior direction relative to the clip. The catheter fixation device according to claim 5, further comprising the following:

8. The catheter fixation device according to claim 7, wherein one or more portions of the outer surface of the frame are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto, and one or more portions of the outer surface of the skin engagement member are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto.

9. A catheter fixation device, A frame, wherein the frame comprises a first section slidably connected to a second section such that the frame has a length that is adjustable to extend and retract. A locking mechanism operably associated with the first section and the second section, wherein the locking mechanism is configured to restrict the movement of the first section and the second section relative to each other when the frame is of a selected length; A skin engagement member attached to the first section, wherein the skin engagement member comprises at least one projection configured to hook onto the patient's skin at the catheter insertion site, and the skin engagement member has a living hinge configuration that allows the frame to pivot relative to the patient's skin without the at least one projection disengaging from the patient's skin; and, A clip attached to the second section, wherein the clip is configured to snugly receive the catheter and to prevent unintended movement of the catheter at the catheter insertion site. The catheter fixation device comprising the above-mentioned features.

10. The catheter fixation device according to claim 9, wherein the at least one projection comprises a pair of projections that are spaced apart from each other and adjacent to one another.

11. The catheter fixation device according to claim 9, wherein one or more portions of the outer surface of the frame are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto, and one or more portions of the outer surface of the skin engagement member are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto.

12. A catheter fixation device, An inflatable sleeve surrounding a portion of a catheter, wherein the inflatable sleeve is configured to expand and form a tight fit at the catheter insertion site that is sufficient to prevent unintended 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 gas or liquid to the inflatable sleeve in order to inflate the inflatable sleeve, and the tube is configured to remove the gas or liquid from the inflatable sleeve in order to deflate the inflatable sleeve. The catheter fixation device comprising the above-mentioned features.

13. The catheter fixation device according to claim 12, wherein the tube comprises an inflatable portion configured to provide an indicator when the sleeve is sufficiently inflated to form the tight fit at the catheter insertion site.

14. The catheter fixation device according to claim 12, wherein at least a portion of the tube is provided with a visual indicator for distinguishing the tube from the catheter.

15. The catheter fixation device according to claim 12, wherein the outer surface of the sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site.

16. The catheter fixation device according to claim 12, wherein one or more portions of the outer surface of the inflatable sleeve are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto.

17. The catheter fixation device according to claim 12, wherein the inflatable sleeve comprises two inflatable portions that are spaced apart.

18. A catheter fixation device, An inflatable sleeve configured to be movable along the outer surface of a catheter and positioned at the catheter insertion site, wherein the inflatable sleeve expands and forms a tight fit at the catheter insertion site that is sufficient to prevent unintended movement of the catheter. The catheter fixation device comprising the above-mentioned features.

19. The catheter fixation device according to claim 18, wherein the inflatable sleeve comprises an annular body, the annular body having a first portion configured to be positioned within the catheter insertion site, and a second portion configured to have circumferentially adjacent regions in contact with the catheter insertion site.

20. The catheter fixation device according to claim 19, wherein the second portion comprises a port through which a gas or liquid can be supplied to the inflatable sleeve in order to inflate the inflatable sleeve.

21. The catheter fixation device according to claim 20, further comprising a tube having fluid communication with the port, the tube being configured to supply the gas or liquid to the inflatable sleeve in order to inflate the inflatable sleeve, and the tube being configured to remove the gas or liquid from the inflatable sleeve in order to deflate the inflatable sleeve.

22. The catheter fixation device according to claim 18, wherein the outer surface of the sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site.

23. The catheter fixation device according to claim 18, wherein one or more portions of the outer surface of the inflatable sleeve are coated with a substance, the coating of the substance inhibits the adhesion of fibroblasts thereto.

24. A catheter fixation device, wherein the catheter fixation device is An anchor configured to be fixed to the skin adjacent to the patient's catheter insertion site; and, A hub movably fixed to the anchor, the hub comprising a catheter receiving channel configured to tightly hold a portion of a catheter inserted into the catheter insertion site, It is equipped with, Here, the anchor and the hub are configured to prevent unintended movement of the catheter at the catheter insertion site. The catheter fixation device.

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

26. The catheter fixation device according to claim 25, wherein the plurality of microneedles are angled with respect to the surface of the anchor.

27. The catheter fixation device according to claim 24, wherein the hub is movably fixed to the anchor by a flexible connecting member.

28. The catheter fixation device according to claim 24, wherein the anchor comprises a first member and a second member adjacent to each other and spaced apart, the first member comprising a plurality of microneedles and the second member comprising a plurality of microneedles.

29. The catheter fixation device according to claim 28, wherein the anchor further comprises a third member disposed between the first member and the second member and connected to the first member and the second member, the hub being movably fixed to the third member.

30. The catheter fixation device according to claim 29, wherein the anchor has a U-shape and is configured to be fixed to the patient's skin such that the catheter insertion site is between the first member and the second member.

31. A catheter fixation device, An anchor configured to be fixed to the skin adjacent to a catheter insertion site in a patient, wherein the anchor comprises a first member, a second member and a third member, the third member being positioned between the first member and the second member and connected to the first member and the second member such that the first member and the second member are adjacent and spaced apart, and each of the first member and the second member comprises a plurality of microneedles configured to be inserted into the skin of the patient; and, A hub movably fixed to the third member of the anchor, the hub comprising a catheter receiving channel configured to tightly hold a portion of the catheter to be inserted into the patient at the catheter insertion site, It is equipped with, Here, the anchor and the hub are configured to prevent unintended movement of the catheter at the catheter insertion site. The catheter fixation device.

32. The device according to claim 31, wherein the plurality of microneedles are angled with respect to the individual surfaces of the first member and the second member.

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

34. The device according to claim 31, wherein the anchor has a U-shape and is configured to be fixed to the patient's skin such that the catheter insertion site is between the first member and the second member.

35. A catheter fixation device, 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 the outer surface of the catheter and is positioned at the catheter insertion site, and the sleeve has expandable and contractible ends; and, A slider device, A flexible tube configured to surround the sleeve and maintain the sleeve end in a contracted state, wherein the slider device is configured to move the sleeve along the catheter and insert the contracted end into the catheter insertion site, wherein the slider device is configured to retract along the catheter from the catheter insertion site so that the sleeve end expands and engages with the patient's skin at the catheter insertion site; and, A joint configured to be fixed to a primary catheter fixation device. The slider device comprising The catheter fixation device comprising the above-mentioned features.

36. The catheter fixation device according to claim 35, wherein the end of the sleeve is provided with an expandable and contractible flap.

37. The catheter fixation device according to claim 35, wherein the joint of the slider device comprises a pair of opposing wings, each wing having an opening configured to engage with an individual post of the primary catheter fixation device.

38. The device according to claim 35, wherein one or more portions of the outer surface of the sleeve are coated with a substance, and the coating of the substance inhibits the adhesion of fibroblasts thereto.

39. The catheter fixation device according to claim 35, wherein the outer surface of the sleeve is provided with one or more grooves configured to allow exudate to flow out of the catheter insertion site.

40. The catheter fixation device according to claim 35, wherein a flexible sleeve is integrated within the catheter.

41. Catheter fixation device according to claim 35, wherein the flexible sleeve further comprises an expandable and contractible second portion, the second portion being adjacent to and spaced apart from the end, the flexible tube of the slider device is configured to surround the flexible sleeve and to maintain the end and the second portion of the flexible sleeve in a contracted state, the slider device is configured to move the flexible sleeve along the catheter and to insert the contracted end into the catheter insertion site, and the slider device is configured to retract along the catheter from the catheter insertion site so that the end of the flexible sleeve expands and engages with the patient's skin at the catheter insertion site and the second portion of the flexible sleeve contacts the outer portion of the patient's skin.

42. A catheter fixation device, 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 unintended movement of the catheter at the catheter insertion site. The catheter fixation device comprising the above-mentioned features.

43. The catheter fixation device according to claim 42, wherein the anchor device comprises a first collar and a second collar that are aligned laterally and opposite to each other, the opposite first collar and the second collar being supported by at least one member that is spaced apart, the at least one member being configured to transition from an elongated configuration to an outwardly extending articulated configuration in response to the external force applied to the catheter.

44. The catheter fixation device according to claim 43, wherein the first collar has a slot configured to allow the catheter to be received within the first collar, and the second collar has a slot configured to allow the catheter to be received within the second collar.

45. The catheter fixation device according to claim 43, wherein the at least one member comprises a pair of members that are opposed to each other in the diametrical direction.

46. The catheter fixation device according to claim 43, wherein the at least one member comprises a first end fixed to the first collar, an opposing second end rotatably fixed to the second collar, and at least two portions of the at least one member between the first end and the second end, the at least two portions having material reduction portions, and the material reduction portions enable the portion of the at least one member between the first end and the second end to articulate outward in response to the external force applied to the catheter.

47. The catheter fixation device according to claim 46, wherein at least one member has an elongated configuration having opposing inner and outer surfaces, wherein a first notch is formed in the inner surface adjacent to the first end, and a second notch is formed in the outer surface at an intermediate position between the first end and the second end.

48. The catheter fixation device according to claim 43, further comprising a locking strap associated with the first collar, the locking strap being configured to securely fix the first collar to the catheter.

49. The catheter fixation device according to claim 42, wherein one or more portions of the outer surface of the anchor are coated with a substance, and the coating of the substance inhibits the adhesion of fibroblasts thereto.

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