The present disclosure relates to a securement assembly comprising an adhering element and a securing element and a method of using the adhering element and securing element to secure a device.
Adhesive tapes and medical dressings are used in a variety of application for securing material to a substrate. In some applications, the adhesive of the tape may secure well to the substrate, but not be well suited for securing with the device. For example, silicone adhesives do not strongly secure to polymeric devices. In some applications, placement of the device directly in contact with the substrate, over which the adhesive tape is applied, can cause damage to the underlying substrate. For example, rigid devices placed adjacent to skin for an extended period of time can cause skin irritation or even pressure ulcers.
The securement assembly uses a combination of adhesive as well as mechanical fasteners for effectively securing a device to a surface. The securement assembly can be used to protect the surface from the device being secured. The securement assembly comprises an adhering element with a first mechanical fastener and a securing element with a second mechanical fastener, wherein in some embodiments the securing element can serve as both a cover for the adhesive on the adhering element while also providing the securement between the first mechanical fastener and second mechanical fastener.
In one embodiment, the securement assembly comprises an adhering element and a securing element. The adhering element comprises a first surface comprising a first mechanical fastener, a second surface, opposite the first surface, comprising an adhesive. The securing element comprises a first surface, a second surface, opposite the first surface, a second mechanical fastener on at least the first surface or second surface of the securing element, wherein the second mechanical fastener is configured to secure with the first mechanical fastener. The first surface of the securing element covers and releasably secures to the adhesive of the second surface of the adhering element.
In one embodiment the securement assembly comprises and adhering element and a securing element. The adhering element comprises a first surface comprising a first mechanical fastener, a second surface, opposite the first surface, comprising an adhesive. The securing element, removable from the adhering element, comprises a first surface, a second surface, opposite the first surface, a second mechanical fastener on at least one of the first surface or second surface of the securing element. The second mechanical fastener secures to the first mechanical fastener.
In one embodiment, the securement assembly comprises an adhering element and a securing element. The adhering element comprises a first surface comprising a first plurality of stems or hooks, a second surface, opposite the first surface, comprising an adhesive. The securing element comprises a first surface, a second surface, opposite the first surface, comprising a second plurality of stems or hooks. A working adhesive is partially embedded into at least one of the first or second plurality of stems or hooks. The first plurality of stems or hooks secures to the second plurality of stems or hooks. A device is positioned between a portion of the first surface of the adhering element and the securing element.
In one embodiment, a method of securing a tape comprises providing a securement assembly, wherein the securement assembly comprises an adhering element comprising a first surface comprising a first mechanical fastener and a second surface, opposite the first surface, comprising an adhesive, a securing element comprising a first surface and a second surface, opposite the first surface, and a second mechanical fastener on at least one of the first surface or second surface of the securing element to secure with the first mechanical fastener, wherein the securing element covers the adhesive of the second surface of the adhering tape, and removing the securing element from the adhering element, and securing the adhesive of the second surface of the adhering element to a surface.
In one embodiment, a method of securing a device comprises providing an adhering element comprising a first surface comprising a first plurality of stems or hooks and a second surface, opposite the first surface, comprising an adhesive, securing the adhesive to a surface, providing a securing element comprising a first surface and a second surface, opposite the first surface, comprising a second plurality of stems or hooks, placing a device on the adhering element, covering at least a portion of the device with the securing element, securing the first plurality of stems or hooks with the second plurality of stems or hooks, where a working adhesive is partially embedded into at least one of the first or second plurality of stems or hooks.
While the above-identified drawings and figures set forth embodiments of the invention, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents the invention by way of representation and not limitation. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of this invention. The figures may not be drawn to scale.
The adhesive 235 may be any type of adhesive useful for securing the adhering element 200 to a surface 500. The type of adhesive selected will depend on the desired properties of peel force, shear force, permanence, removability, characteristics of adherent, etc. Typically, the adhesive 235 will be a pressure sensitive adhesive, which can adhere to a surface with application of light pressure and without the need for heat or other external sources to active adhesion. For example, the adhesive may be an acrylate, silicone, urethane, polyolefin, synthetic rubber, or natural rubber based adhesive.
When the surface to which the adhering element is applied is skin, it may be desirable that the adhesive 235 hold well to the skin, but does not irritate or damage the skin during use or upon removal. Commonly used adhesives for application to skin are acrylate and silicone adhesives. Acrylate adhesives are well suited for securing to skin. The adhesion can be manipulated to have high adhesion or low adhesion. Suitable acrylate adhesives that can be applied to skin such as the acrylate copolymers are described in U.S. Pat. No. RE 24,906, the disclosure of which is hereby incorporated by reference. In particular, a 97:3 iso-octyl acrylate:acrylamide copolymer. Another acrylate adhesive is an 70:15:15 isooctyl acrylate:ethyleneoxide acrylate:acrylic acid terpolymer, as described in U.S. Pat. No. 4,737,410 (Example 31), the disclosure of which is hereby incorporated by reference. Other useful acrylate adhesives are described in U.S. Pat. Nos. 3,389,827; 4,112,213; 4,310,509; and 4,323,557, the disclosures of which are hereby incorporated by reference.
Generally, silicone adhesives are able to effectively secure dressings and tapes to skin and upon removal from the skin produce little or no skin damage. Typically, the silicone adhesives do not adhere well to polymer-based substrates, like tubing or hardgoods. The gentle removal of silicone adhesives from skin makes silicone adhesives well suited as the adhesive intended to contact the skin.
An example of a suitable silicone adhesive is disclosed in PCT Publications WO2010/056541 and WO2010/056543, the disclosures of which are herein incorporate by reference. A radiation cured silicone adhesive is particularly well suited for this application because the extent of crosslinking, and therefore adhesion of the silicone adhesive can be better controlled. Other examples of silicone gel adhesives systems include products marketed with the trade names: Dow Corning MG 7-9850, Wacker SILPURAN® 2110 and 2130, Bluestar SILBIONE® RT Gel 4317 and 4320, Nusil MED-6345 and 6350.
Optionally, backing 210 on the adhering element 200, if included, could be treated physically (e.g., corona, plasma, or flame treatment) or chemically (e.g., primer, adhesion promoter) before the adhesive 235 is applied in order to enhance the adhesion of adhesive 235 on backing 210.
The adhesive 235 may cover all or a portion of the second surface 230 of the adhering element 200. Also, the adhesive 235 may be applied to the second surface 230 in a discontinuous pattern or may be perforated. When the adhering element 200 is applied to skin, it is particularly desirable to have perforations or a pattern coating of adhesive to allow for moisture vapor to move away from the skin and out of the adhering element 200. For example, U.S. Pat. No. 4,595,001 and U.S. Pat. App. Pub. 2008-0233348, the disclosures of which are herein incorporated by reference, disclose a method of pattern coating adhesive.
The adhering element 200, and backing 210 if included, may be constructed from any number of common materials such as, for example, paper, film, foam, fabric, or nonwoven, to which the adhesive 235 is applied. The adhering element 200, and backing 210 if included, may comprise one or more layers of materials secured to one another. In some embodiments, the material selected for the adhering element 200 may itself serve as the first mechanical fastener 225, such as shown in
Overall, the thickness, stiffness, flexibility, permeability of the adhering element 200 will depend on the particular application and surface 500 to which the adhering element 200 is secured. For example, if the surface 500 is skin it may be desirable that the adhering element 200 is highly flexible and conformable to anatomical surface. Also, it may be desirable that the adhering element 200 allow for high moisture vapor permeability, but generally impermeable to liquid water so that microbes and other contaminants are sealed out from the area under the adhering element 200. One example of a suitable material is nonwoven or woven fabric. Another example of a suitable material is a high moisture vapor permeable film such as described in U.S. Pat. Nos. 3,645,835 and 4,595,001, the disclosures of which are herein incorporated by reference. In high moisture vapor permeable film/adhesive composites, the composite should transmit moisture vapor at a rate equal to or greater than human skin such as, for example, at a rate of at least 300 g/m2/24 hrs at 37° C./100-10% RH, or at least 700 g/m2/24 hrs at 37° C./100-10% RH, or at least 2000 g/m2/24 hrs at 37° C./100-10% RH using the inverted cup method as described in U.S. Pat. No. 4,595,001. In one embodiment, the backing 210 is an elastomeric polyurethane, polyester, or polyether block amide films. These films combine the desirable properties of resiliency, high moisture vapor permeability, and transparency.
First mechanical fastener 225 and second mechanical fastener 325 are selected so that a secure mechanical, interlocking interaction is formed when placed in contact with one another. In one embodiment, the first mechanical fastener 225 and second mechanical fastener 325 are reclosable, so that an interlocking interaction is formed that can be opened and reclosed. In one embodiment, the first mechanical fastener 225 and second mechanical fastener 325 are able to interlock with one another to secure, but with sufficient force are able to disengage. In one embodiment, depending on the selection of both materials for achieving mechanical fastening, the first or second mechanical fasteners may comprise various constructions of hooks, loops, or stems, each of which may include selectively placed adhesive.
In one embodiment, as shown in
A hook as used herein is a fastening element that interlocks with a corresponding hook or interlocks with a loop material. Typically, a plurality of hooks are provided. In some embodiment, a hook is a generally outward projecting post with a laterally extending portion, which can interlock with a corresponding hook or loop material. Exemplary hook designs are disclosed in U.S. Pat. Nos. 5,845,375; 5,077,870; 5,607,635; and 5,679,302 the disclosures of which are herein incorporated by reference.
The hooks can be integral (that is, formed at the same time as a unit, unitary) with a backing. Upstanding posts on a backing can be made, for example, by feeding a thermoplastic material onto a continuously moving mold surface with cavities having the inverse shape of the posts. The thermoplastic material can be passed between a nip formed by two rolls or a nip between a die face and roll surface, with at least one of the rolls having the cavities. Pressure provided by the nip forces the resin into the cavities. In some embodiments, a vacuum can be used to evacuate the cavities for easier filling of the cavities. The nip typically has a large enough gap such that a coherent backing is formed over the cavities. The mold surface and cavities can optionally be air or water cooled before stripping the integrally formed backing and upstanding hook elements from the mold surface such as by a stripper roll. If the posts formed upon exiting the cavities do not have loop-engaging heads, loop-engaging heads could be subsequently formed into hooks by a capping method as described in U.S. Pat. No. 5,077,870 (Melbye et al.). Typically, the capping method includes deforming the tip portions of the hook elements using heat and/or pressure. The heat and pressure, if both are used, could be applied sequentially or simultaneously.
A stem as used herein is a fastening element that could be used as the first and/or second mechanical fastener. A stem is a protrusion that projects from a surface. While hooks generally have an overhang, or other portion that projects laterally from the main body of the hook to create the interlocking fastening system, a stem typically does not have a portion that projects laterally from the main body of the stem. In one embodiment, a stem will have linear side walls or slightly tapered side walls. A plurality of stems provide for a high amount of surface area to resist shear forces between the stems and the surface it is contacting.
In one embodiment, the securing element 300 covers the adhesive 235 of the adhering element 200 to serve as a protective liner over the adhesive 235 of the adhering element 200. The securing element 300 is removable from the adhesive 235 of the adhering element 200. Specifically, the first surface 320 of the securing element 300 can be removed from the adhesive 235. In one embodiment, once the securing element 300 is removed, the adhering element 200 (
In one embodiment, a portion of the securing element 300 extends beyond the adhesive 235 of the adhering element 200 to form a tab 340 to aid in removing the securing element 300 from the adhering element 200. In one embodiment, the adhesive 235 may not extend completely to the edge of the second surface 230 of the adhering element 200 such that a tab 240 is formed to aid in removing the securing element 300 from the adhering element 200. In one embodiment, such as would be applicable for
The securing element 300 can be formed of one or more layers of material, such as, for example, paper, film, foam, fabric, or nonwoven. Typically, the securing element 300 will be relatively flexible to allow for a drapable arrangement over a device 600 while still coming into contact with the first mechanical fastener 225 on the adhering element 200 (see
The exposed adhesive 235 of the adhering element 200 can be applied to a surface 500. In one embodiment, the adhering element 200 can be used alone for securement to a surface 500. For example,
In one embodiment, the adhering element 200 can be used with the securing element 300 for securement with an optional underlying device 600 to a surface 500. For example,
The securement assembly 100 shown in
In addition,
In addition,
As shown in
It is understood that any suitable material can be provided that when in contact with the device 600 can provide additional securement. For example, stems (see U.S. Pat. Nos. 6,372,323; 6,610,382; and 6,904,615), hook material, loop material, or adhesive could be used to further secure the device 600. The friction control element 400 can be located on the device 600, such as shown in
Optionally, the first mechanical fastener 225, second mechanical fastener 325 or both may include a working adhesive 226, 326, respectively, such as shown in
Specifically,
In one embodiment, the stems are included in a density of at least 500 stems per square inch. In one embodiment, the stems are included in a density of at least 1000 stems per square inch. In one embodiment the stems have a height at least 50 microns. In one embodiment the stems have a height of at least 100 microns. In one embodiment, the stems have a height less than 500 microns.
When a working adhesive is included in an embodiment where the mechanical fastener is either stems or hooks, the working adhesive may be provided the full height of the stems or hooks or may be recessed from the stems or hooks. Such recessed working adhesives on a plurality of stems or hooks may be coated in a variety of ways, including solvent coating or bulk coating.
A variety of factors, such a stem/hook density, stem/hook flexibility may impact the apparent tackiness of the recessed adhesive. High tackiness may help enable securement of the secured tubing or medical device, but low tackiness prevents the material from sticking to gloved fingers. In one embodiment, a plurality of stems/hooks with a working adhesive will have not finger tack with the working adhesive provided less that 25% of the stem/hook height. In one embodiment, a plurality of stems/hooks with a working adhesive will have slight finger tack with the working adhesive provided between 25% and 45% of the stem/hook height. In one embodiment, a plurality of stems/hooks with a working adhesive will have good finger tack with the working adhesive provided at greater than 45% of the stem/hook height. It is understood that a protective release liner could be used to cover the surface that contains a working adhesive.
Optionally, securing element 300 could have an opening 350, wherein at least a portion of the device 600 could pass through.
The surface and device can be any number of types and materials. For example, the surface may be rigid or compliant, plastic, glass, wood, fabric, or skin. The device can be any kind of device that is desired to be secured to a surface. For example, the device may be rigid or compliant, plastic, glass, wood, fabric and be for electrical, medical, or various types of application. In one specific application, the surface is skin and the device is a medical device, such as a tube, catheter, port, or pump.
The securement assembly 100 can be provided in any number of forms. For example, the securement assembly 100 may be an elongated in a roll and torn or cut to the desired length for use. However, for the construction shown and described in
Although the first and second mechanical fastener 225, 325 are shown over most of the surface of the adhering element 200 and securing element 300, respectively, it is understood that either adhering element 200 or securing element 300 may include the mechanical fasteners over only a small portion of the surface area. For example, a medical dressing, such as a dressing used to cover an intravenous catheter may use the securement assembly 100 construction such that the adhering element 200 is applied to skin and the overlying securing element 300 covers and secures the outwardly projecting medical tubes. In this example, only portions of either the adhering element 200 or securing element 300 might include the mechanical fasteners.
Various embodiments have been described. It is understood that the medical dressing can be provided in a number of sizes, shapes, configurations, in a package, sterilized, with or without liners covering any of the exposed or tacky adhesive surfaces. It is understood that various features, material, components described in one of the embodiment could be used and incorporated into one or more of the other disclosed embodiments. For example any one of the described adhering element could be used with any one of the described securing elements. Additionally, it is understood that additional features such as working adhesive, tabs, or backings described with one embodiment may be applicable to other embodiments.
Although specific embodiments of this invention have been shown and described herein, it is understood that these embodiments are merely illustrative of the many possible specific arrangements that can be devised in application of the principles of the invention. Numerous and varied other arrangements can be devised in accordance with these principles by those of ordinary skill in the art without departing from the spirit and scope of the invention. Thus, the scope of the present invention should not be limited to the structures described in this application, but only by the structures described by the language of the claims and the equivalents of those structures.
Filing Document | Filing Date | Country | Kind |
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PCT/US2013/030431 | 3/12/2013 | WO | 00 |
Number | Date | Country | |
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61673868 | Jul 2012 | US |