Patent Application
20220380632
The disclosure relates to a film backing for releasably securing a device to a surface, such as skin.
Various medical devices are attached to a patient. For example, tubing, monitors, sensors, or catheters are secured to skin. To limit irritation, dislodgement, and potential exposure to infection, the medical devices should be securely attached to the patient. Adhesives and adhesive tapes are commonly used to secure devices to skin. Very strong adhesives can cause trauma to skin upon removal. A very gentle adhesive will remove from the skin easily but might not have sufficient strength to secure the medical device.
The disclosed film backing has an extensible substrate with a securing adhesive that can secure to a surface and a tab to stretch the extensible substrate to remove the adhesive from the underlying surface. Stretching the extensible substrate will release the securing adhesive from the underlying surface easily and without trauma. Therefore, a strong adhesive can be used.
Stretch release tape are known for securing items to a surface, such as walls. For example, 3M™ Command™ tape is a stretch release tape with a foam substrate coated on both surfaces with a strong adhesive. One example of a low modulus material is described in PCT Publication WO2017/136432. Some stretch release materials have high elongation. Therefore, the extensible substrate must stretch significantly to release the adhesive from the underlying surface. In some application, there is simply insufficient space to allow for such stretching. Further, it is common that stretch release materials are elastic and the energy input to elongate the film can release when the adhesive detaches from the underlying substrate, which can cause snapping or catapulting of any overlying device.
When looking to secure a stretch release tape to an underlying substrate that is conformable, such as skin, the extensible substrate should have a low modulus to minimize the force required to stretch and pull the extensible substrate. The extensible substrate should have low elongation to minimize the distance needed to stretch and pull the extensible substrate. Further, it is desirable that a majority of the deformation of the extensible substrate be plastic deformation and that its elastic deformation be minimized. Plastic deformation of the extensible substrate reduces the energy released upon the removal of stress, since the energy input to the extensible substrate is consumed by the re-ordering the film morphology rather than stored as potential energy in elastic structures. Less stored energy improves safety during the removal of devices held in place with an extensible substrate. The combination of low modulus and large degree of plastic deformation makes one-handed stretch and removal of the extensible substrate from the surface possible, without the hazard of the extensible substrate and an overlying device, if included, from being snapped painfully into the removing hand.
To achieve plastic deformation, the disclosed extensible substrate has a core and at least first skin on one side of the core. In some embodiments, there is a first skin on a first side of the core and a second skin on the second, opposite, side of the core. Multilayer films designed for maximum strength often include an elastic layer forming the core sandwiched between two plastically-deforming layers forming the skin. To minimize the elasticity of the overall construction, the elastic content is minimized. The fraction of plastic material increases, and since plastics often have higher modulus values than elastics, the modulus of the film rises. It is possible to keep the modulus of the construction low enough to enable gentle removal from skin by making the total construction thinner Typically, for embodiments with a single skin, the core thickness to skin thickness ratio is less than 10:1. In one embodiment, for embodiments with a single skin, the core thickness to skin thickness ratio is less than 2:1.
Because an advantage of a stretch release materials is that a stronger adhesive can be used for securing to the underlying substrate, a tab is included that has either reduced adhesion as compared to the stronger securing adhesive or is free-of a tacky adhesive. The tab allows the user to easily lift a portion of the extensible substrate and stretch the extensible substrate to remove the securing adhesive from the underlying substrate. In some embodiments, the disclosed film backing with an extensible substrate includes two, opposing tabs.
In one embodiment, the film backing has a first major surface and a second major surface, opposite the first major surface. The film backing comprises extensible substrate comprising a core layer comprising an elastomeric material, a first skin layer adjacent to the core layer comprising a plastically deforming material, and a securing adhesive adjacent to the first major surface. The extensible substrate has a core thickness to first skin thickness ratio of less than 10 to 1, a plastic deformation of at least 50%, an elongation of less than 600%, and a Fn Modulus of less than 20 N per inch width at 50% elongation.
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. 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.
Disclosed is a film backing comprising an extensible substrate with a securing adhesive adjacent to a first major surface of the extensible substrate. The extensible backing comprises a core layer comprising an elastomeric material and a first skin layer adjacent to the core layer comprising a plastically deforming material.
To use the film backing 100, the securing adhesive 120 contacts a surface. To remove the film backing 100 from the surface, an edge of the film substrate 110 can be lifted and peeled from the surface. In embodiments with a tab 140, the tab 140 can be used to peel the film backing 100 from the surface 300. In embodiments with two opposing tabs 140, like shown in
The film backing 100 creates a stable, uniform surface for an overlying device to secure to. When the underlying substrate is skin, the texture, moisture, conformability and flexibility of the skin can vary significantly from one person to another. The disclosed film backing 100 forms a more uniform canvas for an overlying device to secure, such as shown in
In some embodiments, the securing adhesive 120 is a strong adhesive and peeling the film backing 100 from the surface is challenging. Instead, the extensible substrate 110 is pulled with a shear force to longitudinally stretch the extensible substrate 110. This process is referred to as stretch release and results in elongation of the extensible substrate 110 and release of the securing adhesive 120 from the surface 300.
In this embodiment, covers 146 are included on the securing adhesive 120 at the first major surface 102 forming a first tab 140 and second tab 145. Instead of a cover, other materials or techniques could be used to reduce the adhesive properties of the securing adhesive 120. For example, films, coating, crosslinking, curing (radiation), can be used to reduce the adhesive properties of the second adhesive 130. Reducing the adhesive properties at the tab 140, 145 allow for the tab 140, 145 to be easily peeled from the underlying surface 300. Alternatively, it is understood that the securing adhesive 120 could be only provided at a portion of the first major surface 102. For example, the securing adhesive 120 could be provided at all of the first major surface 102, except for at the tab 140, 145. For example, the securing adhesive 120 could be included at the area underlying the device 200.
In this embodiment, covers 144 are included on the second adhesive 130 at the second major surface 104 forming a first tab 140 and second tab 145. Instead of a cover, other materials or techniques could be used to reduce the adhesive properties of the second adhesive 130. For example, films, coating, crosslinking, curing (radiation), can be used to reduce the adhesive properties of the second adhesive 130. Reducing the exposed adhesive on the second major surface 104 can prevent contaminants from contacting the second adhesive 130. In some embodiments, an overlying dressing (not shown), such as a 3M Tegaderm Dressing or a 3M Tegaderm IV Dressing, is included over the film backing 100 Alternatively, it is understood that the second adhesive 130 could be only provided at a portion of the second major surface 104. For example, the second adhesive 130 could be included at the area underlying the device 200.
In this embodiment, the extensible substrate 110 with the underlying securing adhesive 120 underlies the device 200 and extends beyond the perimeter of the device 200 forming a skirt around the device 200. As can be seen, the underlying securing adhesive 120 is vertically underlying the device 200 and the portion extending beyond the perimeter of the device 200. A skirt around the device 200 provides improved stability of the device 200 when attached to the surface 300.
The film backing can be provided in a die cut strips or in an elongated strip that could be rolled. For example,
Materials
The core comprises an elastomeric material. Elastomeric means that the material exhibits at least some ability to return at least in part to its original shape or size after forces causing the deformation are removed. Examples of elastomeric material include elastomeric polymer, SEBS, SEPS, SIS, SBS, polyurethane, ethyl vinylacetate (EVA), ethyl methyl acrylate (EMA) ultra low linear density polyethylene (ULLDPE), hydrogenated polypropylene, and combinations or blends thereof.
The skin comprises a plastically deforming material. Plastic deformation means that the material undergoes a permanent change in shape or size when subjected to a stress exceeding a particular value (the yield value). Examples of plastically deforming materials include polypropylene, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), a polyurethane, EVA, EMA, an adhesive, and combinations or blends thereof.
The securing adhesive and second adhesive may be the same adhesive or different adhesive from one another. The adhesive could be a permanent adhesive for providing strong securement. The adhesive could be a repositionable adhesive, that provides securement but still allows for removing from peeling. The adhesive may be a pressure sensitive adhesive. A general description of useful pressure-sensitive adhesives may be found in the Encyclopedia of Polymer Science and Engineering, Vol. 13, Wiley-Interscience Publishers (New York, 1988). Additional description of useful pressure-sensitive adhesives may be found in the Encyclopedia of Polymer Science and Technology, Vol. I, Interscience Publishers (New York, 1964). Any suitable composition, material or ingredient can be used in the pressure-sensitive adhesive. Exemplary pressure-sensitive adhesives utilize one or more thermoplastic elastomers, e.g., in combination with one or more tackifying resins.
To achieve plastic deformation, the extensible substrate 110 is a multilayer construction of the core with at least one skin secured to the core. Typically, for embodiments with a single skin, the extensible substrate 110 has a core thickness to skin thickness ratio less than 10:1. In one embodiment, the extensible substrate 110 has a core thickness to skin thickness ratio less than 2:1.
The core layer 112 and one or more skin layers 114, 116 can be bonded to one another using any suitable mechanism including, for example, coextruding the core and the skin layer(s), co-molding, extrusion coating, joining through an adhesive composition, joining under pressure, joining under heat, and combinations thereof.
In some embodiments, the adhesive layer can include at least one of rubber, silicone, or acrylic based adhesives. In some embodiments, the adhesive can include tackified rubber adhesives, such as natural rubber; olefins; silicones, such as silicone polyureas; synthetic rubber adhesives such as polyisoprene, polybutadiene, and styrene-isoprene-styrene, styrene-ethylenebutylene-styrene and styrene-butadiene-styrene block copolymers, and other synthetic elastomers; and tackified or untackified acrylic adhesives such as copolymers of isooctylacrylate and acrylic acid, which can be polymerized by radiation, solution, suspension, or emulsion techniques; polyurethanes; silicone block copolymers; and combinations of the above. The adhesive can be, for example, any of the adhesives described in any of the following patent applications, all of which are incorporated by reference herein: PCT Patent Publication Nos. 2015/035556, 2015/035960, and US 2015/034104. In some embodiments, the adhesive includes a tackifier. Some exemplary tackifiers include at least one of polyterpene, terpene phenol, rosin esters, and/or rosin acids.
Extensible Substrate Properties
Modulus and Elongation
The extensible substrate 110 has a low Fn Modulus. The Fn Modulus is the force required to elongate the extensible substrate 110. If a user is removing the film backing 100 from a location that cannot be accessed by both hands, the back of the arm for example, the user will need to remove it by pulling from an edge portion of the film backing 100 or from a single tab 140, if included. As the film backing 100 is pulled, the extensible substrate 110 stretches and the securing adhesive 120 releases from the surface beginning at the edge portion of the film backing and then proceeding along the extensible substrate 110. However, the force needed to stretch the extensible substrate 110 is also applied to the surface. If the surface is skin and if that force is excessive, it can become uncomfortable or even painful until the extensible substrate 110 releases from the skin.
Even in situations in which both hands can be used to hold the device and pull a tab or to pull opposing tabs, a low modulus will still make stretching and removal of the extensible substrate 110 easy for those with below-average strength or limited grip strength.
The extensible substrate 110 has a low elongation to minimize the distance needed to stretch and pull the extensible substrate 110. A very high elongation means the extensible substrate 110 will have a high distance it stretches before releasing from the surface 300. Excessive stretching is an inconvenience in settings where space is constrained.
The Fn Modulus is the force (F) required to elongate the test specimen a specified percent (n). Fn Modulus is usually recorded for elongation of 10%, 50%, and 100% for comparison of films. Elongation is the maximum percent of strain reached by a test sample to the point of breakage.
Modulus and elongation were measured under ambient conditions (25° C. and 50% relative humidity) by a method based upon PSTC-31, ASTM D882 and D3759 Test Methods. The test was performed on a constant rate of extension/tensile tester (Instron, Zwick or equivalent) equipped for either English or Metric units and clamp-type jaws. Samples were razor cut approximately 10 cm longer than the gauge length (gauge length was 25.4 mm) and 25.4 mm in width. Cross head speed was 2286 mm/min.
The extensible substrate 110 ideal for application on skin has a F(50%) Modulus less than 20 N per 25.4 mm width. In one embodiment, the extensible substrate 110 has a F(50%) Modulus less than 10 N per 25.4 mm width at 50% strain. In one embodiment, the extensible substrate 110 has a F(50%) Modulus less than 5 N per 25.4 mm width.
The extensible substrate 110 has an elongation less than 600%. In one embodiment, the extensible substrate 110 has an elongation less than 500%. In one embodiment, the extensible substrate 110 has an elongation less than 600%. In one embodiment, the extensible substrate 110 has an elongation of at least 100%.
Plastic Deformation
It is desirable that a majority of the deformation of the extensible substrate 110 is plastic deformation and that its elastic deformation is minimized. Elasticity is the ability of a deformed material body to return to its original shape and size when the forces causing the deformation are removed. In contrast, plasticity is the property of a solid body whereby it undergoes a permanent change in shape or size when subjected to a stress exceeding a particular value (the yield value). A highly elastic film may present a hazard during stretching to remove the film from a surface because as the film stretches, a significant amount of energy is stored in it. If the stretching film is not secured, upon the release of the film from the surface this energy will accelerate the film, and any attached device, toward the hand stretching the film, possibly resulting in injury or a broken device.
Plastic deformation is calculated using the original length of the extensible substrate 110 (Lo), the length the extensible substrate 110 reached under applied stress (Ls) and the length the extensible substrate 110 relaxed to after the stress was removed (Lr).
% Plastic deformation=(Lr−Lo)/(Ls−Lo)×100
For example, a one-inch (Lo) length of film stretched to five inches (Ls), which relaxes to a length of four inches (Lr) when the applied stress is removed, has a plastic deformation of 75%. ((4−1)/5−1)×100).
Plastic deformation of the extensible substrate 110 reduces the energy released upon the removal of stress, since the energy input to extensible substrate 110 is consumed by the re-ordering the film morphology rather than stored as potential energy in elastic structures. Less stored energy improves safety during the removal of devices held in place with an extensible substrate 110. The combination of low modulus and large degree of plastic deformation makes one-handed stretch and removal of the extensible substrate 110 from the surface possible, without the hazard of the extensible substrate 110 and an overlying device, if included, from being snapped painfully into the removing hand.
The extensible substrate 110 has a plastic deformation of at least 50%. In one embodiment, the extensible substrate 110 has a plastic deformation of at least 60%. In one embodiment, extensible substrate 110 has a plastic deformation of at least 70%.
Although specific embodiments 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 skill in the art without departing from the spirit and scope of the invention. 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 |
|---|---|---|---|
| PCT/IB2020/059297 | 10/2/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62910667 | Oct 2019 | US |
