Securement devices for catheters, kits, and methods of use - Patents.com

Abstract

The fixation device includes a base, a base mount fixedly attached to the base and including a coupling member and a retaining member spaced from the coupling member, and a swing arm including an elongated member pivotally coupled to the coupling member and a cannula locking member connected to the elongated member and spaced from the coupling member. The cannula locking member is configured to removably secure the cannula to the cannula locking member and to be removably coupled to the retaining member. The fixation device includes a maintenance state in which the cannula locking member is pulled away from the retaining member and the swing arm is pivoted away from the retaining member such that the cannula locking member is spaced from the retaining member while secured to the cannula.

Description

[Technical Field]

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

[0002] Catheters may be used for a variety of purposes, such as for delivery, gas supply, and / or fluid removal. Catheters typically include a cannula that is inserted into a patient's skin at an insertion site. In some cases, catheters may be used to administer medications and fluids to a patient. In many cases, catheters may need to be secured onto a patient's skin to prevent movement of the catheter relative to the skin. For example, a catheter may need to be secured onto a patient's skin to prevent the catheter from being pulled out or from moving in a manner that could adversely affect the function of the catheter.

[0003] Catheters are typically secured to a patient's skin using conventional securement devices, such as tape, patches, and sutures. However, conventional securement devices may not adequately secure the catheter to the skin. Specifically, conventional securement devices may not adequately stabilize the catheter, thereby allowing undesirable movement of the catheter during use. Therefore, in some cases, the use of conventional securement devices may result in various complications, such as catheter removal and accidental dislodgement from the patient's skin, phlebitis, extravasation / infiltration, leakage, occlusion, and bloodstream infection. Furthermore, conventional securement devices may need to be removed from the skin to perform maintenance procedures on the skin proximal to the insertion site, which may be inconvenient for the patient. Removing a conventional securement device from the skin may further cause "pistoning" of the cannula, which may cause discomfort and, in some cases, injury. 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 configured to be removably secured to the patient's skin. The fixation device further includes a base mount fixedly attached to the base. The base mount includes a coupling member and a retaining member spaced from the coupling member. The fixation device further includes a swing arm including an elongated member pivotally coupled to the coupling member of the base mount. The swing arm further includes a cannula locking member connected to the elongated member and spaced from the coupling member. The cannula locking member is configured to removably secure the cannula to the cannula locking member. The cannula locking member is further configured to be removably coupled to the retaining member. When the cannula locking member is pulled away from the retaining member, the swing arm is pivotable relative to the base mount. In the locked state of the fixation device, the cannula is removably secured to the cannula locking member, and the cannula locking member is removably coupled to the retaining member. In the maintenance state of the fixation device, the cannula fixation member is pulled away from the holding member, and the swing arm is pivoted away from the holding member so that the cannula fixation member is spaced apart from the holding member while remaining fixed to the cannula.

[0005] In a second aspect, the present disclosure provides a kit. The kit includes a catheter including a cannula configured to be inserted into a patient's skin at an insertion site. The kit further includes a fixation device. The fixation device includes a base configured to be removably secured to the patient's skin. The fixation device further includes a base mount fixedly attached to the base. The base mount includes a coupling member and a retaining member spaced from the coupling member. The fixation device further includes a swing arm including an elongated member pivotally coupled to the coupling member of the base mount. The swing arm further includes a cannula locking member connected to the elongated member and spaced from the coupling member. The cannula locking member is configured to removably secure a cannula to the cannula locking member. The cannula locking member is further configured to be removably coupled to the retaining member. When the cannula locking member is pulled away from the retaining member, the swing arm is pivotable relative to the base mount. In the locked state of the fixation device, the cannula is removably secured to the cannula securing member, which is removably coupled to the retaining member. In the maintenance state of the fixation device, the cannula securing member is pulled away from the retaining member, and the swing arm is pivoted away from the retaining member such that the cannula securing member is spaced apart from the retaining member while remaining 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 configured to be removably secured to the patient's skin, a base mount fixedly attached to the base and having a coupling member and a retaining member spaced from the coupling member, and a swing arm having an elongate member pivotally coupled to the coupling member of the base mount and a cannula securement member connected to the elongate member and spaced from the coupling member. The method includes removably securing the base to the patient's skin. The method further includes removably securing a cannula of the catheter to the cannula securement member. The method further includes removably securing the cannula securement member to the retaining member. The method further includes separating the cannula securement member from the retaining member so that the swing arm is pivotable relative to the retaining member. The method further includes pivoting the swing arm away from the retaining member so that the cannula securement member is separated from the retaining member while remaining 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 is a schematic perspective view of a catheter according to one embodiment of the present disclosure. [Figure 2] FIG. 1 is a schematic top perspective view of a fixation device according to one embodiment of the present disclosure. [Figure 3]1 is a schematic exploded perspective view of a fixation device according to one embodiment of the present disclosure; FIG. [Figure 4] 1 is a schematic cross-sectional view of a portion of a fixation device taken along line 1-1 of FIG. 2, according to one embodiment of the present disclosure. [Figure 5A] 1 is a schematic perspective view of a fixation device, depicting a method of use of the fixation device, according to one embodiment of the present disclosure; [Figure 5B] 1 is a schematic perspective view of a fixation device, depicting a method of use of the fixation device, according to one embodiment of the present disclosure; [Figure 5C] 1 is a schematic perspective view of a fixation device, depicting a method of use of the fixation device, according to one embodiment of the present disclosure; [Figure 5D] 1 is a schematic perspective view of a fixation device, depicting a method of use of the fixation device, according to one embodiment of the present disclosure; [Figure 5E] 1 is a schematic perspective view of a fixation device, depicting a method of use of the fixation device, according to one embodiment of the present disclosure; [Figure 6] FIG. 1 is a schematic block diagram of a kit according to one embodiment of the present disclosure. [Figure 7] 10 is a flowchart depicting various steps of 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, all numbers 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.

[0012] 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).

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] As used herein, "at least one of A and B" should be understood to mean "A only, B only, or both A and B."

[0019] 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.

[0020] As used herein, the terms "layer," "sheet," and "dressing," or variations thereof, are used to describe an article that has a small thickness relative to its length and width.

[0021] As used herein, the term "polymer" refers to both a material prepared from one monomer, such as a homopolymer, or a material prepared from two or more monomers, such as a copolymer or terpolymer. Similarly, the term "polymerizing" refers to the process of making a polymeric material, which may be a homopolymer, copolymer, terpolymer, etc. The term "copolymer" refers to a polymeric material prepared from at least two different monomers.

[0022] As used herein, the term "inserted through the skin," when used in conjunction with the terms "cannula" or "catheter," refers to inserting a catheter or cannula through a patient's skin. For example, the distal end of the catheter or cannula may be located in any desired anatomical location, including, by way of non-limiting example, within the lumen of a vein and / or artery, within the atrium and ventricle of the heart, within a ventral body cavity, within the spinal canal, within the subarachnoid space, within the intracranial space, and within fat and / or muscle tissue.

[0023] As used herein, the term "insertion site" refers to the location where the cannula of the catheter is inserted into the patient's skin.

[0024] As used herein, the term "maintenance procedures" generally refers to procedures that involve cleansing and / or disinfecting the patient's skin proximal to the insertion site. Maintenance procedures may be performed by a physician at regular intervals during intravenous therapy, for example.

[0025] As used herein, the term "pistoning" or "pistoning" refers to the movement of the cannula of a catheter relative to the insertion site.

[0026] 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 configured to be removably secured to the patient's skin. The fixation device further includes a base mount fixedly attached to the base. The base mount includes a coupling member and a retaining member spaced from the coupling member. The fixation device further includes a swing arm including an elongated member pivotally coupled to the coupling member of the base mount. The swing arm further includes a cannula locking member connected to the elongated member and spaced from the coupling member. The cannula locking member is configured to removably secure the cannula to the cannula locking member. The cannula locking member is further configured to be removably coupled to the retaining member. When the cannula locking member is pulled away from the retaining member, the swing arm is pivotable relative to the base mount. In the locked state of the fixation device, the cannula is removably secured to the cannula locking member, and the cannula locking member is removably coupled to the retaining member. In the maintenance state of the fixation device, the cannula fixation member is pulled away from the holding member, and the swing arm is pivoted away from the holding member so that the cannula fixation member is spaced apart from the holding member while remaining fixed to the cannula.

[0027] In the secured state, the securement device of the present disclosure may securely secure the catheter to the patient's skin, thus preventing various complications such as phlebitis, extravasation / infiltration, leakage, occlusion, and bloodstream infection that may otherwise occur due to catheter movement relative to the skin.

[0028] In the maintenance state, the fixation device of the present disclosure may provide a physician with access to the insertion site. The physician may perform a maintenance procedure at the insertion site while the fixation device is in the maintenance state. The fixation device may allow the physician to perform the maintenance procedure without having to remove or pull the fixation device away from the skin.

[0029] The cannula locking member of the locking device can be pulled away from the retention member, and the swing arm can be pivoted away from the retention member to conveniently move the locking device from the locking state to the maintenance state. Thus, the locking device can facilitate the performance of maintenance procedures at the insertion site. Furthermore, the locking device can transition between the locking state and the maintenance state without causing piston movement of the cannula.

[0030] In some examples, the base of the fixation device may be removably secured to the patient's skin via a stretch-release adhesive that may facilitate removal of the base from the patient's skin. In other words, the base may be easily removed from the patient's skin without causing discomfort to the patient.

[0031] Thus, in the fixed state, the fixation device can firmly secure the catheter to the patient's skin, thereby preventing undesired movement of the catheter relative to the skin, and in the maintenance state, can facilitate maintenance procedures at the insertion site and can facilitate removal of the fixation device after use.

[0032] Referring now to the drawings, Figure 1 shows a schematic perspective view of a catheter 10 according to one embodiment of the present disclosure. In Figure 1, catheter 10 is partially positioned on the skin 20 of a patient 22. In some cases, patient 22 may be receiving intravenous therapy.

[0033] The catheter 10 may include a hub 12, one or more lumens 14, and a cannula 16. The one or more lumens 14 may be at least partially received within the hub 12. The one or more lumens 14 are partially shown in FIG. 1. In the illustrated embodiment of FIG. 1, the one or more lumens 14 include three lumens 14. In other words, in the illustrated embodiment of FIG. 1, the catheter 10 is a triple-lumen catheter. However, the number of one or more lumens 14 may vary based on the desired application and / or infusion attributes. The one or more lumens 14 may be fluidly connected to a cannula 16. As shown in FIG. 1, the cannula 16 may be at least partially received within the hub 12. Furthermore, the cannula 16 may be inserted into the skin 20 of the patient 22 at an insertion site 18.

[0034] In some cases, catheter 10 may include a central venous catheter (CVC). A CVC may also 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, which is often necessary for critically ill patients, for patients requiring prolonged intravenous therapy for reliable vascular access, and for administering fluids that may be harmful to smaller peripheral veins. Accordingly, at least a portion of cannula 16 may be inserted into a vein located in the user'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 embodiments, catheter 10 may be a peripherally inserted central catheter (PICC). A PICC may be suitable for insertion into a vein located in the arm of patient 22. It should be noted that catheter 10 may include any suitable type of catheter, which may be selected based on desired application attributes.

[0035] The catheter 10 can be used to administer intravenous therapy (e.g., medications or fluids for parenteral nutrition), obtain blood for analysis, and provide an access point for blood-based therapies such as dialysis or apheresis. The catheter 10 can also be used to perform blood tests (e.g., "central venous oxygen saturation"), administer fluids or blood products for large-scale emergency fluid therapy, and measure central venous pressure.

[0036] Figure 2 shows a schematic top perspective view of a fixation device 100 of a catheter 10, according to one embodiment of the present disclosure. Figure 3 shows a schematic exploded perspective view of a fixation device 100, according to one embodiment of the present disclosure.

[0037] 2, cannula 16 is inserted into skin 20 of patient 22 at insertion site 18. Additionally, fixation device 100 is in fixation state 101. As will be further described below, fixation device 100 may secure catheter 10 to skin 20 in fixation state 101.

[0038] 2 and 3, fixation device 100 includes a base 110 configured to be removably secured to skin 20 of patient 22. Base 110 may be selectively secured to and detached from skin 20 as needed. Base 110 may be removably secured to skin 20 by any suitable method, such as, for example, adhesive, tape, hook-and-loop fasteners, etc.

[0039] 3, the base 110 may include a substrate 111 including a first major surface 112 and a second major surface 114 opposite the first major surface 112. The second major surface 114 may be configured to face the skin 20.

[0040] The substrate 111 may be made of an extensible material capable of conforming to an contoured surface (e.g., the skin 20 of the patient 22). The substrate 111 may be configured to exhibit high elasticity. In some embodiments, the modulus of elasticity of the substrate 111 may be at least about 2500 pounds per square inch (psi) or at least about 3000 psi. In some embodiments, the modulus of elasticity of the substrate 111 may be less than about 50,000 psi. In some embodiments, the modulus of elasticity of the substrate 111 may be between about 5,000 psi and about 30,000 psi. In some embodiments, the substrate 111 may have high tensile strength, low elastic recovery, and high elongation at break.

[0041] The substrate 111 may comprise at least one of a polymer film, a polymer foam, a polymer hydrocolloid, and a polymer alginate. The substrate 111 may comprise polyolefins such as polyethylene, including high-density polyethylene, low-density polyethylene, linear low-density polyethylene, and linear very low-density polyethylene, polypropylene, and polybutylene; vinyl copolymers such as polyvinyl chloride and polyvinyl acetate, both plasticized and unplasticized; olefin copolymers such as ethylene / methacrylate copolymer, ethylene / vinyl acetate copolymer, acrylonitrile-butadiene-styrene copolymer, and ethylene-propylene copolymer; acrylic polymers and copolymers; and combinations thereof. The substrate 111 may be in the form of a monolayer or multilayer film, a nonwoven film, a porous film, a foam-like film, and combinations thereof. The substrate 111 may be manufactured using any suitable film-forming method, such as extrusion, coextrusion, solution casting, foaming, or nonwoven techniques.

[0042] As shown in Figure 3, the substrate 111 can include a first substrate portion 111A and a second substrate portion 111B. As shown in Figures 2 and 3, in some embodiments, the second substrate portion 111B can be separate from the first substrate portion 111A. Alternatively, the first substrate portion 111A and the second substrate portion 111B can be connected to each other such that the substrate 111 is a single, integral component.

[0043] The base 110 may further include at least one pull tab 116. In some embodiments, the at least one pull tab 116 may be disposed on the first major surface 112 of the substrate 111. Alternatively, the at least one pull tab 116 may extend from the substrate 111. The at least one pull tab 116 may be manually graspable, that is, the at least one pull tab 116 may be manually graspable by a physician to pull the base 110 away from the skin 20.

[0044] In some embodiments, the at least one pull tab 116 may include a pair of pull tabs 116 disposed opposite each other on the substrate 111. The pair of pull tabs 116 may facilitate removal of the base 110 from the skin 20. Specifically, the pair of pull tabs 116 may be pulled in opposite directions to pull the base 110 away from the skin 20.

[0045] 2 , in some embodiments, the base 110 may include a pair of pull tabs 116 disposed on each of the first and second substrate portions 111A, 111B, which are not connected to one another. Specifically, in some embodiments, the base 110 may include a first pair of pull tabs 116 disposed at least partially on opposite ends of the first major surface 112 of the first substrate portion 111A, and a second pair of pull tabs 116 disposed at least partially on opposite ends of the first major surface 112 of the second substrate portion 111B. In such embodiments, the pair of pull tabs 116 may facilitate the removal of the first and second substrate portions 111A, 111B from the skin 20 independently of one another.

[0046] The fixation device 100 further includes a base mount 120 fixedly attached to the base 110. The base mount 120 may be fixedly attached to the first major surface 112 of the substrate 111. In other words, the base mount 120 may not move relative to the base 110. As a result, the base mount 120 may remain stationary relative to the skin 20 when the base 110 is removably secured to the skin 20.

[0047] The base mount 120 includes a coupling member 122. The coupling member 122 may include a coupling base 122A, a mount structure 122B extending from the coupling base 122A, and a coupling feature 122C disposed on the mount structure 122B. The coupling base 122A shown in FIGS. 2 and 3 has a generally elliptical shape. However, it should be noted that the coupling base 122A may have any suitable shape, such as a circular, rectangular, polygonal, or the like. In the illustrated embodiment of FIGS. 2 and 3, the coupling feature 122C includes a protrusion extending from the mount structure 122B. In some other embodiments, the coupling feature 122C may include an opening disposed in the mount structure 122B.

[0048] The base mount 120 further includes a retaining member 124 spaced from the coupling member 122. The retaining member 124 may include a retaining base 124A and a wall 124B extending from the retaining base 124A. In some embodiments, the wall 124B may be perpendicular to the retaining base 124A. The wall 124B may define a cavity 124C (shown in FIG. 3 ). In some embodiments, the wall 124B may be substantially continuous. The retaining base 124A shown in FIGS. 2 and 3 has a generally oval shape. However, it should be noted that the retaining base 124A may include any suitable shape, such as a circle, a rectangle, a polygon, etc.

[0049] First major surface 112 of substrate 111 may be fixedly attached to coupling member 122 and retaining member 124. In some embodiments, first substrate portion 111A may be fixedly attached to coupling member 122. In some embodiments, second substrate portion 111B may be fixedly attached to retaining member 124.

[0050] Base mount 120 may further include a connecting member 123 (best shown in FIG. 3) that connects coupling member 122 and retaining member 124. In some embodiments, base mount 120 may be a single, integrally molded part. In other words, in some embodiments, coupling member 122, connecting member 123, and retaining member 124 may be integral with one another.

[0051] The fixation device 100 further includes a swing arm 130. The swing arm 130 includes an elongated member 132 pivotally coupled to the coupling member 122 of the base mount 120. The elongated member 132 may be pivotally coupled to the coupling member 122 via a coupling feature 122C. Specifically, the elongated member 132 may be pivotally coupled to the mounting structure 122B via the coupling feature 122C. The elongated member 132 may include a complementary coupling feature that corresponds to the coupling feature 122C of the base mount 120 such that the elongated member 132 may be pivotally coupled to the coupling member 122. For example, the elongated member 132 may include an opening that receives and mates with the coupling feature 122C.

[0052] The elongated member 132 may include a first end 133A and a second end 133B opposite the first end 133A. The elongated member 132 may extend between the first end 133A and the second end 133B. As shown in FIG. 2 , the elongated member 132 may be pivotally coupled to the coupling member 122 proximal to the first end 133A.

[0053] The swing arm 130 may be pivotable about a pivot axis 126 (also shown in FIG. 3 ). The pivot axis 126 may extend through a coupling feature 122C of the coupling member 122. When the base 110 is removably secured to the skin 20 of the patient 22, the pivot axis 126 may intersect with the insertion site 18. When the base 110 is removably secured to the skin 20 of the patient 22, the pivot axis 126 may further intersect with the cannula 16 at the insertion site 18. As shown in FIG. 2 , the base mount 120 may further include one or more indicia 125 disposed on the coupling member 122. The one or more indicia 125 may be printed on the coupling member 122, for example. When the base 110 is removably secured to the skin 20 of the patient 22, the one or more indicia 125 may be aligned with the insertion site 18. Specifically, base 110 may be removably secured to skin 20 such that one or more markings 125 are aligned with insertion site 18. As shown in FIG. 2 , one or more markings 125 may include a line disposed on coupling base 122A of coupling member 122. This line may be aligned with pivot axis 126.

[0054] Elongated member 132 may further include a tapered portion 132A extending from first end 133A and a curved portion 132B disposed adjacent to tapered portion 132A. Tapered portion 132A may taper from curved portion 132B toward first end 133A. Furthermore, curved portion 132B may curve away from cannula securement member 134. This geometry of swing arm 130 may allow swing arm 130 to pivot freely relative to base mount 120.

[0055] Swing arm 130 further includes a cannula securing member 134 connected to elongated member 132 and spaced from coupling member 122. As shown in FIG. 2 , cannula securing member 134 may be connected to elongated member 132 proximal to second end 133B of elongated member 132. In some embodiments, cannula securing member 134 may be connected to elongated member 132 at second end 133B of elongated member 132. Cannula securing member 134 is configured to removably secure cannula 16 to cannula securing member 134. Cannula securing member 134 is further configured to be removably coupled to retaining member 124. The geometry of swing arm 130 described above may allow cannula 16 to be removably coupled to cannula securing member 134 without obstruction, while swing arm 130 can freely pivot relative to base mount 120.

[0056] Cannula securement member 134 may include a cannula receiving portion 136 connected to elongate member 132. In some embodiments, cannula receiving portion 136 may be connected to elongate member 132 at second end 133B of elongate member 132.

[0057] As described above, cannula securement member 134 is configured to be removably coupled to retention member 124. When cannula securement member 134 is removably coupled to retention member 124, cannula receiving portion 136 of cannula securement member 134 may be at least partially received within cavity 124C of retention member 124 and removably secured thereto. Wall 124B of retention member 124 may engage cannula receiving portion 136 to removably couple cannula securement member 134 to retention member 124. In some embodiments, cannula receiving portion 136 of swing arm 130 may be removably coupled to retention member 124 via a snap-fit ​​connection.

[0058] Cannula locking member 134 may further include a release member 131 extending from cannula receiving portion 136. Release member 131 may be configured to be manually grasped to release cannula receiving portion 136 from retaining member 124. Release member 131 may have any suitable grasping shape. Release member 131 may be grasped by a physician to pull cannula receiving portion 136 away from retaining member 124. When cannula locking member 134 is pulled away from retaining member 124, swing arm 130 becomes pivotable relative to base mount 120.

[0059] Cannula securing member 134 may further include a cap 138 configured to be removably coupled to cannula receiving portion 136. In FIG. 2, cap 138 is in a coupled state 138A. In coupled state 138A, cap 138 may be removably coupled to cannula receiving portion 136.

[0060] In some embodiments, cap 138 may be configured to be removably coupled to cannula receiving portion 136 via a snap-fit ​​connection. Cap 138 may include a release member 140 extending outwardly from cap 138. Release member 140 may be manually grasped to pull cap 138 away from cannula receiving portion 136. In some embodiments, cap 138 may be pivotally coupled to cannula receiving portion 136 or may be tethered to cannula receiving portion 136. Alternatively, cap 138 may not be connected to cannula receiving portion 136.

[0061] Cannula receiving portion 136 may include a first slot 137 (shown in FIG. 3 ) configured to at least partially receive cannula 16 therein. Additionally, cap 138 may include a second slot 139. When cap 138 is removably coupled to cannula receiving portion 136, second slot 139 may be at least partially aligned with first slot 137. Thus, when cannula 16 is inserted into first slot 137 and cap 138 is removably coupled to cannula receiving portion 136, first slot 137 and second slot 139 may cooperate to at least partially receive cannula 16 therebetween such that cannula 16 is removably secured to cannula securement member 134.

[0062] In some embodiments, cannula fixation member 134 may further include a first sleeve 135A at least partially received within first slot 137 and a second sleeve 135B at least partially received within second slot 139. Each of first sleeve 135A and second sleeve 135B may be made from a high-friction material, such as rubber, low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), or other polymers.

[0063] When cannula 16 is inserted into first slot 137 and cap 138 is removably coupled to cannula receiving portion 136, first sleeve 135A and second sleeve 135B may each frictionally engage cannula 16 such that cannula 16 is removably secured to cannula securement member 134. The frictional engagement of first sleeve 135A and second sleeve 135B with cannula 16 may prevent and / or reduce movement of cannula 16 relative to cannula securement member 134, ensuring that catheter 10 remains in place.

[0064] In some embodiments, the swing arm 130 may be a single, unitary piece. In other words, in some embodiments, the elongate member 132 and the cannula locking member 134 may be integral with one another.

[0065] As shown in FIG. 2, in the locked state 101 of the locking device 100, the cannula 16 is removably secured to the cannula locking member 134, which is removably coupled to the retaining member 124.

[0066] FIG. 4 shows a schematic cross-sectional view of fixation device 100 taken along line 1-1 of FIG.

[0067] In some embodiments, base 110 may further include an adhesive layer 115 at least partially disposed on second major surface 114. Adhesive layer 115 may be configured to releasably secure substrate 111 to skin 20 of patient 22. Adhesive layer 115 may be substantially continuous or may be patterned.

[0068] In some embodiments, adhesive layer 115 may be at least partially disposed on second major surface 114 of each of first substrate portion 111A (shown in Figures 2 and 3) and second substrate portion 111B (shown in Figures 2 and 3).

[0069] The second major surface 114 corresponding to the at least one pull tab 116 may be adhesive-free or may define an adhesive-free zone 117. As shown in FIG. 4 , in some embodiments, the second major surface 114 may define a pair of adhesive-free zones 117 corresponding to a pair of pull tabs 116.

[0070] Adhesive layer 115 may include any suitable adhesive, such as a pressure-sensitive adhesive (PSA), tackified rubber adhesives such as natural rubber, olefins, silicones, polyisoprene, polybutadiene, polyurethanes, styrene-isoprene-styrene and styrene-butadiene-styrene block copolymers, and other elastomers, and tackified or untackified acrylic adhesives such as copolymers of isooctyl acrylate and acrylic acid that may be polymerized by radiation, solution, suspension, or emulsion techniques.

[0071] Preferably, adhesive layer 115 may include a stretch-release adhesive. In some cases, the adhesive strength of the stretch-release adhesive may be less than the cohesive strength of the stretch-release adhesive, such that the adhesive ability of the stretch-release adhesive may essentially disappear upon stretching of substrate 111. The tackiness of the stretch-release adhesive may be lost upon stretching of substrate 111. Thus, in some embodiments, base 110 may be easily removed from skin 20 of patient 22 by grasping at least one pull tab 116 and stretching substrate 111.

[0072] The fixation device 100 may further include a release liner 119 disposed on the adhesive layer 115. The release liner 119 may protect the adhesive layer 115 from contaminants such as dust, debris, etc. prior to use of the fixation device 100. The release liner 119 may be peeled from the adhesive layer 115 prior to releasably securing the base 110 to the skin 20 of the patient 22 (shown in FIG. 2). The release liner 119 may comprise any suitable material, such as polyethylene terephthalate (PET), high density polyethylene (HDPE), polyvinyl chloride (PVC), polypropylene (PP), etc.

[0073] 5A-5E show schematic perspective views depicting a method of use of a fixation device 100, according to one embodiment of the present disclosure.

[0074] 5A, the cannula 16 of the catheter 10 may be inserted into the skin 20 of the patient 22 at an insertion site 18. Additionally, the cannula-receiving portion 136 of the swing arm 130 may be removably coupled to the retaining member 124 of the base mount 120.

[0075] The base 110 may be removably secured to the skin 20 of the patient 22. The base 110 may be removably secured to the skin 20 of the patient 22 via an adhesive layer 115 (shown in FIG. 4 ). The base 110 may be removably secured to the skin 20 such that a pivot axis 126 (shown in FIG. 2 ) intersects the insertion site 18. Removably securing the base 110 to the skin 20 such that the pivot axis 126 intersects the insertion site 18 may allow the swing arm 130 to pivot relative to the base mount 120 without causing pistonic movement of the cannula 16.

[0076] In some embodiments, base 110 may be removably secured to skin 20 such that one or more markings 125 on base mount 120 may be aligned with insertion site 18. Additionally, cap 138 may be in a pulled-away state 138B. In pulled-away state 138B, cap 138 may be pulled away from cannula receiving portion 136. Cap 138 may be pulled away from cannula receiving portion 136 by grasping and moving release member 140.

[0077] 5B, the cannula 16 of the catheter 10 may be at least partially received within the first slot 137 of the cannula-receiving portion 136. Also, as shown in FIG. 5C, the cap 138 may be moved from a disengaged position 138B to a coupled position 138A. In the configuration shown in FIG. 5C, the fixation device 100 is in the locked position 101. As described above, in the locked position 101, the cannula 16 is removably secured to the cannula securement member 134, which is removably coupled to the retention member 124.

[0078] In the fixed state 101, the fixation device 100 can firmly fix the catheter 10 to the skin 20 of the patient 22. Thus, the fixation device 100 can prevent various complications such as phlebitis, extravasation / infiltration, leakage, occlusion, and bloodstream infection that may occur due to movement of the catheter 10 relative to the skin 20.

[0079] 5D , cannula locking member 134 may be pulled away from retaining member 124. Cannula locking member 134 may be pulled away from retaining member 124 by grasping and pulling release member 131. As shown in FIG. 5D , after cannula locking member 134 is pulled away from retaining member 124, swing arm 130 may be pivoted away from retaining member 124. Specifically, after cannula locking member 134 is pulled away from retaining member 124, swing arm 130 may be pivoted away from retaining member 124 with cannula 16 secured to cannula locking member 134.

[0080] Once cannula locking member 134 has been pulled away from retaining member 124, swing arm 130 can be pivoted relative to base mount 120 to place locking device 100 in maintenance state 102, as shown in FIGURE 5E. Referring to FIGURE 5E, in maintenance state 102 of locking device 100, cannula locking member 134 has been pulled away from retaining member 124, and swing arm 130 has been pivoted away from retaining member 124 such that cannula locking member 134 is spaced apart from retaining member 124 while remaining secured to cannula 16.

[0081] In some embodiments, the exposed length 16L of the cannula 16 from the cannula securement member 134 to the insertion site 18 is substantially constant during pivoting of the swing arm 130 relative to the retention member 124. If the base 110 is removably secured to the skin 20 such that the pivot axis 126 (shown in FIG. 2 ) intersects the insertion site 18, the exposed length 16L can remain substantially constant during pivoting of the swing arm 130 relative to the retention member 124. As a result, the securement device can transition between the securement state 101 and the maintenance state 102 without causing piston movement of the cannula 16.

[0082] In the maintenance state 102, the fixation device 100 may provide the physician with access to the insertion site 18. The physician may perform a maintenance procedure at the insertion site 18 with the fixation device 100 in the maintenance state 102. The fixation device 100 may allow the physician to perform the maintenance procedure without having to remove or pull the fixation device 100 away from the skin 20.

[0083] FIG. 6 shows a schematic block diagram of a kit 200 according to one embodiment of the present disclosure.

[0084] The kit 200 includes the catheter 10 and the fixation device 100. In some embodiments, the kit 200 may further include gloves. In some embodiments, the kit 200 may further include a sterilizing substance. In some embodiments, the kit 200 may further include a cloth or other absorbent material. In some embodiments, the kit 200 may further include an antimicrobial agent. The antimicrobial agent may be in the form of a liquid or gel. In some embodiments, the kit 200 may further include cleaning supplies such as cleaning cloths, absorbent cotton, cotton swabs, etc.

[0085] The kit 200 may be available in a sterile package for use by a physician. The physician may remove the release liner 119 (shown in FIG. 4 ) and releasably couple the fixation device 100 onto the skin 20. With reference to FIGS. 5A-5E and 6 , the physician may releasably secure the base 110 of the fixation device 100 to the skin 20, releasably secure the cannula 16 to the cannula fixation member 134, and releasably couple the cannula fixation member 134 to the retention member 124 to place the fixation device 100 in the fixation state 101. In this manner, the catheter 10 may be secured and stabilized. If necessary, the physician may pull the cannula fixation member 134 away from the retention member 124 and pivot the swing arm 130 away from the retention member 124 to place the fixation device 100 in the maintenance state 102. In the maintenance state 102, the insertion site 18 may be accessible to the physician. In the maintenance state 102, the fixation device 100 may allow a physician to perform a maintenance procedure at the insertion site 18 without removing the fixation device 100 from the skin 20. The physician may then perform the maintenance procedure.

[0086] FIG. 7 shows a flowchart depicting various steps of a method 300 of using a fixation device (e.g., the fixation device 100 of FIG. 2) with a catheter (e.g., the catheter 10 shown in FIG. 1) having a cannula inserted into a patient's skin at an insertion site, according to one embodiment of the present disclosure. The fixation device includes a base configured to be removably secured to the patient's skin. The fixation device further includes a base mount fixedly attached to the base and having a coupling member and a retaining member spaced from the coupling member. The fixation device further includes a swing arm having an elongated member pivotally coupled to the coupling member of the base mount and a cannula securing member connected to the elongated member and spaced from the coupling member. Method 300 will be further described with further reference to FIGS. 5A-5E.

[0087] At step 302, the method 300 includes removably securing the base to the skin of the patient. For example, as shown in FIG. 5A, the method 300 may include removably securing the base 110 to the skin 20 of the patient 22.

[0088] In some embodiments, removably securing the base to the patient's skin includes removably adhering the base to the patient's skin via an adhesive layer. For example, in some embodiments, removably securing the base 110 to the skin 20 of the patient 22 may include removably adhering the base 110 to the skin 20 of the patient 22 via an adhesive layer 115 (shown in FIG. 4 ).

[0089] In some embodiments, removably securing the base to the patient's skin includes aligning a pivot axis of the swing arm with the insertion site such that the pivot axis intersects the insertion site. For example, as shown in FIGS. 2 and 5A , removably securing the base 110 to the skin 20 of the patient 22 may include aligning the pivot axis 126 of the swing arm 130 with the insertion site 18 such that the pivot axis 126 intersects the insertion site 18. Aligning the pivot axis 126 of the swing arm 130 with the insertion site 18 such that the pivot axis 126 intersects the insertion site 18 may allow the swing arm 130 to be pivoted relative to the base mount 120 without causing piston movement of the cannula 16.

[0090] The method 300 further includes releasably securing the cannula of the catheter to the cannula securement member at step 304. For example, as shown in FIG. 5C, the method 300 may include releasably securing the cannula 16 of the catheter 10 to the cannula securement member 134.

[0091] In some embodiments, removably securing a cannula of the catheter to the cannula securement member may include at least partially inserting the cannula into a first slot of the cannula receiving portion of the cannula securement member, and removably coupling the cap to the cannula receiving portion such that the first slot of the cannula receiving portion and a second slot of the cap cooperate to at least partially receive the cannula therebetween.

[0092] For example, as shown in FIG. 5B, removably securing the cannula 16 of the catheter 10 to the cannula securement member 134 may include at least partially inserting the cannula 16 into a first slot 137 of a cannula receiving portion 136 of the cannula securement member 134, and removably coupling the cap 138 to the cannula receiving portion 136 such that the first slot 137 of the cannula receiving portion 136 and the second slot 139 of the cap 138 cooperate to at least partially receive the cannula 16 therebetween.

[0093] At step 306, method 300 further includes releasably securing the cannula securement member to the retention member. For example, as shown in FIG. 5C, method 300 may include releasably securing cannula securement member 134 to retention member 124. In some embodiments, cannula securement member 134 may be releasably secured to retention member 124 while steps 302 and 304 are performed.

[0094] At step 308, method 300 further includes separating cannula securement member 134 from retention member 124 such that swing arm 130 is pivotable relative to retention member 124. For example, as shown in FIG.

[0095] At step 310, method 300 further includes pivoting the swing arm away from the retaining member such that the cannula securement member is spaced apart from the retaining member while remaining secured to the cannula. For example, as shown in FIG. 5E , method 300 may include pivoting swing arm 130 away from retaining member 124 such that cannula securement member 134 is spaced apart from retaining member 124 while remaining secured to cannula 16.

[0096] In some embodiments, method 300 may further include performing a maintenance procedure at the insertion site after pivoting the swing arm away from the retention member. In some embodiments, method 300 may further include pivoting the swing arm toward the retention member after performing the maintenance procedure. In some embodiments, method 300 may further include releasably coupling a cannula securement member to the retention member.

[0097] For example, the method 300 may include performing a maintenance procedure at the insertion site 18 after pivoting the swing arm 130 away from the retaining member 124 .

[0098] Method 300 may further include, after performing the maintenance procedure, pivoting swing arm 130 toward retention member 124. Method 300 may further include releasably coupling cannula securement member 134 to retention member 124.

[0099] In the fixation state 101, the fixation device 100 of the present disclosure may securely fix the catheter 10 to the skin 20 of the patient 22. Thus, the fixation device 100 may prevent removal and accidental dislodgement of the catheter 10 from the skin 20 of the patient 22. Furthermore, the fixation device 100 may prevent various complications, such as phlebitis, extravasation / infiltration, leakage, occlusion, and bloodstream infection, that may otherwise occur due to migration of the catheter 10. In the maintenance state 102, the fixation device 100 may allow a physician to perform maintenance procedures at the insertion site 18 without removing the fixation device 100 from the skin 20. The fixation device 100 may transition between the fixation state 101 and the maintenance state 102 without causing piston movement of the cannula 16. Thus, the fixation device 100 may facilitate the performance of maintenance procedures.

[0100] 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.

[0101] While specific embodiments have been illustrated and described herein, those skilled in the art will recognize that various alternative and / or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Accordingly, it is intended that the present disclosure be limited only by the claims and their equivalents.

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: a base configured to be removably secured to the skin of the patient; a base mount fixedly attached to the base, the base mount comprising a coupling member and a retaining member spaced from the coupling member; A swing arm, an elongate member pivotally coupled to the coupling member of the base mount; a cannula securement member connected to the elongate member and spaced from the coupling member, the cannula securement member configured to releasably secure the cannula to the cannula securement member, and the cannula securement member further configured to be releasably coupled to the retaining member; When the cannula securing member is pulled away from the retaining member, the swing arm is pivotable relative to the base mount; In the locked state of the locking device, the cannula is removably secured to the cannula locking member, and the cannula locking member is removably coupled to the retaining member; In the maintenance state of the fixation device, the cannula fixing member is pulled away from the holding member, and the swing arm is pivoted away from the holding member so that the cannula fixing member is spaced apart from the holding member while being fixed to the cannula.

2. The base portion is a substrate having a first major surface fixedly attached to the coupling member and the retention member, and a second major surface opposite the first major surface; an adhesive layer disposed at least partially on the second major surface and configured to releasably secure the substrate to the skin of the patient.

3. The fixation device of claim 2 , wherein the adhesive layer comprises a stretch release adhesive.

4. The substrate is a first substrate portion fixedly attached to the coupling member; a second substrate portion fixedly attached to the retaining member; the second substrate portion is not connected to the first substrate portion; The fastening device of claim 2 , wherein the adhesive layer is at least partially disposed on the second major surface of each of the first and second substrate portions.

5. The fixation device of claim 1 , wherein the base mount further comprises a connecting member connecting the coupling member and the retaining member.

6. The cannula fixing member is a cannula receiving portion connected to the elongate member and including a first slot configured to at least partially receive the cannula therein; 2. The fixation device of claim 1, comprising: a cap configured to be removably coupled to the cannula receiving portion, the cap comprising a second slot, the second slot at least partially aligned with the first slot when the cap is removably coupled to the cannula receiving portion.

7. 7. The fixation device of claim 6, wherein the first slot and the second slot cooperate to at least partially receive the cannula between the first slot and the second slot such that the cannula is removably secured to the cannula securement member when the cannula is inserted into the first slot and the cap is removably coupled to the cannula receiving portion.

8. the cannula securement member 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; 7. The fixation device of claim 6, wherein when the cannula is inserted into the first slot and the cap is removably coupled to the cannula receiving portion, the first sleeve and the second sleeve each frictionally engage the cannula such that the cannula is removably secured to the cannula securement member.

9. The fixation device of claim 6 , wherein the cap is pivotally coupled to or captive to the cannula receiving portion.

10. The fixation device of claim 6 , wherein the cannula-receiving portion of the swing arm is removably coupled to the retaining member by a snap-fit ​​connection.

11. the cannula securing member further comprising a release member extending from the cannula receiving portion; The fixation device of claim 1 , wherein the release member is configured to be manually grasped to release the cannula-receiving portion from the retaining member.

12. 2. The fixation device of claim 1, wherein the elongate member has a first end and a second end opposite the first end, the elongate member pivotally coupled to the coupling member proximal to the first end, and the cannula fixation member is connected to the elongate member proximal to the second end.

13. 13. The fixation device of claim 12, wherein the elongate member further comprises a tapered portion extending from the first end and a curved portion disposed adjacent the tapered portion, the tapered portion tapering from the curved portion toward the first end, the curved portion curving away from the cannula fixation member.

14. The fixation device of claim 1 , wherein said swing arm is a single, integrally molded piece.

15. 10. The fixation device of claim 1, wherein the base mount further comprises one or more markings disposed on the coupling member, the one or more markings being aligned with the insertion site when the base is removably secured to the skin of the patient.

16. 2. The fixation device of claim 1, wherein the swing arm is pivotable about a pivot axis, the pivot axis intersecting the insertion site when the base is releasably secured to the skin of the patient.

17. A kit comprising: a catheter including a cannula configured to be inserted into the patient's skin at an insertion site; 1. A fixation device comprising: a base configured to be removably secured to the skin of the patient; a base mount fixedly attached to the base, the base mount including a coupling member and a retaining member spaced from the coupling member; A swing arm, an elongate member pivotally coupled to the coupling member of the base mount; a cannula securing member connected to the elongate member and spaced from the coupling member, the cannula securing member configured to releasably secure the cannula to the cannula securing member and further configured to be releasably coupled to the retaining member; and a locking device comprising: a swing arm; When the cannula securing member is pulled away from the retaining member, the swing arm is pivotable relative to the base mount; In the locked state of the locking device, the cannula is removably secured to the cannula locking member, and the cannula locking member is removably coupled to the retaining member; In a maintenance state of the fixation device, the cannula fixing member is pulled away from the retaining member, and the swing arm is pivoted away from the retaining member so that the cannula fixing member is spaced apart from the retaining member while remaining fixed to the cannula.

18. The base portion is a substrate having a first major surface fixedly attached to the coupling member and the retention member and a second major surface opposite the first major surface; an adhesive layer at least partially disposed on the second major surface and configured to releasably secure the substrate to the skin of the patient.

19. 20. The kit of claim 18, wherein the adhesive layer comprises a stretch release adhesive.

20. The substrate is a first substrate portion fixedly attached to the coupling member; a second substrate portion fixedly attached to the retaining member; 20. The kit of claim 18, wherein the second substrate portion is not connected to the first substrate portion, and the adhesive layer is at least partially disposed on the second major surface of each of the first and second substrate portions.

21. The kit of claim 17 , wherein the base mount further comprises a connecting member connecting the coupling member and the retaining member.

22. The cannula fixing member is a cannula receiving portion connected to the elongate member and including a first slot configured to at least partially receive the cannula therein; 18. The kit of claim 17, comprising: a cap configured to be removably coupled to the cannula receiving portion, the cap comprising a second slot, the second slot at least partially aligned with the first slot when the cap is removably coupled to the cannula receiving portion.

23. 23. The kit of claim 22, wherein the first slot and the second slot cooperate to at least partially receive the cannula between the first slot and the second slot such that the cannula is removably secured to the cannula securing member when the cannula is inserted into the first slot and the cap is removably coupled to the cannula receiving portion.

24. 24. The kit of claim 23, wherein the cannula securing member 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, and wherein when the cannula is inserted into the first slot and the cap is removably coupled to the cannula receiving portion, each of the first sleeve and the second sleeve frictionally engages the cannula such that the cannula is removably secured to the cannula securing member.

25. 24. The kit of claim 23, wherein the cap is pivotally coupled to or captive to the cannula receiving portion.

26. 18. The kit of claim 17, wherein the cannula-receiving portion of the swing arm is removably coupled to the retaining member by a snap-fit ​​connection.

27. 18. The kit of claim 17, wherein the cannula securement member further comprises a release member extending from the cannula receiving portion, the release member configured to be manually grasped to release the cannula receiving portion from the retaining member.

28. 18. The kit of claim 17, wherein the elongate member has a first end and a second end opposite the first end, the elongate member pivotally coupled to the coupling member proximal to the first end, and the cannula fixation member is connected to the elongate member proximal to the second end.

29. 29. The kit of claim 28, wherein the elongate member further comprises a tapered portion extending from the first end and a curved portion disposed adjacent to the tapered portion, the tapered portion tapering from the curved portion toward the first end, the curved portion curving away from the cannula fixation member.

30. 18. The kit of claim 17, wherein the swing arm is a single, integrally molded piece.

31. 20. The kit of claim 17, wherein the base mount further comprises one or more markings disposed on the coupling member, the one or more markings being aligned with the insertion site when the base is removably secured to the skin of the patient.

32. 18. The kit of claim 17, wherein the swing arm is pivotable about a pivot axis, the pivot axis intersecting the insertion site when the base is removably secured to the skin of the patient.

33. 18. The kit of claim 17, wherein the exposed length of the cannula from the cannula securement member to the insertion site remains substantially constant during pivoting of the swing arm relative to the retaining member.

34. 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 configured to be removably secured to the skin of the patient; a base mount fixedly attached to the base, the base mount having a coupling member and a retaining member spaced from the coupling member; and a swing arm having an elongated member pivotally coupled to the coupling member of the base mount and a cannula fixation member connected to the elongated member and spaced from the coupling member, the method comprising: releasably securing the base to the skin of the patient; removably securing the cannula of the catheter to the cannula securing member; Removably fixing the cannula fixing member to the holding member; Pulling the cannula locking member away from the retaining member so that the swing arm is pivotable relative to the retaining member; and pivoting the swing arm away from the retaining member such that the cannula securing member is spaced apart from the retaining member while remaining secured to the cannula.

35. 35. The method of claim 34, wherein releasably securing the base to the skin of the patient comprises releasably adhering the base to the skin of the patient via an adhesive layer.

36. Removably securing the cannula of the catheter to the cannula securing member; at least partially inserting the cannula into a first slot of a cannula-receiving portion of the cannula-securing member; 35. The method of claim 34, comprising: removably coupling the cap to the cannula receiving portion such that the first slot of the cannula receiving portion and the second slot of the cap cooperate to at least partially receive the cannula between the first slot and the second slot.

37. 35. The method of claim 34, wherein releasably securing the base to the skin of the patient comprises aligning a pivot axis of the swing arm with the insertion site such that the pivot axis intersects the insertion site.

38. performing a maintenance procedure at the insertion site after pivoting the swing arm away from the retention member; After performing the maintenance procedure, pivoting the swing arm toward the holding member; releasably coupling the cannula securing member to the retaining member; 35. The method of claim 34, further comprising:

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