Devices and related methods for catheter fixation

Abstract

This application is directed to a catheter fixation device. The device comprises a cover, a drive disc having a plurality of elongated guide slots extending circumferentially, an engagement mechanism, a plurality of microneedle patches, and a base disc. The cover is configured to engage with a catheter. The engagement mechanism comprises a plurality of engagement arms, each engagement arm having a guide pin extending upward therefrom and receiving into a corresponding guide slot of the drive disc. Each microneedle patch is connected to an individual engagement arm and comprises a plurality of microneedles. The base disc is connected to the cover for holding the drive disc and the engagement mechanism between them. When the drive disc rotates in a first direction, each guide pin is configured to slide within its individual guide slot, causing adjacent engagement arms to move radially opposite to the base disc so that the corresponding microneedle engages with the skin.

Description

Technical Field

[0001] This application claims the priority and benefit of U.S. Provisional Patent Application Serial No. 63 / 505,552, filed on June 1, 2023, and Indian Patent Application No. 202341061291, filed on September 12, 2023. The entire disclosures of these are incorporated herein by reference.

[0002] The present invention relates to medical devices, particularly devices for catheter fixation.

Background Art

[0003] 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, digestive, neurovascular, and ophthalmic procedures. In most applications, the catheter is a thin, flexible tube (soft catheter), but catheters of various hardness levels are available depending on the application. The catheter can be inserted into a body cavity, lumen, blood vessel, brain, skin, or adipose tissue. Functionally, the catheter enables drainage, administration of fluids or gases, access by surgical instruments, and many other diverse operations depending on the type of catheter.

[0004] Referring to FIGS. 1, 2A - 2C, 3, and 4A - 4E, when the catheter 12 is to be left in a patient for a long period, fixation techniques are often used to fix the catheter 12 in place. This is particularly applicable to central venous catheters (CVCs and PICCs), which are often inserted into the superior vena cava via the neck and upper arm of the patient, respectively. Solutions for fixing the catheter 12 include suture 11 (e.g., see FIG. 1) and adhesive - based catheter fixation devices 20 (an exemplary catheter fixation device is StatLock available from BD) 商標The device includes, for example, Figure 3). In any of these techniques, it is typically necessary to replace the dressing 25 associated with the insertion site IS of the catheter 12. As can be seen in Figures 2A-2C, cleaning around the catheter 12 secured by sutures 11 results in incomplete (and therefore insufficient) cleaning (for example, an area A of the patient's skin below the catheter hub 14 is not cleaned), which can in turn increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] If the catheter 12 is secured with a fixation device 20, the fixation device 20 is typically replaced at the same time as the dressing 25. During the replacement of the dressing 25, and when replacing the fixation device 20 and cleaning around the insertion site IS (e.g., using a disinfectant applicator 30), the caregiver must avoid excessive movement of the catheter 12 (e.g., tip movement or detachment of the catheter 12, which could cause the catheter 12 to shift too much and become misaligned within the vein or other structure into which it was inserted). This is particularly important for certain catheters, such as CVCs and PICCs.

[0006] Various techniques are currently used for changing the dressing 25 around the catheter. In one technique, a caregiver may use gloved fingers F to hold the catheter 12 in place (see, for example, Figure 4A). However, this may require a second caregiver to clean the treatment site while a first caregiver holds the catheter 12 in place with one hand and removes the fixation device 20 with the other. Furthermore, this technique does not conform to the Aseptic Non-Touch Technique (ANTT) protocol. Alternatively, when the fixation device 20 is replaced, a rolled-up dressing 25 may be used to temporarily hold the catheter 12 (see, for example, Figure 4B). However, the use of a rolled-up dressing 25 for fixation may result in inconsistencies (e.g., the amount of dressing to roll up to secure the catheter at or near the insertion site). As a third technique, a secondary fixation component, such as adhesive tape 15, may be used to temporarily hold the catheter 12 in place during the removal and replacement of the fixation device 20 (see, for example, Figures 4C-4E). This technique requires that the caregiver has the knowledge to perform it and adheres to the protocol for using the adhesive tape 15. Experience has shown that this protocol is often ignored. Furthermore, removal of the adhesive tape 15 may be difficult and / or may cause displacement of 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. 商標 Although adhesive tape is the recommended technique in the instructions for use (IFU) of a similar fixation device, other non-recommended methods, such as using gloved fingers or rolled-up dressings, may be used. [Overview of the project] [Problems that the invention aims to solve]

[0007] It is desirable to provide an alternative device for securing a catheter to the patient's skin during dressing changes of a catheter secured with an adhesive security device, which may improve patient outcomes. [Means for solving the problem]

[0008] A first aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a cover, a drive disc having a plurality of elongated guide slots extending circumferentially, an engagement mechanism, a plurality of microneedle patches, and a base disc. The cover is configured to engage with a catheter hub retaining member. The engagement mechanism comprises a plurality of engagement arms, each engagement arm having a guide pin extending upward therefrom and receiving into a corresponding guide slot of the drive disc. Each microneedle patch is coupled to an individual engagement arm and comprises a plurality of microneedles. The base disc is coupled to the cover and holds the drive disc and the engagement mechanism between them. When the drive disc rotates in a first direction, each guide pin is configured to slide within the individual guide slot of the drive disc, causing adjacent engagement arms to move radially opposite to the base disc, thereby causing the corresponding microneedles to engage with the patient's skin.

[0009] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a top cover configured to engage with a catheter hub retaining member, an internal gear mechanism having an epicyclic gearing arrangement, and concentric inner and outer discs connected to the internal gear mechanism and configured to rotate in opposite directions. Each of the inner and outer discs comprises a plurality of microneedles, the microneedles of the inner disc pointing in opposite directions to the microneedles of the outer disc. The catheter fixation device further comprises a bottom cover, the bottom cover connected to the top cover and holding the internal gear mechanism between them. The catheter fixation device is configured such that the operation of the internal gear mechanism causes the inner and outer discs to rotate in opposite directions so that the corresponding microneedles engage with the patient's skin.

[0010] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises an outer disc having a plurality of first microneedles and an inner disc having a plurality of second microneedles. The inner disc is configured to have a catheter hub retaining member fitted into and fixed to the outer disc. The plurality of first microneedles point in opposite directions to the plurality of second microneedles, and the inner and outer discs are configured to rotate in opposite directions relative to each other in order to engage the corresponding microneedles with the patient's skin.

[0011] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises an upper plate connected to a lower plate. The upper plate is configured to have a catheter hub retaining member fixed to the upper plate and comprises a plurality of cam members extending downward from the upper plate. The lower plate comprises a concentric inner disc and an outer disc, each of which has a plurality of cam members extending upward from its top surface and a plurality of microneedles extending downward from its bottom surface. When the upper plate moves toward the lower plate, the cam members of the upper plate engage with the individual cam members of the lower plate, causing the inner disc and the outer disc to rotate in opposite directions relative to each other, thereby engaging the corresponding microneedles with the patient's skin.

[0012] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a base member configured to hold a catheter and opposing wing members rotatably connected to the base member. Each wing member comprises a microneedle patch having a plurality of microneedles curved radially inward toward the base member. The device further comprises a top cover configured to engage with the wing members to fix the catheter to the base and to prevent vertical movement of the wing members. The wing members are configured to guide the plurality of microneedles along a circular pattern relative to the axis of rotation and engage with the patient's skin.

[0013] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a center plate configured to fix a catheter hub retaining member to the center plate; two base members connected to the center plate; two sliding members, each sliding member movably connected to an individual base member and comprising a microneedle patch, the microneedle patch having a plurality of microneedles extending downward therefrom; and two biasing members within each base member, the two biasing members configured to provide a continuous force to the individual sliding member. The sliding members are configured to allow horizontal movement of the microneedles relative to the base members to facilitate engagement of the microneedles with the patient's skin.

[0014] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a ring-shaped outer member having a plurality of first microneedles and a circular inner member configured to fit into an opening in the ring-shaped outer member. The inner member is configured to have a plurality of second microneedles and a catheter hub retaining member fixed thereto thereto. The outer member and the inner member are configured to rotate in opposite directions to engage the individual microneedles with the patient's skin.

[0015] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a body configured to hold a catheter and a pair of arm members connected to opposite sides of the body. Each arm member comprises one or more microneedle patches, each microneedle patch having a plurality of microneedles. The arm members are configured to move relative to the body to engage the corresponding microneedles with the patient's skin.

[0016] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises an inner disc, the inner disc having a central opening and slots extending radially outward therefrom, which are positioned above the catheter insertion site and configured to receive the catheter; and an outer retaining ring, the outer retaining ring comprising an annular body sized and configured to hold the inner disc and a stabilizing section connected to the body, the stabilizing section being configured to have a catheter hub fixed thereto. The outer retaining ring comprises a plurality of microneedles extending downward therefrom for fixing the device to the patient's skin.

[0017] Another aspect of the present invention is directed toward a catheter fixation device. The catheter fixation device comprises a base and a cover rotatably connected to the base via a hinge mechanism. The base comprises a retaining ring and a pair of stabilizing sections. The retaining ring is substantially circular and has a groove extending around its circumference. The retaining ring is configured to fit around the insertion site of a catheter, and the stabilizing sections are configured to have a catheter hub fixed thereto. The cover has an annular protrusion extending downward therefrom and is configured to be received by the groove of the retaining ring. The base comprises a plurality of microneedles configured to engage with the patient's skin to fix the device.

[0018] It should be noted that any aspect of the invention described in relation to one embodiment may be incorporated into a different embodiment, even if not specifically described in that embodiment. That is, all embodiments and / or features of any embodiment may be combined in any way and / or in any combination. The applicant reserves the right to modify the initially filed claims and / or to file new claims accordingly, including the right to modify the initially filed claims to depend on and / or incorporate features of any other claim or set of claims, even if not initially claimed so. These and other objects and / or aspects of the present invention are described in detail in the specification below. Further features, advantages and details of the present invention will be understood by those skilled in the art by reading the accompanying drawings and the subsequent detailed description of preferred embodiments, but such description is merely illustrative of the present invention. [Brief explanation of the drawing]

[0019] [Figure 1] Figure 1 shows how a central venous catheter line is secured to a patient using sutures. [Figure 2A] Figure 2A shows insufficient site irrigation when sutures are used to secure a central venous catheter line, as shown in Figure 1. [Figure 2B] Figure 2B shows insufficient site irrigation when sutures are used to secure a central venous catheter line, as shown in Figure 1. [Figure 2C] Figure 2C shows insufficient site irrigation when sutures are used to secure a central venous catheter line, as shown in Figure 1. [Figure 3] Figure 3 shows one example of an adhesive-based primary catheter fixation device (i.e., StatLock trademark). [Figure 4A]Figure 4A shows the current art used by a caregiver to temporarily secure a catheter during dressing change of a catheter secured by an adhesive fixation device. [Figure 4B] Figure 4B shows the current art used by a caregiver to temporarily secure a catheter during dressing change of a catheter secured by an adhesive fixation device. [Figure 4C] Figure 4C shows the current art used by a caregiver to temporarily secure a catheter during dressing change of a catheter secured by an adhesive fixation device. [Figure 4D] Figure 4D shows the current art used by a caregiver to temporarily secure a catheter during dressing change of a catheter secured by an adhesive fixation device. [Figure 4E] Figure 4E shows the current art used by a caregiver to temporarily secure a catheter during dressing change of a catheter secured by an adhesive fixation device. [Figure 5A] Figure 5A is a side view of a micro-needle-based catheter fixation device according to an embodiment of the present invention. [Figure 5B] Figure 5B is a top perspective view of the catheter fixation device of Figure 5A. [Figure 5C] Figure 5C is an exploded perspective view of the catheter fixation device of Figure 5A. [Figure 6A] Figure 6A shows the operation of the slider of the catheter fixation device of Figure 5A according to an embodiment of the present invention. [Figure 6B] Figure 6B shows the operation of the slider of the catheter fixation device of Figure 5A according to an embodiment of the present invention. [Figure 7A] Figure 7A is an exploded perspective view of the drive disk and engagement arm of the catheter fixation device of Figure 5A according to an embodiment of the present invention. [Figure 7B] Figure 7B shows the operation of the drive disk with respect to the engagement arm shown in Figure 7A according to an embodiment of the invention. [Figure 7C] Figure 7C shows the operation of the drive disk relative to the engaging arm shown in Figure 7A, according to an embodiment of the invention. [Figure 8A] Figure 8A is an enlarged bottom perspective view of the catheter fixation device of Figure 5A according to an embodiment of the present invention, showing the orientation of the microneedle. [Figure 8B] Figure 8B is a bottom view of the catheter fixation device of Figure 5A according to an embodiment of the present invention, showing the direction of the microneedle with respect to the movement of the engaging arm. [Figure 9A] Figure 9A is a top view of the catheter fixation device of Figure 5A, engaged with a catheter hub, according to an embodiment of the present invention. [Figure 9B] Figure 9B is a top view of a known catheter fixation device engaged with a catheter hub. [Figure 10A] Figure 10A is a bottom perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 10B] Figure 10B is an enlarged bottom perspective view of the catheter fixation device of Figure 10A, according to an embodiment of the present invention, showing the orientation of the microneedle. [Figure 10C] Figure 10C is an exploded view of the catheter fixation device shown in Figure 10A, according to an embodiment of the present invention. [Figure 11A] Figure 11A is a top-view fluoroscopic view of the catheter fixation device shown in Figure 10A, according to an embodiment of the present invention. [Figure 11B] Figure 11B is a magnified view of the slider arm for the catheter fixation device shown in Figure 11A, according to an embodiment of the present invention. [Figure 12A] Figure 12A shows the disengagement of the slider arm of the catheter fixation device of Figure 11B, according to an embodiment of the present invention. [Figure 12B] Figure 12B shows the engagement of the slider arm of the catheter fixation device of Figure 11B according to an embodiment of the present invention. [Figure 13A] Figure 13A is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 13B] Figure 13B is a bottom perspective view of the catheter fixation device shown in Figure 13A. [Figure 14A] Figure 14A shows the orientation of the microneedle for the catheter fixation device of Figure 13A according to an embodiment of the present invention. [Figure 14B] Figure 14B shows the orientation of the microneedle for the catheter fixation device of Figure 13A according to an embodiment of the present invention. [Figure 15A] Figure 15A shows the orientation of the interlocking discs of the catheter fixation device shown in Figure 13A, according to an embodiment of the present invention. [Figure 15B] Figure 15B shows the orientation of the interlocking disk of the catheter fixation device in Figure 13A according to an embodiment of the present invention. [Figure 16A] Figure 16A shows the orientation of the interlocking disk of the catheter fixation device in Figure 13A according to an embodiment of the present invention. [Figure 16B] Figure 16B shows the orientation of the interlocking disk of the catheter fixation device in Figure 13A according to an embodiment of the present invention. [Figure 16C] Figure 16C shows the orientation of the interlocking disk of the catheter fixation device in Figure 13A according to an embodiment of the present invention. [Figure 17A] Figure 17A is a perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 17B] Figure 17B is an exploded view and a top perspective view of the catheter fixation device shown in Figure 17A, according to an embodiment of the present invention. [Figure 17C] Figure 17C shows the orientation of the interlocking disk of the catheter fixation device in Figure 17A according to an embodiment of the present invention. [Figure 18A]Figure 18A is a perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 18B] Figure 18B is a side perspective view of the catheter fixation device shown in Figure 18A. [Figure 18C] Figure 18C is a top view of the catheter fixation device shown in Figure 18A. [Figure 18D] Figure 18D is an alternative perspective view of the catheter fixation device shown in Figure 18A. [Figure 18E] Figure 18E is a bottom perspective view of the catheter fixation device shown in Figure 18A. [Figure 19A] Figure 19A is a perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 19B] Figure 19B is a side view of the catheter fixation device shown in Figure 19A. [Figure 19C] Figure 19C is an exploded view of the catheter fixation device shown in Figure 19A. [Figure 20A] Figure 20A is a perspective view of the lid member of the catheter fixation device shown in Figure 19A. [Figure 20B] Figure 20B is a perspective view of the base member of the catheter fixation device shown in Figure 19A. [Figure 20C] Figure 20C is a perspective view of the microneedle patch of the catheter fixation device shown in Figure 19A. [Figure 21A] Figure 21A is a partial side view of the catheter fixation device shown in Figure 19A, and illustrates the pivoting mechanism for the lateral wing members. [Figure 21B] Figure 21B is an enlarged bottom perspective view of the microneedle patch extending from the lateral wing member in Figure 21A. [Figure 22A] Figure 22A shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 22B]Figure 22B shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 22C] Figure 22C shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 22D] Figure 22D shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 22E] Figure 22E shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 22F] Figure 22F shows the operation of the catheter fixation device shown in Figures 19A to 19C, according to an embodiment of the present invention. [Figure 23A] Figure 23A is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 23B] Figure 23B is an exploded view of the catheter fixation device shown in Figure 23A. [Figure 24A] Figure 24A is a top perspective view of the slider member for the catheter fixation device shown in Figure 23A. [Figure 24B] Figure 24B is a top perspective view of the base frame member for the catheter fixation device shown in Figure 23A, according to an embodiment of the present invention. [Figure 24C] Figure 24C is a top view of a biasing member for the catheter fixation device of Figure 23A, according to an embodiment of the present invention. [Figure 24D] Figure 24D is a bottom perspective view of the microneedle patch for the catheter fixation device of Figure 23A, according to an embodiment of the present invention. [Figure 24E] Figure 24E is an exploded view of the catheter fixation device shown in Figure 23A. [Figure 25A] Figure 25A shows the orientation of the microneedle of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 25B]Figure 25B shows the orientation of the microneedle of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 25C] Figure 25C shows combinations of microneedle patch orientations for the catheter fixation device shown in Figures 23A-23B, according to embodiments of the present invention. [Figure 25D] Figure 25D is a side view showing the movement of the microneedle patch of the catheter fixation device shown in Figures 23A-23B, according to an embodiment of the present invention. [Figure 26A] Figure 26A shows the operation of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 26B] Figure 26B shows the operation of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 26C] Figure 26C shows the operation of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 27A] Figure 27A shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 27B] Figure 27B shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 27C] Figure 27C shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 27D] Figure 27D shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 28A] Figure 28A shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 28B]Figure 28B shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 28C] Figure 28C shows the operating principle and mechanism of the microneedle patch assembly of the catheter fixation device shown in Figures 23A to 23B, according to an embodiment of the present invention. [Figure 29A] Figure 29A is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 29B] Figure 29B is a magnified view of a notch that guides the rotation of the microneedle ring in the catheter fixation device of Figure 29A, according to an embodiment of the present invention. [Figure 29C] Figure 29C shows the orientation of the microneedle in the catheter fixation device of Figure 29A, according to an embodiment of the present invention. [Figure 30A] Figure 30A is another top perspective view of the catheter fixation device of Figure 29A, according to an embodiment of the present invention. [Figure 30B] Figure 30B is a bottom perspective view of the catheter fixation device shown in Figure 30A. [Figure 31A] Figure 31A is a bottom-view exploded stereoscopic view of the catheter fixation device shown in Figure 29A, according to an embodiment of the present invention. [Figure 31B] Figure 31B is a side exploded view of the catheter fixation device shown in Figure 29A, according to an embodiment of the present invention. [Figure 32A] Figure 32A is a perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 32B] Figure 32B is a top perspective view of the catheter fixation device shown in Figure 32A. [Figure 32C] Figure 32C is a schematic top view showing the arrangement of the microneedle patch of the catheter fixation device of Figure 32A according to an embodiment of the present invention. [Figure 33A]Figure 33A is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 33B] Figure 33B is a top perspective view of the disposable inner disc for the catheter fixation device shown in Figure 33A. [Figure 33C] Figure 33C is a side view of the outer retaining ring for the catheter fixation device shown in Figure 33A. [Figure 33D] Figure 33D is a side view of the outer cap for the catheter fixation device shown in Figure 33A. [Figure 34A] Figure 34A shows the operation of the catheter fixation device shown in Figures 33A to 33D, according to an embodiment of the present invention. [Figure 34B] Figure 34B shows the operation of the catheter fixation device shown in Figures 33A to 33D, according to an embodiment of the present invention. [Figure 34C] Figure 34C shows the operation of the catheter fixation device shown in Figures 33A to 33D, according to an embodiment of the present invention. [Figure 35A] Figure 35A is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 35B] Figure 35B is a side view of the catheter fixation device shown in Figure 35A. [Figure 36A] Figure 36A shows the operation of the catheter fixation device shown in Figures 35A to 35B, according to an embodiment of the present invention. [Figure 36B] Figure 36B shows the operation of the catheter fixation device shown in Figures 35A to 35B, according to an embodiment of the present invention. [Figure 36C] Figure 36C shows the operation of the catheter fixation device shown in Figures 35A to 35B, according to an embodiment of the present invention. [Figure 37] Figure 37 is a top perspective view of another microneedle-based catheter fixation device according to an embodiment of the present invention. [Figure 38A] Figure 38A is a top perspective view of the base for the catheter fixation device shown in Figure 37. [Figure 38B] Figure 38B is a side view of the base shown in Figure 38A. [Figure 38C] Figure 38C is a top perspective view of the cover for the catheter fixation device shown in Figure 37. [Figure 38D] Figure 38D is a bottom perspective view of the inner disk for the catheter fixation device shown in Figure 37. [Figure 39A] Figure 39A shows the operation of the catheter fixation device of Figure 37 according to an embodiment of the present invention. [Figure 39B] Figure 39B shows the operation of the catheter fixation device of Figure 37 according to an embodiment of the present invention. [Figure 39C] Figure 39C shows the operation of the catheter fixation device of Figure 37 according to an embodiment of the present invention. [Modes for carrying out the invention]

[0020] Herein, the present invention is described herein with reference to the accompanying drawings illustrating embodiments of the invention. However, the present invention may be used in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided to ensure that this disclosure is complete and thorough and to fully convey the scope of the invention to those skilled in the art.

[0021] In the drawings, certain layers, components, or features may be exaggerated for clarity, and dashed lines indicate any feature or operation unless otherwise specified. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided to ensure that this disclosure is complete and comprehensive and to fully convey the scope of the invention to those skilled in the art.

[0022] In this specification, the terms “first,” “second,” etc., may be used to describe various elements, components, regions, layers, and / or sections, but it will be understood that these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one element, one component, one region, one layer, or one section from another region, another layer, or another section. Accordingly, the first element, first component, first region, first layer, or first section discussed below may be named the second element, second component, second region, second layer, or second section without departing from the teachings of the present invention. The order of operations (or steps) is not limited to the order presented in the claims or drawings unless otherwise specified.

[0023] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as generally understood by one of the ordinary people skilled in the art to which this invention pertains. Furthermore, unless expressly defined herein, terms as defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meanings in the context of this application and related art, and should not be interpreted in an idealized or overly formal sense. Well-known functions or configurations may not be described in detail for the sake of brevity and / or clarity.

[0024] The terms used herein are intended solely to describe specific embodiments and are not intended to limit the invention. Where used herein, the singular forms “one” (a, an) and “the” are intended to also include the plural form unless the context clearly indicates otherwise. Where used herein, the words “equipped with” and / or “equipped with” indicate the presence of the described feature, integer, step, operation, element and / or component, but it will be further understood that they do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. Where used herein, the words “and / or” include any and all combinations of one or more of the associated enumerated items.

[0025] When used herein, phrases such as "X to Y" and "about X to Y" should be interpreted as including X and Y. When used herein, phrases such as "from about X to Y" mean "from about X to about Y". When used herein, phrases such as "about X to Y" mean "from about X to about Y".

[0026] When an element is referred to as being "on top of" another element, "attached" to another element, "connected" to another element, "bonded" to another element, or "in contact" with another element, it is possible that the element is directly attached to, connected to, bonded to, or in contact with the other element, or that an intervening element may also be present. In contrast, when an element is described, for example, "directly on top of" another element, "directly attached" to another element, "directly connected" to another element, "directly bonded" to another element, or "in direct contact" with another element, no intervening element is present. Furthermore, a reference to a structure or feature positioned "adjacent" to another feature will be understood by those skilled in the art to mean that it may have a portion that overlaps with the adjacent feature or a portion that lies beneath the adjacent feature.

[0027] Spatially relative terms, such as “under,” “below,” “lower,” “over,” and “upper,” may be used herein to describe the relationship between one or more elements or features and one or more other elements or features, as shown in the drawings. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation illustrated in the drawings. For example, if the device in the drawings is turned over, an element described as “under” or “beneath” another element or feature will be oriented “over” the other element or feature. Thus, the exemplary term “under” can encompass both “over” and “under” orientations. The device may also be in other orientations (rotated 90 degrees or otherwise), and the spatially relative descriptors used herein will be interpreted accordingly.

[0028] Embodiments of the present invention relate to catheter security solutions that minimize catheter migration and dispersion during dressing changes without increasing other clinical burdens, such as microbial growth, patient pain, and significant impacts on workflow. Embodiments of the present invention provide a catheter security device configured to hold a catheter or catheter hub near the catheter insertion site in the patient's skin using a microneedle-based mechanism. The catheter security device allows for easy attachment and removal from the skin without increasing the risk of catheter migration during dressing changes of catheters, such as long-dwelling intravascular (IV) catheters (e.g., peripherally inserted central catheter (PICC) lines and central venous catheter (CVC) lines). Embodiments of the present invention will be described in further detail below with reference to Figures 5A to 39C.

[0029] Referring to Figures 5A to 5C, a microneedle-based catheter fixation device 100 (also referred to herein as “main catheter fixation device,” “main fixation device,” “catheter fixation device,” or “fixation device”) according to an embodiment of the present invention is illustrated. As can be seen in Figure 5C, in some embodiments, the catheter fixation device 100 of the present invention comprises a (top) cover 120, a drive disk 130, an engagement mechanism 140 having a plurality of engagement arms 142, a plurality of microneedle patches 150, and a base disk 160. Each of these components will be described in more detail below.

[0030] In some embodiments, the cover 120 of the catheter fixation device 100 is one or more currently available adhesive-based catheter fixation devices 20, for example, StatLock as shown in Figure 3. 商標 The device is configured to engage with a catheter hub retaining member 21. As can be seen in Figures 5B-5C, the catheter hub retaining member 21 is configured to engage with and secure the catheter hub 14. In some examples, the catheter hub retaining member 21 has one or more side walls 22 that together define a lumen 24. One or more engaging mechanisms 23 are present within the lumen 24. The engaging mechanism 23 is configured to engage with the catheter hub 14 to secure it within the lumen 24 of the catheter hub retaining member 21. For example, in some examples, the engaging mechanism 23 is a pin member or post configured to be received by the opening 14a of the catheter hub 14.

[0031] As shown in Figure 5C, in some embodiments, the cover 120 has a circular body 122, the circular body 122 having a plurality of projections 124 extending upward therefrom. The plurality of projections 124 are configured to engage with the catheter hub retaining member 21 (and the catheter hub 14 held therein) in order to secure the catheter fixation device 100. As further shown in Figure 5C, the cover 120 further has a plurality of locking tabs 126 extending downward from the body 122. The plurality of locking tabs 126 are located along the periphery of the body 122 and are configured to engage with the base disk 160, thereby holding together the internal mechanism of the catheter fixation device 100 (i.e., the drive disk 130 and the engagement arm 140). Alternatively, in some embodiments, the plurality of locking tabs 126 may extend downward from the base disk 160. The multiple locking tabs 126 may be located along the periphery of the base disk 160 and may be configured to engage with the body 122. In some embodiments, the multiple locking tabs 126 of the cover 120 provide a snap-fit ​​connection to the base disk 160 for securing the components together.

[0032] Still referring to Figure 5C, the drive disk 130 has a circular body 132 having a plurality of elongated guide slots 134. A slider or lever 133 is connected to the body 132 of the drive disk 130 and extends radially outward from the body 132. The slider 133 extends radially outward for a predetermined distance beyond the outer edge of the cover 120, thereby allowing the user to access the slider 133 to activate and deactivate the catheter fixation device 100. In some embodiments, as will be described in more detail below, each of the elongated guide slots 134 is configured to receive a corresponding guide pin for an individual engagement arm 142 (see, for example, Figures 7A-7C). In some embodiments, each of the multiple elongated guide slots 134 is configured to restrict the degree of freedom of movement of each engaging arm 142 to approximately 1 degree (i.e., axially outward movement R1 and axially inward movement R2) (see, for example, Figures 6A-6B and 7B-7C).

[0033] In some embodiments, the engagement mechanism 140 of the catheter fixation device 100 may have 4 to 10 engagement arms 142. For example, as seen in Figure 5C, in some embodiments, the engagement mechanism 140 may have 8 engagement arms 142. As further shown in Figure 5C, each engagement arm 142 has a corresponding sliding member 143, the corresponding sliding member 143 extending radially inward therefrom. Each sliding member 143 is configured to be received by a corresponding channel in the base disk 160 (see, for example, Figure 7A). As will be described in more detail below, in some embodiments, when the engagement arm 142 moves radially outward R1 and radially inward R2 relative to the base disk 160, the sliding member 143 is configured to move / slide within their respective channels 164 (see, for example, Figures 7B-7C). In addition, in some embodiments, the guide pins 144 protrude upward from each slide member 143. As described above, each guide pin 144 is configured to be received in an individual guide slot 134 in the drive disk 130. As will be described in more detail below, when the catheter fixation device 100 is activated / deactivated (i.e., inserted / removed), each guide pin 144 is configured to traverse or slide within the corresponding guide slot 134.

[0034] Each engaging arm 142 further has a microneedle patch 150 connected thereto. Each microneedle patch 150 comprises a plurality of microneedles 151 configured to engage with the patient's skin (see, for example, Figures 5A and 8A-8B). As seen in Figure 8A, the orientation of the plurality of microneedles 151 is opposite to that of adjacent microneedle patches 150.

[0035] Referring to Figures 6A–6B, 7A–7C, and 8A–8B, the operation of the internal mechanism for the catheter fixation device 100 is shown. The operation of the catheter fixation device 100 is inspired by how leeches use their natural microneedle structure to securely grasp their hosts.

[0036] Figures 6A and 6B show that the engaging arm 142 moves when the slider 133 rotates. Once the catheter fixation device 100 is positioned in the desired location on the patient's skin, the user applies force to the slider 133 (i.e., pushes it), thereby rotating the drive disk 130 (e.g., clockwise D1). The activation (rotation) of the drive disk 130 causes axial movement of the engaging arm 142. As seen in Figures 6B and 8A and 8B, the engaging arm 142 with the microneedles 151 facing radially inward moves axially toward the center of the device 100 (i.e., inward axial movement R1), and the engaging arm 142 with the microneedles 151 facing radially outward moves axially away from the center of the device 100 (i.e., outward axial movement R2). Thus, the movement of the engaging arm 142 provides intersecting radial engagement of the microneedles 151 with the patient's skin.

[0037] As further illustrated in Figures 6A-6B, 7B-7C, and 8B, when one engagement arm 142 moves radially inward (R1), the adjacent engagement arm 142 moves radially outward (R2). According to embodiments of the present invention, the microneedle 151 requires only slight movement to engage with the patient's skin. In some embodiments, sufficient movement of the engagement arm 142 is provided by rotating the slider 133 (drive disk 130) by about 35 degrees along a peripheral radius of about 18 millimeters, enabling the microneedle 151 to engage with the skin. The range of movement of the engagement arm 142 can be adjusted by modifying the guide slot 134 of the drive disk 130.

[0038] The slider 133 is pushed (and the drive disk 130 is rotated) until it engages with one end of the engaging arm 142 (for example, via a snap-fit ​​connection), thereby securely holding the catheter fixation device 100 in place on the patient (see, for example, Figure 7C). To remove the catheter fixation device 100 from the patient, the user must apply sufficient force to the slider 133 to disengage from the engaging arm 142 and release the microneedle 151 engaged with the patient's skin. In other words, when the drive disk 130 is rotated in the opposite direction (for example, counterclockwise D2), the microneedle 151 disengages from the patient's skin. This engagement mechanism allows the catheter fixation device 100 to be engaged and disengaged multiple times to clean the area.

[0039] The interaction between the drive disk 130, the engagement mechanism 140, and the base disk 160 is further illustrated in Figures 7A to 7C. As described above, the drive disk 130 is connected to the engagement mechanism 140 by the guide pin 144 of the engagement arm 142 being received in individual guide slots 134 in the drive disk 130. The sliding member 143 of the engagement mechanism 140 is received in individual channels 164 in the base disk 160. As seen in Figures 7B to 7C, the guide slots 134 in the drive disk 130 define the direction of movement (i.e., R1 and R2) of the engagement arm 142. Within the body 132 of the drive disk 130 are two sets of alternately arranged guide slots 134. As the drive disk 130 rotates, the sliding member 143 of the engagement mechanism 140 moves within the individual channels 164 of the base disk 160, and the guide pin 144 of the engagement mechanism 140 moves within the individual guide slots 134 of the drive disk 130. In some embodiments, for example as seen in Figures 7B to 7C, when the drive disk 130 rotates clockwise in direction D1, the guide pin 144 moves counterclockwise in direction D2 within the guide slot 134, thereby causing two adjacent guide slots 134 on the drive disk 130 to move their individual guide pins 144 and sliding members 143 in opposite directions, and consequently, their individual engagement arms 142 move radially outward R1 and radially inward R2, respectively. In some embodiments, the guide slot 134 may have a locking feature (e.g., a snap-locking feature) configured to engage with the individual guide pins 144 and / or engaging arms 142 to hold the catheter fixation device 100 in a predetermined position on the patient.

[0040] As can be seen in Figures 8A and 8B, adjacent engagement arms 142 have a plurality of alternately arranged microneedle patches 150, each of which has microneedles 151 oriented in opposite directions. For example, in some embodiments, four of the microneedle patches 150 have the microneedles 151 oriented radially outward, and four of the microneedle patches 150 have the microneedles 151 oriented radially outward. The orientation of the microneedles 151 corresponds to the direction of movement of the engagement arm 142 during engagement with the skin. (i.e., the engagement arm 142 moving outward during engagement with the skin has microneedles 151 oriented radially outward, and the engagement arm 142 moving inward during engagement with the skin has microneedles 151 oriented radially inward). When the alternately arranged microneedle patches 150 move in opposite directions (i.e., R1 and R2), the microneedles 151 engage with the skin to form a firm bond. The orientation of the microneedles 151 relative to the direction of movement by the engaging arm 142 ensures cross-engagement of the microneedles 151 with the skin, thereby restricting any movement of the catheter fixation device 100 relative to the skin.

[0041] Figures 9A - 9B show the micro - needle - based catheter fixation device 100 (Figure 9A) of the present invention compared to the currently available adhesive - based catheter fixation device 20 (Figure 9B). The catheter fixation device 100 of the present invention provides numerous advantages over the adhesive - based catheter fixation device 20. First, as seen in Figures 9A - 9B, the catheter fixation device 100 of the present invention significantly reduces the overall width (W1 < W2). In addition, the time required to apply and remove the catheter fixation device 100 of the present invention onto the skin is reduced. For example, the adhesive - based catheter fixation device 20 requires peeling the adhesive wings, applying them to the skin, and removing them with antiseptic alcohol. In contrast, the micro - needle - based catheter fixation device 100 of the present invention simply requires rotation of the slider 133. Thus, the application of the catheter fixation device 100 of the present invention, as well as its removal for cleaning, is easier and faster than the adhesive - based catheter fixation device 20.

[0042] Referring to FIGS. 10A - 10C, FIGS. 11A - 11B, and FIGS. 12A - 12B, another micro - needle - based catheter fixation device 200 according to an embodiment of the present invention is shown. As described in more detail below, in some embodiments, the catheter fixation device 200 includes two concentric disks 210 and 220 (i.e., an inner disk 210 and an outer disk 220) having a plurality of micro - needles 211 and 221. According to an embodiment of the present invention, the disks 210 and 220 of the fixation device 200 are configured to rotate in opposite directions relative to each other to engage the corresponding micro - needles 211 and 221 with the patient's skin.

[0043] As shown in Figures 10A and 10C, each disc 210 and 220 comprises a plurality of microneedles 211 and 221. In some embodiments, the microneedles 211 and 221 are oriented to face their direction of rotation (i.e., clockwise or counterclockwise). The inner disc 210 has a circular body 212, and the outer disc 220 has an annular or ring-shaped body 222 that is sized and configured to fit around the inner disc 210. An internal gear mechanism 205 is used to achieve rotation of the concentric discs 210 and 220 in opposite directions. As will be described in more detail below, a lever or slider arm 250 is used to actuate the internal gear mechanism 205 and rotate the discs 210 and 220 when the corresponding microneedles 211 and 221 engage in a string lock with the patient's skin. The lever 250 is configured to lock the fixing device 200 in an engaged state, engaged with the skin. To release the device 200, the user must apply sufficient force to release the lever 250 from the engaged state.

[0044] Figure 10C is an exploded view of the stationary device 200 and shows the internal gear mechanism 205 of the device 200. In some embodiments, the internal mechanism 205 is analogous to a planetary gear configuration that allows the two disks 210 and 220 to rotate in opposite directions. As seen in Figure 10C, in some embodiments, the internal gear mechanism 205 comprises a base or external gear 230, a central gear 240, and a drive gear 250 (see also Figure 11A). In some embodiments, a slider arm 254 is connected to a gear mechanism 256 of the drive gear 250 of the internal mechanism 205 and extends radially outward from the gear mechanism 256. In some embodiments, the central gear 240 of the internal gear mechanism 205 comprises a circular base 242. The gear mechanism 244 is connected to the upper surface of the base 242. In some embodiments, the external gear 230 comprises an annular base 232 having a central opening 233. The gear mechanism 234 is connected to the upper surface of the base 232 of the external gear 230 and extends around the central opening 233. The annular base 232 of the external gear 230 is configured to be connected to the outer disc 220. The base 242 of the central gear 240 is located within the central opening 233 of the external gear 230 and is configured to be connected to the inner disc 210. As seen in Figure 11A, the gear mechanism 256 of the drive gear 250 is located between the gear mechanism 234 of the external gear 230 and the gear mechanism 244 of the central gear 240. The drive gear 250 is configured to engage with each of the gear mechanisms 234 and 244.

[0045] According to embodiments of the present invention, the arrangement of the gear mechanisms 234, 244, and 256 can achieve small rotation angles with high torque sufficient to provide a firm grip on the skin (i.e., by the microneedles 211 and 221 through the rotation of the discs 210 and 220), while causing no damage or scarring to the skin. In some embodiments, the discs 210 and 220 are configured to have a relative rotation in the range of about 5 to about 35 degrees, providing sufficient grip by the microneedles 211 and 221 and engagement of the fixing device 200 with the skin. Note that the sizes of the gear mechanisms 234 and 244 may be changed to achieve optimal rotation angles and torque. Changes in the relative rotation angle would result from changes in the size of the internal gears. For example, smaller angles would require smaller drive gears 250, while larger drive gears 250 would provide higher torque and operability.

[0046] As further shown in Figures 10A to 10C, the fixation device 200 further comprises a top cover 260 and a bottom cover 270. The catheter hub 14 is configured to be fixed to the top cover 260 in a manner similar to that of the catheter fixation device 100 described herein. The top cover 260 is configured to engage with the bottom cover 270 to fix the internal mechanism therein. For example, in some embodiments, the side walls 262 of the top cover 260 and the side walls 272 of the bottom cover 270 may comprise a plurality of corresponding fixation mechanisms 264 and 274 (e.g., a latch 274 and a slot 264) which are configured to engage with each other to fix the top cover 260 and the bottom cover 270 (see, for example, Figures 12A to 12B). In some embodiments, the fixation mechanisms 264 and 274 are snap-fit ​​fixation mechanisms.

[0047] As can be seen in Figures 10A-10B and 11A-11B, when the top cover 260 and the bottom cover 270 are fixed together, the slider arm 254 extends through an opening 266 in the top cover 260. The head 252 of the slider arm 254 is positioned so that the user can grip and move the drive gear 250 relative to the top cover 260 and the bottom cover 270 (i.e., move the slider arm 254 within the opening 266). As will be described in more detail below, the opening 266 is equipped with a locking feature, for example, a plurality of serrations or teeth 266p, which is configured to engage with the sliding arm 254 and lock the sliding arm 254 in an engaged position (see also Figure 12B). When the user pushes the slider arm 254, the gear mechanisms 234, 244, and 256 rotate the discs 210 and 220, thereby engaging the microneedles 211 and 221 with the skin. The position in which the two discs 210 and 220 apply opposite torques and engage with the skin (i.e., the engaged state) is held by the locking function 266p. Sufficient force must be applied by the user to release the slider arm 254 from the locking function 266p, move the two discs 210 and 220, and detach the microneedles 211 and 221 from the skin (i.e., the detached state).

[0048] As seen in Figures 10C and 11A, in some embodiments, the top cover 260 may include one or more extruded features 265 configured to hold the drive gear 250 and the center gear 240 in place within the stationary device 200. The extruded features 265 serve to limit the translational degrees of freedom and two rotational degrees of freedom of the internal gear mechanism 205. In other words, the gear mechanisms 234, 244, and 256 are permitted to rotate only about the Z axis. There are many ways in which such an arrangement can be achieved. However, the embodiment shown in Figure 11A is one of the simplest options available.

[0049] Referring to Figures 12A and 12B, the operation of the fixation device 200 according to embodiments of the present invention is shown. As described above, the two disks 210 and 220 move concentrically in opposite directions to engage the corresponding microneedles 211 and 221 with the patient's skin. The microneedles 211 and 221 are oriented on the individual disks 210 and 220 in the direction of rotation. For example, in some embodiments, the microneedle 211 on the inner disk 210 is oriented clockwise, and the microneedle 221 on the outer disk 220 is oriented counterclockwise.

[0050] Figure 12A shows the detached fixing device 200. As seen in Figure 12A, the slider arm 254 is not engaged with the locking function 266p in the opening 266 of the top cover 260. When the slider arm 254 moves in a first direction D1 (i.e., to the detached state), one of the disks (e.g., the outer disk 220) rotates in the same direction (i.e., the first direction D1), and the other disk (e.g., the inner disk 210) rotates in a second opposite direction D2. For example, the inner disk 210 rotates clockwise, and the outer disk 220 rotates counterclockwise.

[0051] Figure 12B shows the fixed device 200 in the engaged state. As seen in Figure 12B, the slider arm 254 is moved in the second direction D2 to engage with the locking function 266p in the opening of the top cover 260. When the slider arm 254 is moved in the second direction D2 (i.e., to the engaged state), the outer disk 220 rotates in the same direction (i.e., the second direction D2), and the inner disk 210 rotates in the opposite direction (i.e., the first direction D1). For example, the inner disk 210 rotates counterclockwise, and the outer disk 220 rotates clockwise. As seen in Figure 12B, the inner disk 210 and the outer disks 220 rotate in the direction that the corresponding microneedles 211 and 221 are facing. Therefore, when the inner disc 210 and the outer disc 220 rotate in opposite directions, the corresponding microneedles 211 and 221 engage with the patient's skin to achieve a firm grip between the fixation device 200 and the skin. In some embodiments, the rotation directions of the inner disc 210 and the outer disc 220 for engagement and disengagement may be reversed.

[0052] As described above, the locking function 266p holds the slider arm 254 of the drive gear 250 in the locked position, thereby fixing the fixing device 200 in place on the skin. As seen in Figure 12B, the slider arm 254 gets locked with the locking function 266p (e.g., serrations). When the user pushes the slider arm 254, the microneedles 211 and 221 engage with the skin. The inner disc 210 and the outer disc 220 apply torques of opposite torques, and the position of engagement with the skin is maintained in the same state as the locking function 266p and the slider arm 254. The fixing device 200 is unlocked when the user applies sufficient force to overcome the locking force of the locking function 266p on the slider arm 254.

[0053] The catheter fixation device 200 of the present invention offers several advantages over the adhesive-based catheter fixation device 20. For example, the time required to attach and remove the catheter fixation device 200 of the present invention from the skin is reduced. Therefore, attaching and removing the catheter fixation device 200 of the present invention for cleaning is easier and faster than with the adhesive-based catheter fixation device 20.

[0054] Referring here to Figures 13A–13B, 14A–14B, 15A–15B, and 16A–16C, another microneedle-based catheter fixation device 300 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 300 may be those described above with respect to the catheter fixation device 200 described herein, and any overlapping descriptions thereof may be omitted herein for the purpose of illustrating with respect to Figures 13A–16C.

[0055] Similar to the catheter fixation device 200, as seen in Figures 13A to 16C, the catheter fixation device 300 comprises two concentric discs 310 and 320 (i.e., an outer disc 310 and an inner disc 320) having a plurality of microneedles 311 and 321. As seen in Figure 13A, the inner disc 320 is configured such that a catheter hub 14 can be fixed to it. According to embodiments of the present invention, the discs 310 and 320 of the fixation device 300 are configured to rotate in opposite directions to engage the corresponding microneedles 311 and 321 with the patient's skin. In some embodiments, as will be described in more detail below, the catheter fixation device 300 further comprises a locking mechanism 330 that locks the discs 310 and 320 in place to maintain engagement of the microneedles 311 and 321 with the skin.

[0056] As shown in Figures 13B and 14A-14B, each disc 310 and 320 comprises a plurality of microneedles 311 and 321. In some embodiments, the microneedles 311 and 321 are arranged circumferentially along a predetermined diameter of each disc 310 and 320 (see, for example, Figure 14B). In some embodiments, the microneedles 311 and 321 are oriented to face their rotational direction (i.e., clockwise or counterclockwise), which provides a crossed arrangement of the microneedles 311 and 321 (see, for example, Figure 14A). This arrangement of the microneedles on the discs 310 and 320 may provide a better grip to prevent the catheter fixation device 300 from being pulled out of the skin.

[0057] As seen in Figures 15A to 15B, the inner disc 320 of the catheter fixation device 300 has a circular body 325, and the outer disc 310 has an annular or ring-shaped body 312 sized and configured to fit around the inner disc 320. In some embodiments, the inner disc 320 includes a locking member 322 extending radially outward from the body 325 and through an elongated opening or recess 314 in the body 312 of the outer disc 310. As seen in Figures 15A to 15B, in some embodiments, the locking member 322 may have a recess 338, the recess 338 includes a projection member 339 extending into the recess 338 (see also, for example, Figures 16A to 16C). In some embodiments, the inner disc 320 further includes a sliding member 326 extending radially outward from the body 325. The sliding member 326 is configured to slide within the recess 316 that runs along the inner surface of the main body 312 of the outer disk 310.

[0058] As further shown in Figures 15A and 15B, in some embodiments, the outer disk 310 includes a corresponding locking member 334 extending radially outward from the outer surface of the body 312. In some embodiments, the locking member 334 of the outer disk 310 includes a projection 336 extending upward therefrom. The inner disk 310 and the outer disk 320 and the locking members 332 and 334 together form the locking mechanism 330 of the catheter fixation device 300. In some embodiments, the locking mechanism 330 of the catheter fixation device 300 may include a snap-fit ​​locking mechanism.

[0059] Figures 15A-15B and 16A-16C illustrate the operation of the locking mechanism 330 of the fixing device 300 and the engagement of the corresponding locking members 332 and 334. As seen in Figures 15A-15B and 16A-16C, the locking member 332 of the inner disk 320 is configured to slide within the opening 314 of the outer disk 310. When the locking member 332 slides in the first direction D1, the inner disk 310 and the outer disk 320 rotate simultaneously in opposite directions, causing the microneedles 311 and 321 (and the fixing device 300) to engage firmly with the skin. As can be seen in Figures 16A to 16B, the locking member 332 of the inner disc 320 slides within the opening 314 of the outer disc 310 until the projection 336 of the locking member 334 of the outer disc 310 is received in the recess 338 of the locking member 332 of the inner disc 320 and the projection 336 of the outer disc locking member 334 engages with the protruding member 339 of the inner disc locking member 332 (see also Figures 15A to 15B). Simultaneously, in some embodiments, when the locking member 332 of the inner disc 320 slides within the opening 314 of the outer disc 310, the opposing sliding member 326 of the inner disc 320 slides within the recess 316 on the inner surface of the outer disc 310.

[0060] Referring here to Figures 17A to 17C, another microneedle-based catheter fixation device 400 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 400 may be those described above with respect to the catheter fixation device 300 described herein, and any overlapping descriptions thereof may be omitted herein for the purpose of illustrating with respect to Figures 17A to 17C.

[0061] As can be seen in Figures 17A to 17C, similar to the catheter fixation device 300, the catheter fixation device 400 comprises two concentric discs 410 and 420 (i.e., an outer disc 410 and an inner disc 420) having a plurality of microneedles 411 and 421. As can be seen in Figure 17A, the inner disc 420 is configured such that the catheter hub 14 can be fixed to it. According to embodiments of the present invention, the discs 410 and 420 of the fixation device 400 are configured to rotate in opposite directions to engage the corresponding microneedles 411 and 421 with the patient's skin.

[0062] As seen in Figures 17B to 17C, the inner disc 420 of the catheter fixation device 400 has a circular body with two opposing protrusions 422. In some embodiments, the protrusions 422 may have a semi-circular or arcuate shape. As will be described in more detail below, in some embodiments, the protrusions 422 engage with the outer disc 410 to provide a locking function to the catheter fixation device 400. As seen in Figures 17B to 17C, the outer disc 410 has an annular or ring-shaped body sized and configured to fit around the inner disc 420. The outer disc 410 has an annular recess 416 extending along the inner surface of the body. The outer disc 410 further has two opposing openings 412 extending inward from the outer surface of the body toward the annular recess 416. As can be seen in Figure 17B, the opening 412 is sized and configured to provide a position for the opposing projections 422 of the inner disk 420 to be received within the opening 412, so that the inner disk 410 can be placed inside the outer disk 420.

[0063] As described above and as seen in Figure 17C, in some embodiments, the opposing projections 422 can function as a locking mechanism. As seen in Figure 17C, in some embodiments, the outer disc 410 may further have one or more arcuate recesses or indentations 418 corresponding to the shape of the projections 422 of the inner disc 420. After the projections 422 of the inner disc 420 are received by the individual openings 412 of the outer disc 410, the projections 422 are configured to traverse (slide) within the annular recesses 416 of the outer disc 410 when the inner disc 420 and the outer disc 410 are rotated in opposite directions. Similar to the other catheter fixation devices 200 and 300 described herein, the corresponding microneedles 411 and 421 engage with the patient's skin as the inner disc 420 and outer disc 410 of the fixation device 400 rotate. The discs 410 and 420 rotate until the projection 422 of the inner disc 410 is received and engages with the corresponding arcuate indentations 418 of the outer disc 420, thereby locking the inner disc 420 and outer disc 410 in place (and fixing the catheter fixation device 400 to the skin).

[0064] Referring here to Figures 18A to 18E, another microneedle-based catheter fixation device 500 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 500 may also be those described above with respect to other catheter fixation devices 200, 300 and 400 described herein, and any overlapping descriptions thereof may be omitted herein for the purpose of illustrating with Figures 18A to 18E.

[0065] As can be seen in Figures 18A to 18E, the catheter fixation device 500 comprises an upper plate 530 and a lower plate 540. The lower plate 540 comprises two concentric discs 510 and 520 (i.e., an outer disc 510 and an inner disc 520) having a plurality of microneedles 511 and 521 (Figure 18E). As can be seen in Figures 18A to 18D, the upper plate 530 is configured such that a catheter hub 14 can be fixed thereto. According to an embodiment of the present invention, the concentric discs 510 and 520 of the fixation device 500 are configured to rotate in opposite directions to engage the corresponding microneedles 511 and 521 with the patient's skin.

[0066] As can be seen in Figures 18A, 18B, and 18D, the upper plate 530 is provided with a plurality of cam members 532 extending downward therefrom, and the concentric discs 510 and 520 of the lower plate are provided with a plurality of corresponding cam members 512 and 522 extending upward therefrom. Each cam member 532 of the upper plate 530 is configured to engage with the corresponding cam members 512 and 522 of the inner disc 510 or the outer disc 520. As further shown in Figures 18A and 18B, in some embodiments, each of the plurality of cam members 512 and 522 extending upward from the lower plates 510 and 520 has inclined or tapered edges facing in opposite directions.

[0067] As can be seen in Figure 18B, the opposing sloping edges of the cam members 512 and 522 are configured such that when a downward force is applied to the catheter fixation device 500, the inner disk 510 and the outer disk 520 rotate simultaneously in opposite directions. The cam member 512 on the outer disk 510 is tilted in one direction, and the cam member 522 on the inner disk 520 is tilted in the opposite direction. When a downward force is applied to the upper plate 530, the cam member 532 on the upper plate 530 engages with the corresponding cam members 512 and 522 on the inner disk 510 and / or the outer disk 520. The cam member 532, extending downward from the upper plate 530, slides downward the inclined surfaces of the individual cam members 512 and 522 of the inner disc 510 and the outer disc 520, thereby forcing the inner disc 510 and the outer disc 520 to rotate simultaneously in opposite directions (i.e., the inner disc 510 rotates counterclockwise and the outer disc 520 rotates clockwise, or vice versa). As with other catheter fixation devices described herein, the rotation of the inner disc 510 and the outer disc 520 causes the corresponding microneedles 511 and 521 (Figure 18E) to engage with the patient's skin.

[0068] As can be seen in Figures 18B and 18D, in some embodiments, the catheter fixing device 500 may further include a safety clip 550 configured to help prevent accidental rotation of the device 500. In some embodiments, the safety clip 550 is configured to slide within a groove 514 in the lower plate 540 in order to lock the lower plate 540 in place relative to the upper plate 530.

[0069] Referring here to Figures 19A–19C, 20A–20C, 21A–21B, and 22A–22F, another microneedle-based catheter fixation device 600 according to embodiments of the present invention is shown. The characteristics and / or features of the catheter fixation device 600 may also be those described above with respect to other catheter fixation devices described herein, and such overlapping descriptions may be omitted herein for the purpose of illustrating with respect to Figures 19A–22F.

[0070] One of the objectives of the catheter fixation device 600 of the present invention is to simplify the insertion process of non-vertical microneedles by changing the microneedle to a curved geometry (similar to a falcon's claw) and inserting the microneedle in circular motion relative to the axis (similar to mechanisms commonly used in the aerospace (aircraft wings) and automotive (doors) industries).

[0071] As seen in Figures 19A-19C and 20A-20C, the catheter fixation device 600 comprises a base member 630. The base member 630 is configured to hold the catheter 12 or catheter hub 14 in place. In some embodiments, the base member 630 may have vertically downward-facing microneedles (not shown) for initial fixation and positioning of the device 600 on the patient's skin. As seen in Figures 19B and 20B, the catheter fixation device 600 further comprises opposing lateral wing members 610 connected to the base member 630. In some embodiments, each lateral wing member 610 is rotatably connected to the base member 630 by a bistable hinge 646. For example, in some embodiments, the base member 630 may have a plurality of openings 636 to form the hinge 646, each of which is configured to receive a corresponding projection 616 of the wing member 610. The hinge 646 allows the wing member 610 to be locked and unlocked (i.e., to engage and disengage the catheter fixation device 600 from the skin). As seen in Figure 20B, in some embodiments, the base member 630 and the wing member 610 may be further connected via a plurality of support members 633. In some embodiments, the base member 630 is configured to maintain a constant downward pressure on the wing member 610 via the hinge 646 (and, in some embodiments, the support members 633).

[0072] As seen in Figures 19B, 19C, and 20C, each wing member 610 comprises a microneedle patch 650, which extends downward therefrom and comprises a plurality of microneedles 651 that form the fixation mechanism 640 of the catheter fixation device 600. The microneedle patch 650 is fixed within the wing member 610. As described above, the microneedles 651 have a curved geometry and are arranged to curve radially inward toward the base member 630 (Figures 20C and 21B). In some embodiments, curved or hooked microneedles 651 may provide better skin fixation and retention strength compared to vertical or inclined / angled microneedles. See, for example, U.S. Patent No. 10,667,957 to Smith et al., the disclosure of which is incorporated herein by reference. In some embodiments, the microneedle 651 is at an angle of about 20 to about 45 degrees from the base member 630.

[0073] As seen in Figure 21A, the wing member 610 is configured to guide the microneedle 651 along a circular motion during engagement with the skin. The profile of the microneedle 651 is formed using the arch of individual circles around the axis of rotation of the hinge 646. Thus, when the wing member 610 is pivoted toward the skin around the hinge 646, the microneedle 651 engages with the skin in a perpendicular (vertical) direction, thereby facilitating insertion of the microneedle 651 into the skin. In some embodiments, the base member 630 is assumed to have a minimum thickness of about 1 millimeter, and the axis of rotation of the wing member 610 is assumed to be adjacent to or near the skin. Upon contact with the skin, the microneedle 651 prevents movement of the catheter fixation device 600 in all directions (i.e., the X, Y, and Z directions). As can be seen in Figure 20B, in some embodiments, each wing member 610 further comprises a vertically extending post or peg 613. The post 613 is configured to position and secure the catheter 12 or catheter hub 14 to the catheter fixation device 600 (see, for example, Figures 19A and 19C).

[0074] As further shown in Figures 19A-19C and 20A-20C, in some embodiments the catheter fixation device 600 further comprises a (top) lid or cover 620. The lid 620 is configured to engage with the wing member 610 and prevent the wing member 610 from moving vertically. For example, in some embodiments the lid 620 may comprise opposing latch members 622 configured to engage with projections 612 extending outward from the side wall 611 of the wing member 610 (see, for example, Figures 20A and 20B). As seen in Figures 19A and 19C, the lid 620 is also configured to secure the catheter 12 or catheter hub 14 within the catheter fixation device 600. In some embodiments, the lid 620 may include one or more additional fastening features 624 configured to engage with the side walls 611 of the wing member 610 in order to further secure the catheter hub 14 within the device 600.

[0075] Figures 22A to 22F illustrate exemplary operation using the catheter fixation device 600 according to embodiments of the present invention. As seen in Figure 22A, the catheter fixation device 600 is positioned at a fixation site on the skin. As described above, in some embodiments, the base member 630 may include a plurality of vertical microneedles that enable positioning and initial fixation of the catheter fixation device 600 on the skin. As seen in Figure 22A, the projection 612 on the side wall 611 of the wing member 610 may help to grasp the device 600 during placement on the skin.

[0076] As seen in Figures 22B and 22C, when the base member 630 is placed on the skin, a downward force F1 is applied independently to each wing member 610. This downward force F1 causes the wing member 610 to pivot relative to the base member 630 around the hinge 646, thereby engaging the microneedle 651 with the skin. Once full engagement of the microneedle 651 with the skin is confirmed (Figure 22C), the catheter 12 and catheter hub 14 can be secured to the catheter fixation device 600. As seen in Figure 22D, vertical columns / pegs 613 extending from the wing member 610 are received through individual openings 14a in the catheter hub 14, positioning the catheter hub 14 within the device 600. As seen in Figure 22E, the lid 620 is secured to the wing member 610 (for example, via a latch member 622), thereby securing the catheter hub 14 to the device 600 and preventing vertical movement of the catheter hub 14. To release the catheter fixation device 600, as seen in Figure 22F, the lid 620 is removed and an upward force F2 is applied to each wing member 610. The upward force F2 causes the wing member 610 to pivot relative to the base member 630 around the hinge 646, thereby detaching the microneedle 651 from the skin.

[0077] Referring here to Figures 23A–23B, 24A–24E, 25A–25C, 26A–26D, 27A–27D, and 28A–28C, another microneedle-based catheter fixation device 700 according to embodiments of the present invention is shown. The characteristics and / or features of the catheter fixation device 700 may also be those described above with respect to other catheter fixation devices described herein, and such overlapping descriptions may be omitted herein for the purpose of illustrating with respect to Figures 23A–28D.

[0078] As can be seen in Figures 23A-23B and 24A-24E, the catheter fixation device 700 comprises two sliding members 730, each of which is movably connected to a base member 710. As can be seen in Figures 24D and 24E, each sliding member 730 comprises a microneedle patch 750 having a plurality of microneedles 751 extending downward therefrom. As will be described in more detail below, the sliding members 730 allow for the horizontal movement of the microneedles 751 to facilitate engagement between the microneedles 751 and the patient's skin (see, for example, Figures 25A-25C, 26A-26D, 27A-27D, and 28A-28C).

[0079] As seen in Figure 23B, in some embodiments, the catheter fixation device 700 may include a center plate 740. In some embodiments, the center plate 740 is configured to connect the two base members 710 to each other. For example, in some embodiments, the center plate 740 may have opposing latching members 742 extending downward therefrom. The center plate 740 bridges the base members 710, and the latching members 742 engage with the edges of the base members 710. In addition, as seen in Figures 23A to 23B, the center plate 740 provides a position for connecting the catheter 12 or catheter hub 14 (i.e., the catheter hub retaining member 21) to the catheter fixation device 700. In some embodiments, the two base members 710 are integrally formed as a single base member.

[0080] Figure 24A shows a slide member 730 of the catheter fixation device 700. In some embodiments, the upper surface 732 of the slide member 730 may be provided with a gripping element 736 for easier operation by the user. As described above, the slide member 730 is movably connected to the base member 710. In some embodiments, each slide member 730 has a tongue portion 734 extending longitudinally on opposite side walls 733 (note that only one is visible in Figure 24A). The slide member 730 is received in an opening 713 of the base member 710, and each tongue portion 734 is received in a corresponding groove 714 on the inner surface of the body 712 of the base member 730 (see, for example, Figure 24B). Each tongue portion 734 is configured to slide (transverse) within the individual grooves 714 of the base member 710, thereby allowing the sliding member 730 to move relative to the base member 710 within the opening 713 (i.e., along the horizontal plane).

[0081] As seen in Figures 24C and 24E, the catheter fixation device 700 further comprises two biasing members 720. Each biasing member 720 is connected to an individual base member 710. As seen in Figure 24E, in some embodiments, the opposing ends 725 of the biasing member 720 may be held in a recess 715 of the base member 710. The body 722 of the biasing member 720 is configured to extend across the opening 713 of the base member 710 and to contact the inner wall 735 of the slide member 730. In some embodiments, the biasing member 720 may be a spring element or may be formed of a resilient compressible material. As will be described in more detail below, the biasing member 720 is configured to provide a continuous force to the sliding member 730 (see, for example, Figures 25A-25D, 26A-26C, 27A-27D, and 28A-28C).

[0082] Figure 24D shows the microneedle patch 750 of the catheter fixation device 700. As can be seen in Figure 24D, the microneedle patch 750 comprises a plurality of microneedles 751. In some embodiments, the microneedles 751 are inclined or angled. As can be seen in Figures 25A-25B, the microneedles 7511 and 7512 of each microneedle patch 7501 and 7502 are inclined in opposite directions (i.e., inward toward the center plate 740) (see also Figures 26A-26C). In some embodiments, the shape of the microneedles 751 may differ. For example, in some embodiments, the shape of the microneedles 751 may be curved or hooked (e.g., the microneedle 651 of the catheter fixation device 600 described herein). In other embodiments, the shape of the microneedle 751 may be inclined or angled, for example, as seen in Figures 25A to 25C. In other embodiments, the shape of the microneedle 751 may be a combination of inclined and curved (for example, inclined at the base of the microneedle and curved at the tip of the microneedle, or curved at the base of the microneedle and inclined at the tip of the microneedle). The microneedle 751 of the microneedle patch 750 may be a scalable element to be used in sets of one, two or more to enable various applications of fixation. In some embodiments, the microneedle 751 is at an angle of about 20 to about 45 degrees from the base member 710.

[0083] According to embodiments of the present invention, the microneedle 751 can be positioned to engage with the skin in various ways. For example, as seen in Figure 25A, in some embodiments, the microneedles 7511 and 7512 are 、It can provide spaced and symmetrical engagement with the skin. In other embodiments, for example, as seen in Figure 25B, the microneedles 7511 and 7512 can provide crisscross engagement with the skin. See, for example, U.S. Patent Application Publication 2019 / 0314012 to Bertollo et al., the disclosure of which is incorporated by reference herein. In some embodiments, a combination of multiple microneedle patches 7502 and 7503 may be used, as seen in Figure 25C. Figure 25D shows different directions of movement of the microneedle 751 (e.g., vertical, horizontal, angle), which are further described below with respect to Figures 26A-26C.

[0084] Figures 26A–26C, 27A–27D, and 28A–28C illustrate the movement of the microneedle 751 during use of the catheter fixation device 700 according to embodiments of the present invention. Insertion of an inclined microneedle is a difficult procedure requiring considerable user skill. An inclined microneedle must be inserted at a specific angle, which is typically achieved by one of two methods: (1) pressing and sliding motion, or (2) simultaneous pressing and sliding with angled insertion. Complete manual insertion by either of these methods is difficult and may result in insufficient insertion of all the microneedles with optimal penetration force and depth. Failure to properly insert all of the microneedles reduces the retention strength of the microneedle patch, thereby reducing the fixation capability of the catheter fixation device. The catheter fixation device 700 of the present invention helps to simplify the insertion process of the inclined microneedle 751 by incorporating the biasing member 720, which helps to ensure sufficient parallel / horizontal movement of the microneedle 751 into the skin. In addition, as described above and further described below, the biasing member 720 is configured to maintain a contact force on the microneedle 751, thereby helping to prevent the microneedle 751 from disengaging from the skin.

[0085] Note that the sliding member 730 is omitted from Figures 26A to 26B in order to more clearly show the relative movement of the microneedle patch 750 and the corresponding microneedle 751 with respect to the skin. As seen in Figures 26A to 26B, the catheter fixation device 700 is positioned at the fixation site on the skin. The microneedle patch 750 moves horizontally outward in opposite directions (indicated by arrows in Figure 26B). As seen in Figure 26C, when the catheter fixation device 700 moves toward the skin, the microneedle patch 750 moves horizontally inward toward each other (indicated by arrows), thereby engaging the microneedle 751 with the skin.

[0086] The movement of one of the slide members 730 and the corresponding microneedle patch 750 relative to the biasing member 720 is further shown in Figures 27A-27D and 28A-28C. As seen in Figures 27A-27B and 28A-28B, the slide member 730 and the microneedle patch 750 are moved in a first direction D1 which is horizontally outward relative to the base member 710. As the slide member 730 and the microneedle patch 750 move in the first direction D1, the biasing member 720 is compressed between the slide member 730 and the base member 710. As seen in Figure 27C, a downward force F is applied to the catheter fixation device 700 until the base member 710 makes contact with the skin and the microneedle 751 begins to engage with the skin. As can be seen in Figures 27D and 28C, when a downward force F is applied, the return force of the biasing member 720 pushes the sliding member 730 and the corresponding microneedle patch 750 horizontally inward in a second opposite direction D2, thereby causing the inclined microneedle 751 to engage more deeply with the skin, thus providing a strong retention of the catheter fixation device 700 with the skin.

[0087] Referring here to Figures 29A–29C, 30A–30B, and 31A–31B, another microneedle-based catheter fixation device 800 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 800 may also be those described above with respect to other catheter fixation devices described herein, and any overlapping descriptions thereof may be omitted herein for the purpose of illustrating with respect to Figures 29A–31B.

[0088] According to embodiments of the present invention, the catheter fixation device 800 provides a circular actuation mechanism for engaging with the skin. As seen in Figures 29A, 30A-30B and 31A-31B, in some embodiments the catheter fixation device 800 comprises an annular or ring-shaped outer member 810. The annular outer member 810 comprises a plurality of microneedles 811 extending downward from a lower surface 812. In some embodiments the outer member 810 comprises a pair of arm members 814 extending radially outward from there. The arm members 814 provide a position for the user to grasp and rotate the device 800 to engage / disengage from the patient's skin. The fixation device 800 further comprises a circular inner member 830. In some embodiments the inner member 830 also comprises a plurality of microneedles 831. In some embodiments, at least a portion 833 of the inner member 830 is configured to fit into the opening 813 of the outer member 810. The upper surface 832 of the inner member 830 is configured to accommodate the catheter hub retaining member 21.

[0089] As seen in Figures 29A-29B and 31A-31B, in some embodiments, the outer member 810 includes a notch 815 configured to slide (transverse) within a curved slot 834 in the inner member 830. In some embodiments, the notch 815 is configured to guide the outer member 810 to rotate relative to the inner member 830 (e.g., along a threaded path along the inner member 830), thereby helping to bring the corresponding microneedle 811 into engagement with the skin. As seen in Figure 29C, in some embodiments, a plurality of concentric microneedle patches may be utilized. The concentric microneedle patches may be configured to rotate in opposite directions to each other to enable better fixation of the device to the skin by forming an intersecting arrangement of the microneedles (e.g., as with other catheter fixation devices described herein).

[0090] According to embodiments of the present invention, the catheter fixation device 800 may offer numerous advantages, such as prevention of "pull-out" (i.e., detachment from the skin) from all directions (i.e., X, Y, and Z directions), provision of easy deployment of the microneedles into the skin in the region directly beneath the catheter hub retaining member 21, a crisscross microneedle arrangement that provides a stronger force compared to a parallel microneedle arrangement, and may be combined with other embodiments described herein to fix the catheter hub retaining member 21 centrally and / or along its sides.

[0091] Referring here to Figures 32A to 32C, another microneedle-based catheter fixation device 900 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 900 may also be those described above with respect to other catheter fixation devices described herein, and such overlapping descriptions may be omitted herein for the purpose of illustrating with respect to Figures 32A to 32C.

[0092] As can be seen in Figures 32A to 32C, the catheter fixation device 900 has a scissors-door-inspired operating mechanism for engaging the microneedles 911 with the patient's skin. As can be seen in Figures 32A to 32C, opposing arm members 910 are connected to the catheter hub retaining member 21. Each of the arm members 910 has a plurality of microneedles 911. In some embodiments, each arm member 910 is connected to the catheter hub retaining member 21 via a hinge 912, thereby allowing the arm member 910 to pivot or rotate from a closed (engaged) position to an open (disengaged) position. The arm member 910 is configured to rotate around the hinge 912 relative to the catheter hub retaining member 21 in order to bring the corresponding microneedle 911 into contact with the skin.

[0093] As seen in Figure 32C, in some embodiments, the microneedle patches 913 may be arranged in the same direction or in opposite directions. As further shown in Figure 32C, the arm member 910 may be formed in combination with two, four, or more rows of microneedle patch rows 913a and 913b to achieve a cross arrangement of microneedles 911 and to achieve better fixation of the device 900 to the skin. In some embodiments, the arrangement of the microneedle patches 913 may also be configured laterally, for example, with one or more sides of a triangle, quadrilateral, square, rectangle, pentagon, etc., or in a circular or semicircular manner. In addition, the shape of the microneedles 911 may be curved / hooks, angled / slanted, or a combination of both, as described herein for example with respect to other catheter fixation devices.

[0094] Referring here to Figures 33A-33D and 34A-34C, another microneedle-based catheter fixation device 1000 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 1000 may also be those described above with respect to other catheter fixation devices described herein, and such overlapping descriptions may be omitted herein for the purpose of illustrating with respect to Figures 33A-34C.

[0095] As can be seen in Figures 33A to 33D, the catheter fixation device 1000 comprises an inner disc 1010, an outer retaining ring 1020, and an outer cover 1030. The outer cover 1030 may be disposable. In some embodiments, the retaining ring 1020 and the cover 1030 may be non-disposable. The inner disc 1010 is sized and configured to fit into the retaining ring 1020 (see, for example, Figure 34B). In some embodiments, the outer cover 1030 may be rotatably connected to the retaining ring 1020.

[0096] Figure 33A shows the inner disk 1010 in more detail. As seen in Figure 33A, in some embodiments, the inner disk 1010 comprises a foam hemisphere 1012 having a transparent window 1016. The foam hemisphere 1012 comprises a central opening 1014 and slots 1017 extending radially outward from there, configured to receive the catheter 12 (see, for example, Figure 34B). In some embodiments, the foam hemisphere 1012 is formed from an antimicrobial, hemostatic, and water-absorbing material. In some embodiments, the transparent window 1016 comprises an antimicrobial gel pad. The transparent window 1016 allows for monitoring of the insertion site IS. In some embodiments, the inner disc 1010 further comprises a latch mechanism 1018 positioned on a slot 1017 of the foamed hemisphere 1012, which may provide additional fixation of the catheter 12 at the insertion site IS (see, for example, Figure 34B). In some embodiments, the inner disc 1105 may be an antimicrobial hemostatic absorbent dressing, which may or may not have a transparent portion / window.

[0097] Figure 33B shows the outer retaining ring 1020 in more detail. According to embodiments of the present invention, the outer retaining ring 1020 is configured to anchor the device 1000 to the skin (i.e., to restrict horizontal (XY direction) movement), to hold the inner disk 1010, and to secure the catheter hub 14 to the device 1000. As seen in Figure 33B, in some embodiments, the outer retaining ring 1020 has an annular body 1022 configured to receive the inner disk 1010. The body 1022 comprises a plurality of microneedles 1021 extending downward therefrom. In some embodiments, the microneedles 1021 are positioned perpendicular to the body 1022. A stabilizing section 1024 extends radially outward from the body 1022. In some embodiments, additional microneedles 1021 may extend downward (e.g., vertically) from the stabilization section 1024. In some embodiments, the stabilization section 1024 is configured to secure the catheter hub 14 to the device 1000 (see, for example, Figures 34A–34C). For example, in some embodiments, the stabilization section 1024 may include a pair of pins 1023 extending upward therefrom. The pins 1023 are configured to be received by corresponding openings 14a in the catheter hub 14 in order to secure the catheter hub 14 to the catheter fixation device 1000. In some embodiments, the stabilization section 1024 may have channels 1025 configured to receive a portion of the catheter hub 14 in order to provide additional fixation of the catheter hub 14 (see, for example, Figures 33A and 34A). In some embodiments, the retaining ring 1020 provides sufficient space for site cleaning, such as site cleaning using a disinfectant applicator's foam pad.

[0098] Figure 33C shows the outer cover 1030 in more detail. According to embodiments of the present invention, the outer cover 1030 provides further anchoring of the device to the skin and at the same time protects the insertion site IS of the catheter 12 (i.e., restricts vertical (Z-direction) movement). As seen in Figure 33C, the outer cover 1030 comprises a body 1032 pivotably connected to a retaining ring 1020 via a hinge 1035. The hinge 1035 allows the cover 1030 to move between an open (disengaged) position and a closed (engaged) position relative to the retaining ring 1020 (see, for example, Figures 34B to 34D). The body 1032 of the cover 1030 is sized and configured to receive the body 1022 of the outer retaining ring 1020 (i.e., when the cover 1030 is moved to the closed / engaged position). As further shown in Figure 33C, in some embodiments, the cover 1030 includes a plurality of microneedles 1031 extending downward from the body 1032. In some embodiments, the microneedles 1031 are angled (i.e., inclined) relative to the body 1032, thereby helping to prevent movement in the vertical direction. In some embodiments, the outer cover 1033 includes a grip feature 1033 that allows the cover to easily pivot between an open position and a closed position. In some embodiments, at least a portion of the outer cover 1030 is transparent, thereby allowing easy visual monitoring of the insertion site IS of the catheter 12 (i.e., without having to open the cover 1030).

[0099] Figures 34A to 34C illustrate the operation of attaching the catheter fixation device 1000 to the insertion site IS of the catheter 12 according to an embodiment of the present invention. As seen in Figure 34A, the outer retaining ring 1020 is fixed to the skin (i.e., via the microneedle 1021) such that the body 1022 of the retaining ring 1020 is positioned around the insertion site IS of the catheter 12. As described above, the vertically extending microneedle 1021 is configured to prevent the catheter fixation device 1000 from moving horizontally (XY direction). As further shown in Figure 34A, the catheter hub 14 is fixed to the stabilizing section 1024 of the retaining ring 1020 (e.g., via the pin 1023 and channel 1025). The outer cover 1030 is also fixed to the retaining ring 1020 (via the hinge 1035) and is moved (pivoted) to an open / detached position. The inner disc 1010 is positioned on the insertion site IS of the catheter 12. The catheter 12 is secured by the retaining ring 1020 using vertical, angled, and / or curved microneedles 1021 to anchor the catheter hub 14.

[0100] As seen in Figure 34B, the inner disc 1010 is placed within the retaining ring 1020 such that the central opening 1014 of the foam hemisphere 1012 is aligned with the insertion site IS of the catheter 12 and the catheter 12 is positioned within the slot 1017. The latching mechanism 1018 further secures the catheter 12 within the slot 1017 of the foam hemisphere 1012. The inner disc 1010 is fixed in place within the retaining ring 1020, and the catheter 12 is further secured at or near the insertion site IS via the latching mechanism 1018 located on the inner disc.

[0101] As can be seen in Figure 34C, the outer cover 1030 is then pivoted to a closed / engaged position relative to the retaining ring 1020 (around the hinge 1035). The retaining ring 1020 is received by the cover 1030, and the microneedle 1031 of the cover 1030 engages with the skin, thereby preventing vertical movement of the catheter fixation device 1000 and simultaneously protecting the insertion site IS of the catheter 1.

[0102] Referring here to Figures 35A-35B and 36A-36C, another microneedle-based catheter fixation device 1100 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 1100 may also be those described above with respect to other catheter fixation devices described herein, and such overlapping descriptions may be omitted herein for the purpose of illustrating with respect to Figures 35A-36C.

[0103] As can be seen in Figures 35A and 35B, the catheter fixation device 1100 comprises a base 1110 and a retaining ring cover 1120. The retaining ring cover 1120 is rotatably connected to the base 1110 via bistable hinge joints 1115. In some embodiments, the retaining ring cover 1120 may be connected to the base 1110 via an elastic stretchable joint. The joint 1115 allows the retaining ring cover 1120 to pivot / move between an open / detached position and a closed / engaged position relative to the base 1110. In some embodiments, at least a portion of the retaining ring cover 1120 is transparent, allowing for easy visual monitoring of the insertion site IS of the catheter 12.

[0104] As can be seen in Figure 34A, in some embodiments, the base 1110 comprises a first base member 1110a and a second base member 1110b. The first base member 1110a and the second base member 1110b may be spaced apart so that the catheter hub member 14 is positioned between them. In some embodiments, the base 1110 (e.g., the first base member 1110a and the second base member 1110b) may comprise a pair of pins 1113 extending upward therefrom. Similar to the catheter fixation device 1000 described herein, the pins 1113 may be configured to be received in corresponding openings 14a in the catheter hub member 1 in order to fix the catheter hub member 14 to the device 1100.

[0105] As can be seen in Figure 35B, the base 1110 and the retaining ring cover 1120 are provided with a plurality of microneedles 1111 and 1121. The microneedles 1111 and 1121 may be vertical, inclined, or a combination of both, in order to restrict movement in the X, Y, and Z directions. For example, in some embodiments, the base 1110 may be provided with vertical microneedles (to restrict the movement of the device 1100 in the X and Y directions), and the retaining ring cover 1120 may be provided with angled microneedles (to restrict the movement of the device 1100 in the Z direction).

[0106] Figures 36A to 36C illustrate the operation of attaching the catheter fixation device 1100 to the insertion site IS of the catheter 12 according to embodiments of the present invention. As seen in Figure 36A, a dressing 35 (e.g., an antimicrobial hemostatic IV dressing) is applied to the insertion site IS of the catheter 12. In some embodiments, an inner disc similar to the inner disc 1010 described herein may be used as the dressing. A latching mechanism 38 provides additional fixation of the catheter 12 to the catheter hub 14. As seen in Figure 36B, the base 1110 of the catheter fixation device 1100 of the present invention is fixed to the skin (i.e., via a microneedle 1111). The catheter hub 14 is positioned between the first base member 1110a and the second base member 1110b and is fixed to the base 1110 by the pin 1113. The retaining ring cover 1120 is in an open / detached position above the dressing 35 (and insertion site IS). As seen in Figure 36C, the retaining ring cover 1120 pivots to a closed position on the hinge joint 1115 so that the microneedle 1121 engages with the skin. The retaining ring cover 1120 surrounds the dressing 35 to protect the insertion site IS of the catheter 12. In some embodiments, the retaining ring cover 1120 allows for sufficient space for site-cleaning.

[0107] Referring here to Figures 37, 38A–38D, and 39A–39C, another microneedle-based catheter fixation device 1200 according to an embodiment of the present invention is shown. The characteristics and / or features of the catheter fixation device 1200 may be those described above with respect to the catheter fixation devices 1000 and 1100 described herein, and any overlapping descriptions thereof may be omitted herein for the purpose of illustrating with respect to Figures 37–39C.

[0108] As seen in Figures 37 and 38A to 38D, the catheter fixation device 1200 comprises a base 1210 and a cover 1240. In some embodiments, an inner disc 1205 (similar to the inner disc 1010 described herein) is configured to be fixed above the insertion site IS and catheter 12. In other embodiments, a dressing 35 (e.g., an antimicrobial hemostatic IV dressing) may be applied to the insertion site IS of 12. In some embodiments, the cover 1240 is rotatably coupled to the base 1210 via a hinge mechanism 1230. In some embodiments, the base 1210 comprises a retaining ring 1220 and a pair of stabilizing sections 1212a and 1212b. As seen in Figure 37, the retaining ring 1220 is substantially circular and is sized and configured to fit around the inner disk 1205 and the insertion site IS of the catheter 12 (see also, e.g., Figures 39B and 39C). In some embodiments, the retaining ring 1220 includes a recess or groove 1222 extending around the circumference of the retaining ring 1220. As will be described in more detail below, the recess or groove 1222 is configured to receive a corresponding projection or tongue portion 1244 of the cover 1240 (see, e.g., Figure 38C).

[0109] As seen in Figure 38A, the stabilization sections 1212a and 1212b define a channel 1214 that is connected to the opposing ends of the retaining ring 1220 and spaced apart, extending into the retaining ring 1220. The channel 1214 is configured to allow the catheter hub member 14 to be positioned between the stabilization sections 1212a and 1212b. In some embodiments, a projection 1232 extends outward from the retaining ring 1220 and is located opposite the stabilization sections 1212a and 1212b. The projection 1232 provides a position for the cover 1240 to be connected to the retaining ring 1220 and forms part of the hinge mechanism 1230. As with the other catheter fixation devices 1000 and 1100 described herein, in some embodiments the stabilization sections 1212a and 1212b are provided with pins 1213 extending upward therefrom, which are configured to be received by corresponding openings 14a in the catheter hub member 14 (see, for example, Figures 37 and 39B and 39C).

[0110] As seen in Figure 38B, in some embodiments, the base 1210 comprises a plurality of microneedles 1211 and 1221, which extend downward from there. In some embodiments, the microneedle 1211 extending from the stabilizing sections 1212a and 1212b is positioned perpendicular to the base 1210 (thus restricting the horizontal movement of the device 1200 in the X and Y directions). In some embodiments, the microneedle 1221 extending from the retaining ring 1220 is angled (i.e., inclined) with respect to the base 1210 (thus restricting the vertical movement of the device 1200 in the Z direction). In some embodiments, the microneedle 1221 is at an angle of about 20 to about 45 degrees from the base 1210.

[0111] Figure 38C shows the cover 1240 of the catheter fixation device 1200 in more detail. The cover 1240 has a circular body 1242 configured to engage with the base 1210. For example, as described above, in some embodiments, the body 1242 has an annular projection or tongue portion 1244 extending downward therefrom. The projection 1244 is configured to be received by the recess or groove 1222 in the retaining ring 1220 of the base 1210 (i.e., when the cover 1240 is pivoted to the closed position, see, for example, Figure 39C), thereby fixing the cover 1240 to the base 1210 and protecting the insertion site IS of the catheter 12. As seen in Figure 38C, in some embodiments, the cover 1240 further includes a pair of recesses 1243 configured to receive pins 1213 extending upward from the base 1210, for further securing the cover 1240 to the base 1210 when in the closed position (see, for example, Figure 39C). In some embodiments, the cover 1240 includes a grip feature 1245 that allows the user to easily pivot the cover 1240 between an open position and a closed position relative to the base 1210. In some embodiments, the cover 1240 may be transparent. The transparent cover can serve as an alternative to a transparent dressing that does not require dressing changes every seven days, and thus helps reduce the risk of dressing loosening, catheter tip migration, and detachment.

[0112] As seen in Figure 38D, in some embodiments, the inner disk 1205 may also comprise a plurality of microneedles 1206. In some embodiments, the microneedles 1206 of the inner disk 1205 may be vertically positioned, thereby allowing fixation around the circumference of the inner disk 1205 (and around the insertion site IS). As further shown in Figure 38D, in some embodiments, the inner disk 1205 comprises a central opening 1202 and a slot 1203 extending from the central opening 1202 to the outer edge of the inner disk 1205. The central opening 1202 is configured to be located at the insertion site IS of the catheter 12, and the catheter 12 is routed through the slot 1203 to the catheter hub 14 fixed to the base 1210 of the device 1200 (see, for example, Figures 39A–39C). In some embodiments, the inner disc 1205 may be an antimicrobial hemostatic absorbent dressing which may or may not have a transparent portion / window.

[0113] Figures 39A to 39C illustrate the operation of attaching the catheter fixation device 1200 to the insertion site IS of the catheter 12 according to an embodiment of the present invention. As seen in Figure 39A, the catheter 12 is fixed to the insertion site IS using the inner disc 1205 (or other type of dressing). The inner disc 1205 is positioned such that the insertion site IS of the catheter 12 is positioned at the central opening 1202 of the inner disc 1205, and the catheter 12 is routed to the catheter hub 14 through the slot 1203 of the inner disc 1205. As described above, the inner disc 1205 may be fixed around the skin and the insertion site IS through the engagement of microneedles 1206 extending from the inner disc 1205.

[0114] Next, as seen in Figure 39B, the base 1210 of the device 1200 is positioned on the skin such that the retaining ring 1220 surrounds the inner disk 1205 (and insertion site IS). The catheter hub 14 is positioned between the stabilization sections 1212a and 1212b of the base 1210, and the catheter hub 14 is secured to the base 1210 via pins 1213 extending from the stabilization sections 1212a and 1212b (through openings 14a in the catheter hub 14). The base 1210 is secured to the skin via microneedles 1211, 1221 (not visible in Figure 39B). Finally, as can be seen in Figure 39C, the cover 1240 can be pivoted (via the hinge mechanism 1230) to a closed position so that the projection 1244 of the cover 1240 is received in the groove 1222 of the retaining ring 1220, thereby sealing the inner disc 1205 and insertion portion IS within the retaining ring 1220. The pin 1213 of the base 1210 is received in the individual recesses 1243 of the cover 1240, thereby further securing the cover 1240 to the base 1210. When it is necessary to replace the inner disc / absorbent site-protection dressing, the cover 1240 can be opened, the inner disc 1205 can be removed, the site can be cleaned, a new inner disc 1205 can be introduced, and the cover 1240 can be closed.

[0115] The foregoing is illustrative of the present invention and should not be construed as limiting the invention. While several exemplary embodiments of the present invention have been described, those skilled in the art will readily understand that many modifications are possible in the exemplary embodiments without substantially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to fall within the scope of the present invention as described in the claims. The present invention is defined by separate claims, and equivalents of those claims are included within that scope.

Claims

1. A catheter fixation device, A cover configured to engage with a catheter hub retaining member; A drive disk equipped with multiple elongated guide slots extending in the circumferential direction; An engagement mechanism comprising a plurality of engagement arms, each engagement arm comprising a guide pin extending upward therefrom and received in a corresponding guide slot of the drive disk; A plurality of microneedle patches, each microneedle patch being connected to an individual engaging arm and comprising a plurality of microneedles; and, A base disk, wherein the base disk is connected to the cover, and the drive disk and the engagement mechanism are held between them by the base disk It is equipped with, As the drive disk rotates in the first direction, each guide pin slides within its individual guide slot, causing adjacent engaging arms to move radially opposite to the base disk, thereby allowing the corresponding microneedles to engage with the patient's skin. The catheter fixation device.

2. The catheter fixing device according to claim 1, wherein the cover has a circular body, the circular body has a plurality of projections extending upward from the body, and the projections are configured to engage with the catheter hub holding member to fix the catheter hub holding member to the catheter fixing device.

3. The catheter fixation device according to claim 1 or 2, wherein the cover further comprises a plurality of locking tabs extending downward from the main body and located along the periphery of the main body, the plurality of locking tabs configured to engage with the base disk, or alternatively, the cover may comprise a plurality of locking tabs extending upward from the base disk and located along the periphery of the base disk, the plurality of locking tabs configured to engage with the main body.

4. The catheter fixing device according to any one of claims 1 to 3, wherein the drive disk further comprises a slider connected to the main body and extending radially outward from the main body beyond the outer edge of the cover, thereby allowing a user to access the slider and rotate the drive disk.

5. The catheter fixation device according to any one of claims 1 to 4, wherein each guide slot is configured to limit the axial movement of each engaging arm to about 1 degree.

6. The catheter fixation device according to any one of claims 1 to 5, wherein the engagement mechanism comprises 4 to 10 engagement arms.

7. A catheter fixation device according to any one of claims 1 to 6, wherein each engaging arm comprises a sliding member that is received in a corresponding channel in the base disk, and each of the sliding members is configured to slide in its respective channel when the engaging arm moves radially relative to the base disk.

8. A catheter fixation device according to any one of claims 1 to 7, wherein the microneedles of adjacent microneedle patches are configured to point in opposing radial directions, providing intersecting radial engagement of the microneedles to the patient's skin and preventing movement of the catheter fixation device relative to the skin.

9. A catheter fixation device according to any one of claims 1 to 8, wherein when the drive disk rotates in the first direction, the guide pin moves in the guide slot in a second opposite direction, thereby causing two adjacent guide slots in the drive disk to move their individual guide pins and slide members in opposite directions, thereby causing their individual engaging arms to move radially in opposite directions.

10. A catheter fixation device, A top cover configured to engage with the catheter hub retaining member; Internal gear mechanism having a planetary gear configuration; A concentric inner disk and an outer disk connected to the internal gear mechanism and configured to rotate in opposite directions, wherein each of the inner disk and the outer disk is provided with a plurality of microneedles, the microneedles of the inner disk point in the opposite direction to the microneedles of the outer disk; and, A bottom cover, the bottom cover being connected to the top cover, and holding the internal gear mechanism between them, the bottom cover It is equipped with, Here, the operation of the internal gear mechanism causes the inner and outer disks to rotate in opposite directions, engaging the corresponding microneedles with the patient's skin. The catheter fixation device.

11. The catheter fixation device according to claim 10, wherein the inner disc has a circular body, and the outer disc has an annular body that is sized and configured to fit around the inner disc.

12. The catheter fixation device according to claim 10 or 11, wherein the planetary gear configuration of the internal gear mechanism comprises a base gear, a center gear, and a drive gear, the base gear being connected to the outer disk, the center gear being connected to the inner disk, and the drive gear engaging with the base gear and the center gear.

13. The catheter fixation device according to claim 12, wherein the inner disc and the outer disc are configured to have relative rotation in the range of about 5 degrees to about 35 degrees in order to provide sufficient gripping by the microneedle and engagement of the catheter fixation device with the skin.

14. The catheter fixation device according to claim 12 or 13, wherein the drive gear is provided with a slider arm extending radially outward through an opening in the top cover, thereby allowing a user to access the slider arm and operate the drive gear.

15. The catheter fixation device according to claim 14, wherein the opening in the top cover is provided with a locking function configured to engage with the sliding arm.

16. The catheter fixing device according to any one of claims 10 to 15, wherein the top cover is provided with one or more protrusions configured to hold the internal gear mechanism in a predetermined position within the catheter fixing device and to restrict the translational motion of the internal gear mechanism.

17. A catheter fixation device, An outer disk equipped with multiple first microneedles; An inner disk, the inner disk having a catheter hub holding member fitted into and fixed thereto within the outer disk, the inner disk comprising a plurality of second microneedles, the inner disk It is equipped with, Here, the plurality of first microneedles point in the opposite direction to the plurality of second microneedles. Here, the inner disc and the outer disc are configured to rotate in opposite directions relative to each other in order to engage the corresponding microneedles with the patient's skin. The catheter fixation device.

18. The catheter fixation device according to claim 17, further comprising a locking mechanism configured to lock the inner disc and the outer disc in predetermined positions to maintain engagement of the microneedle with the patient's skin.

19. The catheter fixation device according to claim 17 or 18, wherein the plurality of first microneedles and the plurality of second microneedles are arranged circumferentially along a predetermined diameter of the inner disk and the outer disk.

20. The catheter fixation device according to any one of claims 17 to 19, wherein the plurality of first microneedles and the plurality of second microneedles are oriented in their respective directions of rotation, providing an intersecting arrangement of these microneedles.

21. The catheter fixation device according to any one of claims 17 to 20, wherein the inner disc has a circular body, and the outer disc has an annular body that is sized and configured to fit around the inner disc.

22. The catheter fixation device according to claim 21, wherein the inner disc comprises a locking member extending radially outward from the main body and through an elongated opening in the main body of the outer disc, the locking member comprising a recess and a protruding member extending into the recess, and wherein the outer disc comprises a corresponding locking member extending radially outward from the outer surface of the main body, the locking member of the outer disc comprising a projection configured to be received in the recess of the locking member of the inner disc and to engage with the protruding member present therein.

23. The catheter fixation device according to claim 21 or 22, wherein the inner disk further comprises a sliding member extending radially outward from the main body, the sliding member being configured to be received by a corresponding recess along the inner surface of the main body of the outer disk and to slide within the corresponding recess.

24. The catheter fixation device according to any one of claims 17 to 21, wherein the inner disc comprises two opposing projections configured to engage with the outer disc to provide a locking function for the catheter fixation device.

25. The catheter fixation device according to claim 24, wherein the outer disc comprises a body having an annular recess extending along its inner surface, wherein the opposing projections of the inner disc are configured to slide within the recess of the outer disc.

26. The catheter fixation device according to claim 25, wherein the recess of the outer disk has one or more indentations, and the projection of the inner disk is configured to engage with the individual indentations of the outer disk when the inner disk is rotated relative to the outer disk, thereby locking the inner disk and the outer disk in a predetermined position.

27. A catheter fixation device, An upper plate, wherein the upper plate is configured to have a catheter hub holding member fixed to the upper plate, and the upper plate is provided with a plurality of cam members extending downward from the upper plate; and, A lower plate connected to the upper plate, wherein the lower plate comprises a concentric inner disk and an outer disk, and each of the concentric inner disk and outer disk is provided with a plurality of cam members extending upward from the upper surface, and a plurality of microneedles extending downward from the lower surface, the lower plate It is equipped with, Here, when the upper plate moves toward the lower plate, the cam member of the upper plate engages with the individual cam members of the lower plate, causing the inner disc and the outer disc to rotate in opposite directions relative to each other, thereby engaging the corresponding microneedle with the patient's skin. The catheter fixation device.

28. The catheter fixing device according to claim 27, wherein each of the plurality of cam members extending upward from the lower plate has an inclined edge or a tapered edge.

29. The catheter fixing device according to claim 28, wherein the opposing inclined edges of the cam member are configured such that when a downward force is applied to the upper plate, the inner disc and the outer disc rotate simultaneously in opposite directions.

30. The catheter fixation device according to any one of claims 27 to 29, further comprising safety clips configured to engage with the upper plate and the lower plate in order to prevent the upper plate and the lower plate from rotating accidentally relative to each other.

31. A catheter fixation device, A base member configured to hold a catheter; A wing member comprising two opposing wing members rotatably connected to the base member, wherein each wing member comprises a microneedle patch having a plurality of microneedles curved radially inward toward the base member; and A top cover configured to engage with the wing member to fix the catheter to the base and to prevent vertical movement of the wing member. It is equipped with, Here, the wing member is configured to guide the plurality of microneedles along a circular pattern relative to the axis of rotation and engage with the patient's skin. The catheter fixation device.

32. The catheter fixation device according to claim 31, wherein the base member comprises a plurality of microneedles extending vertically downward from the base member.

33. The catheter fixation device according to claim 31 or 32, wherein the wing member is connected to the base member via a bistable hinge.

34. The catheter fixation device according to any one of claims 31 to 33, wherein each wing member further comprises a vertically extending column configured to position and fix the catheter to the catheter fixation device.

35. The catheter fixation device according to any one of claims 31 to 34, wherein the top cover comprises opposing latch members configured to engage with corresponding projections extending outward from the side walls of each wing member.

36. A catheter fixation device, A center plate, wherein a catheter hub holding member is configured to be fixed to the center plate; Two base members connected to the center plate; Two sliding members, each sliding member being movably connected to an individual base member and having a microneedle patch, the microneedle patch having a plurality of microneedles extending downward therefrom; and, Two biasing members within each base member, the two biasing members configured to provide a continuous force to the individual slide members. It is equipped with, Here, the sliding member allows the microneedle to move horizontally relative to the base member, thereby facilitating engagement of the microneedle with the patient's skin. The catheter fixation device.

37. The catheter fixation device according to claim 36, wherein the two base members are integrally formed as a single base member.

38. The catheter fixation device according to claim 36 or 37, wherein each slide member is provided with a tongue portion extending longitudinally on opposite side walls, the tongue portion being configured to be received in a corresponding groove on the inner surface of the base member, thereby allowing the slide member to move relative to the individual base member.

39. The catheter fixation device according to any one of claims 36 to 38, wherein the upper surface of each sliding member is provided with a gripping element for easier operation by the user.

40. The catheter fixation device according to any one of claims 36 to 39, wherein each biasing member is held in a recess of the base member and configured to contact a corresponding slide member.

41. The catheter fixation device according to any one of claims 36 to 40, wherein the plurality of microneedles on each microneedle patch are inclined inward toward the center plate and in the opposite direction to the microneedles on other microneedle patches to provide cross engagement with the skin.

42. A catheter fixation device, An annular outer member comprising a plurality of first microneedles; and, A circular inner member configured to fit into the opening of the annular outer member, wherein the inner member comprises a plurality of second microneedles and is configured to have a catheter hub holding member fixed thereto. It is equipped with, Here, the outer member and the inner member are configured to rotate in opposite directions to engage the individual microneedles with the patient's skin. The catheter fixation device.

43. The catheter fixation device according to claim 42, wherein the outer member comprises a pair of arm members extending radially outward from the outer member.

44. The catheter fixation device according to claim 42 or 43, wherein the outer member is provided with a notch configured to slide within a curved slot in the inner member, thereby helping to guide the rotation of the outer member relative to the inner member.

45. A catheter fixation device according to any one of claims 42 to 44, comprising a concentric microneedle patch configured such that the inner member and the outer member rotate in opposite directions.

46. A catheter fixation device, A body configured to hold a catheter; and, A pair of arm members connected to opposite sides of the main body, each arm member having one or more microneedle patches, and each microneedle patch having multiple microneedles, the pair of arm members It is equipped with, Here, the arm member is configured to move relative to the main body in order to engage the corresponding microneedle with the patient's skin. The catheter fixation device.

47. The catheter fixation device according to claim 46, wherein each arm member is connected to the main body via a hinge that allows each arm member to pivot between a closed engaged position and an open disengaged position.

48. The catheter fixation device according to claim 46 or 47, wherein the microneedle patch is arranged such that the corresponding microneedles are oriented in the same direction, in opposite directions, or in a combination thereof.

49. The catheter fixation device according to any one of claims 46 to 48, wherein the arm member comprises two or four rows of microneedle patches.

50. The catheter fixation device according to any one of claims 46 to 49, wherein the microneedle has a curved configuration / hook configuration, an angled / inclined configuration, or a combination thereof.

51. A catheter fixation device, An inner disk comprising a central opening and slots extending radially outward therefrom, the inner disk being positioned above the catheter insertion site and configured to receive the catheter; and An outer retaining ring comprising an annular body sized and configured to hold the inner disk and a stabilizing section connected to the body, wherein the stabilizing section is configured to have a catheter hub fixed thereto, and the outer retaining ring comprises a plurality of microneedles extending downward therefrom for securing the device to the patient's skin, the outer retaining ring The catheter fixation device comprising the above-mentioned features.

52. The catheter fixation device according to claim 51, wherein the inner disk comprises a disposable foam hemisphere having a transparent window.

53. The catheter fixation device according to claim 52, wherein the foam-like hemisphere is formed from an antibacterial, hemostatic, and water-absorbing material, and the transparent window is equipped with an antibacterial gel pad.

54. The catheter fixation device according to any one of claims 51 to 53, wherein the inner disc further comprises a latching mechanism positioned above the slot to provide additional fixation of the catheter at the insertion site.

55. The catheter fixation device according to any one of claims 51 to 54, wherein the microneedle is arranged perpendicular to the main body.

56. The catheter fixation device according to any one of claims 51 to 55, wherein the stabilization section comprises a pair of pins and channels extending upward therefrom, the pins being configured to be received by corresponding openings in the catheter hub, and the channels being configured to receive a portion of the catheter hub.

57. A catheter fixation device according to any one of claims 51 to 56, further comprising an outer cover pivotably connected to the outer retaining ring via a hinge, the outer cover being configured to move between an open position and a closed position to cover the inner disk.

58. The catheter fixation device according to claim 57, wherein the outer cover comprises a plurality of microneedles extending downward from the main body.

59. The catheter fixing device according to claim 58, wherein the microneedle is angled relative to the main body.

60. The catheter fixation device according to any one of claims 51 to 56, wherein the stabilizing section forms a base, and the outer retaining ring is pivotably connected to the base via a hinge.

61. The catheter fixation device according to claim 60, wherein the outer retaining ring is provided with a transparent cover.

62. The catheter fixation device according to claim 60 or 61, wherein the base comprises a plurality of microneedles extending vertically downward, and the outer retaining ring comprises a plurality of angled microneedles.

63. The catheter fixation device according to claim 57, wherein the annular body of the outer retaining ring is provided with a groove extending around the circumference of the body, and the outer cover is provided with a corresponding annular projection configured to be received in the groove when the cover is pivoted to the closed position.

64. A catheter fixation device, A base comprising a retaining ring and a pair of stabilizing sections, wherein the retaining ring is substantially circular and sized and configured to fit around the insertion site of a catheter, the retaining ring has a groove extending around the circumference, and the stabilizing sections are configured to have a catheter hub fixed thereto; and A cover rotatably connected to the base via a hinge mechanism, the cover having an annular projection extending downward therefrom and configured to be received by the groove of the retaining ring, the cover It is equipped with, Here, the base comprises a plurality of microneedles configured to engage with the patient's skin to secure the device. The catheter fixation device.

65. The catheter fixation device according to claim 64, wherein the stabilizing sections are spaced apart to define channels extending into the retaining ring, and the channels are configured to fix the catheter hub between them.

66. The catheter fixation device according to claim 64 or 65, wherein the stabilizing section has a plurality of microneedles extending perpendicularly to the base, and the retaining ring has a plurality of microneedles extending at an angle to the base.

67. A catheter fixation device according to any one of claims 64 to 66, further comprising an inner disc having a plurality of microneedles, wherein the inner disc is configured to be fixed above the insertion site of the catheter.

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