Catheter anchoring devices, kits, and methods of use - Patents.com

Abstract

A fixation device for a cannula configured to be inserted into a patient's skin at an insertion site is described. The fixation device includes a base including a receiving member configured to be removably secured to the cannula. The base further includes a pair of opposing arms extending from the receiving member. The fixation device further includes a pair of spaced-apart anchor assemblies corresponding to the pair of arms. Each of the pair of anchor assemblies is pivotally coupled to a corresponding one of the pair of arms. Each of the pair of anchor assemblies is configured to be removably secured to the patient's skin in a locked state. In the locked state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while secured to the cannula.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to fixation devices for catheters, kits including fixation devices, and methods of using fixation devices. [Background technology]

[0002] Catheters are well known in medical applications and are used for a variety of purposes, such as administering medications and fluids to users, performing blood tests, measuring venous pressure, etc. Catheters are typically secured to a user's skin to limit their movement, e.g., to prevent them from being pulled out or otherwise moved in a manner that may adversely affect their function. Traditionally, catheters are secured to a user's skin using catheter securement units such as tape, patches, and sutures. Improperly stabilized catheters can lead to complications such as dislodgement and accidental removal, phlebitis, blockage / infiltration and leakage, and bloodstream infection.

[0003] Conventional catheter securement units, such as tapes and patches, suffer from high rates of dislodgement. Furthermore, the use of such catheter securement units often allows partial or minute movement of the catheter. The use of sutures to secure the catheter in place can lead to suture-related infections and complications. Additionally, conventional catheter securement units may not allow full circumferential access to the cannulation site (insertion point) on the user's skin for maintenance purposes without removing the catheter or catheter hub. The cannulation site is only accessible after releasing the catheter from any current securement unit. This can lead to catheter pistoning, i.e., mechanical movement of the catheter in and out of the user's skin. Summary of the Invention

[0004] In a first aspect, the present disclosure provides a fixation device for a catheter having a cannula configured to be inserted into a patient's skin at an insertion site. The fixation device includes a base including a receiving member configured to be removably secured to the cannula. The base further includes a pair of opposing arms extending from the receiving member. The fixation device further includes a pair of anchor assemblies corresponding to the pair of arms and spaced apart from each other. Each of the pair of anchor assemblies is pivotally coupled to a corresponding one of the pair of arms of the base. Each of the pair of anchor assemblies is configured to be removably secured to the patient's skin in a fixed state. In the fixed state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while secured to the cannula.

[0005] In a second aspect, the present disclosure provides a kit including a catheter. The catheter includes a cannula configured to be inserted into a patient's skin at an insertion site. The kit further includes a fixation device including a base. The base includes a receiving member configured to be removably secured to the cannula. The base further includes a pair of opposing arms extending from the receiving member. The fixation device further includes a pair of anchor assemblies corresponding to the pair of arms and spaced apart from each other. Each of the pair of anchor assemblies is pivotally coupled to a corresponding one of the pair of arms of the base. Each of the pair of anchor assemblies is configured to be removably secured to the patient's skin in a fixed state. In the fixed state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while secured to the cannula.

[0006] In a third aspect, the present disclosure provides a method of using a fixation device with a catheter having a cannula inserted into a patient's skin at an insertion site. The fixation device includes a base having a receiving member and paired arms extending from the receiving member, and a pair of anchor assemblies corresponding to the pair of arms. Each of the pair of anchor assemblies is pivotally coupled to a corresponding one of the pair of arms of the base. The method includes releasably securing the cannula of the catheter to the receiving member of the base. The method further includes releasably securing each of the pair of anchor assemblies to the patient's skin in the secured state. The method further includes pivoting the base away from the patient's skin while the base is secured to the cannula.

[0007] The details of one or more examples of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0008] The exemplary embodiments disclosed herein may be more fully understood by considering the following detailed description in conjunction with the following drawings: The drawings are not necessarily drawn to scale. Like numbers used in the figures refer to like components. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number. [Figure 1] 1 shows a schematic perspective view of a catheter according to one embodiment of the present disclosure. [Figure 2] FIG. 1 shows a schematic perspective view of a fixation device detached from a catheter, according to an embodiment of the present disclosure. [Figure 3] 1 shows a schematic exploded perspective view of a fixation device according to one embodiment of the present disclosure. [Figure 4]1 shows a schematic perspective view of a fixation device and catheter, with the cannula of the catheter removably secured to a receiving member of the base of the fixation device, according to one embodiment of the present disclosure. [Figure 5] 1 shows a schematic perspective view of a fixation device and a catheter, with the cap of the fixation device removably coupled to the receiving member, according to one embodiment of the present disclosure. [Figure 6A] 1A-1C show partial schematic perspective views of a fixation device for a pair of anchor assemblies in a released state, an intermediate state, and a locked state, respectively, according to one embodiment of the present disclosure. [Figure 6B] 1A-1C show partial schematic perspective views of a fixation device for a pair of anchor assemblies in a released state, an intermediate state, and a locked state, respectively, according to one embodiment of the present disclosure. [Figure 6C] 1A-1C show partial schematic perspective views of a fixation device for a pair of anchor assemblies in a released state, an intermediate state, and a locked state, respectively, according to one embodiment of the present disclosure. [Figure 7] 1 shows a schematic perspective view of a fixation device with each of a pair of anchor assemblies in a locked state, according to one embodiment of the present disclosure. [Figure 8] 1 shows a schematic perspective view of a fixation device in a fixed state of each of a pair of anchor assemblies and in a maintenance state of the base, according to one embodiment of the present disclosure. [Figure 9] 1 shows a schematic perspective view of a fixation device according to one embodiment of the present disclosure, in which the longitudinal axis of the receiving member is perpendicular to the support plane defined by each of a pair of anchor assemblies. [Figure 10] FIG. 1 shows a schematic block diagram of a kit according to one embodiment of the present disclosure. [Figure 11] 10 is a flowchart illustrating a method of using a fixation device with a catheter, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] In the following description, reference is made to the accompanying drawings, which form a part hereof, and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope and spirit of the present disclosure. Accordingly, the following detailed description is not to be taken in a limiting sense.

[0010] In the disclosure that follows, the following definitions are adopted:

[0011] As used herein, the term "coupled" generally means a direct connection between two or more elements that are connected, or an indirect connection through one or more passive or active intermediary devices.

[0012] As used herein, the term "pivot" generally means to rotate or turn a component about a fixed axis.

[0013] As used herein, the term "pivotally coupled" generally refers to elements that are coupled in a manner that allows one element to pivot relative to another element.

[0014] As used herein, the terms "removably secured" or "removably coupled" generally mean that one component can be secured to a second component in a fixed position and can be removed from the second component without causing structural damage to either component.

[0015] As used herein, the term "living hinge" generally refers to a flexible hinge that is made from the same material as the elements that it pivotally joins together, rather than being a separate material or mechanism distinct from the elements that it connects.

[0016] As used herein, the term "fixation" generally means the state of being fixed, the act or instance of being fixed, or the result of fixing something.

[0017] As used herein, the term "slidably engage" generally refers to the movement of one surface over a second surface while maintaining smooth, continuous contact between the two surfaces.

[0018] As used herein, the term "catheter" is used throughout to describe a thin tube extruded from medical-grade materials that serves a wide variety of functions. Catheters are medical devices that can be inserted into a user's body to treat disease or perform surgical procedures. By modifying the material or adjusting the way the catheter is manufactured, it is possible to tailor catheters for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications. Catheters can be inserted into body cavities, ducts, or blood vessels. Functionally, catheters can enable drainage, administration of fluids or gases, access to surgical instruments, and a wide variety of other tasks depending on the type of catheter. The process of inserting a catheter is sometimes called catheterization. In most cases, catheters are thin, flexible tubes ("soft" catheters), but catheters with various levels of stiffness are available depending on the application. Catheters that remain in the body, either temporarily or permanently, are sometimes called indwelling catheters. Permanently inserted catheters are sometimes called permcaths. A variety of polymers may be used to manufacture the catheter, including, but not limited to, silicone rubber, nitinol, nylon, polyurethane, polyethylene terephthalate (PETE) latex, and / or thermoplastic elastomers.

[0019] As used herein, the term "maintenance" or "maintenance purposes" generally refers to procedures involving cleansing and / or disinfection of a patient's skin proximal to the insertion site. Maintenance may be performed, for example, by a healthcare professional at regular intervals during intravenous therapy.

[0020] As used herein, the term "pistoning" or "pistoning motion" refers to the movement of the cannula of the catheter relative to the insertion site.

[0021] As used herein, all numerical values ​​should be considered to be modified by the term "about." As used herein, "a," "an," "the," "at least one," and "one or more" are used interchangeably.

[0022] The term "substantially," unless otherwise specifically defined, means a high degree of approximation (e.g., within + / - 10% for quantifiable properties), but again does not require absolute precision or perfect agreement.

[0023] The term "about," unless otherwise specifically defined, means a high degree of approximation (e.g., within + / - 5% for quantifiable properties), but again does not require absolute precision or exact agreement.

[0024] The term "generally," when used herein as a modifier to a characteristic or attribute, unless specifically defined otherwise, means that the characteristic or attribute is readily recognizable by one of ordinary skill in the art, but does not require absolute precision or perfect agreement (e.g., within + / - 20% for quantifiable characteristics).

[0025] As used herein, terms such as "configured to" are at least as restrictive as the term "adapted to," requiring actual design intent to perform a specified function, rather than merely a physical capability to perform such function.

[0026] Terms such as same, equal, uniform, constant, exactly, etc. are understood to not require absolute precision or exact agreement, but rather within normal tolerances or measurement errors applicable to a particular situation.

[0027] As used herein, the terms "first" and "second" are used as identifiers. Therefore, such terms should not be construed as limiting the present disclosure. The terms "first" and "second" when used in conjunction with a feature or element are interchangeable throughout multiple embodiments of the present disclosure.

[0028] As used herein, when a first material is said to be "similar" to a second material, at least 90% by weight of the first and second materials are identical, with any variation between the first and second materials being less than about 10% by weight of each of the first and second materials.

[0029] As used herein, "at least one of A and B" should be understood to mean "A only, B only, or both A and B."

[0030] Unless otherwise specified or limited, the terms "mounted" and "connected" and variations thereof are used broadly and encompass both direct and indirect mounting, connecting, and coupling.

[0031] The present disclosure provides a fixation device for a catheter having a cannula configured to be inserted into a patient's skin at an insertion site. The fixation device includes a base including a receiving member configured to be removably secured to the cannula. The base further includes a pair of opposing arms extending from the receiving member. The fixation device further includes a pair of spaced-apart anchor assemblies corresponding to the pair of arms. Each of the pair of anchor assemblies is pivotally coupled to a corresponding one of the pair of arms of the base. Each of the pair of anchor assemblies is configured to be removably secured to the patient's skin in a locked state. In the locked state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while secured to the cannula.

[0032] The fixation device of the present disclosure can firmly secure and stabilize a catheter on a patient's skin. Furthermore, the fixation device can limit movement of the cannula relative to the patient's skin during normal use. Specifically, the pair of anchor assemblies can prevent dislodgement of the catheter or cannula when removably secured to the patient's skin. Furthermore, the pair of anchor assemblies can potentially facilitate removal of the fixation device from the patient's skin.

[0033] In the locked state of each of the pair of anchor assemblies, the fixation device can allow the base to be pivoted relative to the pair of anchor assemblies while secured to the cannula, thereby allowing full circumferential access to the insertion site for cleaning and maintenance purposes without having to remove the catheter from the fixation device. Furthermore, the fixation device can be secured to the patient's skin away from the insertion site, allowing for minimal interference with the insertion site. The fixation device may be used for extended periods of time without causing discomfort to the patient, thereby improving the user experience.

[0034] Additionally, the fixation device can allow for fixing the length of the cannula between the base and the insertion site, thereby eliminating pistoning of the cannula during pivotal movement of the base relative to the pair of anchor assemblies. Additionally, the fixation device of the present disclosure can eliminate the need for tape, patches, and / or sutures to secure the catheter to the patient's skin, thereby preventing the complication of medical adhesive-associated skin injury (MARSI). Furthermore, the base of the fixation device can removably secure cannulas of various sizes and geometries, thereby enabling compatibility with multiple brands and applications.

[0035] Referring now to the figures, Figure 1 shows a schematic perspective view of a catheter 10. Catheter 10 includes a cannula 12 configured to be inserted into the skin 14 of a patient (not shown) at an insertion site 16. As shown in Figure 1, catheter 10 is at least partially disposed on the patient's skin 14. In some cases, a patient utilizing catheter 10 may be undergoing intravenous treatment.

[0036] In the following description, "inserted into the skin" includes insertion through the skin. The distal end of catheter 10 or cannula 12 may be positioned at any medically desired anatomical location, including, by way of non-limiting example, the lumens of veins and arteries, the atria and ventricles of the heart, the ventral body cavity, the spinal canal, the subarachnoid space, the intracranial cavity, and fat or muscle tissue.

[0037] In some examples, the catheter 10 includes a catheter hub 20 and at least one lumen 22 at least partially received within the catheter hub 20. Further, the cannula 12 is at least partially received within the catheter hub 20. In the illustrated embodiment of FIG. 1, the at least one lumen 22 includes three lumens 22. In other words, the catheter 10 is a three-lumen catheter. However, the number of lumens 22 may vary based on the desired application and / or infusion characteristics. The at least one lumen 22 is fluidly connected to the cannula 12 through the catheter hub 20.

[0038] In some examples, the catheter 10 may include a central venous catheter (CVC). A CVC may be referred to as a central line, central venous line, or central venous access catheter. A CVC may be used to access a large, centrally located vein (not shown), which is often required for critically ill patients, for patients requiring long-term intravenous therapy for secure vascular access, and for administering fluids that may damage small peripheral veins. Thus, in some examples, at least a portion of the cannula 12 may be inserted into a vein located in the patient's neck (e.g., the internal jugular vein), a vein located in the chest (e.g., the subclavian vein or the axillary vein), or a vein located in the groin (e.g., the femoral vein). In some examples, the catheter 10 may include a peripherally inserted central venous catheter (PICC). A PICC may be suitable for insertion into a vein located in the patient's arm. However, the catheter 10 may include any suitable type of catheter, which may be selected based on desired application characteristics.

[0039] In some examples, catheter 10 may be used to administer intravenous therapy (e.g., administering medication or fluids for parenteral nutrition), obtain blood for analysis, and / or provide an access point for blood-based therapies such as dialysis or apheresis. Catheter 10 may also be used to measure one or more characteristics of blood (e.g., "central venous oxygen saturation"), administer fluids or blood products for large-scale emergency fluid therapy, and / or measure central venous pressure.

[0040] 2 shows a schematic perspective view of a fixation device 100 for a catheter 10. In FIG. 2, the fixation device 100 is removed and spaced apart from the catheter 10. The fixation device 100 includes a base 102. The base 102 includes a receiving member 104 configured to be removably secured to the cannula 12. In some examples, the receiving member 104 of the base 102 is configured to be removably secured to the cannula 12 after the cannula 12 is inserted into the patient's skin 14 (or central vein) at the insertion site 16.

[0041] In some examples, the fixturing device 100 further includes a cap 110 configured to be removably coupled to the receiving member 104. In the illustrated embodiment of FIG. 2, the cap 110 is shown separated from the receiving member 104. In some examples, the base 102 further includes a living hinge 116 pivotally coupling the cap 110 to the receiving member 104. In some examples, the cap 110 can pivot relative to the receiving member 104 to receive the cannula 12 between the cap 110 and the receiving member 104. In some examples, the cap 110 and the receiving member 104 are configured to receive the cannula 12 between the cap 110 and the receiving member 104 after the cannula 12 is inserted into the patient's skin 14.

[0042] The base 102 further includes a pair of opposing arms 120 extending from the receiving member 104. However, it should be understood that the base 102 may include any number of arms 120. In some examples, each of the pair of arms 120 may be arc-shaped. The fixation device 100 further includes a pair of spaced-apart anchor assemblies 130 corresponding to the pair of arms 120. Each of the pair of anchor assemblies 130 is pivotally coupled to a corresponding one of the pair of arms 120 of the base 102. Each of the pair of anchor assemblies 130 is configured to be removably secured to the patient's skin 14 in a secured state A1 (shown in FIGS. 6C and 7 ). In some examples, each of the pair of anchor assemblies 130 is configured to be removably secured to the patient's skin 14 after removably securing the cannula 12 to the receiving member 104.

[0043] 3 shows a schematic exploded perspective view of fixation device 100. Referring now to FIGS. 2 and 3, in some examples, receiving member 104 includes a first slot 106 configured to at least partially and removably receive cannula 12. In some examples, fixation device 100 further includes a first sleeve 108 at least partially received within first slot 106. In some examples, cap 110 includes a second slot 112. In some examples, second sleeve 114 is at least partially received within second slot 112. It should be understood that the dimensions and geometry of first sleeve 108 and second sleeve 114 can vary based on application requirements.

[0044] In some examples, the receiving member 104 further includes a longitudinal axis X-X' extending along its length L (shown in FIG. 2). In some examples, the first slot 106 of the receiving member 104 extends at least partially along the longitudinal axis X-X'. Furthermore, the second slot 112 of the cap 110 also extends at least partially along the longitudinal axis X-X'. In some examples, the longitudinal axis X-X' corresponds to an axis of symmetry of the base 102 such that the pair of arms 120 are disposed symmetrically about the longitudinal axis X-X'. In some examples, each of the pair of arms 120 curves away from the longitudinal axis X-X'. Furthermore, the longitudinal axis X-X' may also be aligned with the insertion site 16 on the patient's skin 14. In some examples, each of the pair of arms 120 is pivotable about a common pivot axis Y-Y' that is substantially perpendicular to the longitudinal axis X-X'.

[0045] In some examples, each of the pair of anchor assemblies 130 includes a flat support surface 132 configured to be placed on the patient's skin 14. In some examples, the flat support surface 132 may allow each of the pair of anchor assemblies 130 to be seated on the patient's skin 14. In some examples, each of the pair of anchor assemblies 130 further includes an anchor wheel 134 pivotally coupled to the corresponding arm 120. Specifically, the anchor wheel 134 includes the flat support surface 132. For example, a portion of the anchor wheel 134 may be removed to form the flat support surface 132. Alternatively, the anchor wheel 134 may be a molded part that includes the flat support surface 132.

[0046] In some examples, the anchor wheel 134 of each of the pair of anchor assemblies 130 includes a protrusion 138, and each arm 120 includes a collar 122 proximal to the distal end 124 of the receiving member 104. The protrusion 138 corresponding to only one of the pair of anchor assemblies 130 and the collar 122 corresponding to only one of the pair of arms 120 are visible in FIG. 3 . In some examples, the collar 122 of each arm 120 at least partially and rotatably receives the protrusion 138 of the anchor wheel 134 of the corresponding anchor assembly 130 to pivotally couple each arm 120 to the corresponding anchor assembly 130. In some examples, the collar 122 of each arm 120 can retain the protrusion 138 of the anchor wheel 134 of the corresponding anchor assembly 130 to pivotally couple each arm 120 to the corresponding anchor assembly 130. In some examples, each arm 120 is pivotable relative to the corresponding anchor assembly 130 along a common pivot axis Y-Y′. In some examples, the common pivot axis YY′ may pass through the protrusion 138 of each anchor wheel 134 of the pair of anchor assemblies 130 .

[0047] In some examples, each of the pair of anchor assemblies 130 is fixedly coupled to the anchor wheel 134 and further includes an anchor guide 140 disposed around the anchor wheel 134. In some examples, the anchor guide 140 may be disposed around the periphery of the anchor wheel 134 adjacent the flat support surface 132. In some examples, the anchor guide 140 may be molded into the anchor wheel 134, for example, if the anchor guide 140 and anchor wheel 134 are made of a polymeric material, or may be formed on the anchor wheel 134, for example, if the anchor guide 140 and anchor wheel 134 are made of a metallic material. In some examples, the anchor guide 140 may be in the form of an arc-shaped hollow tube. In some examples, the anchor guide 140 includes an arc-shaped slot 142 extending therethrough.

[0048] In some examples, each of the pair of anchor assemblies 130 further includes an anchor ring 150 including an arcuate penetrating portion 152 slidably and at least partially received within the arcuate slot 142 of the anchor guide 140 such that the anchor ring 150 is rotatable relative to the anchor guide 140 along the arcuate slot 142. In some examples, the anchor ring 150 of each of the pair of anchor assemblies 130 is rotatable about a common axis of rotation Z-Z'. Further, in some examples, the common pivot axis Y-Y' is coaxial with the common axis of rotation Z-Z'. In some examples, the anchor ring 150 may be made of plastic (e.g., a molded part) or medical-grade stainless steel.

[0049] In some examples, the anchor ring 150 further includes a coupling portion 156 defining an aperture 158 therethrough and positioned adjacent the anchor wheel 134. In some examples, the aperture 158 of the coupling portion 156 at least partially receives the protrusion 138 of the anchor wheel 134 therethrough to rotatably couple the anchor ring 150 to the anchor wheel 134. Thus, the anchor ring 150 is rotatable relative to the anchor wheel 134 and the anchor guide 140 about a common axis of rotation Z-Z'. In some examples, the coupling portion 156 is disc-shaped.

[0050] In some examples, anchor ring 150 further includes an intermediate portion 160 extending radially from coupling portion 156. In some examples, arcuate piercing portion 152 extends from intermediate portion 160 radially distal to coupling portion 156. In some examples, arcuate piercing portion 152 further extends at least partially from intermediate portion 160 about a common axis of rotation Z-Z'. In some examples, arcuate piercing portion 152 includes a sharpened tip 154 ​​configured to removably pierce the patient's skin 14. In some examples, sharpened tip 154 ​​is disposed at an end of arcuate piercing portion 152 remote from intermediate portion 160.

[0051] In some examples, the anchor wheel 134 can serve as a guide for rotating the anchor ring 150 about the common rotational axis Z-Z' without slipping out of the corresponding anchor assembly 130. In some examples, the anchor ring 150 is coupled to the intermediate portion 160 and further includes a gripping pad 162 disposed at least partially around the intermediate portion 160. In some examples, the gripping pad 162 includes a plurality of ridges 164 configured to be manually grasped to rotate the anchor ring 150 relative to the anchor guide 140. In some examples, the intermediate portion 160 tapers radially inward from the gripping pad 162 to the coupling portion 156.

[0052] 4 shows a schematic perspective view of the fixation device 100 and catheter 10, with the cannula 12 removably secured to the receiving member 104. Further, as shown in FIG. 4, the cap 110 of the fixation device 100 is separated from the receiving member 104. In some examples, the fixation device 100 may be appropriately positioned under the catheter 10 after the cannula 12 has been inserted into the patient's skin 14 at the insertion site 16 and before the cannula 12 is removably secured to the receiving member 104. In some examples, the flat support surface 132 of each of the pair of anchor assemblies 130 engages the patient's skin 14 when the fixation device 100 is positioned thereon.

[0053] In some examples, the fixation device 100 can be positioned on the patient's skin 14 such that the fixation device 100 is aligned with the insertion site 16 and the cannula 12 is at least partially disposed between the pair of arms 120. Additionally, the fixation device 100 can be positioned such that the common pivot axis Y-Y' or the common rotational axis Z-Z' is aligned with the insertion site 14 and the longitudinal axis X-X' intersects the common pivot axis Y-Y' directly above the insertion site 16. Specifically, the longitudinal axis X-X' and the common pivot axis Y-Y' intersect each other at an intersection 165 located directly above the insertion site 16.

[0054] In some examples, each anchor guide 140 of the pair of anchor assemblies 130 includes an alignment mark 166 aligned with the insertion site 16. The alignment mark 166 may allow a clinician to properly position the fixation device 100 on the patient's skin 14 relative to the insertion site 16. In some examples, the alignment mark 166 may also be aligned with the common pivot axis Y-Y' or the common rotational axis Z-Z'. In some examples, a clinician may properly adjust the length of the cannula 12 disposed between the receiving member 104 and the insertion site 16 before removably securing the cannula 12 to the receiving member 104. Furthermore, the cannula 12 is at least partially removably received in the first slot 106 of the receiving member 104.

[0055] 5 shows a schematic perspective view of the fixation device 100 and catheter 10, with the cap 110 removably coupled to the receiving member 104. Once the fixation device 100 is positioned on the patient's skin 14, the clinician can rotate the cap 110 to removably secure the cap 110 to the receiving member 104. In some examples, the cap 110 is pivotable relative to the receiving member 104 through a living hinge 116 (shown in FIG. 4) from a separated state (shown in FIG. 4) to a coupled state (shown in FIG. 5) to removably couple the cap 110 to the receiving member 104.

[0056] In some examples, the cap 110 is removably coupled to the receiving member 104 via a snap-fit ​​connection. However, it should be understood that the cap 110 may be removably coupled to the receiving member 104 via any other suitable coupling mechanism. In some examples, the cap 110 includes a lip 111 configured to be manually grasped to release the cap 110 from the receiving member 104. In some examples, the lip 111 may extend away from the cap 110, allowing the lip 111 to be manually grasped to apply force to release the cap 110 from the receiving member 104. In some examples, the cap 110 may be released from the receiving member 104, for example, when the fixturing device 100 needs to be discarded after use.

[0057] 4 and 5 , in some examples, when cap 110 is removably coupled to receiving member 104, second slot 112 is at least partially aligned with first slot 106. In some examples, when cannula 12 is inserted into first slot 106 and cap 110 is removably coupled to receiving member 104, first slot 106 and second slot 112 collectively at least partially receive cannula 12 between first slot 106 and second slot 112 such that cannula 12 is removably secured to receiving member 104.

[0058] Furthermore, when cannula 12 is inserted into first slot 106 and cap 110 is removably coupled to receiving member 104, first sleeve 108 and second sleeve 114 each frictionally engage cannula 12 such that cannula 12 is removably secured to receiving member 104. In some examples, first sleeve 108 and second sleeve 114 may be soft, high-friction material sleeves that may fit snugly over cannula 12 when cap 110 is removably coupled to receiving member 104. Furthermore, first sleeve 108 and second sleeve 114 each can resist any pulling force to hold cannula 12 in place, thereby enabling a secure and stable fit of cannula 12 between cap 110 and receiving member 104.

[0059] In some examples, first sleeve 108 and second sleeve 114 may be interchangeable, thereby allowing cannula 12 of various sizes and geometries to be removably secured to receiving member 104. This may allow compatibility with multiple brands and applications of fixation device 100. In some examples, when cannula 12 is inserted into first slot 106 and cap 110 is removably coupled to receiving member 104, cannula 12 extends at least partially from receiving member 104 along longitudinal axis X-X'.

[0060] In some examples, the anchor ring 150 is rotatable relative to the corresponding arm 120 between a locked state A1 (shown in FIGS. 6C and 7) and a released state A2 (shown in FIGS. 5 and 6A) of the corresponding anchor assembly 130. In some examples, the anchor ring 150 is configured to rotate while the anchor wheel 134 and anchor guide 140 are configured to remain fixed on the patient's skin 14.

[0061] 6A and 6C show partial schematic perspective views of the fixation device 100 in the released state A2 and the locked state A1, respectively, of each of the pair of anchor assemblies 130. Furthermore, FIG. 6B shows a partial schematic perspective view of the fixation device 100 in the intermediate state A3 of each of the pair of anchor assemblies 130. Furthermore, FIG. 7 shows a schematic perspective view of the fixation device 100 in the locked state A1 of each of the pair of anchor assemblies 130.

[0062] 5-7 , in the locked state A1 (shown in FIGS. 6C and 7 ) of each of the pair of anchor assemblies 130, the arcuate penetrating portion 152 at least partially penetrates the patient's skin 14 to releasably secure the corresponding anchor assembly 130 to the patient's skin 14. In some examples, the anchor ring 150 rotates relative to the corresponding arm 120 as each of the pair of anchor assemblies 130 moves from the released state A2 (shown in FIGS. 5 and 6A ) to the locked state A1 (shown in FIGS. 6C and 7 ), thereby causing the arcuate penetrating portion 152 of each of the anchor ring 150 of the pair of anchor assemblies 130 to at least partially penetrate the patient's skin 14.

[0063] 6B and 6C , in some examples, the arcuate piercing portion 152 of the anchor ring 150 pierces the patient's skin 14 with the sharp tip 154. In some examples, rotation of the anchor ring 150 relative to the anchor guide 140 can cause the sharp tip 154 ​​of the arcuate piercing portion 152 to pierce the skin 14 at one end of the anchor guide 140 and return back into the anchor guide 140 at the other end, thereby forming a loop and securing each of the pair of anchor assemblies 130 to the patient's skin 14. Thus, each of the pair of anchor assemblies 130 can secure itself on the patient's skin 14 with the aid of the anchor ring 150. Furthermore, the loop can form a hook fastening to hold the fixation device 100 in place on the skin 14. In some examples, the piercing point is located away from the insertion site 16, thereby ensuring no interference at the insertion site 16.

[0064] In some examples, the anchor ring 150 is rotatable along a first rotational direction R1 to switch the corresponding anchor assembly 130 from a released state A2 (shown in FIGS. 5 and 6A ) to a locked state A1 (shown in FIGS. 6C and 7 ). In some examples, a clinician may apply force along the first rotational direction R1 to the plurality of ridges 164 of the grip pad 162 of the anchor ring 150 to rotate the anchor ring 150 along the first rotational direction R1, thereby causing the arcuate piercing portion 152 to at least partially penetrate the patient's skin 14. In some examples, the clinician may need to apply force to the base 102 to hold it in place while rotating the anchor ring 150. For example, the clinician may use one hand to push the base 102 and the other hand to rotate the anchor ring 150.

[0065] In some examples, the anchor ring 150 is rotatable along a second rotational direction R2 opposite to the first rotational direction R1 to switch the corresponding anchor assembly 130 from the secured state A1 (shown in FIGS. 6C and 7 ) to the released state A2 (shown in FIGS. 5 and 6A ). In some examples, a clinician may apply force along the second rotational direction R2 to the plurality of ridges 164 of the grip pad 162 of the anchor ring 150 to rotate the anchor ring 150 along the second rotational direction R2, thereby rotating the arcuate piercing portion 152 along the second rotational direction R2 and releasing it from the patient's skin 14. In some examples, in the released state A2 (shown in FIGS. 5 and 6A ) of each of the pair of anchor assemblies 130, the arcuate piercing portion 152 is removed from the patient's skin 14 such that the corresponding anchor assembly 130 is released from the patient's skin 14.

[0066] In some examples, the anchor wheel 134 further includes an arcuate shoulder 136. In some examples, the anchor ring 150 includes a protrusion 170 (shown in FIGS. 6A and 6B ) that slidably engages the arcuate shoulder 136. In some examples, as the anchor ring 150 rotates, the protrusion 170 of the anchor ring 150 slides along the arcuate shoulder 136, thereby guiding the rotation of the anchor ring 150 relative to the anchor wheel 134.

[0067] In some examples, the anchor wheel 134 further includes one or more first locking features 172. In the illustrated example of FIGS. 6A-6C, the one or more first locking features 172 are in the form of notches located at opposite ends of the arcuate shoulder 136. In some examples, the anchor ring 150 includes one or more second locking features 174 (shown in FIGS. 6A and 6B) that are complementary to the one or more first locking features 172. In some examples, the one or more second locking features 174 are in the form of ridges configured to lockingly and releasably engage the one or more first locking features 172.

[0068] In some examples, one or more first locking features 172 are provided on each anchor wheel 134 of a pair of anchor assemblies 130 corresponding to each of the locked state A1 (shown in FIGS. 6C and 7 ) and the released state A2 (shown in FIGS. 5 and 6A ). Accordingly, the one or more first and second locking features 172, 174 may allow the anchor ring 150 to be releasably locked in the locked state A1 and the released state A2, thereby preventing the anchor ring 150 from moving forward or backward more than necessary. Furthermore, the one or more first and second locking features 172, 174 may prevent any unintentional movement of the anchor ring 150 relative to the anchor wheel 134 in the locked state A1. It should be understood that the one or more first and second locking features 172, 174 may include any other suitable locking mechanisms based on application requirements.

[0069] In some examples, at least one of the anchor wheel 134 and the anchor guide 140 includes one or more indicia 168 that indicate a first rotational direction R1, a second rotational direction R2, a locked state A1 (shown in FIGS. 6C and 7), and a released state A2 (shown in FIGS. 5 and 6A). In the illustrated example of FIGS. 5-7, the anchor wheel 134 includes one or more indicia 168 that indicate the first rotational direction R1, the second rotational direction R2, the locked state A1, and the released state A2.

[0070] 7 , in the fixed state A1 of each of the pair of anchor assemblies 130, the base 102 is pivotable relative to the pair of anchor assemblies 130 while being fixed to the cannula 12. In some examples, each of the pair of anchor assemblies 130 defines a support plane 176 parallel to the common pivot axis Y-Y′. In some examples, in the home state B1 of the base 102, the longitudinal axis X-X′ is parallel to the support plane 176 while the base 102 is fixed to the cannula 12. In some examples, each of the pair of arms 120 includes an alignment line 126 that is perpendicular to the longitudinal axis X-X′. In some examples, in the home state B1 of the base 102, the alignment line 126 is also perpendicular to the common pivot axis Y-Y′. Thus, in the home state B1, the base 102 is positioned on the patient's skin 14, and the catheter 10 is fixed. In some instances, the clinician may apply an additional window dressing (not shown) over the insertion site 16 to provide additional protection against infection.

[0071] 8 shows a schematic perspective view of the fixation device 100 in a fixed state A1 of each of the pair of anchor assemblies 130 and a maintenance state B2 of the base 102. In some examples, in the maintenance state B2 of the base 102, the longitudinal axis X-X' is inclined relative to the support plane 176 while the base 102 is fixed to the cannula 12. In some examples, the base 102 is pivotable relative to the pair of anchor assemblies 130, thereby moving the base 102 from the home state B1 (shown in FIG. 7) to the maintenance state B2. The alignment line 126 may be inclined obliquely relative to the longitudinal axis X-X' based on the oblique rotation angle of the base 102 from the home state B1.

[0072] In some examples, each of the pair of arms 120 is rotatable through an angular range AR of approximately 180 degrees relative to the corresponding anchor assembly 130. In other words, each of the pair of arms 120 is rotatable through an angular range AR of approximately 180 degrees relative to the patient's skin 14. In some examples, the flat support surface 132 of each of the pair of anchor assemblies 130 may remain engaged with the patient's skin 14 while the base 102 is pivoted relative to the pair of anchor assemblies 130.

[0073] 9 shows a schematic perspective view of the fixation device 100 in which the longitudinal axis X-X' of the receiving member 104 is perpendicular to the support plane 176 defined by each of the pair of anchor assemblies 130. In the illustrated example of FIG. 9, the fixation device 100 may allow full circumferential access 16 to the insertion site for cleaning or maintenance purposes. In some examples, the fixation device 100 may allow access to the insertion site 16 without removing the fixation device 100 from the patient's skin 14 or removing the cannula 12 of the catheter 10 from the fixation device 100. In some examples, after any necessary cleaning or maintenance, the base 102 may be pivoted back to the home state B1 (shown in FIG. 7).

[0074] 8 and 9 , in some examples, the exposed length 178 (shown in FIG. 8 ) of the cannula 12 from the receiving member 104 to the insertion site 16 is substantially constant during pivoting of the base 102 relative to the pair of anchor assemblies 130. In some examples, the exposed length 178 may remain substantially constant because the insertion site 16 is located at the focus of the arc formed by each of the pair of arms 120. Thus, the fixation device 100 may prevent pistoning of the catheter 10 during pivoting of the base 102 relative to the pair of anchor assemblies 130.

[0075] FIG. 10 shows a schematic block diagram of a kit 200. Referring now to FIGS. 1-10, the kit 200 includes a catheter 10 including a cannula 12 configured to be inserted into a patient's skin 14 at an insertion site 16. The kit 200 further includes a fixation device 100. The fixation device 100 is used to secure the catheter 10 to the patient's skin 14. In some examples, the cannula 12 of the catheter 10 is configured to be removably secured to a receiving member 104 of a base 102. Thus, the catheter 10 can be secured and stabilized on the patient's skin 14.

[0076] The fixation device 100 includes a base 102 and a pair of anchor assemblies 130. In some embodiments, the kit 200 may further include gloves (not shown), a sterile material (not shown), and a cloth or other absorbent material (not shown). In some embodiments, the kit 200 may further include cleaning articles (not shown), such as cleaning cloths, cotton balls, cotton swabs, etc.

[0077] The kit 200 may be available to the clinician (or medical professional) for use in a sealed and sterilized package. In some cases, the clinician may also apply a window dressing to the injection site 16 to provide additional protection from infection at the injection site 16. Furthermore, the fixation device 100 may allow the clinician to access the insertion site 16 by pivoting the base 102 relative to each of the pair of anchor assemblies 130 in the locked state A1 of each of the pair of anchor assemblies 130 without removing the catheter 10 from the patient's skin 14.

[0078] 11 is a flow chart illustrating a method 300 of using the fixation device 100 with a catheter 10 having a cannula 12 inserted into a patient's skin 14 at an insertion site 16. The method 300 will be described with reference to the catheter 10 of FIG. 1 and the fixation device 100 of FIGS. 2-10.

[0079] 1-11 , in some examples, a fixation device 100 includes a base 102 having a receiving member 104 and a pair of arms 120 extending from the receiving member 104, and a pair of anchor assemblies 130 corresponding to the pair of arms 120. In some examples, each of the pair of anchor assemblies 130 is pivotally coupled to a corresponding one of the pair of arms 120 of the base 102.

[0080] In step 302, the method 300 includes removably securing the cannula 12 of the catheter 10 to the receiving member 104 of the base 102. In some examples, removably securing the cannula 12 of the catheter 10 to the receiving member 104 includes inserting the cannula 12 into the first slot 106 of the receiving member 104. In some examples, removably securing the cannula 12 of the catheter 10 to the receiving member 104 further includes removably coupling the cap 110 to the receiving member 104 such that the first slot 106 of the receiving member 104 and the second slot 112 of the cap 110 collectively, at least partially, receive the cannula 12 between the first slot 106 of the receiving member 104 and the second slot 112 of the cap 110.

[0081] At step 304, the method 300 further includes positioning the base 102 adjacent to the skin 14. At step 306, the method 300 further includes releasably securing each of the pair of anchor assemblies 130 to the patient's skin 14 in the secured state A1. In some examples, releasably securing each of the pair of anchor assemblies 130 to the patient's skin 14 includes rotating the anchor ring 150 of each of the pair of anchor assemblies 130 along a first rotational direction R1 such that the arcuate penetrating portion 152 of the anchor ring 150 at least partially and releasably penetrates the patient's skin 14. In some examples, releasably securing each of the pair of anchor assemblies 130 to the patient's skin 14 includes aligning the common pivot axis Y-Y' of the pair of arms 120 with the insertion site 16 such that the insertion site 16 is disposed between the pair of arms 120.

[0082] At step 308, the method 300 further includes pivoting the base 102 away from the patient's skin 14 while the base 102 is secured to the cannula 12. In some examples, the method 300 further includes performing a maintenance procedure at the insertion site 16 after pivoting the base 102 away from the patient's skin 14. In some examples, the maintenance procedure may include cleansing the patient's skin 14 disposed adjacent to the insertion site 16. In some examples, the method 300 further includes, after performing the maintenance procedure, pivoting each of the pair of arms 120 toward the patient's skin 14 so that the base 102 is disposed adjacent to the skin 14.

[0083] In some examples, to remove the fixation device 100, the clinician may rotate the anchor ring 150 along the second rotational direction R2 from the locked state A1 to the unlocked state A2 of each of the pair of anchor assemblies 130. The clinician may then separate the cap 110 from the receiving member 104 to release the cannula 12 of the catheter 10 from the base 102.

[0084] The fixation device 100 of the present disclosure can firmly secure and stabilize the catheter 10 on the patient's skin 14. Furthermore, the fixation device 100 can limit movement of the cannula 12 relative to the patient's skin 14 during normal use. Specifically, each of the pair of anchor assemblies 130 can prevent dislodgement of the catheter 10 or cannula 12 when removably secured to the patient's skin 14 by the arcuate piercing portion 152 of the anchor ring 150. Furthermore, each of the pair of anchor assemblies 130 may facilitate removal of the fixation device 100 from the patient's skin 14 by rotating the anchor ring 150 along the second rotational direction R2 and separating the cap 110 from the receiving member 104.

[0085] In the locked state A1 of each of the pair of anchor assemblies 130, the locking device 100 may allow the base 102 to be pivoted relative to the pair of anchor assemblies 130 while secured to the cannula 12, thereby allowing full circumferential access to the insertion site 16 for cleaning and maintenance purposes without having to remove the catheter 10 from the locking device 100. Furthermore, the locking device 100 may be secured to the patient's skin 14 away from the insertion site 16, allowing minimal interference with the insertion site 16. The locking device 100 may be used for extended periods of time without causing discomfort to the patient, thereby enhancing the user experience.

[0086] Additionally, the fixation device 100 can allow for fixing the length (e.g., exposed length 178) of the cannula 12 between the base 102 and the insertion site 16, thereby eliminating pistoning of the cannula 12 during pivotal movement of the base 102 relative to the pair of anchor assemblies 130. Additionally, the fixation device 100 of the present disclosure can eliminate the need for tape, patches, and / or sutures to secure the catheter 10 on the patient's skin 14, thereby preventing the complication of medical adhesive-associated skin injury (MARSI). Additionally, the base 102 of the fixation device 100 can removably secure cannulas 12 of various sizes and geometries, thereby allowing compatibility with multiple brands and applications.

[0087] Unless otherwise indicated, all numbers expressing characteristic sizes, quantities, and physical properties used in the specification and claims should be understood to be modified by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the foregoing specification and appended claims may vary depending upon the desired properties sought to be obtained by one of ordinary skill in the art utilizing the teachings of the present disclosure.

[0088] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0089] Spatial relationship terms, including but not limited to "proximate," "distal," "lower," "upper," "beneath," "below," "above," and "on top," as used herein, are used to facilitate describing the spatial relationship of an element to other elements. Such spatial relationship terms encompass different orientations of the device in use or operation in addition to the specific orientations shown in the figures and described herein. For example, if an object shown in the figures is turned upside down or flipped over, parts previously described as being below or below other elements will now be above or above those other elements.

[0090] As used herein, for example, when an element, component, or layer is described as "forming a coincident interface with," "on," "connected to," "bonded to," "laminated," or "contacting" another element, component, or layer, it can be directly on, directly connected to, directly bonded to, directly laminated to, or in direct contact, or intervening elements, components, or layers may be on, connected to, bonded to, or in contact with, for example, the particular element, component, or layer. For example, when an element, component, or layer is referred to as being "directly on," "directly connected to," "directly bonded to," or "in direct contact with" another element, there are, for example, no intervening elements, components, or layers.

[0091] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. 1. A fixation device for a catheter having a cannula configured to be inserted into a patient's skin at an insertion site, the fixation device comprising: It is a base, a receiving member configured to be removably secured to the cannula; a pair of opposing arms extending from the receiving member; a base comprising: a pair of spaced apart anchor assemblies corresponding to the pair of arms, each of the pair of anchor assemblies pivotally coupled to a corresponding one of the pair of arms of the base, each of the pair of anchor assemblies configured to be releasably secured to the skin of the patient in a secured state; Equipped with In the locked state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while being secured to the cannula. Fixed device.

2. The fixation device of claim 1 , wherein the receiving member includes a first slot configured to at least partially and removably receive the cannula.

3. 3. The fixation device of claim 2, further comprising a cap configured to be removably coupled to the receiving member and including a second slot, wherein when the cap is removably coupled to the receiving member, the second slot is at least partially aligned with the first slot, and when the cannula is inserted into the first slot and the cap is removably coupled to the receiving member, the first slot and the second slot collectively at least partially receive the cannula between the first slot and the second slot such that the cannula is removably secured to the receiving member.

4. 4. The fixation device of claim 3, further comprising a first sleeve at least partially received in the first slot and a second sleeve at least partially received in the second slot, wherein when the cannula is inserted into the first slot and the cap is removably coupled to the receiving member, the first sleeve and the second sleeve each frictionally engage the cannula such that the cannula is removably secured to the receiving member.

5. 4. The fixation device of claim 3, wherein the cap is removably coupled to the receiving member by a snap-fit ​​connection, the cap including a lip configured to be manually grasped to release the cap from the receiving member.

6. The fixation device of claim 3 , wherein the base further comprises a living hinge pivotally connecting the cap to the receiving member.

7. 3. The fixation device of claim 2, wherein the receiving member further comprises a longitudinal axis extending along a length of the receiving member, and the first slot extends at least partially along the longitudinal axis such that the cannula extends from the receiving member at least partially along the longitudinal axis.

8. The fixation device of claim 7 , wherein the longitudinal axis corresponds to an axis of symmetry of the base such that the pair of arms are symmetrically disposed about the longitudinal axis.

9. The fixation device of claim 7 , wherein each of the pair of arms is curved away from the longitudinal axis such that the cannula is at least partially disposed between the pair of arms.

10. 8. The fixation device of claim 7, wherein each of the pair of arms is pivotable about a common pivot axis substantially perpendicular to the longitudinal axis, and wherein the longitudinal axis and the common pivot axis intersect each other at or directly above the insertion site.

11. 11. The fixation device of claim 10, wherein each of the pair of anchor assemblies is configured to be placed on the skin of the patient and comprises a flat support surface defining a support plane parallel to the common pivot axis, and wherein in a home state of the base while secured to the cannula, the longitudinal axis is parallel to the support plane, and in a maintenance state of the base while secured to the cannula, the longitudinal axis is inclined relative to the support plane.

12. 12. The fixation device of claim 11, wherein each of the pair of arms includes an alignment line that is perpendicular to the longitudinal axis, and in the home state of the base, the alignment line is also perpendicular to the common pivot axis.

13. Each of the pair of anchor assemblies comprises: an anchor wheel pivotally coupled to the corresponding arm; an anchor guide fixedly coupled to and disposed about the anchor wheel, the anchor guide including an arcuate slot extending therethrough; an anchor ring having an arcuate piercing portion slidably received within and at least partially received within the arcuate slot of the anchor guide, the anchor ring rotatable relative to the anchor guide along the arcuate slot, the arcuate piercing portion including a sharp tip configured to removably pierce the skin of the patient; Equipped with In the locked state of the corresponding anchor assembly, the arcuate penetrating portion at least partially penetrates the skin of the patient to releasably secure the corresponding anchor assembly to the skin of the patient. The fixation device of claim 1 .

14. 14. The fixation device of claim 13, wherein the anchor rings are rotatable relative to the corresponding arms between the locked state and the released state of the corresponding anchor assemblies, wherein in the released state of the corresponding anchor assemblies the arcuate piercing portions are removed from the skin of the patient such that the corresponding anchor assemblies are released from the skin of the patient, the anchor rings are rotatable along a first rotational direction to switch the corresponding anchor assemblies from the released state to the locked state, and the anchor rings are rotatable along a second rotational direction opposite the first rotational direction to switch the corresponding anchor assemblies from the locked state to the released state.

15. 15. The fixation device of claim 14, wherein at least one of the anchor wheel and the anchor guide comprises one or more indicia indicating the first rotational orientation, the second rotational orientation, the locked state, and the released state.

16. 14. The fixation device of claim 13, wherein the anchor ring of each of the pair of anchor assemblies is rotatable about a common axis of rotation and each of the pair of arms is pivotable about a common pivot axis coaxial with the common axis of rotation.

17. The fixation device of claim 13 , wherein the anchor guide of each of the pair of anchor assemblies includes an alignment mark aligned with the insertion site.

18. 14. The fixation device of claim 13, wherein the anchor wheel includes one or more first locking features and the anchor ring includes one or more second locking features complementary to the one or more first locking features, and wherein in the locked state of the corresponding anchor assembly, the one or more first locking features are configured to releasably lockingly engage the one or more second locking features to prevent the anchor ring from rotating relative to the corresponding arm.

19. 14. The fixation device of claim 13, wherein the anchor wheel includes an arcuate shoulder and the anchor ring includes a protrusion that slidably engages the arcuate shoulder, and wherein the protrusion of the anchor ring slides along the arcuate shoulder as the anchor ring rotates.

20. 14. The fixation device of claim 13, wherein the anchor wheel of each of the pair of anchor assemblies includes a protrusion and each arm includes a collar proximal to a distal end of the receiving member, the collar of each arm at least partially and rotatably receiving the protrusion of the anchor wheel of the corresponding anchor assembly to pivotally couple each arm to the corresponding anchor assembly.

21. The anchoring ring is a coupling portion positioned adjacent to the anchor wheel, the coupling portion defining an aperture therethrough, the aperture of the coupling portion at least partially receiving the protrusion of the anchor wheel therethrough to rotatably couple the anchor ring to the anchor wheel; an intermediate portion extending radially from the connecting portion, the arcuate piercing portion extending from the intermediate portion radially distal to the connecting portion; a grip pad coupled to the intermediate portion and disposed at least partially around the intermediate portion, the grip pad including a plurality of ridges configured to be manually grasped to rotate the anchor ring relative to the anchor guide; and The fixation device of claim 20 further comprising:

22. The fixation device of claim 21 , wherein the coupling portion is disc-shaped.

23. 22. The fixation device of claim 21, wherein the intermediate portion tapers radially inward from the gripping pad to the coupling portion.

24. The fixation device of claim 1 , wherein each of the pair of arms is rotatable relative to the corresponding anchor assembly through an angular range of approximately 180 degrees.

25. A kit comprising: a catheter including a cannula configured to be inserted into the patient's skin at an insertion site; 1. A stationary device, comprising: It is a base, a receiving member configured to be removably secured to the cannula; a pair of opposing arms extending from the receiving member; a base comprising: a pair of spaced apart anchor assemblies corresponding to the pair of arms, each of the pair of anchor assemblies pivotally coupled to a corresponding one of the pair of arms of the base, each of the pair of anchor assemblies configured to be releasably secured to the skin of the patient in a secured state; Equipped with In the locked state of each of the pair of anchor assemblies, the base is pivotable relative to the pair of anchor assemblies while being secured to the cannula. A fixation device; A kit comprising:

26. 26. The kit of claim 25, wherein the receiving member comprises a first slot configured to at least partially and removably receive the cannula.

27. 27. The kit of claim 26, wherein the fixation device further comprises a cap configured to be removably coupled to the receiving member and including a second slot, wherein when the cap is removably coupled to the receiving member, the second slot is at least partially aligned with the first slot, and when the cannula is inserted into the first slot and the cap is removably coupled to the receiving member, the first slot and the second slot collectively at least partially receive the cannula between the first slot and the second slot such that the cannula is removably secured to the receiving member.

28. 28. The kit of claim 27, wherein the fixation device further comprises a first sleeve at least partially received in the first slot and a second sleeve at least partially received in the second slot, wherein each of the first sleeve and the second sleeve frictionally engages the cannula such that the cannula is removably secured to the receiving member upon insertion of the cannula into the first slot and removably coupling the cap to the receiving member.

29. 28. The kit of claim 27, wherein the cap is removably coupled to the receiving member by a snap-fit ​​connection, the cap including a lip configured to be manually grasped to release the cap from the receiving member.

30. 28. The kit of claim 27, wherein the base further comprises a living hinge pivotally connecting the cap to the receiving member.

31. 27. The kit of claim 26, wherein the receiving member includes a longitudinal axis extending along a length of the receiving member, and the first slot extends at least partially along the longitudinal axis such that the cannula extends from the receiving member at least partially along the longitudinal axis.

32. 32. The fixation device of claim 31, wherein the longitudinal axis corresponds to an axis of symmetry of the base such that the pair of arms are symmetrically disposed about the longitudinal axis.

33. 32. The kit of claim 31, wherein each of the pair of arms is curved away from the longitudinal axis such that the cannula is at least partially disposed between the pair of arms.

34. 32. The kit of claim 31, wherein each of the pair of arms is pivotable about a common pivot axis substantially perpendicular to the longitudinal axis, and wherein the longitudinal axis and the common pivot axis intersect each other at or directly above the insertion site.

35. 35. The kit of claim 34, wherein each of the pair of anchor assemblies is configured to be placed on the skin of the patient and comprises a flat support surface defining a support plane parallel to the common pivot axis, wherein in a home state of the base, while the base is secured to the cannula, the longitudinal axis is parallel to the support plane, and in a maintenance state of the base, while the base is secured to the cannula, the longitudinal axis is inclined relative to the support plane.

36. 36. The kit of claim 35, wherein each of the pair of arms includes an alignment line that is perpendicular to the longitudinal axis, and in the home state of the base, the alignment line is also perpendicular to the common pivot axis.

37. Each of the pair of anchor assemblies comprises: an anchor wheel pivotally coupled to the corresponding arm; an anchor guide fixedly coupled to and disposed about the anchor wheel, the anchor guide including an arcuate slot extending therethrough; an anchor ring comprising an arcuate penetrating portion slidably received within and at least partially received within the arcuate slot of the anchor guide, the anchor ring rotatable relative to the anchor guide along the arcuate slot, the arcuate penetrating portion comprising a sharp tip configured to removably penetrate the skin of the patient; Equipped with In the locked state of the corresponding anchor assembly, the arcuate penetrating portion at least partially penetrates the skin of the patient to releasably secure the corresponding anchor assembly to the skin of the patient.

26. The kit of claim 25.

38. 38. The kit of claim 37, wherein the anchor ring is rotatable relative to the corresponding arm between the locked state and a released state of the corresponding anchor assembly, wherein in the released state of the corresponding anchor assembly, the arcuate piercing portion is removed from the patient's skin such that the corresponding anchor assembly is released from the patient's skin, the anchor ring is rotatable along a first rotational direction to switch the corresponding anchor assembly from the released state to the locked state, and the anchor ring is rotatable along a second rotational direction opposite the first rotational direction to switch the corresponding anchor assembly from the locked state to the released state.

39. 39. The kit of claim 38, wherein at least one of the anchor wheel and the anchor guide comprises one or more indicia indicating the first rotational orientation, the second rotational orientation, the locked state, and the released state.

40. 38. The kit of claim 37, wherein the anchor ring of each of the pair of anchor assemblies is rotatable about a common axis of rotation and each of the pair of arms is pivotable about a common pivot axis coaxial with the common axis of rotation.

41. 38. The kit of claim 37, wherein the anchor guide of each of the pair of anchor assemblies includes an alignment mark aligned with the insertion site.

42. 38. The kit of claim 37, wherein the anchor wheel comprises one or more first locking features and the anchor ring comprises one or more second locking features complementary to the one or more first locking features, and wherein in the locked state of the corresponding anchor assembly, the one or more first locking features are configured to releasably lockingly engage the one or more second locking features to prevent the anchor ring from rotating relative to the corresponding arm.

43. 38. The kit of claim 37, wherein the anchor wheel includes an arcuate shoulder and the anchor ring includes a protrusion that slidably engages the arcuate shoulder, such that as the anchor ring rotates, the protrusion on the anchor ring slides along the arcuate shoulder.

44. 38. The kit of claim 37, wherein the anchor wheel of each of the pair of anchor assemblies includes a protrusion and each arm includes a collar proximal to a distal end of the receiving member, the collar of each arm at least partially and rotatably receiving the protrusion of the anchor wheel of the corresponding anchor assembly to pivotally couple each arm to the corresponding anchor assembly.

45. The anchoring ring is a coupling portion positioned adjacent to the anchor wheel, the coupling portion defining an aperture therethrough, the aperture of the coupling portion at least partially receiving the protrusion of the anchor wheel therethrough to rotatably couple the anchor ring to the anchor wheel; an intermediate portion extending radially from the connecting portion, the arcuate piercing portion extending from the intermediate portion radially distal to the connecting portion; a grip pad coupled to the intermediate portion and disposed at least partially around the intermediate portion, the grip pad including a plurality of ridges configured to be manually grasped to rotate the anchor ring relative to the anchor guide; and 45. The kit of claim 44, further comprising:

46. 46. ​​The kit of claim 45, wherein the binding portion is disc-shaped.

47. 46. ​​The kit of claim 45, wherein the intermediate portion tapers radially inward from the grip pad to the connecting portion.

48. 26. The kit of claim 25, wherein each of the pair of arms is rotatable relative to the corresponding anchor assembly through an angular range of approximately 180 degrees.

49. 26. The kit of claim 25, wherein an exposed length of the cannula from the receiving member to the insertion site remains substantially constant during pivoting of the base relative to the pair of anchor assemblies.

50. 1. A method of using a fixation device with a catheter having a cannula inserted into a patient's skin at an insertion site, the fixation device including a base having a receiving member and a pair of arms extending from the receiving member, and a pair of anchor assemblies corresponding to the pair of arms, each of the pair of anchor assemblies pivotally coupled to a corresponding one of the pair of arms of the base, the method comprising: removably securing the cannula of the catheter to the receiving member of the base; placing the base adjacent to the skin; releasably securing each of the pair of anchor assemblies to the skin of the patient in a secured state; pivoting the base away from the skin of the patient while the base is secured to the cannula; A method comprising:

51. 51. The method of claim 50, wherein releasably securing each of the pair of anchor assemblies to the skin of the patient comprises rotating an anchor ring of each of the pair of anchor assemblies such that an arcuate penetrating portion of the anchor ring at least partially and releasably penetrates the skin of the patient.

52. 51. The method of claim 50, wherein releasably securing each of the pair of anchor assemblies to the skin of the patient comprises aligning a common pivot axis of the pair of arms with the insertion site such that the insertion site is disposed between the pair of arms.

53. Removably securing the cannula of the catheter to the receiving member comprises: Inserting the cannula into the first slot of the receiving member; removably coupling the cap to the receiving member such that the first slot of the receiving member and the second slot of the cap collectively and at least partially receive the cannula between the first slot of the receiving member and the second slot of the cap; 51. The method of claim 50, comprising:

54. performing a maintenance procedure at the insertion site after pivoting the base away from the patient's skin; After performing the maintenance procedure, pivoting each of the pair of arms toward the patient's skin so that the base is positioned adjacent to the skin; 51. The method of claim 50, further comprising:

Images