Device for fixing catheter

Abstract

The present application relates to a secondary catheter fixation device (100). The secondary catheter fixation device includes a shim (110) configured to be secured to the skin of a patient, and a clamping mechanism (130) pivotally coupled to the adhesive shim (110) and configured to grasp and retain a catheter therein without risk of mechanical kink. Pivoting of the clamping mechanism (130) enables the catheter to be lifted a sufficient distance relative to the patient's skin to permit cleaning of the patient's skin.

Description

[0001] Related applications

[0002] This application claims priority and benefit to Indian Provisional Patent Application No. 202341061291, filed on September 12, 2023, and Indian Provisional Patent Application No. 202441028018, filed on April 4, 2024, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to medical devices, and in particular, to devices for catheter fixation. Background Technology

[0004] 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, urinary, gastrointestinal, neurovascular, and ophthalmic surgery. In most uses, a catheter is a thin, flexible tube (soft catheter), but catheters can have different levels of rigidity depending on the application. Catheters can be inserted into body cavities, blood vessels, the brain, skin, or adipose tissue. Functionally, catheters can perform drainage, delivery of fluids or gases, access for surgical instruments, and a wide variety of other tasks depending on the type of catheter.

[0005] Referring to Figures 1-4E, when catheter 12 is left in place in a patient for an extended period, fixation techniques are typically used to secure catheter 12 in its position. This is particularly true for central venous catheters (CVCs and PICCs), which are typically inserted into the superior vena cava via the patient's neck and upper arm, respectively. Solutions for securing catheter 12 include sutures 11 (see, for example, Figure 1) and an adhesive-based catheter fixation device 20 (an exemplary catheter fixation device is the STATLOCK, available from Becton Dickinson (BD)). TM (See, for example, Figure 3). For any of these techniques, it is typically necessary to change the dressing 25 associated with the insertion site IS of the catheter 12. As can be seen from Figures 2A-2C, cleaning around the catheter 12 secured by the suture 11 results in incomplete (and therefore inadequate) cleaning (e.g., the area A of the patient's skin S below the catheter interface 14 is not cleaned), which may in turn increase the risk of central catheter-related bloodstream infection (CLABSI).

[0006] When catheter 12 is secured using catheter fixation device 20, catheter fixation device 20 is typically changed simultaneously with dressing 25. During dressing changes, replacement of catheter fixation device 20, and cleaning around the insertion site IS (e.g., using sterilizer applicator 30), caregivers should avoid inappropriate movement of catheter 12 (e.g., tip migration or dislodgement of catheter 12, which could cause catheter 12 to shift sufficiently, thus deviating from its correct position within the inserted vein or other structure). This is particularly important for certain catheters, such as CVCs and PICCs.

[0007] Currently, different techniques are used to change the dressing 25 around the catheter. In one technique, a caregiver may attempt to hold the catheter 12 in place with gloved fingers F (see, for example, Figure 4A); however, this may require a second caregiver to clean the site while the first caregiver holds the catheter 12 in place with one hand and removes the catheter fixation device 20 with the other. Furthermore, this technique does not conform to the Aseptic Non-Touch Technique (ANTT) guidelines. Alternatively, when replacing the catheter fixation device 20, a rolled-up dressing 25 can be used to temporarily hold the catheter 12 (see, for example, Figure 4B). However, there may be inconsistencies in using a rolled-up dressing 25 for fixation (e.g., how much dressing needs to be rolled up to secure the catheter at / near the insertion site). As a third technique, during the removal and replacement of the fixation device 20, a secondary catheter fixation component (such as adhesive strip 15) can be used to temporarily hold the catheter 12 in place (see, for example, Figures 4C-4E). This technique requires caregivers to have the knowledge to do so and to follow the guidelines for using the adhesive strip 15. Experience shows that these guidelines are often ignored. In addition, removing the adhesive strip 15 can be difficult and / or may cause the catheter 12 to move, and in some cases, the adhesive strip 15 may leave residue on the catheter lumen after removal that could attract contaminants.

[0008] Some technology may need to be provided to enable the use of adhesive-based primary fixation devices (STATLOCK). TM Improving adherence to the usage guidelines for secondary catheter fixation devices during the replacement of dressings for fixed catheters can, in turn, improve patient treatment outcomes. Summary of the Invention

[0009] A first aspect of the invention relates to a catheter fixation device. The catheter fixation device includes a pad configured to be secured to a patient's skin and a clamping mechanism pivotally coupled to the pad. The clamping mechanism is configured to grip and hold the catheter therein, while pivoting of the clamping mechanism allows the catheter to be lifted a sufficient distance from the extension line relative to the patient's skin during site cleaning (without increasing the risk of displacement of the catheter at / near the insertion site) to allow for cleaning of the patient's skin.

[0010] Another aspect of the invention relates to a catheter fixation device. The catheter fixation device includes a pad configured to be fixed to a patient's skin, a base coupled to the pad, and a cantilever member pivotally coupled to the base at one end. The cantilever member includes a latching mechanism at its opposite end relative to the base. The latching mechanism is configured to grip and hold the catheter therein, while pivoting of the cantilever member allows the catheter to be raised a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

[0011] Another aspect of the invention relates to a catheter fixation device. The catheter fixation device includes a pad configured to be fixed to a patient's skin, a base coupled to the pad, and a pair of arm members pivotally coupled to the base. Each arm member has a recessed end that together define a first orifice configured to receive a catheter passing through it. One of the arm members further has a second orifice extending into the corresponding recessed end. The catheter fixation device further includes a fixation mechanism configured to receive through the second orifice to secure the catheter within the first orifice. When the catheter is secured within the first orifice by the fixation mechanism, the pair of arm members are configured to elevate the catheter above the patient's skin a sufficient distance to allow for cleaning of the patient's skin.

[0012] Another aspect of the invention relates to a catheter fixation device. The catheter fixation device includes a pad configured to be fixed to a patient's skin, a base coupled to the pad, and an extending arm member, the base having an arcuate recess. The extending arm member includes a slider at one end and a latching mechanism at the opposite end, the slider being configured to travel along a guide path within the arcuate recess of the base, and the latching mechanism being configured to grip and hold the catheter therein, such that the catheter is held a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

[0013] Another aspect of the invention relates to a catheter fixation assembly. The catheter fixation assembly includes a disinfectant applicator and a catheter fixation device. The catheter fixation device has a body and a clamp coupled to and extending outward from the body. The clamp is configured to receive and hold one or more catheter extension lines therein. One end of the disinfectant applicator is received by the body of the catheter fixation device to secure the catheter fixation device to the disinfectant applicator, and the catheter fixation device is configured to hold the one or more catheter extension lines a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

[0014] It should be noted that various aspects of the invention described with respect to one embodiment may be incorporated into different embodiments, although not specifically described therein. That is, features of all embodiments and / or any embodiment may be combined in any manner and / or combination. The applicant reserves the right to amend any originally filed claim and / or accordingly file any new claim, including the right to modify any originally filed claim to rely on and / or incorporate any feature of any other one or more claims, although not originally required to do so. These and other objects and / or aspects of the invention are explained in detail in the specification set forth below. Other features, advantages, and details of the invention will be understood by those skilled in the art upon reading the accompanying drawings and the subsequent detailed description of preferred embodiments, which are merely illustrative of the invention. Attached Figure Description

[0015] Figure 1 illustrates the use of sutures to secure a central venous catheter to a patient.

[0016] Figures 2A-2C illustrate examples of incomplete site cleaning when using sutures to secure a central venous catheter line as shown in Figure 1.

[0017] Figure 3 illustrates a known primary catheter fixation device.

[0018] Figures 4A-4E illustrate existing techniques for temporarily securing catheters by caregivers during dressing changes.

[0019] Figure 5A This is a rear perspective view of a secondary catheter fixation device according to an embodiment of the present invention.

[0020] Figure 5B for Figure 5A A frontal perspective view of the secondary catheter fixation device.

[0021] Figure 6A-6G Illustrative examples illustrate the use of embodiments of the present invention. Figure 5A Exemplary steps for changing the dressing of a secondary catheter fixation device.

[0022] Figure 7A for Figure 5A Top perspective view of an alternative configuration of a secondary catheter fixation device according to an embodiment of the present invention.

[0023] Figure 7B for Figure 7A Exploded view of the secondary catheter fixation device.

[0024] Figure 7C Example description Figure 7A A secondary catheter fixation device in use according to an embodiment of the present invention.

[0025] Figure 8 for Figure 5A A perspective view of another alternative configuration of the secondary catheter fixation device according to an embodiment of the present invention.

[0026] Figures 9A-9B for Figure 5A A perspective view of another alternative configuration of the secondary catheter fixation device according to an embodiment of the present invention.

[0027] Figures 10A-10B for Figure 5A A perspective view of another alternative configuration of the secondary catheter fixation device according to an embodiment of the present invention.

[0028] Figure 10C Example description Figure 10B A prototype of a secondary catheter fixation device in use according to an embodiment of the present invention.

[0029] Figure 10D Example description Figure 10A An alternative configuration of the secondary catheter fixation device according to an embodiment of the present invention, wherein with Figures 10A-10C Compared to other devices, the adhesive pad is positioned further away from the insertion site.

[0030] Figure 11A-11B A perspective view and a partial transparent view of an alternative clamping mechanism for a secondary catheter fixation device according to an embodiment of the present invention.

[0031] Figure 12A This is a perspective view of another secondary catheter fixation device according to an embodiment of the present invention.

[0032] Figure 12B for Figure 12A Enlarged view of the head / catheter retention mechanism of the secondary catheter fixation device.

[0033] Figures 13A-13C for Figure 12A A partial sectional view of a secondary catheter fixation device, illustrating an exemplary locking feature of the hinged joint.

[0034] Figure 14A-14F Illustrative examples illustrate the use of embodiments of the present invention. Figure 12A Exemplary steps for changing the dressing of a secondary catheter fixation device.

[0035] Figure 15A An example illustrates another configuration of a secondary catheter fixation device positioned in the patient's neck according to an embodiment of the present invention.

[0036] Figure 15B for Figure 15A Enlarged view of the secondary catheter fixation device.

[0037] Figure 15C for Figure 15A Another enlarged view of the secondary catheter fixation device.

[0038] Figure 15D for Figure 15A Exploded view of the secondary catheter fixation device.

[0039] Figure 16A-16L Illustrative examples illustrate the use of embodiments of the present invention. Figure 15A Exemplary steps for changing the dressing of a secondary catheter fixation device.

[0040] Figures 17A-17B Example description Figure 15A The operation of the clamping mechanism of the secondary conduit fixing device. Figure 17A The clamping mechanism is shown in the non-latch position. Figure 17B The clamping mechanism is shown in the latched position.

[0041] Figures 18A-18B Example description Figure 15A The operation of the secondary catheter fixation device is an alternative to the clamping mechanism. Figure 18A An alternative clamping mechanism in the non-latch position is shown. Figure 18B An alternative clamping mechanism is shown in the latched position.

[0042] Figure 19A This is a perspective view of another secondary catheter fixation device according to an embodiment of the present invention.

[0043] Figure 19B for Figure 19A Exploded view of the secondary catheter fixation device.

[0044] Figure 19C Example description Figure 19A A secondary catheter fixation device according to an embodiment of the present invention, the secondary catheter fixation device holding the catheter lumen.

[0045] Figure 20A This is an exploded view of another secondary catheter fixation device according to an embodiment of the present invention.

[0046] Figure 20B for Figure 20A A three-dimensional diagram of the secondary catheter fixation device.

[0047] Figure 20C Show Figure 20B A secondary catheter fixation device for fixing the catheter to the main catheter.

[0048] Figure 21A-21L Illustrative examples illustrate the use of embodiments of the present invention. Figure 20A Exemplary steps for changing the dressing of a secondary catheter fixation device.

[0049] Figures 22A-22H This example illustrates another secondary catheter fixation device according to an embodiment of the present invention, and schematically illustrates exemplary steps for changing the dressing of a catheter using said secondary catheter fixation device.

[0050] Figures 23A-23G This example illustrates another secondary catheter fixation device according to an embodiment of the present invention, and schematically illustrates exemplary steps for changing the dressing of a catheter using said secondary catheter fixation device.

[0051] Figures 24A-24H This example illustrates another secondary catheter fixation device according to an embodiment of the present invention, and schematically illustrates exemplary steps for changing the dressing of a catheter using said secondary catheter fixation device. Detailed Implementation

[0052] The invention will now be described more fully below with reference to the accompanying drawings, in which embodiments of the invention are illustrated. However, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0053] In the accompanying drawings, certain layers, components, or features may be enlarged for clarity, and dashed lines illustrate optional features or operations unless otherwise stated. However, the invention can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0054] It will be understood that although the terms first, second, etc., may be used herein to describe various elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, or segment from another region, layer, or segment. Therefore, without departing from the teachings of the invention, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment. Unless otherwise expressly indicated, the order of operations (or steps) is not limited to the order presented in the claims or drawings.

[0055] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It will also be understood that terms (such as those defined in common dictionaries) shall be interpreted as having the meaning consistent with their meaning in the context of the specification and related art, and shall not be interpreted in an idealized or overly formal form unless expressly defined herein. For the sake of brevity and / or clarity, well-known functions or constructions may not be described in detail.

[0056] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used herein, the singular forms “a,” “an,” and “described” are also intended to include the plural forms unless the context clearly indicates otherwise. It will also be understood that, when used in this specification, the terms “comprising” and / or “including” specify the presence of the stated features, integrals, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0057] As used herein, phrases such as “between X and Y” and “approximately between X and Y” should be interpreted as including both X and Y. As used herein, phrases such as “approximately between X and Y” mean “between approximately X and approximately Y”. As used herein, phrases such as “approximately from X to Y” mean “from approximately X to approximately Y”.

[0058] It will be understood that when an element is referred to as being "on," "attached," "connected," "joined," "in contact" with another element, etc., the element may be directly on, attached to, connected to, joined to, or in contact with the other element, or there may be intermediate elements present. Conversely, when an element is referred to, for example, as being "directly on," "directly attached," "directly connected," "directly joined to," or "directly in contact" with another element, there are no intermediate elements. Those skilled in the art will also recognize that a reference to a structure or feature configured to be "adjacent" to another feature may have portions that overlap with or are below the adjacent feature.

[0059] For ease of description, spatially related terms such as “below,” “under,” “lower,” “above,” “upper,” “side,” “left,” and “right” may be used herein to describe the relationship between one element or feature and another element or feature as illustrated in the figures. It will be understood that, in addition to the orientations depicted in the figures, spatially related terms are intended to encompass different orientations of the device in use or operation. For example, if the device in the figures is inverted, elements described as being “below” or “under” other elements or features will be oriented “above” those other elements or features. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the descriptions of related spatial relationships used herein should be interpreted accordingly.

[0060] Embodiments of the present invention relate to catheter fixation solutions that help minimize catheter migration and dislodgement during catheter dressing changes without adding other clinical burdens, such as microbial growth, patient pain, and significant disruption to workflow. Embodiments of the present invention provide a secondary catheter fixation device configured to hold the catheter or catheter interface near the insertion site in the patient's skin using a cantilever-based mechanism. The secondary catheter device allows for 360° site cleaning without increasing the risk of catheter (e.g., long-term indwelling intravascular (IV) catheters, such as peripherally inserted central catheter (PICC) lines and central venous catheter (CVC) lines) movement during catheter dressing changes. Reference will now be made to... Figures 5A to 24H Embodiments of the invention are described in more detail below.

[0061] refer to Figure 5A and Figure 5B The following example illustrates a catheter fixation device 1001 according to an embodiment of the present invention (also referred to herein as a "secondary catheter fixation device," "secondary fixation device," or "fixation device"). For example... Figures 5A-5B As shown, in some embodiments, the secondary catheter fixation device 1001 includes a pad 1101 and a clamping mechanism 1301. The pad 1101 is configured to be secured to the patient's skin. In some embodiments, the pad 1101 may be an adhesive pad. In some embodiments, the body 1201 of the clamping mechanism 1301 is coupled to the pad 1101 via a pair of hinge joints 1151 (i.e., bistable hinge joints). In some embodiments, the pad 1101 has a recess 1111 that allows the secondary catheter fixation device 1001 to adhere to the patient's skin S adjacent to the insertion site IS of the catheter 12 (also referred to herein as the "main tube" or "catheter lumen") (see, for example...). Figure 6C As described in further detail below, the articulated connector 1151 is configured such that the secondary catheter fixation device 1001 can raise the catheter 12 (and catheter interface 14) a sufficient distance D relative to the patient's skin S to allow for 360° site cleaning near the catheter insertion site IS (see, for example...). Figure 6D And after cleaning is complete, lower catheter 12.

[0062] In some embodiments, the gasket 1101 of the secondary catheter fixation device 1001 may include a pair of arms 1121 extending upward therefrom. In some embodiments, each arm 1121 may include a hole 112a1 configured to receive a corresponding protrusion 122a1 extending outwardly from the body 1201 of the clamping mechanism 1301 to form a hinge joint 1151. In some embodiments, the hinge joint 1151 may provide a progressive locking function (see, for example...). Figures 9A-9B and Figures 10A-10B The locking features 1234, 1235 shown enable the secondary catheter fixation device 1001 to hold the catheter 12 (and catheter interface 14) above the patient's skin S (i.e., at distance D) to allow for site cleaning (see example...). Figure 6D ).

[0063] Still referencing Figures 5A-5B In some embodiments, the clamping mechanism 1301 of the secondary catheter fixation device 1001 may include a pair of wing-shaped members 1321, which are coupled together to form a latching mechanism 1341. The latching mechanism 1341 is sized and configured to accommodate most commercially available sizes (i.e., diameters) of catheters 12. Figure 5BAs shown, in some embodiments, the inner wall of the latching mechanism 1341 may include a gripping feature 1351 to help securely hold the outer diameter surface of the catheter 12 within the latching mechanism 1341 without increasing the risk of impeding fluid flow or causing mechanical kinking due to compression of the catheter 12. The gripping feature 1351 may also help prevent any forward or backward movement (i.e., piston-like movement) of the catheter 12 at the insertion site IS (especially when the catheter interface 14 is not secured by the primary fixation device 20 during dressing changes and / or when a caregiver manipulates the catheter interface 14 for site cleaning). In some embodiments, the outer surface of each wing member 1321 may include one or more gripping features 1361 to facilitate better user interaction with the secondary catheter fixation device 1001.

[0064] Figure 6A-6G The exemplary steps of replacing the dressing (e.g., first dressing 25a and / or second dressing 25b) of the catheter 12 using the secondary catheter fixation device 1001 according to an embodiment of the present invention are illustrated schematically.

[0065] Figure 6A The catheter interface 14 is shown secured by a primary fixation device 20, which is adhered to the patient's skin S. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter interface 14, and a main tube 12 is coupled to and extends from the opposite end of the catheter interface 14. The catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. A first dressing 25a (e.g., an antimicrobial hemostatic IV dressing) is applied over the catheter insertion site IS. A second (transparent) dressing 25b is applied to cover the insertion site IS, the first dressing 25a, the catheter 12, the primary fixation device 20, the catheter interface 14, and at least a portion of the catheter extension lines 12a, 12b.

[0066] like Figure 6B As shown, during dressing changes, the first and second dressings 25a and 25b are removed to allow cleaning of the area around the insertion site IS. However, it may be difficult to clean the area of ​​the skin S below the catheter 12 and the primary fixation device 20.

[0067] like Figure 6CAs shown, the secondary catheter fixation device 1001 of the present invention is fixed adjacent to the catheter insertion site IS such that the insertion site IS (and the catheter 12 extending therefrom) is located within the recess 1111 of the gasket 1101. The clamping mechanism 1301 of the secondary catheter fixation device 1001 is lowered toward the catheter 12 (by pivoting downward via a bistable hinge joint 1151). The caregiver presses (squeezes) the wing members 1321 of the clamping mechanism 1301 together, which allows the latching mechanism 1341 to fully open to receive the outer diameter of the catheter 12, and releases the wing members 1341 to grip the catheter 12 therein. After the catheter 12 is securely held within the latching mechanism 1341, the catheter interface 14 can be released from the primary fixation device 20, and the old primary fixation device 20 can be removed from the patient's skin S.

[0068] According to an embodiment of the invention, the secondary catheter fixation device 1001 of the invention allows the catheter 12 (and catheter interface 14) to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning (e.g., using a disinfection applicator 30) around the catheter insertion site IS and the skin S below the catheter 12 and catheter interface 14 (previously inaccessible due to the presence of the primary fixation device 20). Figure 6D As shown, in order to elevate catheter 12 and catheter interface 14, the clamping mechanism 1301 of the secondary catheter fixation device 1001 is pivoted upward via a hinge joint 1151. In some embodiments, the hinge joint 1151 may be configured to lock the clamping mechanism 1301 of the fixation device 1001 in the elevated position, thereby allowing caregivers to clean the area with their hands.

[0069] like Figure 6E As shown, after cleaning of the site is completed, the clamping mechanism 1301 is lowered (pivoted downwards) via the hinge joint 1151, and the catheter interface 14 is secured in the new primary fixation device 20. Once the catheter interface 14 is secured in the primary fixation device 20, the secondary catheter fixation device 1001 can be removed from the patient's skin. Next, as... Figure 6F As shown, the area initially covered by the pad 1101 of the secondary catheter fixation device 1001 is cleaned (e.g., using a disinfectant applicator 30). Finally, as... Figure 6G As shown, new first and / or second dressings 25a, 25b are applied over the site.

[0070] Now for reference Figures 7A-7C The example illustrates an alternative configuration for the secondary catheter fixation device 1002. The nature and / or characteristics of the secondary catheter fixation device 1002 can be as described in the reference above. Figures 5A-5B and Figure 6A-6GAs described in the secondary catheter fixation device 1001 shown, and for ease of discussion Figures 7A-7C Repeated discussion of it can be omitted here.

[0071] like Figures 7A-7B As shown, the secondary catheter fixation device 1002 is similar to the secondary catheter fixation device 1001 described herein in that the secondary catheter fixation device 1002 includes a gasket 1102 and a clamping mechanism 1302, and the body 1202 of the clamping mechanism 1302 is connected to the gasket 1102 via a pair of hinge joints 1152 (bistable hinge joints). In some embodiments, the gasket 1102 may be an adhesive gasket. The secondary catheter fixation device 1002 differs from the secondary catheter fixation device 1001 in the configuration (i.e., shape) of the wing member 1322 of the clamping mechanism 1302.

[0072] like Figures 5A-5B As shown, the wing-shaped member 1321 of the clamping mechanism 1301 of the secondary conduit fixing device 1001 is a roughly triangular shape with rounded corners. Figures 7A-7B As shown, the wing member 1322 of the clamping mechanism 1302 of the secondary catheter fixation device 1002 has a generally rectangular shape with rounded corners. Additionally, in some embodiments, the gasket 1102 of the secondary catheter fixation device 1002 may have a smaller recess 1112 than the recess 1111 of the gasket 1101 of the secondary catheter fixation device 1001 described above.

[0073] like Figure 7C As shown, the operation of the secondary catheter fixation device 1002 is similar to that of the secondary catheter fixation device 1001 described herein, wherein the clamping mechanism 1302 of the secondary catheter fixation device 1002 is lowered (pivoted downward) toward the catheter 12 via the hinge joint 1152, and the wing members 1322 are pressed (compressed) together, which allows the latching mechanism 134' to fully open to grip the outer diameter of the catheter 12 without increasing the risk of impeding fluid flow / mechanical kinking due to compression of the catheter 12. The procedure for changing the dressing of the catheter 12 using the secondary catheter fixation device 1002 is the same as the procedure described above (see, for example...). Figure 6A-6G )same.

[0074] exist Figure 8 The example illustrates another configuration of the secondary catheter fixation device 1003 according to an embodiment of the present invention. For example... Figure 8As shown, in some embodiments, the secondary catheter fixation device 1003 may have a gasket 1103 and a clamping mechanism 1303 integrally formed as a single component. In some embodiments, the gasket 1103 of the secondary catheter fixation device 1003 may have an extension member 1123 to which the clamping mechanism 1303 may be coupled. In some embodiments, a transition section or small body 1203 may be located between the clamping mechanism 1303 and the extension member 1123.

[0075] Similar to the secondary catheter fixation devices 1001 and 1002 described above, the clamping mechanism 1303 of the secondary catheter fixation device 1003 includes a pair of wing-shaped members 1323, which are coupled together to form a latching mechanism 1343. The latching mechanism is sized and configured to accommodate most commercially available sizes (i.e., diameters) of catheters 12. In some embodiments, each wing-shaped member 1323 may include one or more gripping features 1363 to facilitate better user interaction. The secondary catheter fixation device 1003 differs from the secondary catheter fixation devices 1001 and 1002 in that it does not include a pair of hinged joints 1151 and 1152.

[0076] In addition, such as Figure 8 As shown, the clamping mechanism 1303 is oriented differently from the clamping mechanisms 1301 and 1302 of the secondary catheter fixation devices 1001 and 1002, so that the latching mechanism 1343 of the secondary catheter fixation device 1003 can grip the catheter 12 without increasing the risk of obstructing fluid flow / causing mechanical kinking due to compression of the catheter 12. Figures 5A-5B and Figures 7A-7B As shown, when the clamping mechanisms 1301 and 1302 of the secondary catheter fixation devices 1001 and 1002 pivot to grip the catheter 12, the clamping mechanisms extend along a plane substantially perpendicular to the respective gaskets 1101 and 1102. Conversely, as Figure 8 As shown, the clamping mechanism 1303 of the secondary catheter fixation device 1003 extends along a plane generally parallel to the gasket 1103 to grip the catheter 12.

[0077] exist Figures 9A-9B and Figure 10A-10D Further examples illustrate and discuss below of additional configurations of the secondary catheter fixation devices 1004, 1005 according to embodiments of the present invention. The nature and / or features of the secondary catheter fixation devices 1004, 1005 may be as referenced above. Figures 5A-5B and Figures 7A-7B As described in the secondary catheter fixation devices 1001 and 1002 shown, and for ease of discussion Figures 9A-9B and Figure 10A-10D Repeated discussion of it can be omitted here.

[0078] It should be noted that, although in Figures 9A-9B The gaskets of the secondary catheter fixation device 1004 are not shown, but the secondary catheter fixation device 1004 may include gaskets 1101, 1102 that are the same as or similar to those of the secondary catheter fixation devices 1001, 1002 described herein (e.g., adhesive gaskets), and Figure 10C The secondary catheter fixation device 1005 shown has a gasket 1105. The secondary catheter fixation devices 1004 and 1005 differ from the secondary catheter fixation devices 1001 and 1002 described herein in the configuration of the clamping mechanisms 1304 and 1305, and in particular the shape of the corresponding wing members 1324 and 1325.

[0079] For example, such as Figures 9A-9B As shown, compared to the triangular shape of the wing-shaped member 1321 of the secondary catheter fixation device 1001, the ends of each wing-shaped member 1324 of the clamping mechanism 1304 of the secondary catheter fixation device 1004 have a slightly wider (i.e., more blunt) triangular shape. Figure 10A-10D As shown, each wing member 1325 of the clamping mechanism 1305 of the secondary conduit fixing device 1005 has an arc-shaped (generally circular) end.

[0080] In addition, as mentioned above, and as... Figures 9A-9B and Figures 10A-10B As shown, in some embodiments, a corresponding arm (e.g., as shown) extends upward from the gasket. Figures 5A-5B The protrusions 1224, 1225 that together form the articulated joints 1154, 1155 (as shown in the diagram) may include locking features 1234, 1235. In some embodiments, the locking features 1234, 1235 may be configured to perform a step-locking function to secure the respective clamping mechanisms 1304, 1305 (and catheter 12) in an elevated or raised position (i.e., at a distance D above the patient's skin).

[0081] Figure 10C An example illustrates a secondary catheter fixation device 1005 according to an embodiment of the present invention, which is positioned adjacent to the catheter insertion site 15 and ready to grip the catheter 12. Similar to the secondary catheter fixation device 1001 described herein, in some embodiments, such as... Figure 10C As shown, the gasket 1105 of the secondary catheter fixation device 1005 may include a recess 1115 that allows the secondary catheter fixation device 1005 to be positioned close to the insertion portion IS of the catheter 12. For example, in some embodiments, the secondary catheter fixation device 1005 may be positioned such that the insertion portion IS of the catheter 12 is located within the recess 1115 of the gasket 1105.

[0082] refer to Figure 10D In some embodiments, the secondary catheter fixation device 1005 may further include a pair of extension arms 1255. For example... Figure 10D As shown, the extension arm 1255 can be configured to position the gasket 1105 at a distance D2 from the insertion site IS of the catheter 12, thereby avoiding adhesive residue near the insertion site IS. In some embodiments, a first pair of hinged joints 1155 is formed at one end of each extension arm 1255 where it is connected to the gasket 1105, and a second pair of hinged joints 1155 is formed at the opposite end of each extension arm 1255 where it is connected to the body 1205 of the secondary catheter fixation device 1105.

[0083] refer to Figure 11A-11B The example illustrates an alternative clamping mechanism 1306, which can be incorporated into one or more secondary catheter fixation devices 1001-1005 described herein. Figure 11A-11B As shown, the clamping mechanism 1306 may include a pair of airfoil members 1326 at one end of the clamping mechanism 1306, the pair of airfoil members together defining a latching mechanism 1346. In some embodiments, a biasing member 1336 (e.g., a torsion spring) is located between the pair of airfoil members 1326. In some embodiments, the biasing member 1336 is configured to move the latching mechanism 1346 to an open position to receive the conduit 12 (i.e., when the opposite ends of the airfoil members 1326 are pressed together), and is configured to move the latching mechanism 1346 to a closed position to grip the conduit 12 (i.e., when the opposite ends of the airfoil members 1326 are released). The airfoil members 1326 are configured to grip the conduit without increasing the risk of impeding fluid flow / causing mechanical kinking due to compression of the conduit 12. Figure 11B As shown, in some embodiments, the latching mechanism 1346 may include one or more gripping features 1356 to help securely hold the outer diameter surface of the conduit 12 within the latching mechanism 1346.

[0084] exist Figure 12A-12B and Figures 13A-13C The following example illustrates another secondary catheter fixation device 200 according to an embodiment of the present invention. As described in further detail below, in some embodiments, the secondary catheter fixation device 200 is configured to grasp and hold the catheter interface 14 at a sufficient distance D above the patient's skin S (see, for example...). Figure 14D This allows for 360° cleaning around the catheter insertion site IS and the skin S beneath the catheter 12 and catheter interface 14.

[0085] like Figure 12A-12BAs shown, in some embodiments, the secondary catheter fixation device 200 includes a pad 210, a base 220, and a cantilever member 230 coupled to the base 220. The pad 210 is configured to be secured to the patient's skin. In some embodiments, the pad 210 may be an adhesive pad. In some embodiments, a hinge joint 225 is formed at the end of the cantilever member 230 that is coupled to the base 220. Figure 12B As shown, in some embodiments, at the opposite end of the articulated joint 225, the cantilever member 230 includes a latching mechanism 232. The latching mechanism 232 is configured to grip and hold the catheter 12 or catheter interface 14 without increasing the risk of impeding fluid flow or causing mechanical kinking due to compression of the catheter 12. For example, in some embodiments, the latching mechanism 232 may include a recess 234 configured to receive a segment of the catheter 12 or catheter interface 14. In some embodiments, the recess 234 may include one or more gripping features 235 to further retain the segment of the catheter 12 or catheter interface 14 within the recess 234. In some embodiments, the latching mechanism 232 may be configured to deflect such that a segment of the catheter 12 or catheter interface 14 may be received within the recess 234 (e.g., a snap-fit ​​feature forming an interference fit therewith).

[0086] Figures 13A-13C This is a cross-sectional view of the base 220 of a secondary catheter fixation device 200 according to some embodiments of the present invention, illustrating an exemplary locking feature 231 that may be incorporated into the hinge joint 225 of the secondary catheter fixation device 200. In some embodiments, the base 220 of the secondary catheter fixation device 200 may include a recess 222. Figures 13A-13C As shown, in some embodiments, when the cantilever member 230 is raised (pivoting upward about the hinge joint 225), a portion 233 of the locking feature 231 can be configured to be received within the recess 222 of the base 220. Figure 13C When the portion 233 is received within the recess 222, the cantilever member 230 is locked in the raised position (see also, for example...). Figure 14D ).

[0087] Figure 14A-14F The exemplary steps of replacing the dressing 25 (e.g., transparent dressing 25b) of the catheter 12 using the secondary catheter fixation device 200 according to an embodiment of the present invention are illustrated schematically. Figure 14A A catheter port 14 is shown, secured to the patient's skin S by a primary fixation member 20. A main tube 12 is attached to and extends from one end of the catheter port 14 and is inserted into the patient's body (e.g., a vein) at the insertion site IS. A transparent dressing 25b covers the insertion site IS, the catheter 12, the primary fixation member 20, and the catheter port 14. Figure 14BThe dressing 25b is shown to have been removed.

[0088] Figure 14C The secondary catheter fixation device 200 is shown secured to the patient's skin S via a pad 210, and the cantilever member 230 pivots downward (around the hinge joint 225) such that the latching mechanism 232 engages (grips) the catheter interface 14. Figure 14C As shown, in some embodiments, the gasket 210 is positioned near the catheter insertion site IS. Once the latching mechanism 232 securely holds the catheter interface 14 (i.e., the section of the catheter interface 14 is received and secured therein by the recess 234 of the latching mechanism 232), as Figure 14D As shown, the cantilever member 230 can be raised (pivoting upward about the hinge joint 225) to elevate the catheter interface 14 (and catheter 12) to a sufficient distance D above the patient's skin S (or until the portion 233 of the locking feature 231 is received within the recess 222 of the base 220) to enable site cleaning. When the cantilever member 230 is locked in the raised / lifted position ( Figure 14D After insertion, the area around the catheter insertion site IS and the skin S below the catheter 12 and catheter interface 14 can be cleaned (e.g., using a disinfectant applicator or cotton swab).

[0089] like Figure 14E As shown, after cleaning of the site is completed, a new primary fixation device 20 is adhered to the skin S, and the cantilever member 230 is pivoted downwards (around the hinge joint 225) so that the catheter interface 14 (and catheter 12) are lowered toward the new primary fixation device 20. After securing the catheter interface 14 to the new primary fixation device 20, the secondary catheter fixation device 200 can be removed, and a new transparent dressing 25b can be applied over the insertion site S, catheter 12, catheter interface 14, and primary fixation device 20. Figure 14F ).

[0090] Now for reference Figures 15A-15D and Figure 16A-16L This example illustrates another secondary catheter fixation device 300 according to an embodiment of the present invention. The nature and / or features of the secondary catheter fixation device 300 may be as described above with reference to the secondary catheter fixation device 100. 1-6 As described, and for the sake of discussion Figures 15A-15D and Figure 16A-16L Repeated discussion of it can be omitted here.

[0091] Figure 15A Example illustration of a secondary catheter fixation device 300 positioned in the neck N of a patient. Figure 15B for Figure 15A An enlarged view of the secondary fixing device 300 shown. (See diagram below.) Figure 15BAs shown, according to an embodiment of the invention, and similar to other secondary catheter fixation devices described herein, the secondary catheter fixation device 300 may be positioned adjacent to the insertion site IS of the catheter 12 such that the insertion site IS is located between the secondary catheter fixation device 300 and the primary fixation device 20 (as described herein, the primary fixation device is configured to retain / fix the catheter interface 14 when the catheter 12 is inserted into the patient).

[0092] Figure 15C This is an enlarged view of the secondary catheter fixation device 300 of the present invention, and Figure 15D This is an exploded view of the secondary catheter fixation device 300. (See diagram below.) Figure 15C-15D As shown, in some embodiments, the secondary catheter fixation device 300 includes a pad 310, a base 320, a pair of arm members 324, 326, and a fixation or clamping mechanism 330. The pad 310 is configured to secure the secondary catheter fixation device 300 to the patient's skin S. In some embodiments, the pad 310 may be an adhesive pad. Similar to the pads 1101, 1102 of other secondary catheter fixation devices 1001, 1002 described herein, the pad 310 of the secondary catheter fixation device 300 may include a recess 311 that allows the secondary catheter fixation device 300 to be positioned closer to the insertion site IS of the catheter 12 (see, for example...). Figure 15C In some embodiments, the base 322 of the secondary catheter fixation device 300 may be connected to or integrated with the gasket 310.

[0093] In some embodiments, the base 320 and arm members 324, 326 include corresponding fixing features 322a, 322b. In some embodiments, when each arm member 324, 326 is fixed to the base 320, the corresponding fixing features 322a, 322b are configured to engage with each other to form a corresponding hinge joint 315. For example, in some embodiments, the base 320 may include a pair of recesses or holes 322a, and each arm member 324, 326 may include a protrusion 322b configured to be received by a corresponding recess / hole 322a in the base 320, thereby enabling the arm members 324, 326 to pivotally move relative to the base 320. In some embodiments, the recess / hole 322a may be located on the arm members 324, 326, and the corresponding protrusion 322b may be located on the base 320.

[0094] like Figure 15D As shown, in some embodiments, each arm member 324, 326 includes a corresponding recess 324r, 326r that, when positioned together, defines an aperture 328 configured to receive the conduit 12 (see, for example...). Figure 15CIn some embodiments, the inner surfaces of the recesses 324r, 326r may include a resilient compressible material. The resilient compressible material can help prevent compression and / or kinking of the catheter lumen 12 when received by the recesses 324r, 326r (i.e., within the orifice 328). Additionally, in some embodiments, the orifice 327 extends through an arm member 324 and into the recess 324r. Figure 15C As shown and described in further detail below, the size and configuration of the hole 327 are set to receive a fixing mechanism 330 (e.g., a rod) passing through it, such that the fixing mechanism 330 can secure the conduit 12 within the secondary conduit fixing device 300.

[0095] Figure 16A-16L The exemplary steps of replacing the dressing 25 of the catheter 12 using the secondary catheter fixation device 300 according to an embodiment of the present invention are illustrated schematically. Figure 16A The catheter interface 14 is shown attached to the patient's skin S via a primary fixation device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter interface 14, and a main tube 12 is coupled to and extends from the opposite end of the catheter interface 14. The catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. A first dressing 25a (e.g., an antimicrobial hemostatic IV dressing) is applied over the catheter insertion site IS. A second transparent dressing 25b is applied and covers the insertion site IS, the first dressing 25a, the catheter 12, the primary fixation device 20, the catheter interface 14, and at least a portion of the catheter extension lines 12a, 12b. Figure 16B-16C As shown, during dressing changes, the first and second dressings 25a and 25b are removed so that the area around the insertion site IS can be cleaned (e.g., via sterilizer 30), except for the skin S below the catheter 12 and primary fixation member 20.

[0096] like Figure 16D-16E As shown, the secondary catheter fixation device 300 is positioned adjacent to the insertion site IS. In some embodiments, the secondary catheter fixation device 300 is positioned such that the insertion site IS is located within the recess 311 of the gasket 310 of the secondary catheter fixation device 300. Figure 16D As shown, the secondary catheter fixation device 300 is positioned on the side of the insertion portion IS opposite to the catheter interface 14 and the primary fixation device 20, wherein the hinge axis is aligned with the catheter insertion portion IS. Figure 16EAs shown, the arm members 324, 326 of the secondary conduit fixation device 300 are then lowered toward the conduit 12 (by pivoting downwards via the hinge joint 315). The conduit 12 is positioned between the recesses 324r, 326r of the arm members 324, 326. A fixation mechanism 330 (e.g., a rod) is inserted into a hole 327 extending through one arm member 324 until the fixation mechanism 330 contacts the outer diameter of the conduit 12 located within the hole 328 and presses the conduit 12 against the inner surface of the recess 324r of the other arm member 324, thereby securing the conduit 12 in the proper position within the hole 328 and to the secondary conduit fixation device 300 (see also, for example...). Figures 17A-17B and Figures 18A-18B ).

[0097] like Figure 16F As shown, after the secondary catheter fixation device 300 securely holds the catheter 12 in place by its fixation mechanism 330, the catheter interface 14 is released from the old primary fixation device 20, and the old primary fixation device 20 is removed. The catheter 12 can then be raised (by pivoting upwards via the bistable hinge joint 315 of the secondary catheter fixation device 300). Figure 16G As shown, the catheter 12 can be raised using the fixation mechanism 330 (i.e., without the need for caregivers to access the catheter 12 and / or catheter interface 14). Figure 16H As shown, this is similar to other secondary catheter fixation devices 100 described herein. 1-6 Similarly, the secondary catheter fixation device 300 of the present invention allows the catheter 12 and catheter interface 14 to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning around the catheter insertion site IS and the skin S below the catheter 12 and catheter interface 14 (e.g., using a disinfection applicator 30). In some embodiments, the hinged joint 315 may be configured to lock the secondary catheter fixation device 300 (and the catheter 12) in the raised position, thereby allowing caregivers to clean around the catheter insertion site IS with both hands.

[0098] like Figure 16I As shown, after cleaning is complete, the catheter 12 is lowered (rotated downwards via the hinge joint 315 of the secondary catheter fixation device 300), and the catheter interface 14 is secured in the new primary fixation device 20. Once the catheter interface 14 is secured, the fixation mechanism 330 can be released (e.g., removed from the hole 327), and the secondary catheter fixation device 300 can be removed. Figure 16J Then, the area initially covered by the pad 310 of the secondary catheter fixation device 300 can be cleaned (e.g., using a sterilizer applicator 30). Finally, as... Figure 16K-16L As shown, new first and second dressings 25a and 25b are applied over the site.

[0099] Figures 17A-17B Examples illustrate the operation of the fixation mechanism 330 of the secondary catheter fixation device 300 described herein. Figure 17A The fixing mechanism 330 is shown in the non-latched position. (Example) Figure 17A As shown, in some embodiments, the fixing mechanism 330 extends through a hole 327 in an arm member 326. In some embodiments, the fixing mechanism 330 and the arm member 326 form a sliding joint within the hole 327. Figure 17B The fixing mechanism 330 is shown in the latched position. (Example) Figure 17B As shown, as described above, the fixing mechanism 330 contacts the outer diameter of the conduit 12 located within the hole 328 (formed by recesses 324r, 326r) and pushes the conduit 12 against the inner surface of the recess 324r of the other arm member 324, thereby securing the conduit 12 within the hole 328 of the secondary conduit fixing device 300. In some embodiments, the fixing mechanism 330 may include a locking and / or anti-rotation feature 329 to further secure the conduit 12 within the hole 328 of the secondary conduit fixing device 300.

[0100] Figures 18A-18B The example illustrates the operation of an alternative fixation mechanism 330', which can be incorporated into the secondary catheter fixation device 300 described herein. Figure 18A The fixing mechanism 330' in the non-latched position is shown. Figure 18A As shown, in some embodiments, the fixing mechanism 330' can be configured to be driven by the rack and pinion mechanism 329'. Figure 18B A retaining mechanism 330' in the latched position is shown. A rack and pinion mechanism 329' is configured to allow the retaining mechanism 330' to move laterally within a hole 327 in an arm member 326. Similar to the retaining mechanism 330, the retaining mechanism 330' is configured to apply a force F that pushes the catheter 12 against the inner surface of a recess 324r in another arm member 324, thereby securing the catheter 12 within a hole 328 in a secondary catheter retainer 300. In some embodiments, the retaining mechanisms 330, 330' can be used to secure the catheter 12 within the secondary catheter retainer 300 for both short-term (e.g., during dressing changes) and long-term (e.g., during indwelling) fixation.

[0101] Now for reference Figures 19A-19C This example illustrates another secondary catheter fixation device 400 according to an embodiment of the present invention. The properties and / or features of the secondary catheter fixation device 400 may be as referenced above. Figure 12A-12B As described in the secondary catheter fixation device 200 shown, and for ease of discussion Figures 19A-19C Repeated discussion of it can be omitted here.

[0102] As described in further detail below, in some embodiments, the secondary catheter fixation device 400 is configured to grip the catheter 12 and elevate it to a sufficient distance D above the patient's skin S (see, for example...). Figure 19C This allows for 360° cleaning around the catheter insertion site IS and the skin S beneath the catheter 12 and catheter interface 14. In some embodiments, such as Figures 19A-19B As shown, the secondary catheter fixation device 400 includes a pad 410, a base 420, and an extended arm member 430 coupled to the base 420. The pad 410 is configured to be secured to the patient's skin. For example, in some embodiments, the pad 410 is an adhesive pad.

[0103] In some embodiments, the base 420 has an arcuate recess 422 extending therein. For example... Figure 19A As shown, the extended arm member 430 includes a slider 432 configured to be received and held within an arcuate recess 422 in the base 420. As further described below, the slider 432 is configured to travel along a guide path within the recess 422 of the base 420. In some embodiments, at the end opposite to the slider 432, the extended arm member 430 includes a latching mechanism 434. The latching mechanism 434 is configured to grip and hold the conduit 12 or conduit interface 14 therein. For example, in some embodiments, the latching mechanism 434 may include a recess 436 configured to receive a segment of the conduit 12 or conduit interface 14 and form an interference fit therewith to hold the conduit 12 or conduit interface 14 within the latching mechanism 434 without increasing the risk of impeding fluid flow / mechanical kinking due to compression of the conduit 12.

[0104] like Figure 19C As shown, the secondary catheter fixation device 400 is secured to the patient's skin adjacent to the catheter insertion site IS (e.g., via adhesive pad 410 or using a microneedle). A slider 432 (at one end of the extended arm member 430) is secured within a recess 422 of the base 420, and a latching mechanism 434 (at the opposite end of the extended arm member 430) grips the catheter 12. In some embodiments, the arcuate shape of the base 420 (and the guide path of the recess 422) positions the secondary catheter fixation device 400 on the patient such that the secondary catheter fixation device maintains a constant radial distance R from the insertion site IS of the catheter 12, thereby ensuring that the catheter 12 does not migrate into and out of the insertion site IS when moved during site cleaning and dressing changes.

[0105] Now for reference Figures 20A-20C and Figure 21A-21LThis example illustrates another secondary catheter fixation device 500 according to an embodiment of the present invention. The nature and / or features of the secondary catheter fixation device 500 may be as described above with reference to other secondary catheter fixation devices described herein, and for ease of discussion... Figure 20A-21L Repeated discussion of it can be omitted here.

[0106] like Figures 20A-20C As shown, in some embodiments, the secondary catheter fixation device 500 can be configured to be used as an existing sterilization applicator 30 (e.g., BD Chloraprep). TM Additional features of ). For example Figure 20B-20C As shown, in some embodiments, the secondary catheter fixation device 500 may be configured to be fixed to end 30e of the applicator 30 and latched to one or more catheter extension lines 12a, 12b connected to and extending from one end of the catheter interface 14, thereby supporting the catheter extension lines 12a, 12b using the existing sterilization applicator 30 during dressing changes. Adhesive tape or straps 40 may be used to hold the applicator sponge 32 of the applicator 30 above the insertion site IS to help reduce the risk of displacement of the catheter 12 during cleaning (see, for example...). Figure 20C ).

[0107] In some embodiments, the secondary catheter fixation device 500 includes an annular body 512 configured to receive an end of the applicator 30 passing through it (see, for example...). Figure 20B Clamps 514 extend outward from the body 512. In some embodiments, the secondary catheter fixation device 500 may be formed of a polymer material that allows clamps 514 to deflect and open to receive and hold catheter extension lines 12a, 12b therein. Figure 20C As shown and described in further detail below, the secondary catheter fixation device 500 allows the catheter extension lines 12a, 12b (and catheter interface 14) to be held at a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing changes.

[0108] Figure 21A-21L The exemplary steps of replacing the dressing 25 of the catheter 12 using the secondary catheter fixation device 500 according to an embodiment of the present invention are illustrated schematically. Figure 21AThe catheter interface 14 is shown secured by a primary fixation device 20. One or more catheter extension lines 12a, 12b are connected to and extend from one end of the catheter interface 14, and a main tube 12 extends from the opposite end of the catheter interface 14. The catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. A first dressing 25a (e.g., an antimicrobial hemostatic IV dressing) is applied over the insertion site IS of the catheter 12. A second transparent dressing 25b is applied and covers the insertion site IS, the first dressing 25a, the catheter 12, the primary fixation device 20, the catheter interface 14, and at least a portion of the catheter extension lines 12a, 12b. Figure 21B-21C As shown, during dressing changes, the first and second dressings 25a and 25b are removed so that the area surrounding the insertion site IS can be cleaned, except for the skin S below the catheter 12 and the primary fixation device 20.

[0109] like Figure 21D As shown, the sponge 32 of the disinfectant applicator 30 is secured above the insertion site IS via adhesive tape or strap 40. Next, as... Figure 21E As shown, the catheter extension lines 12a and 12b are secured by the clamp 514 of the secondary catheter fixation device 500 (this conforms to ANTT practice, i.e., caregivers only need to contact the secondary catheter fixation device 500 without contacting the extension lines 12a and 12b). After the catheter extension lines 12a and 12b (via the secondary catheter fixation device 500) are secured to the applicator 30, the catheter interface 14 can be released from the primary fixation device 20, and the body 512 of the secondary catheter fixation device 500 can be slid onto the end 30e of the applicator 30. Figure 21F ).

[0110] like Figure 21G As shown, when catheter 12 is secured at the insertion site IS and catheter extension lines 12a, 12b are held by the secondary catheter securing device 500, the old primary securing device 20 can be removed. Figure 21H As shown, similar to other secondary catheter fixation devices described herein, the secondary catheter fixation device 500 allows the catheter 12, catheter interface 14, and catheter extension lines 12a, 12b to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning of the skin S below the catheter 12 and catheter interface 14 (e.g., using another disinfection applicator 35, such as a disinfectant swab).

[0111] like Figure 21I As shown, after cleaning, the catheter interface 14 is secured in the new primary fixation device 20. Once the catheter interface 14 is secured in the primary fixation device 20, the adhesive tape 40 and the applicator 30 are removed from the catheter insertion site IS. Figure 21JAnd the area can be cleaned (e.g., using a disinfectant applicator 30) Figure 21K Finally, as Figure 21L As shown, new first and second dressings 25a and 25b are applied over the site.

[0112] Now for reference Figures 22A-22H This example illustrates another secondary catheter fixation device 600 according to an embodiment of the present invention and exemplary steps for replacing the dressing 25 of catheter 12 using the secondary catheter fixation device 600. The nature and / or features of the secondary catheter fixation device 600 may be as described above with reference to the secondary catheter fixation device 500 described herein, and for ease of discussion Figures 22A-22H Repeated discussion of it can be omitted here.

[0113] like Figures 22A-22H As shown in the diagram, and similar to the secondary catheter fixation device 500 described herein, the secondary catheter fixation device 600 can be configured to be used as an existing sterilization applicator 30 (e.g., BD Chloraprep). TM Additional features of the secondary catheter fixation device 600. In some embodiments, the secondary catheter fixation device 600 is configured to be fixed to the applicator 30 and clamped to the catheter extension lines 12a, 12b coupled to and extending from the catheter interface 14, thereby supporting the catheter extension lines 12a, 12b using the existing sterilization applicator 30 during dressing changes. Adhesive tape or straps 40 can be used to hold the applicator sponge 32 of the applicator 30 above the insertion site IS to help reduce the risk of displacement of the catheter 12 during cleaning (see, for example...). Figure 22B-22G ).

[0114] In some embodiments, the secondary catheter fixation device 600 has a concave body 610 (see, for example) Figure 22C-22D In some embodiments, the concave body 610 is sized and configured to receive the outer diameter of the applicator 30. In some embodiments, one end of the body 610 of the secondary conduit fixation device 600 is pivotally connected to the lower end of the applicator 30 via a hinge 615 (see, for example...). Figure 22CThe opposite end of the secondary catheter fixation device 600 includes a clamp 620. Similar to the clamp 514 of the secondary catheter fixation device 500, the clamp 620 of the secondary catheter fixation device 600 can be configured to deflect to receive and retain catheter extension lines 12a, 12b therein without increasing the risk of impeding fluid flow / mechanical kinking due to compression of the catheter extension lines 12a, 12b. In some embodiments, the secondary catheter fixation device 600 further includes a fixation mechanism 630 opposite to the clamp 620. The fixation mechanism 630 is configured to releasably fix the secondary catheter fixation device 600 to the applicator 30. Different fixation mechanisms 630 can be used to releasably fix the secondary catheter fixation device 600 to the applicator 30. For example, in some embodiments, the fixation mechanism 630 may include a snap-fit ​​feature configured to engage and / or form an interference fit with the outer diameter of the applicator 30. In other embodiments, the fixing mechanism 630 may include a protrusion or similar feature configured to be received by a corresponding recess or hole in the applicator 30.

[0115] like Figure 22A As shown, catheter interface 14 is secured to primary fixation device 20. One or more catheter extension lines 12a, 12b are connected to and extend from one end of catheter interface 14, and a main guide tube 12 is connected to and extends from the opposite end of catheter interface 14. Catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. Figure 22A In this process, as previously described herein, the first and second dressings 25a, 25b have been removed so that the area around the insertion site IS can be cleaned except for the skin S below the catheter 12 and the primary fixation device 20, and the sponge 32 of the disinfection applicator 30 has been placed over the insertion site IS.

[0116] like Figure 22B As shown, the sponge 32 of the applicator 30 is secured above the insertion site IS using adhesive tape or strap 40. Next, as... Figure 21C As shown, the fixation mechanism 630 of the secondary catheter fixation device 600 is released from the applicator 30, and the body 610 of the secondary catheter fixation device 600 is pivoted downward (lowered) toward the catheter extension lines 12a, 12b via the hinge 615. The catheter extension lines 12a, 12b are secured within the clamp 620 of the secondary catheter fixation device 600 without increasing the risk of impeding fluid flow / mechanical kinking due to compression of the catheter extension lines 12a, 12b. This facilitates compliance with ANTT practice, where caregivers only need to access the secondary catheter fixation device 600 without accessing the catheter extension lines 12a, 12b. Figure 22DAs shown, after the catheter extension lines 12a, 12b are secured within the clamp 620 of the secondary catheter fixation device 600, the catheter interface 14 can be released from the old primary fixation device 20, and the body 610 of the secondary catheter fixation device 600 can be pivoted (raised) upward toward the applicator 30 via the hinge 615. A portion of the applicator 30 is received by the concave body 610 of the secondary catheter fixation device 600, and in some embodiments, the fixation mechanism 630 secures one end of the secondary catheter fixation device 600 to the applicator 30. Figure 22E ).

[0117] like Figure 22F As shown, the primary fixation device 20 is removed when the catheter 12 is secured near the insertion site IS and the catheter interface 14 and catheter extension lines 12a, 12b are held by the clamp 620 of the secondary catheter fixation device 600 (and abut against the applicator 30). Similar to other catheter fixation devices described herein, the secondary catheter fixation device 600 allows the catheter 12, catheter interface 14, and catheter extension lines 12a, 12b to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning of the skin S beneath the catheter 12 and catheter interface 14 (e.g., using another disinfection applicator 35).

[0118] like Figure 22G As shown, after cleaning is complete, the fixing mechanism 630 of the secondary catheter fixation device 600 is released from the applicator 30, and the body 610 of the secondary catheter fixation device 600 is pivoted downward (lowered) via the hinge 615, and the catheter interface 14 is secured in the new primary fixation device 20. Once the catheter interface 14 is secured, the adhesive tape 40 and the applicator 30 are removed from the insertion site IS, and the area around the insertion site IS of the catheter 12 can be cleaned (e.g., using the sterilizing applicator 30). Figure 22H Finally, as previously described, new first and second dressings 25a, 25b are applied over the site.

[0119] Now for reference Figures 23A-23G This example illustrates another secondary catheter fixation device 700 according to an embodiment of the present invention and exemplary steps for replacing the dressing 25 of catheter 12 using the secondary catheter fixation device 700. The nature and / or features of the secondary catheter fixation device 700 may be as described above with reference to the secondary catheter fixation device 500 described herein, and for ease of discussion Figures 23A-23G Repeated discussion of it can be omitted here.

[0120] like Figures 23A-23GAs shown in the diagram, and similar to the secondary catheter fixation devices 500 and 600 described herein, the secondary catheter fixation device 700 can be configured to be used as an additional feature of the existing sterilization applicator 30. In some embodiments, the secondary catheter fixation device 700 is configured to be secured to the applicator 30 and clamped to the catheter extension lines 12a and 12b extending from the catheter interface 14, thereby supporting the catheter extension lines 12a and 12b using the existing sterilization applicator 30 during dressing changes. Adhesive tape or straps 40 can be used to hold the applicator sponge 32 of the applicator 30 above the insertion site IS to help reduce the risk of displacement of the catheter 12 during cleaning.

[0121] In some embodiments, similar to the secondary catheter fixation device 500 described herein, the secondary catheter fixation device 700 may include an annular body 710 configured to receive the end of an applicator 30 passing therethrough. A clamp 720 extends outwardly from the annular body 710. In some embodiments, the secondary catheter fixation device 700 may be formed of a polymeric material that allows the clamp 720 to deflect to receive and retain catheter extension lines 12a, 12b therein. Figure 23C As shown and described in further detail below, the secondary catheter fixation device 700 allows the catheter extension lines 12a, 12b (and catheter interface 14) to be held at a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing changes.

[0122] In some embodiments, the secondary catheter fixation device 700 differs from the secondary catheter fixation device 500 in that the positioning of the secondary catheter fixation device 700 on the applicator 30 (i.e., different from being located at one end of the applicator 30 as described above). For example, as Figure 23A As shown, in some embodiments, the body 710 of the secondary catheter fixation device 700 may be configured to be held between (or within) a pair of annular rings 31 along the length of the applicator 30. In some embodiments, the annular rings 31 may be configured to prevent the secondary catheter fixation device 700 from sliding or moving along the length of the applicator 30.

[0123] like Figure 23A As shown, the catheter interface 14 is secured by a primary fixation device 20. One or more catheter extension lines 12a, 12b are connected to and extend from one end of the catheter interface 14, and a main guide tube 12 is connected to and extends from the opposite end of the catheter interface 14. The catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. Figure 23AIn this process, as previously described herein, the first and second dressings 25a, 25b have been removed so that the area around the insertion site IS can be cleaned except for the skin S below the catheter 12 and the primary fixation member 20, and the sponge 32 of the disinfection applicator 30 has been placed over the insertion site IS.

[0124] like Figure 23B As shown, the sponge 32 of the applicator 30 is secured above the insertion site IS using adhesive tape or strap 40. Next, as... Figure 23C As shown, the catheter interface 14 is released from the primary fixation device 20, and the catheter interface 14 and catheter extension lines 12a, 12b are lifted toward the applicator 30. Figure 23D As shown, the body 710 of the secondary catheter fixation device 700 is rotated relative to the applicator 30 so that the clamp 720 engages with the catheter extension lines 12a, 12b.

[0125] like Figure 23E As shown, with catheter 12 secured near the insertion site IS and catheter interface 14 and catheter extension lines 12a, 12b held by clamps 720 of the secondary catheter fixation device 700, the old primary fixation device 20 is removed. Similar to other fixation devices described herein, the secondary catheter fixation device 700 allows catheter 12, catheter interface 14, and catheter extension lines 12a, 12b to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning of the skin S beneath catheter 12 and catheter interface 14 (e.g., using another disinfection applicator 35, such as a disinfectant swab).

[0126] like Figure 23F As shown, after cleaning, the catheter extension lines 12a and 12b are released from the clamps 720 of the secondary catheter fixation device 700, and the catheter interface 14 is secured in the new primary fixation device 20. Once the catheter interface 14 is secured, the adhesive tape 40 and the applicator 30 are removed from the insertion site IS, and the area around the insertion site IS of the catheter 12 can be cleaned (e.g., using the disinfectant applicator 30). Figure 23G Finally, as previously described, new first and second dressings 25a, 25b are placed over the site.

[0127] Now for reference Figures 24A-24H This example illustrates another secondary catheter fixation device 800 according to an embodiment of the present invention and exemplary steps for changing the dressing 25 of catheter 12 using the secondary catheter fixation device 800. The nature and / or features of the secondary catheter fixation device 800 may be as described above with reference to the secondary catheter fixation device 500 described herein, and for ease of discussion Figures 24A-24HRepeated discussion of it can be omitted here.

[0128] like Figures 24A-24H As shown in the diagram, and similar to the secondary catheter fixation devices 500, 600, and 700 described herein, the secondary catheter fixation device 800 can be configured to serve as an additional feature of the existing sterilization applicator 30. In some embodiments, the secondary catheter fixation device 800 is configured to be secured to the applicator 30 and clamped to the catheter extension lines 12a, 12b extending from the catheter interface 14, thereby supporting the catheter extension lines 12a, 12b using the existing sterilization applicator 30 during dressing changes. Adhesive tape or straps 40 can be used to hold the applicator sponge 32 of the applicator 30 above the insertion site IS to help reduce the risk of displacement of the catheter 12 during cleaning.

[0129] In some embodiments, the secondary catheter fixation device 800 includes a body 810 having a recess or cavity 812 configured to receive an end of the applicator 30 (see, for example...). Figure 24D The secondary catheter fixation device 800 further includes a clamping mechanism 820 coupled to the body 810. In some embodiments, the clamping mechanism 820 includes one or more recesses 822. Each recess 822 is sized and configured to receive and retain a corresponding catheter extension line 12a, 12b (e.g., to form an interference fit therewith). In some embodiments, the secondary catheter fixation device 800 may be formed of a polymer material that allows the recesses 822 to deflect open to receive and retain the catheter extension lines 12a, 12b therein. Figure 24E As shown and described in further detail below, the secondary catheter fixation device 800 enables the catheter extension lines 12a, 12b (and catheter interface 14) to be held at a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing changes.

[0130] like Figure 24A As shown, the catheter interface 14 is secured by a primary fixation device 20. One or more catheter extension lines 12a, 12b are connected to and extend from one end of the catheter interface 14, and a main guide tube 12 is connected to and extends from the opposite end of the catheter interface 14. The catheter 12 is inserted into the patient's body (e.g., a vein) at the insertion site IS. Figure 24A In this process, as previously described herein, the first and second dressings 25a, 25b have been removed so that the area around the insertion site IS can be cleaned except for the skin S below the catheter 12 and the primary fixation member 20, and the sponge 32 of the disinfection applicator 30 has been placed over the insertion site IS.

[0131] like Figure 24B As shown, the sponge 32 of the applicator 30 is secured above the insertion site IS using adhesive tape or strap 40. Next, as... Figure 24C-24D As shown, the catheter interface 14 is released from the old primary fixation device 20, and the catheter interface 14 and the catheter extension lines 12a, 12b are lifted toward the applicator 30. Each catheter extension line 12a, 12b is received by and secured in the fixation mechanism 820 of the secondary catheter fixation device 800 (e.g., each extension line 12a, 12b is secured in a corresponding recess 822).

[0132] like Figure 24E As shown, with catheter 12 secured near the insertion site IS and catheter interface 14 and catheter extension lines 12a, 12b secured by secondary catheter fixation device 800, the old primary fixation device 20 is removed. Similar to other secondary catheter fixation devices described herein, secondary catheter fixation device 800 allows catheter 12, catheter interface 14, and catheter extension lines 12a, 12b to be raised a sufficient distance D relative to the patient's skin S to allow for 360° cleaning of the skin S beneath catheter 12 and catheter interface 14 (e.g., using another disinfection applicator 35, such as a disinfectant swab).

[0133] like Figure 24F As shown, after cleaning is complete, the catheter extension lines 12a and 12b are released from the fixing mechanism 820 of the device 800, and the catheter interface 14 is secured in the new primary fixing device 20. Once the catheter interface 14 is secured, the adhesive tape 40 and the applicator 30 are removed from the insertion site IS, and the area around the insertion site IS of the catheter 12 can be cleaned (e.g., using the disinfectant applicator 30). Figure 24G Finally, as Figure 24H As shown, new first and second dressings 25a and 25b are placed over the site.

[0134] The foregoing description is illustrative of the invention and should not be construed as limiting it. Although some exemplary embodiments of the invention have been described, those skilled in the art will readily understand that many modifications can be made to the exemplary embodiments without substantially departing from the novel teachings and advantages of the invention. Therefore, all such modifications are intended to be included within the scope of the invention as defined in the claims. The invention is defined by the appended claims, which include their equivalents.

Claims

1. A catheter fixation device, comprising: A pad configured to be fixed to the patient's skin; as well as A clamping mechanism, pivotally coupled to the gasket and configured to grip and retain the conduit without increasing the risk of impeding fluid flow or causing mechanical kinking due to compression of the conduit. The pivoting of the clamping mechanism allows the catheter to be raised a sufficient distance relative to the patient's skin to allow for cleaning of the patient's skin.

2. The catheter fixation device according to claim 1, wherein, The gasket is an adhesive gasket.

3. The catheter fixation device according to claim 1, wherein, The pad includes a recess, and wherein, when the pad is secured to the patient's skin, the insertion site of the catheter is positioned within the recess.

4. The catheter fixation device according to claim 1, wherein, The gasket includes a pair of arms extending upward therefrom, each arm being configured to engage with a segment of the clamping member to form a hinged joint.

5. The catheter fixation device according to claim 1, wherein, The clamping mechanism includes a pair of wing-shaped members connected together to form a latching mechanism, the size and configuration of which are set to grip and hold conduits of different sizes.

6. The catheter fixation device according to claim 5, wherein, The inner wall of the latching mechanism includes gripping features.

7. The catheter fixation device according to claim 5, wherein, Each airfoil component's outer surface includes one or more gripping features.

8. The catheter fixation device according to claim 1, wherein, The gasket and the clamping mechanism are integrally formed as a single component.

9. The catheter fixation device according to claim 1, wherein, The gasket includes an extension member, and the clamping mechanism is coupled to the extension member.

10. The catheter fixation device according to claim 1, wherein, When the clamping mechanism is positioned to grip the conduit, the clamping mechanism extends along a plane that is substantially perpendicular to the gasket.

11. The catheter fixation device according to claim 9, wherein, When the clamping mechanism is positioned to grip the conduit, the clamping mechanism extends along a plane that is generally parallel to the gasket.

12. The catheter fixation device according to claim 4, wherein, The hinged joint includes a locking feature configured to secure the clamping mechanism at a distance above the patient's skin.

13. The catheter fixation device according to claim 5, wherein, The clamping mechanism includes an offset member located between the pair of airfoil members.

14. A catheter fixation device, comprising: A pad configured to be fixed to the patient's skin; The base is connected to the gasket; as well as A cantilever member, pivotally connected at one end to the base and including a latching mechanism at the opposite end, the latching mechanism being configured to grip and retain the catheter. in, The pivoting of the cantilever component allows the catheter to be raised to a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

15. The catheter fixation device according to claim 14, wherein, The gasket is an adhesive gasket.

16. The catheter fixation device according to claim 14, wherein, The latching mechanism includes a recess configured to receive a segment of the conduit and to form an interference fit therewith.

17. The catheter fixation device according to claim 14, wherein, The cantilever member includes a first locking feature and the base includes a second locking feature, wherein the cantilever member is configured to be held in a raised position when the first locking feature engages with the second locking feature.

18. The catheter fixation device according to claim 17, wherein, The second locking feature is a recess, and the first locking feature is configured to be received by the recess.

19. A catheter fixation device, comprising: A pad configured to be fixed to the patient's skin; The base is connected to the gasket; A pair of arm members pivotally coupled to the base, each arm member including a recessed end that together define a first orifice configured to receive a conduit passing through it, wherein one of the arm members includes a second orifice extending into the corresponding recessed end; as well as A fixing mechanism, configured to receive through the second hole, for securing the conduit within the first hole. When the catheter is secured in the first hole by the fixing mechanism, the pair of arm members are configured to raise the catheter to a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

20. The catheter fixation device according to claim 19, wherein, The gasket is an adhesive gasket.

21. The catheter fixation device according to claim 19, wherein, The pad includes a recess, and wherein, when the pad is secured to the patient's skin, the insertion site of the catheter is positioned within the recess.

22. The catheter fixation device according to claim 19, wherein, The base and the gasket are integrally formed.

23. The catheter fixation device according to claim 19, wherein, The base and each arm member include corresponding fixing features configured to engage with each other to form a corresponding hinge joint, thereby allowing the arm member to pivot relative to the base.

24. The catheter fixation device according to claim 19, wherein, The inner surface of each recessed end of the arm component comprises an elastically compressible material.

25. The catheter fixation device according to claim 19, wherein, One of the arm components and the fixing mechanism both form a sliding joint with the second hole.

26. The catheter fixation device according to claim 19, wherein, The fixing mechanism is a rod that includes anti-rotation features.

27. The catheter fixation device according to claim 19, wherein, The fixing mechanism includes a rack and pinion mechanism configured to allow the clamping mechanism to move laterally within the second hole.

28. A catheter fixation device, comprising: A pad configured to be fixed to the patient's skin; A base connected to the gasket, the base including an arcuate recess; as well as An extended arm member, comprising a slider at one end and a latching mechanism at the opposite end, the slider being configured to travel along a guide path within an arcuate recess of the base. The latching mechanism is configured to grip and hold the catheter therein, such that the catheter can be held at a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

29. The catheter fixation device according to claim 28, wherein, The gasket is an adhesive gasket.

30. The catheter fixation device according to claim 28, wherein, The latching mechanism includes a recess configured to receive a segment of the conduit and to form an interference fit therewith.

31. The catheter fixation device according to claim 28, wherein, The arc-shaped recess positions the secondary catheter fixation device on the patient's skin so that the secondary catheter fixation device maintains a constant radial distance from the insertion site of the catheter.

32. A catheter fixation assembly, the catheter fixation assembly comprising: Disinfectant applicator; The catheter fixation device includes: The main body; and A clamp connected to and extending outward from the body, the clamp being configured to receive and hold one or more conduit extension lines therein. Wherein, one end of the disinfectant applicator is received by the main body of the catheter fixing device, so as to fix the catheter fixing device to the disinfectant applicator, and The catheter fixation device is configured to hold one or more catheter extension lines at a sufficient distance above the patient's skin to allow for cleaning of the patient's skin.

33. The catheter fixation assembly according to claim 32, wherein, The catheter fixation device has an annular body configured to receive the end of a disinfectant applicator passing through it.

34. The catheter fixation assembly according to claim 33, wherein, The catheter securing device is positioned along the length of the disinfectant applicator and is configured to rotate around the disinfectant applicator to engage one or more catheter extension lines.

35. The catheter fixation assembly according to claim 32, wherein, The catheter fixation device is formed of a polymer material that allows the clamp to deflect and open to receive and hold one or more catheter extension lines therein.

36. The catheter fixation assembly according to claim 32, wherein, The catheter fixation device has a concave body, the size and configuration of which are set to receive the outer diameter of the disinfectant applicator, wherein the clamp is located at one end of the body and the opposite end of the body is pivotally connected to the lower end of the disinfectant applicator.

37. The catheter fixation assembly according to claim 32, wherein, The clamp includes multiple recesses, each configured to receive and hold a corresponding conduit extension line.

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