Fixation device for fastening medical articles, kit including fixation device, and method of use thereof

Abstract

The fixation device (100) includes a body (110) including a first major surface (112), a second major surface (114) opposite the first major surface (112), a perimeter (115) extending between the first and second major surfaces (112, 114), and a groove (116) extending from the perimeter (115) and through the body (110) from the first major surface (112) to the second major surface (114). The fixation device (100) further includes a clip (120) extending from the first major surface (112) and a plurality of microhooks (150) extending from the second major surface (114). Each microhook (150) includes a base (152) disposed on the second major surface (114) and a tip (154) distal to the base (152). The plurality of microhooks (150) includes at least one microhook (150-1) and at least one opposing microhook (150-2) facing the at least one microhook (150-1), with the respective tips (152) of the at least one microhook (150-1) and the at least one opposing microhook (150-2) pointing toward each other.

Description

[Technical field]

[0001] SUMMARY The present disclosure relates to fixation devices for securing medical articles, kits including fixation devices, and methods of using the kits. [Background technology]

[0002] Various medical procedures often require the use of medical articles (e.g., catheters) having medical lines. Such medical articles may be used for a variety of purposes, such as feeding, supplying air, removing liquids, and / or administering medications and fluids to a patient. In many cases, the medical article may need to be secured to the patient. Securing the medical article to the patient may facilitate proper positioning of the medical article, which may further prevent leakage or interruption of medication delivery, minimize patient discomfort, and limit tangling, snagging, and / or dislodging of the medical lines due to patient movement.

[0003] One common method of securing a medical article to a patient is to tape the medical article to the patient's skin (e.g., with surgical tape). However, taping can be time consuming and labor intensive. Tape can also collect contaminants and therefore may need to be replaced frequently. In addition, taping can be ineffective at securing the medical article to the patient, can cause undesirable movement of the medical article relative to the skin, and can cause adhesive-related skin damage to the patient. Summary of the Invention

[0004] In a first aspect, the present disclosure provides a fixation device for securing a medical article having at least one medical line insertable into a user's skin at an insertion site. The fixation device includes a body including a first major surface. The body further includes a second major surface opposite the first major surface. The second major surface is configured to face the user's skin. The body further includes a perimeter extending between the first major surface and the second major surface. The body further includes a groove extending from the perimeter and extending through the body from the first major surface to the second major surface. The groove is configured to slidably receive at least one medical line therethrough. The fixation device further includes a clip coupled to the body and extending from the first major surface. The clip is configured to receive the medical article at least partially therethrough and releasably secure the medical article to the body. The fixation device further includes a plurality of micro hooks coupled to the body and extending from the second major surface. The plurality of microhooks are spaced apart from one another and are configured to be at least partially inserted into a user's skin to secure the body to the skin. Each microhook of the plurality of microhooks includes a base disposed on the second major surface and a tip distal to the base. The plurality of microhooks includes at least one microhook and at least one opposing microhook facing the at least one microhook, with the respective tips of the at least one microhook and the at least one opposing microhook pointing toward one another.

[0005] In a second aspect, the present disclosure provides a kit. The kit includes a fixation device for securing a medical article having at least one medical line insertable into a user's skin at an insertion site. The fixation device includes a body including a first major surface. The body further includes a second major surface opposite the first major surface. The second major surface is configured to face the user's skin. The body further includes a perimeter extending between the first major surface and the second major surface. The body further includes a groove extending from the perimeter and extending through the body from the first major surface to the second major surface. The groove is configured to slidably receive at least one medical line at least partially therethrough. The fixation device further includes a clip coupled to the body and extending from the first major surface. The clip is configured to receive the medical article at least partially therethrough and releasably secure the medical article to the body. The fixation device further includes a plurality of microhooks coupled to the body and extending from the second major surface. The plurality of microhooks are spaced apart from one another and configured to be at least partially inserted into the skin of a user to secure the body to the skin. Each microhook of the plurality of microhooks includes a base disposed on the second major surface and a tip distal to the base. The plurality of microhooks includes at least one microhook and at least one opposing microhook facing the at least one microhook, with the respective tips of the at least one microhook and the at least one opposing microhook pointing toward one another. The kit further includes a gel pad configured to be at least partially received in the opening and cover the insertion site. The gel pad includes chlorhexidine gluconate.

[0006] In a third aspect, the present disclosure provides a method of using the kit of the second aspect. The method includes positioning a fixation device against a user's skin with a second major surface of the body facing the skin. The method further includes slidably inserting at least one medical line through the channel such that the at least one medical line is at least partially received through an opening in the body. The method further includes inserting a medical article at least partially through the clip to releasably secure the medical article to the body. The method further includes inserting a plurality of microhooks into the user's skin such that the body is secured to the user's skin. The method further includes inserting a gel pad at least partially into the opening such that the gel pad covers the insertion site. Exemplary embodiments disclosed herein may be more fully understood by considering the following detailed description in conjunction with the following drawings, in which: The drawings are not necessarily drawn to scale. In particular, the thickness of certain layers has been exaggerated in proportion to other certain items for ease of illustration and clarity. 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]

[0007] [Figure 1] FIG. 1 is a schematic top perspective view of a fixation device according to one embodiment of the present disclosure. [Diagram 2] 2 is a schematic bottom perspective view of the fixation device of FIG. 1 according to one embodiment of the present disclosure. [Diagram 3] FIG. 2 is a schematic bottom view of the fixation device of FIG. 1, according to one embodiment of the present disclosure. [Figure 4A] FIG. 2 is a schematic top perspective view of a microhook of the fixation device of FIG. 1, according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is a schematic bottom perspective view of the microhook of FIG. 4A according to one embodiment of the present disclosure. [Figure 4C]FIG. 4B is a schematic side view of the microhook of FIG. 4A according to one embodiment of the present disclosure. [Diagram 5] 2 is a schematic top perspective view of a portion of the fixation device of FIG. 1, 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] 7 is a flow chart illustrating various steps of a method of using the kit of FIG. 6 according to one embodiment of the present disclosure. [Figure 8A] 8 illustrates the method of FIG. 7. [Figure 8B] 8 illustrates the method of FIG. 7. [Figure 8C] 8 illustrates the method of FIG. 7. [Figure 8D] 8 illustrates the method of FIG. 7. [Figure 8E] 8 illustrates the method of FIG. 7. [Figure 8F] 8 illustrates the method of FIG. 7. [Figure 8G] 8 illustrates the method of FIG. 7. [Figure 8H] 8 illustrates the method of FIG. 7. [Figure 8I] 8 illustrates the method of FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] 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. Thus, the following detailed description is not to be taken in a limiting sense.

[0009] In the disclosure that follows, the following definitions apply:

[0010] 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.

[0011] 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).

[0012] The term "substantially" means, unless specifically defined otherwise, a high degree of approximation (e.g., within + / - 10% for quantifiable characteristics), but again does not require absolute precision or perfect agreement.

[0013] 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 correspondence.

[0014] 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.

[0015] 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 with features or elements are interchangeable throughout the multiple embodiments of the present disclosure.

[0016] 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 material and the second material are exactly the same, and the difference between the first material and the second material is less than about 10% by weight of each of the first material and the second material.

[0017] As used herein, "at least one of A and B" should be understood to mean "A only, B only, or both A and B."

[0018] Unless otherwise specified or limited, the terms "mounted," "connected," and "coupled," and variations thereof, are used broadly and encompass both direct and indirect mounting, connecting, and coupling.

[0019] As used herein, terms such as "configured to" are at least as restrictive as the term "adapted to," and require an actual design intent to perform a specified function, rather than merely a physical capability to perform such function.

[0020] As used herein, the term "spaced apart" refers to elements that are positioned a distance from each other.

[0021] The present disclosure relates to a fixation device for securing a medical article having at least one medical line insertable into a user's skin at an insertion site. The fixation device includes a body including a first major surface. The body further includes a second major surface opposite the first major surface. The second major surface is configured to face the user's skin. The body further includes a perimeter extending between the first major surface and the second major surface. The body further includes a groove extending from the perimeter and extending through the body from the first major surface to the second major surface. The groove is configured to slidably receive at least one medical line therethrough. The fixation device further includes a clip coupled to the body and extending from the first major surface. The clip is configured to receive the medical article at least partially therethrough and releasably secure the medical article to the body. The fixation device further includes a plurality of micro hooks coupled to the body and extending from the second major surface. The plurality of microhooks are spaced apart from one another and are configured to be at least partially inserted into a user's skin to secure the body to the skin. Each microhook of the plurality of microhooks includes a base disposed on the second major surface and a tip distal to the base. The plurality of microhooks includes at least one microhook and at least one opposing microhook facing the at least one microhook, with the respective tips of the at least one microhook and the at least one opposing microhook pointing toward one another.

[0022] The fixation device of the present disclosure may fix the medical article to the skin of a user via a plurality of micro hooks. Specifically, the medical article may be fixed to the body by a clip, and the body may be fixed to the skin of the user by a plurality of micro hooks. The plurality of micro hooks may not penetrate the dermis layer of the skin of the user. Therefore, the fixation device may not cause pain and discomfort to the user during use.

[0023] The fixation device may provide various advantages over traditional fixation methods such as taping. The fixation device may be convenient to use and may not need to be replaced periodically. Furthermore, the fixation device may be easily applied to various locations on the user. By fastening via multiple microhooks, the fixation device may further prevent adhesive-related skin damage to the user that may occur with taping.

[0024] Since the tips of the at least one microhook and the at least one opposing microhook point toward each other, the at least one microhook and the at least one opposing microhook may be securely inserted into the skin of the user, thereby substantially preventing any relative movement between the body and the skin. Furthermore, the relative configuration of the at least one microhook and the at least one opposing microhook may prevent any accidental dislodging of the body from the skin. Thus, the fixation device may securely fix the medical article to the skin of the user, thereby preventing the medical article from moving from the skin of the user and from accidentally dislodging. As a result, the fixation device may prevent various complications, such as phlebitis, extravasation / infiltration, leakage, blockage, and bloodstream infection, that may otherwise occur due to the movement of the medical article.

[0025] In some cases, a gel pad may be used in conjunction with the fixation device to at least partially cover the insertion site, which may protect the insertion site from microorganisms and prevent infection.

[0026] Referring now to the drawings, Figures 1 and 2 show a securement device 100 according to one embodiment of the present disclosure. Specifically, Figure 1 shows a schematic top perspective view of the securement device 100 for securing a medical article 10 having at least one medical line 12 insertable into the skin 22 of a user 20 at an insertion site 25. The medical article 10 is partially shown in Figure 1. Additionally, Figure 2 shows a bottom perspective view of the securement device 100.

[0027] Fixation device 100 defines mutually orthogonal x-, y-, and z-axes. The x-axis is defined along the width of fixation device 100 and the y-axis is defined along the length of fixation device 100. The z-axis is defined along the thickness of fixation device 100.

[0028] The fixation device 100 includes a body 110. The body 110 includes a first major surface 112 and a second major surface 114 opposite the first surface 112. The second major surface 114 is configured to face the skin 22 of the user 20. The body 110 may further include a first end 102 and a second end 104 opposite the first end 102. The first end 102 and the second end 104 may correspond to longitudinal ends of the body 110 disposed along the y-axis.

[0029] The body 110 further includes a perimeter 115 extending between the first major surface 112 and the second major surface 114. The body 110 further includes a groove 116 extending from the perimeter 115 and extending through the body 110 from the first major surface 112 to the second major surface 114. In other words, the body 110 may define the groove 116 extending therethrough from the perimeter 115. The groove 116 is configured to slidably receive, at least in part, the at least one medical line 12 therethrough. The fixation device 100 may be slid over the at least one medical line 12 such that the groove 116 slidably receives the at least one medical line 12 therethrough.

[0030] When the fixation device 100 is applied to the skin 22 of the user 20, a portion of the groove 116 is aligned with the insertion site 25 such that the at least one medical line 12 is inserted through the groove 116 and into the skin 22 of the user 20. Alternatively, as shown in FIG. 1 , the body 110 may further include an opening 118 extending therethrough and in communication with the groove 116. The opening 118 may be configured to at least partially receive the at least one medical line 12 therethrough. The fixation device 100 may be slid over the at least one medical line 12 such that the at least one medical line 12 is at least partially received by the opening 118 via the groove 116.

[0031] 1, the grooves 116 are substantially straight grooves extending from the perimeter 115 to the openings 118. Moreover, the grooves 116 are substantially perpendicular to the perimeter 115. Specifically, the grooves 116 are substantially parallel to the y-axis. However, in some other embodiments, the grooves 116 may be inclined at an angle relative to the y-axis. Moreover, in other embodiments, the grooves 116 may have a curved shape.

[0032] As shown in FIG. 1, the opening 118 may be further configured to at least partially receive a gel pad 140 therein. The gel pad 140 is not shown in FIG. 2 for purposes of clarity. The gel pad 140 may be configured to be at least partially received within the opening 118 and cover the insertion site 25. The gel pad 140 may include any suitable disinfectant and / or antiseptic, such as povidone iodine, cetrimide, etc. In some examples, the gel pad 140 may include chlorhexidine gluconate. The gel pad 140 may protect the insertion site 25 from microorganisms and may help keep the insertion site 25 clean and disinfected during use of the fixation device 100.

[0033] Body 110 may be made of any suitable material. Preferably, body 110 may be made of a stretchable material that conforms to contoured surfaces (e.g., skin 22 of user 20). Body 110 may have a modulus of elasticity of about 0.1 megapascals (MPa) to about 1000 MPa. In some examples, body 110 may have a modulus of elasticity of about 100 MPa, about 200 MPa, about 300 MPa, about 500 MPa, about 700 MPa, about 800 MPa, or about 900 MPa.

[0034] Body 110 may include at least one of polyurethane, neoprene, polyester, butyl rubber, silicone, and polymer foam. Different materials may provide different advantageous properties to body 110. For example, polymer foam may provide good breathability to body 110, while polyurethane may be economical due to its good ability to integrate with other materials. Thus, the material of body 110 may be selected based on desired application attributes.

[0035] The body 110 may have any suitable shape, such as rectangular, elliptical, oval, circular, polygonal, etc. For example, as shown in FIG. 1, the body 110 may be substantially rectangular with rounded corners. Specifically, the body 110 may have a maximum length 110L and a maximum width 110W. The maximum length 110L may be defined substantially along a y-axis, and the maximum width 110W may be defined substantially along an x-axis. In one example, the maximum length 110L of the body 110 may be about 50 millimeters (mm), and the maximum width 110W of the body 110 may be about 40 mm. Such dimensions of the body 110 may make the fixation device 100 suitable for application to various parts of the user 20.

[0036] The fixation device 100 further includes a clip 120 coupled to the body 110 and extending from the first major surface 112. The clip 120 may be coupled to the body 110 by any suitable method or technique. For example, the clip 120 may be coupled to the body 110 by molding, heat welding, adhesive bonding, tacking, etc. The clip 120 is configured to at least partially receive the medical article 10 therethrough and removably secure the medical article 10 to the body 110. The clip 120 may be adjustable to accommodate medical articles having various shapes and sizes. More details about the clip 120 are provided below.

[0037] 2, the fixation device 100 further includes a plurality of microhooks 150 coupled to the body 110 and extending from the second major surface 114. The plurality of microhooks 150 may be coupled to the body 110 by any suitable method or technique. For example, the plurality of microhooks 150 may be coupled to the body 110 by molding, heat welding, adhesive bonding, tacking, etc. The plurality of microhooks 150 are spaced apart from one another and are configured to be at least partially inserted into the skin 22 of the user 20 to secure the body 110 to the skin 22.

[0038] The plurality of microhooks 150 may be made of any material capable of penetrating the skin 22 of the user 20. Each of the plurality of microhooks 150 may include at least one of stainless steel, carbon fiber reinforced polymer, poly(methyl methacrylate), dissolvable polyester, nickel alloy, and titanium alloy. Each of the plurality of microhooks 150 may further include a magnesium alloy. Different materials may provide different advantageous properties to the plurality of microhooks 150. For example, stainless steel, nickel alloy, and titanium alloy may improve the ability of the plurality of microhooks 150 to penetrate the skin 22, while using a dissolvable polyester may be economical.

[0039] Each microhook 150 of the plurality of microhooks 150 includes a base 152 disposed on the second major surface 114 and a tip 154 ​​distal to the base 152. The plurality of microhooks 150 includes at least one microhook 150-1 and at least one opposing microhook 150-2 facing the at least one microhook 150-1, with the tips 154 of the at least one microhook 150-1 and the at least one opposing microhook 150-2 pointing toward each other. In other words, an imaginary line extending from the tip 154 ​​of the at least one microhook 150-1 may extend in the general direction of the tip 154 ​​of the at least one opposing microhook 150-2. This orientation of the plurality of microhooks 150 may improve fixation of the body 110 to the skin 22 of the user 20. 2, the plurality of microhooks 150 includes at least one pair of microhooks 150 and at least one pair of opposing microhooks 150, with the tips 154 of each of the at least one pair of microhooks 150 and the tips 154 of each of the at least one pair of opposing microhooks 150 pointing toward each other. The plurality of microhooks 150 can have many suitable arrangements and configurations. One particular arrangement and configuration of the plurality of microhooks 150 will be described in detail with reference to FIG.

[0040] FIG. 3 shows a bottom view of the fixation device 100 according to one embodiment of the present disclosure.

[0041] The second major surface 114 may define a surface centroid 113. The surface centroid 113 may be a geometric center of the second major surface 114. Further, the plurality of microhooks 150 may include at least one first microhook 161. A tip 154 ​​of the at least one first microhook 161 may point toward the surface centroid 113.

[0042] In some examples, the at least one first micro hook 161 may include a set of first micro hooks 161 arranged in a circular array 171 about the surface centroid 113. Further, a tip 154 ​​of each first micro hook 161 in the set of first micro hooks 161 may point toward the surface centroid 113. In other words, the set of first micro hooks 161 may be arranged in the circular array 171 about the surface centroid 113 with each first micro hook 161 pointing toward the surface centroid 113.

[0043] 3, the set of first micro hooks 161 may include at least two first micro hooks 161-1, 161-2 disposed diametrically opposite one another such that tips 154 of each of the at least two first micro hooks 161-1, 161-2 point toward one another. The set of first micro hooks 161 may further include at least two first micro hooks 161-4, 161-5 disposed on either side of the groove 116.

[0044] In some examples, the surface centroid 113 of the second major surface 114 may be disposed within the aperture 118. Additionally, the set of first micro hooks 161 may be disposed at least partially around the aperture 118. More specifically, as shown in FIG. 3, the aperture 118 may be circular and may define a center 119. The center 119 of the aperture 118 may coincide with the surface centroid 113 of the second major surface 114. As a result, the set of first micro hooks 161 may be disposed at least partially within a circular array 171 around the aperture 118, with the center 119 of the aperture 118 coinciding with the center of the circular array 171.

[0045] The set of first micro hooks 161 may further include at least one first micro hook 161-3 disposed opposite the groove 116, such that a tip 154 ​​of the at least one first micro hook 161-3 points toward the groove 116. In the exemplary embodiment of FIG. 3, the at least one first micro hook 161-3 includes only one first micro hook 161-3. Because the tip 154 ​​of the one first micro hook 161-3 points toward the groove 116, the plurality of micro hooks 150 may not include any corresponding micro hooks with tips pointing directly toward or directly away from the tip 154 ​​of the one first micro hook 161-3. In the embodiment illustrated in FIG. 3, each first micro hook 161 in the set of first micro hooks 161 has a corresponding first micro hook 161 located diametrically opposite, except for one first micro hook 161-3 located on the opposite side of the groove portion 116.

[0046] The groove 116 may extend partially along the length of the body 110. Specifically, the groove 116 may extend linearly from the perimeter 115 toward the surface centroid 113 of the second major surface 114 such that the length 116L of the groove 116 is about 30% to about 50% of the maximum length 110L of the body 110. Additionally, the maximum width 116W of the groove 116 may be less than the diameter 118D of the opening 118. Having the diameter 118D greater than the maximum width 116W may allow the gel pad 140 (shown in FIG. 1 ) to be securely received within the opening 118.

[0047] The plurality of microhooks 150 may further include a set of second microhooks 162 arranged in a pair of rectangular arrays 172 disposed on either side of the groove 116. One rectangular array 172 may be disposed proximate the first end 102 of the body 110 and the other rectangular array 172 may be disposed proximate the second end 104 of the body 110.

[0048] Additionally, the tip 154 ​​of each second micro hook 162 in the set of second micro hooks 162 may point toward the groove 116. In other words, the pair of rectangular arrays 172 may be disposed on either side of the groove 116 with the tip 154 ​​of each second micro hook 162 pointing toward the groove 116.

[0049] Further, each rectangular array 172 includes rows and columns of second micro hooks 162. In the embodiment shown in Figure 3, each row of one rectangular array 172 is substantially aligned with a corresponding row of the other rectangular array 172. In other words, each row of one rectangular array 172 and the corresponding row of the other rectangular array 172 are disposed substantially along a single line. Furthermore, the tips 154 in each row of one rectangular array 172 and the tips 154 in the corresponding row of the other rectangular array 172 point toward each other.

[0050] The second major surface 114 may further define at least one axis of symmetry 117 (shown in FIG. 3 by a dashed line). Additionally, the plurality of microhooks 150 further includes a set of third microhooks 163 arranged in a pair of rectangular arrays 173 disposed on either side of the axis of symmetry 117. The set of third microhooks 163 may be disposed on an opposite side of the set of second microhooks 162 with respect to the opening 118. A tip 154 ​​of each of the set of third microhooks 163 may point toward the axis of symmetry 117. In other words, the pair of rectangular arrays 173 may be disposed on either side of the axis of symmetry 117 such that a tip of each of the third microhooks 163 points toward the axis of symmetry 117.

[0051] Further, each rectangular array 173 includes rows and columns of third micro hooks 163. In the embodiment shown in Figure 3, each row of one rectangular array 173 is substantially aligned with a corresponding row of the other rectangular array 173. In other words, each row of one rectangular array 173 and the corresponding row of the other rectangular array 173 are disposed substantially along a single line. Furthermore, the tips 154 present in each row of one rectangular array 173 and the tips 154 present in the corresponding row of the other rectangular array 173 point toward each other.

[0052] Thus, the plurality of microhooks 150 are arranged in a circular array 171 about the surface centroid 113 of the second major surface 114, a pair of rectangular arrays 172 disposed on either side of the groove 116, and a pair of rectangular arrays 173 disposed on either side of the axis of symmetry 117 and spaced apart from the pair of rectangular arrays 172. Thus, the circular array 171 is disposed proximate to the geometric center of the body 110, the pair of rectangular arrays 172 are disposed proximate to each rounded corner of the body 110 proximate to the groove 116, and the pair of rectangular arrays 173 are disposed proximate to each rounded corner of the body 110 distal to the groove 116. Such an arrangement of the plurality of microhooks 150 may improve attachment between the body 110 and the skin 22 of the user 20 while reducing the overall density of the plurality of microhooks 150 on the second major surface 114 (i.e., the number of microhooks per unit area).

[0053] Having the microhooks 150 pointing towards each other and towards the opening 118 also aids in compressing the skin towards the axis of symmetry 117 and towards the surface centroid 113 where needles for IVs are located and may be inserted through the skin compromising the integrity of the skin. Compressing damaged skin helps to prevent the skin from tearing, especially at wounds created by needles. The body 110 may be elastic or stretchable in some embodiments so that once the microhooks engage the skin after slightly stretching the fixation device 100 during application as described later herein, the elastic body 110 may contract and the skin may become slightly compressed due to the microhooks engaging the skin.

[0054] The plurality of microhooks 150 may be strategically positioned on the second major surface 114 such that, when the plurality of microhooks 150 are inserted into the skin 22 of the user 20, the body 110 is securely secured to the skin 22 (shown in FIG. 1 ) of the user 20 without causing discomfort or inconvenience to the user 20. To this end, in some examples, at least 50% of the area of ​​the second major surface 114 may be devoid of the plurality of microhooks 150. In some examples, at least 70% of the area of ​​the second major surface 114 may be devoid of the plurality of microhooks 150. In some examples, at least 90% of the area of ​​the second major surface 114 may be devoid of the plurality of microhooks 150. The absence of the plurality of microhooks 150 in one or more regions of the second major surface 114 may also facilitate gripping and removal of the body 110 from the skin 22 without causing discomfort or pain to the user 20.

[0055] The arrangement of the plurality of microhooks 150 on the second major surface 114 as shown in FIG. 3 is exemplary in nature and the arrangement may vary based on desired application attributes.

[0056] 4A-4C show schematic diagrams of one microhook 150 of a plurality of microhooks 150 according to one embodiment of the present disclosure.

[0057] As described above, each microhook 150 in the plurality of microhooks 150 includes a base 152 and a tip 154 ​​.

[0058] Each microhook 150 may define a height 150H between base 152 and tip 154. Height 150H may be between about 300 microns (μm) and about 600 μm. As a result, the plurality of microhooks 150 may not penetrate the dermis layer of skin 22 (shown in FIG. 1 ) of user 20. Thus, insertion of the plurality of microhooks 150 into skin 22 may not cause pain to user 20.

[0059] 4B, at least one microhook 150 of the plurality of microhooks 150 may have a square cross-sectional shape. At least one microhook 150 may have a pyramidal shape. Further, each microhook 150 of the plurality of microhooks 150 may have a solid configuration without a channel. In other words, each microhook 150 may not be hollow.

[0060] The base 152 may define a base plane 156 (indicated by a dashed rectangle in FIG. 4B), a base region 153 within the base plane 156, and a base centroid 155 of the base region 153 (indicated by a circle in FIG. 4B). The base region 153 corresponds to the effective area of ​​the base 152 within the base plane 156. The base centroid 155 may correspond to the geometric center of the base region 153 within the base plane 156. Each microhook 150 may further define a hook axis 151 (indicated by a dashed line in FIG. 4C) extending along its length from the base centroid 155 to the tip 154. Each microhook 150 extends between the base 152 and the tip 154 ​​along the hook axis 151. The hook axis 151 may be obtained by connecting the centroids of the cross-sectional areas of the microhooks 150 from the base 152 to the tip 154. The hook axis 151 may be curved or straight. As shown in Figure 4C, the hook axis 151 may be curved.

[0061] In some examples, an imaginary line 157 (shown by a dashed line in FIG. 4C) connecting the tip 154 ​​and the centroid 155 may be inclined obliquely with respect to the base plane 156. Specifically, as shown in FIG. 4C, the imaginary line 157 may be inclined obliquely with respect to the reference plane 156 by an inclination angle α. The inclination angle α may be from about 20 degrees to about 70 degrees. Furthermore, the tip 154 ​​of each micro hook 150 may be oriented away from the base 152 such that an imaginary vertical line 159 (shown by a dashed line in FIG. 4C) extending perpendicularly from the tip 154 ​​to the base plane 156 is outside the base 152. This configuration of the tip 154 ​​relative to the base 152 may allow the tip 154 ​​of each microhook 150 to point toward the tip 154 ​​of the opposing microhook 150, toward at least one axis of symmetry 117 (shown in FIG. 3 ) of the second major surface 114, and / or toward the surface centroid 113 (shown in FIG. 3 ) of the second major surface 114. In various embodiments, the overall shape of the microhooks may resemble the beak or talons of a bird of prey, having a curved pyramidal structure terminating in a sharp tip, allowing for better penetration into the skin of a patient using a fixation device.

[0062] FIG. 5 illustrates a top perspective view of a portion of a fixation device 100 according to one embodiment of the present disclosure.

[0063] As mentioned above, the clip 120 is coupled to the body 110 and extends from the first major surface 112. Additionally, the clip 120 is configured to at least partially receive the medical article 10 (shown in FIG. 1 ) therethrough and releasably secure the medical article 10 to the body 110.

[0064] As shown in FIG. 5, the clip 120 may include a clip base 122 coupled to the body 110 and extending from the first major surface 112 of the body 110 .

[0065] The clip 120 may further include a split ring 124 resiliently coupled to the clip base 122. The split ring 124 may be resiliently coupled to the clip base 122 by a ring coupling portion 136. Additionally, the split ring 124 may be configured to at least partially receive the medical article 10 therethrough (as shown in FIG. 1 ).

[0066] The split ring 124 may include a first ring portion 124A proximal to the clip base 122 and a second ring portion 124B distal to the clip base 122. The second ring portion 124B may be integral with the first ring portion 124A. Additionally, the second ring portion 124B may be connected to the first ring portion 124A by a ring connecting portion 124C.

[0067] The second ring portion 124B may include an outer ring surface 125 facing away from the first ring portion 124A. The second ring portion 124B may further include a plurality of locking teeth 126 extending from the outer ring surface 125.

[0068] Split ring 124 may be deformable and movable relative to clip base 122 such that a gap 139 between first ring portion 124A and second ring portion 124B can be adjusted. Adjusting gap 139 between first ring portion 124A and second ring portion 124B can allow adjustment of width 124W of split ring 124. Gap 139 also allows for insertion of a medical line into the circular opening of clip 120 when second ring portion 124B is not engaged with locking arm 128. Second ring portion 124B can then engage locking arm 128 to secure the medical line within the circular opening, as best shown in FIG. 1 .

[0069] The clip 120 may further include a locking arm 128 resiliently coupled to and extending from the clip base 122. Specifically, the locking arm 128 may be resiliently coupled to the clip base 122 by an arm coupling portion 138. The locking arm 128 may include a plurality of detents 130 that correspond to the plurality of predetermined widths of the split ring 124.

[0070] The second ring portion 124B may be resiliently movable relative to the locking arm 128 in a first direction 132. Each detent 130 of the plurality of detents 130 may be configured to selectively lockingly engage a corresponding locking tooth 126 of the plurality of locking teeth 126 to prevent the second ring portion 124B from moving in a second direction 134 opposite the first direction 132. Thus, the plurality of detents 130 and the plurality of locking teeth 126 may form a ratchet pawl mechanism.

[0071] 5, each locking tooth 126 may include a tooth curved surface 127 and a tooth flat 129 opposite the tooth curved surface 127. Further, each detent 130 may include a detent curved surface 131 and a detent flat 133. The tooth curved surface 127 may be configured to movably engage the detent curved surface 131 to allow the second ring portion 124B to move in the first direction 132. Further, the tooth flat 129 may be configured to lockingly engage the detent flat 133 to prevent the second ring portion 124B from moving in the second direction 134.

[0072] Thus, the width 124W of the split ring 124 may be adjusted by selectively lockingly engaging one or more of the plurality of detents 130 with a corresponding one or more of the plurality of locking teeth 126 such that the medical article 10 can be at least partially received therethrough (as shown in FIG. 1 ). To reduce the gap 139 and width 124W, the second ring portion 124B may be moved along a first direction 132 toward the clip base 122. When the desired width 124W is achieved, releasing the second ring portion 124B may cause engagement of a detent flat 133 of one or more of the plurality of detents 130 with a corresponding tooth flat 129 of the plurality of locking teeth 126 such that the split ring 124 is secured at the desired width 124W. To expand width 124W, for example to remove medical article 10, locking arm 128 and split ring 124 may be moved away from one another such that detents 130 may disengage from locking teeth 126. As a result, second ring portion 124B may move freely in second direction 134, thereby allowing gap 139 and a desired increase in width 124W or, alternatively, second ring portion 124B to fully disengage from locking arm 128 when it is desired to remove the medical line from the circular opening.

[0073] Split ring 124 may be designed to accommodate a variety of medical articles. For example, width 124W of split ring 124 may be adjustable between about 1 mm and 3 mm. This may allow split ring 124 to accommodate medical articles of standardized shapes and sizes.

[0074] FIG. 6 shows a schematic block diagram of a kit 200 according to one embodiment of the present disclosure.

[0075] The kit 200 includes the immobilization device 100 and the gel pad 140. As mentioned above, the gel pad 140 may be configured to be at least partially received within the opening 118 (shown in FIG. 1 ) and cover the insertion site 25. The kit 200 may further include gloves, sterile materials, wipes or other absorbent materials, and antiseptics (e.g., chlorhexidine gluconate). The kit 200 may further include cleaning articles such as cleaning wipes, cotton wool, cotton swabs, etc. The kit 200 may be available to the clinician for use in sterile packaging.

[0076] Figure 7 shows a flow chart illustrating a method 300 of using the kit 200 of Figure 6, according to one embodiment of the present disclosure. Method 300 is also shown generally in Figures 8A-8I and will be described with reference to Figures 7 and 8A-8I.

[0077] 8A, the method 300 includes, at step 310, positioning the fixation device 100 against the skin 22 of the user 20 such that the second major surface 114 of the body 110 faces the skin 22.

[0078] Method 300 further includes, at step 320, slidably inserting at least one medical line 12 through groove 116 such that at least one medical line 12 is at least partially received through opening 118 of body 110. For example, as shown in Figures 8B-8D, fixation device 100 may be slid along direction D1 toward at least one medical line 12 such that at least one medical line 12 is slidably inserted through groove 116 and at least one medical line 12 is at least partially received through opening 118 of body 110.

[0079] 8E, at step 330, the method 300 further includes inserting the medical article 10 at least partially through the clip 120 to removably secure the medical article 10 to the body 110. In some examples, inserting the medical article 10 at least partially through the clip 120 may occur when there is a gap when the second ring portion 124B is not engaged with the locking arm 128. In some examples, inserting the medical article 10 at least partially through the clip 120 may further include adjusting a width of the clip 120 (i.e., width 124W of the split ring 124, shown in FIG. 5 and described above) based on a width of the medical article 10.

[0080] At step 340 , the method 300 further includes inserting a plurality of micro hooks 150 into the skin 22 of the user 20 such that the body 110 is secured to the skin 22 of the user 20 .

[0081] In some examples, inserting the plurality of microhooks 150 into the skin 22 of the user 20 may further include inserting at least some of the plurality of microhooks 150 proximal to the first end 102 of the body 110 into the skin 22 of the user 20, stretching the body 110, and inserting at least some of the plurality of microhooks 150 proximal to a second end 104 opposite the first end 102 of the body 110 into the skin 22 of the user 20. For example, as shown in FIGS. 8F-8H, after inserting at least some of the plurality of microhooks 150 proximal to the first end 102 of the body 110 into the skin 22, the body 110 may be stretched at the second end 104, and then at least some of the plurality of microhooks 150 proximal to the second end 104 of the body 110 may be inserted into the skin 22.

[0082] 8I, the method 300 further includes, at step 350, at least partially inserting the gel pad 140 into the opening 118 such that the gel pad 140 covers the insertion site 25. The gel pad 140 may include a pre-made slit for receiving the at least one medical line 12 therethrough.

[0083] The method 300 may enable a clinician or user to conveniently use the kit 200 to secure the medical article 10 to the skin 22 via the securement device 100.

[0084] Unless otherwise indicated, all numbers expressing feature sizes, quantities, and physical properties used in the specification and claims should 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 may vary depending upon the desired properties desired to be obtained by one of ordinary skill in the art utilizing the teachings of the present disclosure.

[0085] Although specific embodiments have been illustrated and described herein, those skilled in the art will appreciate that the specific embodiments illustrated and described may be substituted with various alternative and / or equivalent implementations 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 securement device for securing a medical article having at least one medical line insertable into a user's skin at an insertion site, the securement device comprising: A main body, a first major surface; a second major surface opposite the first major surface, the second major surface configured to face the skin of the user; and a perimeter extending between the first major surface and the second major surface; a body including a groove extending from the perimeter and extending through the body from the first major surface to the second major surface, the groove being configured to slidably receive at least one medical line therethrough; a clip coupled to the body and extending from the first major surface, the clip configured to at least partially receive the medical article therethrough and releasably secure the medical article to the body; a plurality of microhooks coupled to the body and extending from the second major surface, the plurality of microhooks being spaced apart from one another and configured to be at least partially inserted into the skin of the user to secure the body to the skin, each microhook of the plurality of microhooks comprising a base disposed on the second major surface and a tip distal to the base, the plurality of microhooks comprising at least one microhook and at least one opposing microhook facing the at least one microhook, the respective tips of the at least one microhook and the at least one opposing microhook pointing towards each other; A fixing device comprising:

2. 2. The fixation device of claim 1, wherein the second major surface defines a surface centroid, and the plurality of microhooks includes at least one first microhook, the tip of the at least one first microhook pointing toward the surface centroid.

3. 3. The fixation device of claim 2, wherein the at least one first microhook comprises a set of first microhooks arranged in a circular array about the surface centroid, a tip of each first microhook of the set of first microhooks pointing toward the surface centroid.

4. 4. The fixation device of claim 3, wherein the body further comprises an opening extending therethrough in communication with the groove, the opening configured to at least partially receive the at least one medical line, the opening further configured to at least partially receive a gel pad, the surface centroid of the second major surface disposed within the opening, and the set of first micro hooks disposed at least partially around the opening.

5. The fixation device of claim 4 , wherein said opening is circular and defines a center, said center of said opening coinciding with said surface centroid of said second major surface.

6. The fixation device of claim 5 , wherein a maximum width of said groove is less than a diameter of said opening.

7. 4. The fixation device of claim 3, wherein the set of first microhooks comprises at least two first microhooks disposed diametrically opposite one another, with respective tips of the at least two first microhooks pointing toward one another.

8. 4. The fixation device of claim 3, wherein the set of first microhooks includes at least one first microhook disposed on opposite sides of the groove, a tip of the at least one first microhook pointing toward the groove.

9. The fixation device of claim 3 , wherein the set of first microhooks includes at least two first microhooks disposed on opposite sides of the groove.

10. 3. The fixation device of claim 2, wherein the groove extends linearly from the perimeter toward the surface centroid of the second major surface such that a length of the groove is between about 30% and about 50% of a maximum length of the body.

11. 2. The fixation device of claim 1, wherein the plurality of microhooks includes a set of second microhooks arranged in a pair of rectangular arrays disposed on either side of the groove, with a tip of each second microhook in the set of second microhooks pointing toward the groove.

12. 2. The fixation device of claim 1, wherein said second major surface defines at least one axis of symmetry, and said plurality of microhooks includes a set of third microhooks arranged in a pair of rectangular arrays disposed on either side of said axis of symmetry, with a tip of each third microhook in said set of third microhooks pointing toward said axis of symmetry.

13. The fixation device of claim 1 , wherein at least 50% of the area of ​​said second major surface is devoid of said plurality of microhooks.

14. 2. The fixation device of claim 1, wherein the base defines a base plane, a base region within the base plane, and a base centroid of the base region, and an imaginary line connecting the tip and the base centroid is inclined obliquely relative to the base plane.

15. The fixation device of claim 14, wherein the imaginary line is obliquely inclined with respect to the base plane at an inclination angle of about 20 degrees to about 70 degrees.

16. 15. The fixation device of claim 14, wherein each microhook defines a hook axis extending along its length from the base centroid to the tip, the hook axis being curved or straight.

17. 15. The fixation device of claim 14, wherein the tip of each microhook faces away from the base such that an imaginary perpendicular line extending from the tip perpendicular to the plane of the base is outside the base.

18. The fixation device of claim 1 , wherein at least one microhook of the plurality of microhooks has a square cross-sectional shape.

19. 10. The fixation device of claim 1, wherein each microhook of the plurality of microhooks defines a height between the base and the tip, the height being between about 300 microns (μm) and about 600 μm.

20. The fixation device of claim 1 , wherein each microhook of the plurality of microhooks has a solid configuration without channels.

21. The fixation device of claim 1 , wherein the body has a modulus of elasticity of about 0.1 megapascals (MPa) to about 1000 MPa.

22. The fixation device of claim 1 , wherein the body comprises at least one of polyurethane, neoprene, polyester, butyl rubber, silicone, and polymer foam.

23. 10. The fixation device of claim 1, wherein each of the plurality of microhooks comprises at least one of stainless steel, carbon fiber reinforced polymer, poly(methyl methacrylate), soluble polyester, nickel alloy, and titanium alloy.

24. The fixation device of claim 1 , wherein the body is substantially rectangular with rounded corners.

25. The clip is a clip base coupled to the body and extending from the first major surface of the body; a split ring resiliently coupled to the clip base, the split ring including a first ring portion proximal to the clip base, a second ring portion distal to the clip base and including an outer ring surface facing away from the first ring portion, and a plurality of locking teeth extending from the outer ring surface, the split ring configured to at least partially receive the medical article therethrough; a locking arm resiliently coupled to the clip base and extending from the clip base, the locking arm including a plurality of detents corresponding to a plurality of predetermined widths of the split ring; Equipped with the second ring portion is resiliently movable relative to the locking arm in a first direction, and each detent of the plurality of detents is configured to selectively lockingly engage a corresponding one of the plurality of locking teeth to prevent movement of the second ring portion in a second direction opposite the first direction. The fixation device of claim 1 .

26. 26. The fixation device of claim 25, wherein each locking tooth comprises a tooth surface and a tooth plane opposite the tooth surface, and each detent comprises a detent surface and a detent plane, the tooth surface configured to movably engage the detent surface to permit movement of the second ring portion in the first direction, and the tooth plane configured to lockingly engage the detent plane to prevent movement of the second ring portion in the second direction.

27. A kit comprising:

1. A securement device for securing a medical article having at least one medical line insertable into a user's skin at an insertion site, the securement device comprising: A main body, a first major surface; a second major surface opposite the first major surface, the second major surface configured to face the skin of the user; a perimeter extending between the first major surface and the second major surface; a groove extending from the perimeter and through the body from the first major surface to the second major surface, the groove being configured to slidably receive at least one medical line therethrough; an opening extending therethrough and in communication with the groove, the opening being configured to at least partially receive the at least one medical line therethrough; A main body comprising: a clip coupled to the body and extending from the first major surface, the clip configured to at least partially receive the medical article therethrough and releasably secure the medical article to the body; a fixation device comprising: a plurality of microhooks coupled to the body and extending from the second major surface, the plurality of microhooks being spaced apart from one another and configured to be at least partially inserted into the skin of the user to secure the body to the skin, each microhook of the plurality of microhooks comprising a base disposed on the second major surface and a tip distal to the base, the plurality of microhooks comprising at least one microhook and at least one opposing microhook facing the at least one microhook, the respective tips of the at least one microhook and the at least one opposing microhook pointing towards each other; a gel pad configured to be at least partially received within the opening and cover the insertion site, the gel pad comprising chlorhexidine gluconate; A kit comprising:

28. 28. The kit of claim 27, wherein the second major surface defines a surface centroid, the plurality of microhooks includes at least one first microhook, and the tip of the at least one first microhook points toward the surface centroid.

29. 29. The kit of claim 28, wherein the at least one first microhook comprises a set of first microhooks arranged in a circular array about the surface centroid, with a tip of each first microhook of the set of first microhooks pointing toward the surface centroid.

30. 30. The kit of claim 29, wherein the surface centroid of the second major surface is disposed within the opening and the set of first micro hooks is disposed at least partially around the opening.

31. 30. The kit of claim 29, wherein the opening is circular and defines a center, the center of the opening coinciding with the surface centroid of the second major surface.

32. 28. The kit of claim 27, wherein the maximum width of the groove is less than the diameter of the opening.

33. 30. The kit of claim 29, wherein the set of first microhooks comprises at least two first microhooks arranged diametrically opposite one another, with respective tips of the at least two first microhooks pointing towards one another.

34. 30. The kit of claim 29, wherein the set of first microhooks includes at least one first microhook disposed on opposite sides of the groove, a tip of the at least one first microhook pointing toward the groove.

35. 30. The kit of claim 29, wherein the set of first microhooks comprises at least two first microhooks disposed on opposite sides of the groove.

36. 30. The kit of claim 28, wherein the groove extends linearly from the perimeter of the second major surface toward the surface centroid such that a length of the groove is between about 30% and about 50% of a maximum length of the body.

37. 28. The kit of claim 27, wherein the plurality of microhooks includes a set of second microhooks arranged in a pair of rectangular arrays disposed on either side of the groove, with a tip of each second microhook in the set of second microhooks pointing toward the groove.

38. 28. The kit of claim 27, wherein the second major surface defines at least one axis of symmetry, and the plurality of microhooks includes a set of third microhooks arranged in a pair of rectangular arrays disposed on either side of the axis of symmetry, and a tip of each third microhook in the set of third microhooks points toward the axis of symmetry.

39. 30. The kit of claim 27, wherein at least 50% of the area of ​​said second major surface is devoid of said plurality of microhooks.

40. 28. The kit of claim 27, wherein the base defines a base plane, a base region within the base plane, and a base centroid of the base region, and an imaginary line connecting the tip and the base centroid is inclined obliquely relative to the base plane.

41. 41. The kit of claim 40, wherein the imaginary line is inclined obliquely with respect to the base plane at an inclination angle of about 20 degrees to about 70 degrees.

42. 41. The kit of claim 40, wherein each microhook defines a hook axis extending along its length from the base centroid to the tip, the hook axis being curved or straight.

43. 41. The kit of claim 40, wherein the tip of each microhook faces away from the base such that an imaginary perpendicular line extending from the tip perpendicular to the plane of the base is outside the base.

44. 30. The kit of claim 27, wherein at least one microhook of the plurality of microhooks has a square cross-sectional shape.

45. 28. The kit of claim 27, wherein each microhook of the plurality of microhooks defines a height between the base and the tip, the height being between about 300 (μm) and about 600 μm.

46. 30. The kit of claim 27, wherein each microhook of the plurality of microhooks has a solid configuration without channels.

47. 28. The kit of claim 27, wherein the body has an elastic modulus of about 0.1 megapascals (MPa) to about 1000 MPa.

48. 28. The kit of claim 27, wherein the body comprises at least one of polyurethane, neoprene, polyester, butyl rubber, silicone, and polymer foam.

49. 28. The kit of claim 27, wherein each of the plurality of microhooks comprises at least one of stainless steel, carbon fiber reinforced polymer, poly(methyl methacrylate), soluble polyester, nickel alloy, and titanium alloy.

50. 28. The kit of claim 27, wherein the body is substantially rectangular with rounded corners.

51. The clip is a clip base coupled to the body and extending from the first major surface of the body; a resilient split ring resiliently coupled to the clip base, the resilient split ring including a first ring portion proximal to the clip base, a second ring portion distal to the clip base and including an outer ring surface facing away from the first ring portion, and a plurality of locking teeth extending from the outer ring surface, the split ring configured to at least partially receive the medical article therethrough; a locking arm resiliently coupled to the clip base and extending from the clip base, the locking arm including a plurality of detents corresponding to a plurality of predetermined widths of the split ring; Equipped with the second ring portion is resiliently movable relative to the locking arm in a first direction, and each detent of the plurality of detents is configured to selectively lockingly engage a corresponding one of the plurality of locking teeth to prevent movement of the second ring portion in a second direction opposite the first direction.

28. The kit of claim 27.

52. 52. The kit of claim 51, wherein each locking tooth comprises a tooth surface and a tooth plane opposite the tooth surface, and each detent comprises a detent surface and a detent plane, the tooth surface configured to movably engage the detent surface to permit movement of the second ring portion in the first direction, and the tooth plane configured to lockingly engage the detent plane to prevent movement of the second ring portion in the second direction.

53. 28. A method of using the kit of claim 27, comprising: positioning the fixation device against the skin of the user such that the second major surface of the body faces the skin; slidably inserting the at least one medical line through the channel such that the at least one medical line is at least partially received through the opening in the body; inserting the medical article at least partially through the clip to releasably secure the medical article to the body; inserting the plurality of microhooks into the skin of the user such that the body is secured to the skin of the user; inserting the gel pad at least partially into the opening such that the gel pad covers the insertion site; A method comprising:

54. 54. The method of claim 53, wherein inserting the medical article at least partially through the clip further comprises adjusting a width of the clip based on a width of the medical article.

55. inserting the plurality of microhooks into the skin of the user, inserting at least some of the plurality of microhooks proximal to a first end of the body into the skin of the user; stretching the body; inserting at least some of the plurality of microhooks proximate a second end of the body opposite the first end into the skin of the user; 54. The method of claim 53, further comprising:

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