Fixation device, kit including fixation device, and method for fixing a fixation device to a user's skin - Patents.com

Abstract

The fixation device (100) for fixing a lumen (12) of a medical device (14) includes a body (110) configured to be removably fixed to the skin of a user. The body includes a first body portion (112) including a first cavity surface (118) and a second body portion (142) including a second cavity surface (148) pivotally coupled to the first cavity surface. The first and second cavity surfaces together define a cavity (170). The fixation device further includes an insert (180) fixedly coupled to the body and at least partially received within the cavity. The insert includes a groove (184) configured to receive the lumen of the medical device. The body is transformable between an open configuration and a closed configuration, and the insert is correspondingly transformable between a released state and a locked state. In the released state, the groove is configured to receive the lumen therein. In the locked state, the lumen is secured within the groove.

Description

[Technical field]

[0001] The present disclosure relates to a fixation device for fixing a lumen of a medical device on the skin of a user, and a kit including the fixation device. The present disclosure further relates to a method for fixing the fixation device on the skin of a user. [Background technology]

[0002] Various medical devices, such as catheters, may be used for purposes such as feeding, gas supply, and / or fluid removal. In some cases, such medical devices may be used to administer medications and fluids to a patient. In many cases, the medical device may need to be secured onto the patient's skin to prevent the medical device from moving. For example, the medical device may need to be secured onto the patient's skin to prevent the medical device from being pulled out or from moving in a manner that may adversely affect the function of the medical device.

[0003] Generally, medical devices can be fixed on the patient's skin using conventional fastening means such as tapes, patches, and sutures. However, such conventional fastening means may not adequately fasten the medical device to the skin. In some cases, the use of conventional fastening means may result in various complications such as removal and accidental dislodgement of the medical device from the patient's skin, phlebitis, extravasation / infiltration, leakage, blockage, and bloodstream infection. In addition, conventional methods for fastening medical devices may cause discomfort to the patient due to high fluid pressure within the medical device.

[0004] In some instances, fastening means such as tapes or patches may allow partial or minor movement of the medical device, which may cause discomfort to the patient. Additionally, conventional fastening means may not provide adequate coverage of the injection site, which may result in infection at the injection site. Additionally, the use of sutures to fasten the medical device to the skin may result in suture-related infections and complications.

[0005] Therefore, improved fastening means may be needed to overcome the above-mentioned problems presented by conventional fastening means. Summary of the Invention

[0006] In a first aspect, the present disclosure provides a fixation device for fixing at least one lumen of a medical device. The fixation device includes a body having a first elastic modulus and configured to be removably fixed to the skin of a user. The body includes a first body portion including a first upper surface, a first lower surface facing opposite the first upper surface, and a first cavity surface extending from the first upper surface partially toward the first lower surface. The body further includes a second body portion pivotally coupled to the first body portion. The second body portion includes a second upper surface spaced apart from the first upper surface, a second lower surface pivotally coupled to the first lower surface along a first pivot interface, and a second cavity surface extending from the second upper surface partially toward the second lower surface. The second cavity surface is pivotally coupled to the first cavity surface along a second pivot interface spaced apart from the first pivot interface. The first cavity surface and the second cavity surface together define a body cavity disposed between the first top surface and the second top surface. The fixation device further includes an insert fixedly coupled to the body and at least partially received within the body cavity. The insert engages at least the first cavity surface of the first body portion, the second cavity surface of the second body portion, and the second pivot interface. The insert includes a groove along its length. The insert has a second elastic modulus less than the first elastic modulus. The insert is configured to at least partially and removably receive the at least one lumen within the groove. The body is deformable between an open configuration and a closed configuration. The insert is deformable between a released state and a locked state based on deformation of the body between the open configuration and the closed configuration. The released state of the insert corresponds to the open configuration of the body and the locked state of the insert corresponds to the closed configuration of the body. In the open configuration of the body, the first underside of the first body portion and the second underside of the second body portion are angled relative to one another at the first pivot interface. Further, in the open configuration of the body, the insert is in a released state such that the groove is configured to removably and at least partially receive the at least one lumen therein.In the closed configuration of the body, the first lower surface of the first body portion and the second lower surface of the second body portion are substantially parallel to one another at the first pivot interface. Further, in the closed configuration of the body, the insert is in a fixed state such that the at least one lumen is fixed within the groove.

[0007] In a second aspect, the present disclosure provides a kit. The kit includes a medical device including at least one lumen. The kit further includes a fixation device for fixing the at least one lumen of the medical device. The fixation device includes a body having a first elastic modulus and configured to be removably fixed to the skin of a user. The body includes a first body portion including a first upper surface, a first lower surface facing opposite the first upper surface, and a first cavity surface extending from the first upper surface partially toward the first lower surface. The body further includes a second body portion pivotally coupled to the first body portion. The second body portion includes a second upper surface spaced apart from the first upper surface, a second lower surface pivotally coupled to the first lower surface along a first pivot interface, and a second cavity surface extending from the second upper surface partially toward the second lower surface. The second cavity surface is pivotally coupled to the first cavity surface along a second pivot interface spaced from the first pivot interface. The first cavity surface and the second cavity surface together define a body cavity disposed between the first top surface and the second top surface. The fixation device further includes an insert fixedly coupled to the body and at least partially received within the body cavity. The insert engages at least the first cavity surface of the first body portion, the second cavity surface of the second body portion, and the second pivot interface. The insert includes a groove along its length. The insert has a second elastic modulus less than the first elastic modulus. The insert is configured to at least partially and removably receive at least one lumen within the groove. The body is deformable between an open configuration and a closed configuration. The insert is deformable between a released state and a locked state based on deformation of the body between the open configuration and the closed configuration. The released state of the insert corresponds to an open configuration of the body, and the locked state of the insert corresponds to a closed configuration of the body. In the open configuration of the body, the first lower surface of the first body portion and the second lower surface of the second body portion are inclined relative to one another at the first pivot interface. Further, in the open configuration of the body, the insert is in the released state, such that the groove is configured to removably and at least partially receive the at least one lumen therein.In the closed configuration of the body, the first lower surface of the first body portion and the second lower surface of the second body portion are substantially parallel to one another at the first pivot interface. Further, in the closed configuration of the body, the insert is in a fixed state such that the at least one lumen is fixed within the groove.

[0008] In a third aspect, the present disclosure provides a method of fixing a fixation device on a user's skin. The fixation device includes a body including a first body portion and a second body portion. The fixation device includes an insert fixedly coupled to the body. The method includes transforming the body to an open configuration. In the open configuration of the body, a first underside of the first body portion and a second underside of the second body portion are inclined relative to one another at a first pivot interface. The method further includes transforming the insert to a released state based on the transformation of the body to the open configuration. The released state of the insert corresponds to the open configuration of the body. The method further includes engaging at least one lumen with the insert when the insert is transformed to the released state. When the insert is in the released state, the groove of the insert is configured to removably and at least partially receive the at least one lumen therein. The method further includes transforming the body to a closed configuration. In the closed configuration of the body, the first underside of the first body portion and the second underside of the second body portion are substantially parallel to one another at the first pivot interface. The method further includes transforming the insert to a locked state based on the transformation of the body to the closed configuration. The locked state of the insert corresponds to the closed configuration of the body. The method further includes securing the at least one lumen within the groove when the insert is transformed to the locked state.

[0009] The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will become apparent from the description and drawings, and from the claims.

[0010] Exemplary embodiments disclosed herein will be more fully understood by considering the following detailed description in conjunction with the following drawings, in which: The drawings are not necessarily 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. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic perspective view of a kit including a fixation device according to one embodiment of the present disclosure. [Figure 2A] 1 is a schematic side view of a body of a fixation device according to one embodiment of the present disclosure. FIG. [Figure 2B] FIG. 1 is a schematic side view of a fixation device without a base shown, according to one embodiment of the present disclosure. [Diagram 3] 1 is a schematic perspective view of a fixation device showing the body in an open configuration according to one embodiment of the present disclosure; FIG. [Figure 4] FIG. 1 is a schematic perspective view of a fixation device, showing the body in a closed configuration, according to one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a schematic perspective view of a fastening device secured to a user's skin using a closure tape, according to one embodiment of the present disclosure. [Figure 6] 1 is a schematic cross-sectional view of a base of a fixation device according to one embodiment of the present disclosure. [Figure 7] 1 is a schematic perspective view of a fastening device illustrating removal of a release liner of the fastening device according to one embodiment of the present disclosure. FIG. [Figure 8] 1 is a schematic perspective view of a fixation device according to one embodiment of the present disclosure, the base of the fixation device including several pull tabs. [Figure 9] FIG. 13 is a schematic side view of a fixation device according to another embodiment of the present disclosure, with the base not shown. [Figure 10] 1 shows a flowchart depicting a method of securing a securement device onto a user's skin, according to one embodiment of the present disclosure. [Figure 11A]1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. [Figure 11B] 1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. [Figure 11C] 1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. [Figure 11D] 1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. [Figure 11E] 1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. [Figure 11F] 1 illustrates various steps for securing a fixation device onto a user's skin according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 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 or spirit of the present disclosure. Thus, the following detailed description is not to be taken in a limiting sense.

[0013] In the disclosure that follows, the following definitions apply:

[0014] As described herein, all numbers should be considered as modified by the term "about." As used herein, "a," "an," "the," "at least one," and "one or more" are used interchangeably.

[0015] 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 discernible by one of ordinary skill in the art, but does not require absolute precision or perfect agreement (e.g., within + / - 20% for quantifiable characteristics).

[0016] The term "substantially" unless otherwise defined means a high degree of approximation (e.g., within + / - 10% for quantifiable characteristics), but again does not require absolute precision or perfect agreement.

[0017] The term "about," unless specifically defined otherwise, means a high degree of approximation (e.g., within + / - 5% for quantifiable properties), but again does not require absolute precision or exact agreement.

[0018] Terms such as same, equal, uniform, constant, exactly, etc. are understood not to require absolute precision or perfect correspondence, but within normal tolerances or measurement errors applicable to a particular situation.

[0019] As used herein, the terms "first" and "second" are used as identifiers. Thus, such terms should not be interpreted as limiting the present disclosure. The terms "first" and "second" when used in conjunction with features or elements are interchangeable throughout the embodiments of the present disclosure.

[0020] As used herein, when a first material is referred to as being "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.

[0021] As used herein, "at least one of A and B" should be understood to mean "A only, B only, or both A and B."

[0022] 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.

[0023] 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.

[0024] As used herein, the term "polymer" refers to both a material prepared from one monomer (e.g., a homopolymer) or a material prepared from two or more monomers (e.g., a copolymer, a terpolymer, etc.). 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.

[0025] As used herein, the term "elastic modulus" (also interchangeably referred to as Young's modulus or storage modulus) refers to a quantity that measures the resistance of a material to being elastically deformed when stress is applied to it. Essentially, elastic modulus is a quantitative measure of the stiffness of an elastic material that measures the ability of the material under test to recover to its original shape or size. Elastic modulus can be calculated using a formula derived by Hooke's law, where elastic modulus is equal to the ratio of stress to strain (i.e., the ratio of applied force to percent change in size).

[0026] The present disclosure relates to a fixation device for fixing at least one lumen of a medical device, a kit including the fixation device, and a method of fixing the fixation device on the skin of a user. The fixation device includes a body having a first elastic modulus and configured to be removably fixed to the skin of a user. The body includes a first body portion including a first upper surface, a first lower surface facing opposite the first upper surface, and a first cavity surface extending from the first upper surface partially toward the first lower surface. The body further includes a second body portion pivotally coupled to the first body portion. The second body portion includes a second upper surface spaced apart from the first upper surface, a second lower surface pivotally coupled to the first lower surface along a first pivot interface, and a second cavity surface extending from the second upper surface partially toward the second lower surface. The second cavity surface is pivotally coupled to the first cavity surface along a second pivot interface spaced apart from the first pivot interface. The first cavity surface and the second cavity surface together define a body cavity disposed between the first top surface and the second top surface. The fixation device further includes an insert fixedly coupled to the body and at least partially received within the body cavity. The insert engages at least the first cavity surface of the first body portion, the second cavity surface of the second body portion, and the first pivot interface. The insert includes a groove along its length. The insert has a second elastic modulus less than the first elastic modulus. The insert is configured to at least partially and removably receive the at least one lumen within the groove. The body is deformable between an open configuration and a closed configuration. The insert is deformable between a released state and a locked state based on deformation of the body between the open configuration and the closed configuration. The released state of the insert corresponds to the open configuration of the body and the locked state of the insert corresponds to the closed configuration of the body. In the open configuration of the body, the first underside of the first body portion and the second underside of the second body portion are angled relative to one another at the first pivot interface. Further, in the open configuration of the body, the insert is in a released state such that the groove is configured to removably and at least partially receive the at least one lumen therein.In the closed configuration of the body, the first lower surface of the first body portion and the second lower surface of the second body portion are substantially parallel to one another at the first pivot interface. Further, in the closed configuration of the body, the insert is in a fixed state such that the at least one lumen is fixed within the groove.

[0027] Medical devices, such as catheters, may be used for a variety of purposes, such as for delivery, gas supply, and / or fluid removal. In some cases, medical devices may be used to administer medications and fluids to a user, such as a patient in need of medical treatment. In many cases, medical devices may need to be secured onto the skin of a user to prevent movement of the medical device. For example, medical devices may need to be secured onto the skin of a user to prevent the medical device from being pulled out or from moving in a manner that may adversely affect the function of the medical device.

[0028] Traditionally, medical devices may be secured onto the skin of a user using fastening means such as tapes, patches, and / or sutures. However, such traditional fastening means may not adequately secure the medical device to the skin. For example, fastening means such as sutures may require advanced techniques, and if the sutures are not applied properly, not only may the medical device be improperly secured onto the skin, but the user may also feel discomfort at the suture site. Other fastening means (e.g., tapes and patches) may allow partial or micro-movement of the medical device, which may cause discomfort to the user. Furthermore, tapes and patches may use adhesives that are not easily removable, thus requiring additional adhesive remover or alcohol for removal. Furthermore, traditional fastening means may not provide adequate coverage of the injection site, which may result in an infection at the injection site.

[0029] The fixation device of the present disclosure may securely secure at least one lumen of the medical device to the skin of a user. The fixation device may further allow lumens of different sizes and / or shapes to be secured within the grooves of the insert. Additionally, the base of the fixation device may be removably secured to the skin of the user. The base may include one or more pull tabs that may be grasped by the clinician and pulled to remove the base from the skin of the user. The adhesive layer may securely secure the base on the skin of the user. The adhesive layer may include a stretch release adhesive such that upon stretching of the base, the adhesive layer may lose its adhesive properties. The base may then be easily peeled off to remove the fixation device from the skin of the user. In other words, the base may be easily removed from the skin of the user without causing discomfort to the user. Additionally, the fixation device may prevent the medical device from becoming dislodged and accidentally removed from the skin of the user.

[0030] Thus, the fixation device of the present disclosure can securely secure the medical device to the user's skin, inhibit unwanted migration of the medical device, prevent infection at the injection site, and facilitate easy removal of the fixation device after use.

[0031] Referring now to the drawings, FIG. 1 shows a schematic perspective view of a kit 10 according to one embodiment of the present disclosure. The kit 10 includes a medical device 14 including at least one lumen 12. In some embodiments, the at least one lumen 12 may be a catheter used for purposes such as administering intravenous therapy (e.g., medication or fluids for parenteral nutrition), obtaining blood for analysis, and / or providing an access point for blood-based therapy such as dialysis or apheresis. The catheter may be used to measure one or more characteristics of the blood (e.g., "central venous oxygen saturation"), administer fluids or blood products for large-scale emergency fluid therapy, and / or measure central venous pressure. In some cases, the catheter may be a central venous catheter (CVC). A CVC, also called a central line, CV line, or central venous access catheter, may be used to access a user's large, centrally located veins, which may be required for critically ill patients, for patients who require long-term intravenous therapy for reliable vascular access, and for administering fluids that may be harmful to smaller peripheral veins. A peripheral venous catheter (PVC) 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 or axillary vein), or a vein located in the groin (e.g., the femoral vein). In some cases, the catheter may be a peripherally inserted central venous catheter (PICC). A PICC may be suitable for insertion into a vein located in the user's arm. In some other cases, the catheter may be any other suitable type of catheter that may be selected based on desired application attributes.

[0032] In some embodiments, at least one lumen 12 may be made from any one or combination of medical grade materials, such as polyvinyl chloride (PVC), silicone, silicone coated latex, polyurethane (PU), low density polyethylene (LDPE), metallocene polyolefins, silicone, polyamide (PA), polyester, and the like. Silicones may include silicones cured by moisture or hydrosilylation. Metallocene polyolefins may include metallocene polyethylene and metallocene polypropylene. Polyesters may include elastomeric polyesters, such as Hytrel brand polyesters, fluoropolymers, such as Teflon® and fluoroelastomers, and the like. Lumen 12 may also include blends, mixtures, laminates, and / or coextrusions of one or more of the above-mentioned materials.

[0033] In some embodiments, the lumen 12 may have a minimum width W. The minimum width W may be defined as the distance between the outermost walls of the lumen 12. In the illustrated embodiment of FIG. 1, the lumen 12 may have a circular cross-section. In such cases, the minimum width W may be defined as the diameter of the lumen 12. In some other cases, the lumen 12 may include any other cross-section. In such cases, the minimum width W may be defined as the diameter of a circumscribing circle around the geometric shape of the cross-section. Additionally, the minimum width W of the lumen 12 may be, but is not limited to, about 1 millimeter (mm) to about 8 mm.

[0034] The kit 10 also includes a fixation device 100 for fixing at least one lumen 12 of the medical device 14. In some embodiments, the fixation device 100 may be removably secured to a user 18, e.g., the skin 16 of a patient. In the illustrated embodiment of FIG. 1, the kit 10 includes a single lumen 12 that may be coupled to the fixation device 100. Alternatively, the kit 10 may include, but is not limited to, two or more lumens 12. In some embodiments, the kit 10 may further include gloves (not shown). In some embodiments, the kit 10 may further include a sterile substance (not shown). In some embodiments, the kit 10 may further include a cloth or other absorbent material (not shown). In some embodiments, the kit 10 may further include cleaning supplies (not shown), such as cleaning cloths, absorbent cotton, cotton swabs, etc. The kit 10 may be available to the clinician (or medical professional) for use in a sterile package.

[0035] Further, the fixation device 100 includes a body 110. The body 110 is configured to be removably secured to the skin 16 of the user 18. In some embodiments, the body 110 may be a single piece integral component. However, in some other embodiments, the body 110 may include multiple separate components that may be assembled to form the body 110. The body 110 has a first modulus of elasticity E1. In some embodiments, the first modulus of elasticity E1 may be between about 1 gigapascal (GPa) and about 5 GPa. In some embodiments, the body 110 may include at least one of a polymer, an elastomer, and a metal. In some embodiments, the body 110 may include a combination of different materials. In some embodiments, the body 110 may include any one of a plastic and a composite material. In some embodiments, the body 110 can include, but is not limited to, one or more of acrylonitrile butadiene styrene (ABS), polypropylene, polycarbonate, polyethylene, PVC, nylon, olefin, acrylic, polyester, silicone, thermoplastic urethane, thermoplastic elastomer, and the like.

[0036] 2A shows a schematic side view of a body 110 of a fixation device 100 according to one embodiment of the present disclosure. With reference to FIG. 2A, the body 110 includes a first body portion 112 including a first upper surface 114, a first lower surface 116 facing opposite the first upper surface 114, and a first cavity surface 118 extending from the first upper surface 114 partially toward the first lower surface 116. The body 110 is transformable between an open configuration (as shown in FIGS. 2A and 3) and a closed configuration (as shown in FIGS. 1 and 2B).

[0037] In some embodiments, the first body portion 112 may further include a pair of first side surfaces 120 (only one of which is shown in FIG. 2A ) facing away from one another and extending between the first upper surface 114 and the first lower surface 116. In some embodiments, the first body portion 112 may further include a first end surface 122 disposed distal to the first cavity surface 118 and extending between the pair of first side surfaces 120. In some embodiments, the first end surface 122 may further be disposed between the first upper surface 114 and the first lower surface 116. Additionally, in some embodiments, the first cavity surface 118 may extend between the pair of first side surfaces 120.

[0038] In some embodiments, the first body portion 112 may at least partially taper from the cavity 170 toward the first end surface 122 such that the first body portion 112 may further include a first gripping region 124 disposed adjacent the first end surface 122. In the illustrated embodiment of FIG. 2A, the first upper surface 114 may be substantially curved. In some other embodiments, the first upper surface 114 may be substantially planar. Additionally, the first gripping region 124 may include one or more textures that may improve the gripping characteristics of the fixation device 100. For example, the first gripping region 124 may include a knurled surface.

[0039] The body 110 further includes a second body portion 142 pivotally coupled to the first body portion 112. The second body portion 142 includes a second upper surface 144 spaced apart from the first upper surface 114, a second lower surface 146 pivotally coupled to the first lower surface 116 along a first pivot interface 160, and a second cavity surface 148 extending from the second upper surface 144 partially toward the second lower surface 146. In some embodiments in which the body 110 is embodied as a single piece integral component, the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 may be part of the same monolith of the body 110. Thus, the first lower surface 116 and the second lower surface 146 may be pivotable by deformation of the body 110 along the first pivot interface 160. In some embodiments, the fixation device 100 may be fixed on the skin 16 (see FIG. 1 ) of a user 18 (see FIG. 1 ) such that the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 may be proximal to the skin 16 of the user 18, and the first upper surface 114 of the first body portion 112 and the second upper surface 144 of the second body portion 142 may be distal to the skin 16 of the user 18.

[0040] Additionally, the second cavity surface 148 is pivotally coupled to the first cavity surface 118 along a second pivot interface 162 that is spaced from the first pivot interface 160. The first cavity surface 118 and the second cavity surface 148 together define a cavity 170 in the body 110 disposed between the first top surface 114 and the second top surface 144. When the body 110 is in the closed configuration, the cavity 170 comprises a generally semicircular shape. Alternatively, the cavity 170 may comprise any other shape without any limitation when the body 110 is in the closed configuration.

[0041] In some embodiments in which the body 110 is embodied as a single piece, integral component, the first cavity side 118 of the first body portion 112 and the second cavity side 148 of the second body portion 142 may be part of the same monolith of the body 110. Thus, the first cavity side 118 and the second cavity side 148 may be pivotable by deformation of the body 110 along the second pivot interface 162. In some embodiments, the first pivot interface 160 and the second pivot interface 162 may be spaced apart from one another within the same monolith of the body 110. Thus, deformation of the body 110 along the first pivot interface 160 may result in a corresponding deformation of the body 110 along the second pivot interface 162. In other words, pivotal movement of the first lower surface 116 relative to the second lower surface 146 may result in corresponding pivotal movement of the first cavity surface 118 relative to the second cavity surface 148. Further, in some embodiments, the first pivot interface 160 and the second pivot interface 162 may be spaced apart from one another along a vertical axis 172. Further, the body 110 may define a portion 174 of the body 110 that separates the first pivot interface 160 and the second pivot interface 162.

[0042] In some embodiments, the second body portion 142 may further include a pair of second side surfaces 150 (only one of which is shown in FIG. 2A ) facing away from one another and extending between the second upper surface 144 and the second lower surface 146. In some embodiments, the second body portion 142 may further include a second end surface 152 disposed distally of the second cavity surface 148. In some embodiments, the second end surface 152 may extend between the pair of second side surfaces 150. In some embodiments, the second end surface 152 may further be disposed between the second upper surface 144 and the second lower surface 146. Additionally, in some embodiments, the second cavity surface 148 may extend between the pair of second side surfaces 150.

[0043] In some embodiments, each of the pair of second sides 150 may be joined to a corresponding first side 120 from the pair of first sides 120 of the first body portion 112 between the first pivot interface 160 and the second pivot interface 162.

[0044] In some embodiments, the second body portion 142 may at least partially taper from the cavity 170 toward the second end surface 152 such that the second body portion 142 may further include a second gripping region 154 disposed adjacent the second end surface 152. In the illustrated embodiment of FIG. 2A, the second upper surface 144 may be substantially curved. In some other embodiments, the second upper surface 144 may be substantially planar. Additionally, the second gripping region 154 may include one or more textures that may improve the gripping characteristics of the fixation device 100. For example, the second gripping region 154 may include a knurled surface.

[0045] 1 and 2A, the fixation device 100 may further include a base 190. In some embodiments, the fixation device 100 may be removably secured onto the skin 16 of the user 18 such that the base 190 of the fixation device 100 contacts the skin 16 of the user 18. The base 190 may include a pull tab 192 disposed along the perimeter 622 of the base 190, which may be used to remove the fixation device 100 from the skin 16 of the user 18. In particular, the pull tab 192 may assist a clinician during removal of the base 190 from the skin 16 of the user 18.

[0046] FIG. 2B shows a schematic side view of a fixation device 100 according to one embodiment of the present disclosure. The base 190 is not shown in FIG. 2B for clarity. With reference to FIG. 2B, the fixation device 100 further includes an insert 180 fixedly coupled to the body 110 and at least partially received within the cavity 170 (see FIG. 2A) of the body 110. In some embodiments, the insert 180 may extend between a pair of first sides 120 (only one of which is shown in FIG. 2B). In some embodiments, the insert 180 may extend between a pair of second sides 150 (only one of which is shown in FIG. 2B).

[0047] 1 and 2B, the insert 180 engages at least the first cavity surface 118 of the first body portion 112, the second cavity surface 148 of the second body portion 142, and the second pivot interface 162. The insert 180 includes a groove 184 along its length L. Additionally, the insert 180 has a second elastic modulus E2 that is less than the first elastic modulus E1. In some embodiments, the first elastic modulus E1 of the body 110 may be at least two times greater than the second elastic modulus E2 of the insert 180. In some embodiments, the first elastic modulus E1 of the body 110 may be at least three times, at least four times, at least five times, at least six times, at least eight times, or at least ten times greater than the second elastic modulus E2 of the insert 180. In some embodiments, the second elastic modulus E2 may be about 1 GPa. However, in some embodiments, the second elastic modulus E2 may be about 0, i.e., the insert 180 may be substantially plastic. In some embodiments, the insert 180 may comprise an elastomer. In some embodiments, the insert 180 may comprise silicone, polydimethylsiloxane (PDMS), liquid silicone rubber, poly(styrene-butadiene-styrene), other suitable thermoplastic elastomers, and / or combinations thereof.

[0048] Additionally, insert 180 is configured to at least partially and removably receive at least one lumen 12 (see FIG. 1 ) within groove 184. In some embodiments, groove 184 of insert 180 may include a first groove portion 186 disposed proximal to second pivot interface 162 and a second groove portion 188 extending from first groove portion 186 away from second pivot interface 162. In some embodiments, insert 180 may include two split insert portions 182 defining second groove portion 188 therebetween, such that second groove portion 188 is open.

[0049] Furthermore, the insert 180 is deformable between a released state (as shown in FIG. 3 ) and a locked state (as shown in FIGS. 1 and 2B ) based on the deformation of the body 110 between the open and closed configurations. The released state of the insert 180 corresponds to the open configuration of the body 110, and the locked state of the insert 180 corresponds to the closed configuration of the body 110. In some embodiments, the body 110 and the insert 180 may be deformable about a common pivot axis 176 (also shown in FIG. 3 ). In some embodiments, the common pivot axis 176 may be substantially perpendicular to the vertical axis 172. As seen in FIG. 3 , the length L of the insert 180 may extend substantially along the common pivot axis 176. Thus, the direction of deformation of the body 110 and the insert 180 about the common pivot axis 176 may be substantially similar.

[0050] FIG. 3 is a schematic perspective view of the fixation device 100 showing the body 110 in an open configuration, according to one embodiment of the present disclosure.

[0051] In the open configuration of the body 110, the first underside 116 of the first body portion 112 and the second underside 146 of the second body portion 142 are inclined relative to one another at the first pivot interface 160. In some embodiments, the body 110 can be transformed into the open configuration based on moving the first body portion 112 in the counterclockwise direction C2 and moving the second body portion 142 in the clockwise direction C1. For example, the clinician can hold the first body portion 112 with the left hand to effect the movement of the first body portion 112 in the counterclockwise direction C2. In some examples, the clinician can hold the first body portion 112 at the first gripping region 124 and the first underside 116. Additionally, the clinician can hold the second body portion 142 with the right hand to effect the movement of the second body portion 142 in the clockwise direction C1. In some examples, the clinician can hold the second body portion 142 at the second gripping area 154 and the second lower surface 146. Movement of the first body portion 112 and the second body portion 142 can deform the body 110 along the first pivot interface 160 and the second pivot interface 162. Additionally, the first body portion 112 and the second body portion 142 can pivot about a common pivot axis 176 such that the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 move toward one another, forming an angle θ at the first pivot interface 160.

[0052] In some cases, the first body portion 112 and the second body portion 142 may be moved the same angular distance. In some other cases, the first body portion 112 and the second body portion 142 may be moved different angular distances. It may also be contemplated that the clinician may hold one of the first body portion 112 and the second body portion 142 stationary and move only the other of the first body portion 112 and the second body portion 142.

[0053] In some embodiments, the deformation of the body 110 may also cause the cavity 170 to deform. In some embodiments, the cavity 170 may have a first maximum cavity width W1 in the open configuration of the body 110 and a second maximum cavity width W2 (shown in FIG. 2B) in the closed configuration of the body 110. Furthermore, the first maximum cavity width W1 may be greater than the second maximum cavity width W2. Furthermore, the deformation of the body 110 may also cause the insert 180 to deform such that the split insert portions 182 of the insert 180 may move away from each other relative to the common pivot axis 176. In the open configuration of the body 110, the insert 180 is in a released state and the groove 184 is configured to removably and at least partially receive the at least one lumen 12 therein. Specifically, the first groove portion 186 may be configured to removably and at least partially receive the at least one lumen 12 therein.

[0054] FIG. 4 illustrates the body 110 in a closed configuration, according to one embodiment of the present disclosure. With reference to FIGS. 3 and 4, in the closed configuration of the body 110, the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 are substantially parallel to each other at the first pivot interface 160. In some embodiments, the closed configuration of the body 110 may be the normal state of the body 110. When the body 110 moves from the open configuration to the closed configuration, the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 move away from each other. In other words, the first body portion 112 can move in a clockwise direction C1 and the second body portion 142 can move in a counterclockwise direction C2 with respect to the common pivot axis 176.

[0055] In some embodiments, deformation of the body 110 to the closed configuration may also cause deformation of the cavity 170 (see FIG. 2A ) such that the cavity 170 may have a second maximum cavity width W2 in the closed configuration of the body 110. In some embodiments, the fixed state of the insert 180 may be a normal state of the insert 180. Thus, when the body 110 moves to the closed configuration, the insert 180 may also move to the fixed state. In the closed configuration of the body 110, the insert 180 is in a fixed state such that the at least one lumen 12 (see FIG. 1 ) is fixed within the groove 184. In some embodiments, the at least one lumen 12 may be fixed within the first groove portion 186.

[0056] Generally, in the fixed state of the insert 180, the at least one lumen 12 can be fixed in the fixation device 100 such that any movement of the lumen 12 can be limited without deforming the at least one lumen 12. Thus, in the fixed state of the insert 180, the first groove portion 186 can include a cross-sectional shape S1 similar to the cross-sectional shape S2 of the lumen 12 (see FIG. 1). In some embodiments, the shape of the cavity 170 can be substantially similar to the cross-sectional shape S1 of the first groove portion 186 such that the first groove portion 186 can be concentric with the cavity 170 (also shown in FIG. 2A) when the body 110 is in the closed configuration. In the illustrated embodiment of FIG. 4, the cavity 170 includes a semicircular shape and the first groove portion 186 includes a cross-sectional shape S1. In other embodiments, the cavity 170 can have a rectangular or square shape and the first groove portion 186 can include a circular cross-sectional shape S1.

[0057] In some embodiments, in the locked state of the insert 180, the first groove portion 186 may include a cross-sectional shape S1 that matches the cross-sectional shape S2 of the at least one lumen 12. Further, in the locked state of the insert 180, the first groove portion 186 may include a circular cross-sectional shape S1, and the second groove portion 188 may include a rectangular cross-sectional shape S3 (shown in FIG. 4). Thus, in the locked state of the insert 180, the groove 184 may be substantially keyhole shaped. However, in some other embodiments, the first groove portion 186 and the second groove portion 188 may include other cross-sectional shapes according to desired application attributes. For example, the first groove portion 186 may include a square cross-sectional shape or a rectangular cross-sectional shape.

[0058] Further, in the locked state of the insert 180, the first groove portion 186 defines a first maximum groove width W3 and the second groove portion 188 defines a second maximum groove width W4. In some embodiments, in the locked state, the first maximum groove width W3 of the first groove portion 186 may be at least two times greater than the second maximum groove width W4 of the second groove portion 188. In other embodiments, the first maximum groove width W3 of the first groove portion 186 may be at least 2.5 times, 3 times, 4 times, 5 times, etc., greater than the second maximum groove width W4 of the second groove portion 188. Further, in some embodiments, in the locked state of the insert 180, the second maximum groove width W4 of the second groove portion 188 may be less than the minimum width W (see FIG. 1 ) of at least one lumen 12. Thus, in the secured state of the insert 180 , the at least one lumen 12 cannot be inadvertently displaced from the first groove portion 186 and received within the second groove portion 188 .

[0059] As shown in FIG. 4, in some embodiments, in the released state, the two split insert portions 182 of the insert 180 can be moved away from one another relative to their respective positions in the fixed state such that at least one lumen 12 is configured to be slidably received through the second groove portion 188 and insertable into the first groove portion 186.

[0060] In some embodiments, the body 110 may define a maximum body height H1 in the closed configuration. In some embodiments, the insert 180 may define a maximum insert height H2 in the locked state such that the maximum body height H1 is greater than the maximum insert height H2. Thus, the portion 174 of the body may be defined between the first pivot interface 160 and the second pivot interface 162 such that the height H3 of the portion 174 may be substantially equal to the difference between the maximum body height H1 and the maximum insert height H2. Additionally, the height H3 may also be defined as the distance between the first pivot interface 160 and the second pivot interface 162 along the vertical axis 172.

[0061] 5, in some embodiments, the fixation device 100 may include a retaining means for maintaining or holding the body 110 in a closed configuration after the insert 180 at least partially and removably receives the at least one lumen 12. In some embodiments, the fixation device 100 further includes a closure tape 502. In some embodiments, the closure tape 502 may be adapted to be coupled to the first upper surface 114 of the first body portion 112 and the second upper surface 144 of the second body portion 142 to hold the body 110 in the closed configuration. In some embodiments, the closure tape 502 may be configured to be removably applied to the body 110 such that the closure tape 502 may apply a downward force on the body 110 to prevent the body 110 from moving toward the open configuration. In some embodiments, the closure tape 502 may be secured to the first body portion 112 and the second body portion 142 of the body 110. In other embodiments, the closure tape 502 may be secured to the body 110 and base 190 of the fixation device 100. In yet other embodiments, the closure tape 502 may be further secured onto the skin 16 (see FIG. 1 ) of a user 18 (see FIG. 1 ). In some embodiments, the closure tape 502 may be an adhesive tape suitable for medical applications.

[0062] The base 190 may have a first major surface 612 and a second major surface 614 (shown in FIG. 6 ) facing opposite the first major surface 612. In some embodiments, the first major surface 612 may be fixedly coupled to the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142. In some embodiments, the second major surface 614 may be configured to at least partially engage and removably secure to the skin 16 of the user 18. In some embodiments, the base 190 may be a passive dressing. In other words, in some embodiments, the base 190 may be non-occlusive. However, in some embodiments, the base 190 may be an interactive dressing. In other words, in some embodiments, the base 190 may be semi-occlusive or occlusive. Thus, in some embodiments, the base 190 may act as a barrier against bacterial intrusion. In some cases, the base 190 may maintain hydration of the area of ​​the skin 16 to which the base 190 may be removably secured, and may reduce infection in the area of ​​the skin 16 to which the base 190 may be removably secured.

[0063] In some embodiments, the base 190 may be deformable based on the deformation of the body 110 between the open and closed configurations. In some embodiments, the base 190 may have a curvilinear shape in the open configuration of the body 110, as shown in FIG. 3. In some embodiments, the base 190 may have a substantially planar shape in the closed configuration of the body 110, as shown in FIG. 4. In some embodiments, the area of ​​the second major surface 614 of the base 190 may be greater than the sum of the areas of the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142, respectively. Thus, the base 190 may have an area greater than the area of ​​the body 110 in contact with the base 190.

[0064] 6, in some embodiments, the base 190 may include a base body 602 that includes a stretchable polymeric material and forms a first major surface 612. The base 190 may be made of a stretchable material that can conform to an contoured surface (e.g., the skin 16 of the user 18 shown in FIG. 1). Thus, in some embodiments, the base 190 may be configured to exhibit high elasticity. In some embodiments, the base 190 can have a high tensile strength, a low elastic recovery, and a high elongation to break.

[0065] In some embodiments, the base body 602 of the base 190 may comprise at least one of a polymeric film, a polymeric foam, a polymeric hydrocolloid, and a polymeric alginate. In some embodiments, the base body 602 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, both plasticized and unplasticized, and polyvinyl acetate, olefin copolymers, such as ethylene / methacrylate copolymers, ethylene / vinyl acetate copolymers, acrylonitrile-butadiene-styrene copolymers, and ethylene propylene copolymers, acrylic polymers and copolymers, and combinations thereof. In some embodiments, the base body 602 may comprise a monolayer or multilayer film, a nonwoven film, a porous film, a foam-like film, and combinations thereof. In some embodiments, the base body 602 may be manufactured using any suitable film-forming method, such as extrusion, coextrusion, solution casting, foaming, and nonwoven techniques.

[0066] In some embodiments, the base 190 may further include an adhesive layer 616 disposed on the base body 602 and at least partially forming the second major surface 614. In some embodiments, the adhesive layer 616 may include a stretch releasing adhesive.

[0067] In some cases, the adhesive strength of the stretch releasing adhesive may be less than the cohesive strength of the stretch releasing adhesive, such that the adhesive ability of the stretch releasing adhesive may essentially disappear upon stretching of the base 190. Specifically, the tackiness of the stretch releasing adhesive may be lost upon stretching of the base 190. Thus, in some embodiments, the base 190 may be easily removed from the skin 16 of the user 18 upon stretching of the base 190.

[0068] Additionally, the adhesive may be a pressure sensitive adhesive. In some embodiments, the adhesive may have a relatively high water vapor transmission rate to allow for water evaporation. In some embodiments, suitable pressure sensitive adhesives may include those based on acrylates, urethanes, hydrogels, hydrocolloids, block copolymers, silicones, rubber-based adhesives (including natural rubber, polyisoprene, polyisobutylene, butyl rubber, etc.), as well as combinations of such adhesives. In some embodiments, the adhesive component of the pressure sensitive adhesive may contain tackifiers, plasticizers, rheology modifiers, as well as active ingredients, such as antimicrobial agents. In some embodiments, the pressure sensitive adhesive may be reasonably skin compatible and "hypoallergenic."

[0069] In some embodiments, adhesive layer 616 may comprise a multi-layer elastomeric layer including an elastomeric polymer, such as, for example, styrene-ethylene-butylene-styrene (SEBS), styrene-ethylene-propylene-styrene (SEPS), styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), polyurethane, ethyl vinyl acetate (EVA), ethyl methyl acrylate (EMA), ultra low density polyethylene (ULLDPE), hydrogenated polypropylene, polypropylene, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), and combinations or blends thereof. Additionally, adhesive layer 616 may be flood coated or pattern coated.

[0070] In some embodiments, the fixation device 100 may further include a release liner 620 removably secured to the second major surface 614 of the base 190. In some embodiments, the release liner 620 may be removed from the base 190 to removably secure the base 190 to the skin 16 of the user 18. FIG. 7 is a schematic perspective view of the fixation device 100 illustrating removal of the release liner 620, according to one embodiment of the present disclosure. In some embodiments, when the release liner 620 may be removed from the base 190, the adhesive layer 616 (see FIG. 6 ) of the base 190 may be exposed. Additionally, the exposed adhesive layer 616 may enable the base 190 to be removably secured to the skin 16 of the user 18.

[0071] The release liner 620 can protect the adhesive layer 616 from contaminants such as dust, debris, etc. prior to use of the fixation device 100. The release liner 620 can be manufactured using a plastic substrate. The release liner 620 can include a shape substantially similar to that of the base 190. The release liner 620 can be peeled off from the adhesive layer 616 prior to releasably securing the base 190 to the skin 16 of the user 18. The release liner 620 can include any suitable material such as polyethylene terephthalate (PET), high density polyethylene (HDPE), polyvinyl chloride (PVC), polypropylene (PP), etc.

[0072] In some embodiments, the base 190 may further include one or more pull tabs 192 disposed on the periphery 622 of the base 190 and not including the adhesive layer 616. In the illustrated embodiment of FIG. 7, the base 190 includes a single pull tab 192. Alternatively, the base 190 may include two pull tabs disposed on opposite facing ends of the base 190. The pull tab 192 may be embodied as an adhesive-free area such that the pull tab 192 cannot adhere to the skin 16 of the user 18. The pull tab 192 may be configured to be grasped to remove the base 190 from the skin 16. In particular, the pull tab 192 may allow the base 190 to be grasped to apply and remove the fixation device 100, and may also allow the clinician or any other medical professional to peel off the release liner 620 to apply the fixation device 100 onto the skin 16 of the user 18. Additionally, in some embodiments, to remove the base 190 from the skin 16 of the user 18, the base 190 may be stretched by grasping and pulling the pull tab 192.

[0073] 8, the base 190 may include multiple pull tabs 618 instead of the single pull tab 192 (see FIG. 7). Specifically, in the illustrated embodiment of FIG. 8, the base 190 includes four pairs of pull tabs 618, i.e., a total of eight pull tabs 618. The pull tabs 618 may be substantially semicircular. In other embodiments, the pull tabs 618 may include any other shape or any number of pull tabs 618 without any limitation. In some examples, the pull tabs 618 may include markings thereon that indicate the direction in which the pull tabs 618 must be pulled to remove the fixation device 100. The pull tabs 618 may be embodied as adhesive-free areas such that the pull tabs 618 cannot adhere to the skin 16 (see FIG. 1) of the user 18 (see FIG. 1). The pull tabs 618 may be configured to be grasped to remove the base 190 from the skin 16. In particular, the pull tab 618 may allow the base 190 to be grasped to apply and remove the fixation device 100, and may allow a clinician or any other medical professional to peel away the release liner 620 to apply the fixation device 100 onto the skin 16 of the user 18. Additionally, in some embodiments, the base 190 may be stretched by grasping and pulling the pull tab 618 to remove the base 190 from the skin 16 of the user 18.

[0074] FIG. 9 shows a schematic side view of a fixation device 100 according to another embodiment of the present disclosure. The base 190 is not shown in FIG. 9 for clarity. In some embodiments, the fixation device 100 includes an insert 980. The insert 980 may be substantially similar to the insert 180 (see FIG. 2B). However, the insert 980 may be configured to receive a plurality of lumens 912. In some embodiments, the insert 980 may include a plurality of grooves 984 such that each groove 984-1, 984-2 at least partially and slidably receives a corresponding lumen 912-1, 912-2 from the plurality of lumens 912. In the illustrated embodiment of FIG. 9, the insert 980 includes two grooves 984-1, 984-2. The grooves 984-1, 984-2 are configured to at least partially and slidably receive a corresponding lumen 912-1, 912-2, respectively. The grooves 984-1, 984-2 may have a generally circular shape when the insert is in the fixed state. In some examples, the insert 980 may include three or more grooves depending on the requirements of the application. The insert 980 further includes a groove portion 988 similar to the groove portion 188 (see FIG. 4 ) and two split insert portions 982 defining the groove portion 988 therebetween such that the groove portion 988 is open. The groove portion 988 may have a generally rectangular shape when the insert is in the fixed state.

[0075] 1 , the fixation device 100 can firmly fix the medical device 14 onto the skin 16 of the user 18. Furthermore, the fixation device 100 can prevent the medical device 14 from moving. As a result, the fixation device 100 can prevent various complications that may occur due to minute movement of the medical device 14.

[0076] FIG. 10 shows a flow chart illustrating a method 1000 of securing a fixation device 100 on the skin 16 of a user 18, according to one embodiment of the disclosure. FIGS. 11A-11F show various steps of securing a fixation device 100 to the skin 16 of a user 18, according to one embodiment of the disclosure. The method 1000 will now be described with reference to FIGS. 10 and 11A-11F. The fixation device 100 includes a body 110 including a first body portion 112 and a second body portion 142, and an insert 180 fixedly coupled to the body 110. With reference to FIGS. 10, 11A, and 11B, in step 1002, the body 110 is transformed into an open configuration. Specifically, the body 110 is transformed from a closed configuration as shown in FIG. 11A to an open configuration as shown in FIG. 11B. In the open configuration of the body 110, the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 are angled relative to one another at the first pivot interface 160. In step 1004, the insert 180 is transformed to a released state based on the transformation of the body 110 to the open configuration. The released state of the insert 180 corresponds to the open configuration of the body 110. In some embodiments, the body 110 and the insert 180 are transformed about a common pivot axis 176.

[0077] 10 and 11C, in step 1006, the at least one lumen 12 engages the insert 180 as the insert 180 is transformed to the released state. When the insert 180 is in the released state, the groove 184 of the insert 180 is configured to removably and at least partially receive the at least one lumen 12 therein.

[0078] 10 and 11D, in step 1008, the body 110 is transformed to a closed configuration. In the closed configuration of the body 110, the first lower surface 116 of the first body portion 112 and the second lower surface 146 of the second body portion 142 are substantially parallel to one another at the first pivot interface 160. In step 1010, the insert 180 is transformed to a fixed state based on the transformation of the body 110 to the closed configuration. The fixed state of the insert 180 corresponds to the closed configuration of the body 110. In step 1012, the at least one lumen 12 is secured within the groove 184 as the insert 180 is transformed to the fixed state.

[0079] 10 , 11E and 11F , in some embodiments, the base 190 may engage the skin 16 of the user 18. As shown in FIG 11E , in some embodiments, a release liner 620 may be removably secured to the second major surface 614 of the base 190. In some embodiments, the release liner 620 may be removed from the base 190 prior to removably securing the base 190 to the skin 16 of the user 18.

[0080] The base 190 may have a first major surface 612 and a second major surface 614 facing opposite the first surface 612. The first major surface 612 may be fixedly coupled to the first underside 116 of the first body portion 112 and the second underside 146 of the second body portion 142. Additionally, the second major surface 614 may be configured to at least partially engage and removably secure to the skin 16 of the user 18. Additionally, the base 190 may be deformable based on a deformation of the body 110 between the open configuration and the closed configuration. As shown in FIG. 11B and FIG. 11C, the base 190 may have a curved shape in the open configuration of the body 110. Additionally, as shown in FIG. 11D, the base 190 may have a substantially planar shape in the closed configuration of the body 110.

[0081] 5 and 10, in some embodiments, the method 1000 may include bonding a closure tape 502 to the first top surface 114 of the first body portion 112 and the second top surface 144 of the second body portion 142 to hold the body 110 in a closed configuration. Further, in some embodiments, one or more pull tabs 192, 618 (see FIGS. 7 and 8, respectively) may be grasped to remove the base 190 from the skin 16.

[0082] Further, in some embodiments, the insert 980 (see FIG. 9) can include a plurality of grooves 984 (see FIG. 9) such that each groove 984-1, 984-2 (see FIG. 9) can at least partially and slidably receive a corresponding lumen 912-1, 912-2 (see FIG. 9) from the plurality of lumens 912 (see FIG. 9). Thus, the plurality of lumens 912 can be at least partially received within the insert 980.

[0083] Unless otherwise indicated, all numbers expressing sizes, quantities, physical properties, and the like used in the specification and claims are to be understood as being modified by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the foregoing specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by those of ordinary skill in the art utilizing the teachings of the present disclosure.

[0084] While specific embodiments have been shown 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 the equivalents thereof.

Claims

1. 1. A fixation device for fixating at least one lumen of a medical device, said fixation device comprising: a body having a first modulus of elasticity and configured to be removably secured to a user's skin, the body comprising: a first body portion including a first upper surface, a first lower surface facing opposite the first upper surface, and a first cavity surface extending from the first upper surface partially toward the first lower surface; a body comprising: a second body portion pivotally coupled to the first body portion, the second body portion including a second upper surface spaced from the first upper surface, a second lower surface pivotally coupled to the first lower surface along a first pivot interface, and a second cavity surface extending from the second upper surface partially toward the second lower surface, the second cavity surface pivotally coupled to the first cavity surface along a second pivot interface spaced from the first pivot interface, the first cavity surface and the second cavity surface together defining a cavity of the body disposed between the first upper surface and the second upper surface; an insert fixedly coupled to the body and at least partially received within the cavity of the body, the insert engaging at least the first cavity surface of the first body portion, the second cavity surface of the second body portion, and the second pivot interface, the insert including a groove along its length, the insert having a second modulus of elasticity less than the first modulus of elasticity, and configured to at least partially and removably receive the at least one lumen within the groove; the body is deformable between an open configuration and a closed configuration, and the insert is deformable between a released state and a locked state based on deformation of the body between the open configuration and the closed configuration, the released state of the insert corresponding to the open configuration of the body and the locked state of the insert corresponding to the closed configuration of the body; In the open configuration of the body: the first lower surface of the first body portion and the second lower surface of the second body portion are inclined relative to one another at the first pivot interface; the insert is configured in the released state such that the groove removably and at least partially receives the at least one lumen therein; In the closed configuration of the body: the first lower surface of the first body portion and the second lower surface of the second body portion are substantially parallel to one another at the first pivot interface; The insert is in the locked state such that the at least one lumen is locked within the groove.

2. 10. The fixation device of claim 1, further comprising a base having a first major surface and a second major surface facing opposite the first major surface, the first major surface fixedly coupled to the first underside of the first body portion and the second underside of the second body portion, the second major surface configured to at least partially engage and be releasably secured to the skin of the user, the base being deformable based on the deformation of the body between the open configuration and the closed configuration, the base having a curved shape in the open configuration of the body and the base having a substantially planar shape in the closed configuration of the body.

3. The base portion is a base body comprising a stretchable polymeric material and forming the first major surface; an adhesive layer disposed on the base body facing away from the body and at least partially forming the second major surface, the adhesive layer comprising a stretch releasing adhesive; The fixation device of claim 2 .

4. 4. The fixation device of claim 3, wherein the base further comprises one or more pull tabs disposed around a periphery of the base and free of the adhesive layer, the one or more pull tabs configured to be grasped to remove the base from the skin.

5. 3. The fixation device of claim 2, wherein an area of ​​the second major surface of the base is greater than a sum of an area of ​​the first lower surface of the first body portion and an area of ​​the second lower surface of the second body portion.

6. 3. The securement device of claim 2, further comprising a release liner removably secured to the second major surface of the base, the release liner being removed from the base to removably secure the base to the skin of the user.

7. The fixation device of claim 1 , wherein the body is a single, integral piece.

8. The fixation device of claim 1 , wherein the body comprises at least one of a polymer, an elastomer, and a metal.

9. The fixation device of claim 1 , wherein the insert comprises an elastomer.

10. The fixation device of claim 1 , wherein the first modulus of elasticity of the body is at least two times greater than the second modulus of elasticity of the insert.

11. The first body portion is a pair of first side surfaces facing opposite each other and extending between the first upper surface and the first lower surface; 2. The fixation device of claim 1, further comprising a first end surface disposed distal to the first cavity surface and extending between the pair of first side surfaces, the first end surface being further disposed between the first upper surface and the first lower surface.

12. The fixation device of claim 11 , wherein the first cavity surface extends between the pair of first side surfaces.

13. The fixation device of claim 11 , wherein the insert extends between the pair of first sides.

14. 12. The fixation device of claim 11, wherein the first body portion is at least partially tapered from the cavity toward the first end face such that the first body portion further comprises a first gripping region disposed adjacent the first end face.

15. The second body portion is a pair of second side surfaces facing opposite each other and extending between the second upper surface and the second lower surface; a second end surface disposed distal to the second cavity surface and extending between the pair of second side surfaces, the second end surface being further disposed between the second upper surface and the second lower surface; 12. The fixation device of claim 11, wherein each of the pair of second sides is joined to a corresponding first side from the pair of first sides of the first body portion between the first pivot interface and the second pivot interface.

16. The fixation device of claim 15 , wherein the second cavity surface extends between the pair of second side surfaces.

17. The fixation device of claim 15 , wherein the insert extends between the pair of second sides.

18. 16. The fixation device of claim 15, wherein the second body portion is at least partially tapered from the cavity toward the second end face such that the second body portion further comprises a second gripping region disposed adjacent the second end face.

19. The fixation device of claim 1 , wherein the first upper surface is curved and the first lower surface is substantially planar.

20. The fixation device of claim 1 , wherein the second upper surface is curved and the second lower surface is substantially planar.

21. 10. The fixation device of claim 1, further comprising a closure tape adapted to be coupled to the first upper surface of the first body portion and the second upper surface of the second body portion to hold the body in the closed configuration.

22. 2. The fixation device of claim 1, wherein the cavity has a first maximum cavity width in the open configuration of the body and a second maximum cavity width in the closed configuration of the body, the first maximum cavity width being greater than the second maximum cavity width.

23. 2. The fixation device of claim 1, wherein the groove of the insert comprises a first groove portion disposed proximal to the second pivot interface and a second groove portion extending from the first groove portion away from the second pivot interface, the insert comprises two split insert portions defining the second groove portion therebetween such that the second groove portion is released, wherein in the locked state, a first maximum groove width of the first groove portion is at least two times greater than a second maximum groove width of the second groove portion, and the at least one lumen is secured within the first groove portion, and in the released state, the two split insert portions of the insert are separated from each other relative to their respective positions in the locked state, and the at least one lumen is configured to be slidably received through the second groove portion and insertable into the first groove portion.

24. 24. The fixation device of claim 23, wherein in the locked state of the insert, the first groove portion includes a circular cross-sectional shape and the second groove portion includes a rectangular cross-sectional shape.

25. 24. The fixation device of claim 23, wherein in the locked state of the insert, the second maximum groove width of the second groove portion is less than a minimum width of the at least one lumen.

26. The fixation device of claim 1 , wherein the body and the insert are deformable about a common pivot axis.

27. The fixation device of claim 1 , wherein the insert is configured to receive multiple lumens.

28. 28. The fixation device of claim 27, wherein the insert comprises a plurality of grooves, each groove at least partially and slidably receiving a corresponding lumen from the plurality of lumens.

29. The fixation device of claim 1 , wherein the body defines a maximum body height in the closed configuration and the insert defines a maximum insert height in the locked state, the maximum body height being greater than the maximum insert height.

Images