Embodiments of the present invention relate to the field of bandages, and, more specifically, to an adhesive overbandage.
Perspiration may be a major problem for patients who are wearing a device that is taped or adhered to the skin. Water may build up beneath the dressing/bandage and lift it off the skin because of perspiration, and/or due to other sources of water or other substances, etc. In the case of a biosensor that is kept in place or anchored by a bandage, dislodgement of the bandage may lead to dislodgement (full or partial) of the sensor itself. The degree of the problems may increase in some users with prolonged use.
Embodiments of the present invention will be readily understood by the following detailed description in conjunction with the accompanying drawings. Embodiments of the invention are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of embodiments in accordance with the present invention is defined by the appended claims and their equivalents.
Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments of the present invention; however, the order of description should not be construed to imply that these operations are order dependent.
The description may use perspective-based descriptions such as up/down, back/front, and top/bottom. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of embodiments of the present invention.
The terms “coupled” and “connected,” along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, “connected” may be used to indicate that two or more elements are in direct physical or electrical contact with each other. “Coupled” may mean that two or more elements are in direct physical or electrical contact. However, “coupled” may also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other.
For the purposes of the description, a phrase in the form “A/B” or in the form “A and/or B” means “(A), (B), or (A and B)”. For the purposes of the description, a phrase in the form “at least one of A, B, and C” means “(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)”. For the purposes of the description, a phrase in the form “(A)B” means “(B) or (AB)” that is, A is an optional element.
The description may use the phrases “in an embodiment,” or “in embodiments,” which may each refer to one or more of the same or different embodiments. Furthermore, the terms “comprising,” “including,” “having,” and the like, as used with respect to embodiments of the present invention, are synonymous.
Embodiments of the present invention provide an adhesive overbandage. In an embodiment, there is provided an adhesive overbandage for use with a biosensor.
For the purposes of the present invention, the term “overbandage” refers to a bandage that may be applied over a device that is resident on the skin or already adhered to skin using adhesive and/or another bandage. An overbandage has particular benefits in that it may be applied over an existing device/bandage to extend the time that the existing device/bandage adheres to or remains on the skin.
During prolonged use of adhesives or adhesive bandages on skin, the strength or tackiness of the adhesive may decline and the secured device and/or bandage may begin to peel away from the skin. This may be caused, for example, by the user sweating, by contact with water from showering, swimming, etc., by contact with skin oils and/or sebum, by contact with dirt and other substances, etc. In addition, a device and/or bandage may begin to peel away from the skin prior to the desired time for removal as a result of the individual picking at the bandage or bumping or catching the device/bandage on clothing, furniture, etc. Thus, there are numerous situations that may cause the adhesive on a device or bandage to become dislodged giving rise to the need for an overbandage to further secure the device.
As an example, a continuous glucose monitoring device may include a sensor coupled to an on-skin monitoring unit. The sensor may be inserted into skin of a user, and a signal indicative of the amount of glucose in the sensed tissue/fluid of the user may be communicated to electronic circuitry in the on-skin unit. In an embodiment, such a continuous glucose monitoring device may be adhered to the skin with an adhesive bandage or adhesive which may be applied directly to the underside of the device and/or on the skin of the user. Such a device may have a prescribed usage period of, for example, 3, 5, 7 days or more before which the sensor needs to be replaced. Due to the relative cost difference of the goods, and the relative difficulty of replacement, if the device or adhesive becomes partially dislodged prior to the expiration of the usage period (3, 5, 7 days or more), it may, in embodiments, be more cost effective and/or more desirable to utilize an overbandage to resecure the device on the skin as opposed to removing the device/sensor and starting anew with a new sensor and/or with new adhesive.
Thus, in an embodiment, there is provided an overbandage, comprising a frame having an upper surface, a lower surface, an outer boundary and an inner boundary, wherein the inner boundary defines an interior opening configured to receive a monitoring device, adhesive disposed on the lower surface of the frame, and a release liner removably coupled to the adhesive.
While
The width of the frame of an overbandage (such as frames 102 and 202 shown in
In an embodiment, a frame may be approximately 0.25 inch to approximately 2 inches wide, or larger. In an embodiment, an interior (such as interiors 104 and 204) may have width and length dimensions of approximately 1-2 inches by 1-2 inches. These dimensions are merely exemplary and may be adjusted as desired for use with various devices. In an embodiment, an interior may be sized and shaped specifically to match the shape of a device with which the overbandage is intended to be associated.
In an embodiment, a frame may be single layered or multilayered. In an embodiment, a frame may be a plastic, foam, or fabric-based material/tape with adhesive on one side. In an embodiment, a frame may be a film-based or polyurethane-based bandage material. In an embodiment, a frame may be transparent, translucent, or opaque, and, in an embodiment, may be made in one or more of a variety of colors. In an embodiment, a frame may provide wicking of water, such as sweat, and/or breathability to allow passage of water vapor.
In embodiments, suitable adhesives include medical adhesives, acrylics, cyanoacrylates, methacrylates, fibrin glue, etc. In an embodiment, an adhesive having a relatively high vapor transmission rate may be utilized to enhance the movement of water and/or water vapor away from the skin.
In an embodiment, an overbandage may be breathable (i.e., it may allow water vapor to release toward the outside but not allow liquid water to penetrate inward). In an embodiment, a breathable overbandage may be constructed from one or more breathable materials in one or more layers. In another embodiment, regardless of the material(s) selected, a breathable overbandage may be constructed, for example, by creating small pores (by using a laser or other means) in the frame material. In an embodiment, suitable pores may have a diameter of approximately 100 Angstroms to approximately 5 microns. In embodiments, the pores may be interconnected, or may be separate.
In an embodiment, water vapor release by the overbandage may be enhanced by utilizing a material that wicks moisture away from the skin. In an embodiment, a separate wicking layer (e.g. a nonwoven fabric layer) may be applied above or, preferably, below a breathable layer.
In embodiments, any suitable material may be used for a breathable and/or wicking layer, such as a polymer, for example polyethylene terephthalate, semi-crystalline polyamides, polyimides such as Nylon 6 or Nylon 66, polyolefins such as polyethylene and polypropylene, polymethylpentene, polyisobutylene, polyolefin copolymers, polyester copolymers, fluoropolymers, poly vinyl acetate, poly vinyl alcohol, polyethylene oxide, functionalized polyolefins, ethylene vinyl acetate copolymers, polytetrafluoroethylene, or amorphous thermoplastic materials to include polycarbonates, polyacrylics, polymethacrylics, polybutadiene, polyisoprene, polychloroprene, random and block copolymers of styrene and dienes, butyl rubber, ethylene-propylene-diene monomer rubber, natural rubber, ethylene-propylene rubber, and mixtures thereof. Other examples of suitable materials may include polyvinyl chloride, thermoplastic polyurethanes, aromatic epoxies, amorphous polyesters, amorphous polyamides, acrylonitrile-butadiene-styrene (ABS) copolymers, polyphenylene oxide alloys, high impact polystyrene, polystyrene copolymers, fluorinated elastomers, polydimethyl siloxane, polyetherimides, methacrylic acid-polyethylene copolymers, impact-modified polyolefins, or amorphous fluoropolymers.
In an embodiment as mentioned above, an overbandage may have an interior which is absent any material, or, in an embodiment, an overbandage may be provided with material spanning the interior.
In an embodiment, material 404 may be waterproof, such as a waterproof film. In an embodiment, material 404 may be selected to keep microorganisms from penetrating through the bandage, and may, in an embodiment, allow water vapor to escape. In an embodiment, material 404 may prevent water in any form in any significant quantity to cross the bandage in a direction toward the underlying device or skin. In an embodiment, material 404 may be transparent, translucent, or opaque, and/or may be made in one or more of a variety of colors. In an embodiment, material 404 may be entirely non-adhesive, or at least non-adhesive in the region that spans the interior defined by frame 402. In another embodiment, material 404 may include adhesive on the surface that contacts the underlying device to help secure overbandage 400 to the underlying device. In such an embodiment, a suitable adhesive may be one that allows overbandage 400 to be relatively easily detached from the underlying device. In an embodiment, material 404 may be sufficiently flexible to stretch without breaking when placed over and around an on-skin unit/device. In an embodiment, material 404 may be flexible or elastic to permit material 404 to fit relatively snug to an associated device and to permit the placement of overbandage 400 in a proper secure position on the underlying bandage/device and skin of the user.
In an embodiment, a frame may be provided with adhesive on the underside or lower surface (skin-contact surface). In an embodiment, the adhesive on an overbandage may be covered by a release liner that may be easily removed just prior to adhering the overbandage to the skin. In an embodiment, a release liner may be provided in a variety of shapes and may be in one or multiple parts, such as including tabs or wings, to enable attachment of the overbandage with minimal difficulty for the user.
In embodiments, overbandage 500 may be placed over an on-skin unit before or after removal of release liner 506. In an embodiment, providing a release liner that does not cover or encircle interior 504 allows overbandage 500 to be placed over an on-skin unit and for subsequent removal of release liner 506 thus reducing the extent to which the adhesive of overbandage 500 is disturbed by the user or impacted by environmental conditions (dirt, debris, water, etc.).
In other embodiments, a release liner may be provided with more or less parts that may or may not overlap. In an embodiment, tabs may or may not be provided, and, if provided, such tabs may be of any suitable size, shape, color, etc. In an embodiment, tabs may be color coded and/or numbered to indicate the recommended order of removing the various release liner parts.
In an embodiment, an overbandage may be provided individually in a peel pouch, sterilized, for example, by ethylene oxide or another sterilizing agent.
In an embodiment when an overbandage is applied to a device on the skin of a user, additional adhesive may be applied to the underside of the overbandage and/or to the contact surfaces on the device, existing bandage/patch, and/or skin to increase the adhesive qualities of the components. In an embodiment, prior to applying the overbandage, the skin or surfaces of the device/bandage may be cleaned or prepped with a suitable solution or compound to sterilize and/or pre-treat the area.
Thus, in an embodiment, there is provided a method of further securing a monitoring device to skin, comprising placing an overbandage over and around the monitoring device, the monitoring device being at least partially secured to the skin with a primary bandage, the overbandage comprising a frame having an upper surface, a lower surface, an outer boundary and an inner boundary, wherein the inner boundary defines an interior opening, adhesive disposed on the lower surface of the frame, and a release liner removably coupled to the adhesive, and removing the release liner to expose the adhesive and adhere the overbandage to the skin and over at least part of the primary bandage.
Guide 902 may be used to help a user properly align overbandage 904 with on-skin monitoring device 906 and primary bandage/patch 908. Guide 902 has an opening 910 in the base of the housing of guide 902 that may be configured to mate with the size and/or shape of one or more on-skin monitoring devices, such as on-skin monitoring device 906. In an embodiment, the orientation of guide 902 may be specific to the size and/or shape of an on-skin monitoring device, such that guide 902 will fit in one orientation, but not in another. In an embodiment, additional markings, colors, etc. on guide 902, overbandage 904, primary bandage/patch 908, and/or on-skin monitoring device 906 may be used to orient and/or properly align the components.
In an embodiment, guide 902 may be reused a plurality of times, or, if desired, may be disposable.
In an embodiment, there is provided an overbandage guide, comprising a housing having an opening configured to mate with an on-skin monitoring device, the housing having a base, and the base having a size and/or shape configured to correspond to an opening of an overbandage to guide the orientation and/or direction of the overbandage over the housing and onto skin of a user or on and/or around a component on the skin of the user.
For the purposes of describing embodiments, the term “configured to correspond” means that the size and/or shape of various components are matched or similar or that one component does not substantially hinder the placement and/or function of an associated component.
In an embodiment, placement guide 1002 may comprise a housing having a base integrated with or coupled to overbandage support 1012. To accommodate placement of overbandage 1004 on/around on-skin monitoring device 1006, the base of the placement guide housing and/or support 1012 may have an opening (not shown). In this configuration, in an embodiment, overbandage 1004 may have material spanning the opening of overbandage 1004 as the material may be accommodated by the opening in the base of the placement guide housing and/or support 1012. In other embodiments, the opening of overbandage 1004 may be absent any such material.
In an embodiment, placement guide 1002 and support 1012 may be reused a plurality of times, or, if desired, may be disposable.
In an embodiment, there is provided an overbandage placement guide, comprising a housing having a base, an overbandage support coupled to the base and configured to couple with an overbandage for placement of the overbandage on and/or around a component on skin of a user, and the base and overbandage support having an opening configured to mate with an on-skin monitoring device, and configured to correspond to an opening of an overbandage to guide the orientation and/or direction of the overbandage on and/or around a component on the skin of the user.
Although certain embodiments have been illustrated and described herein for purposes of description of preferred embodiments, it will be appreciated by those of ordinary skill in the art that a wide variety of alternate and/or equivalent embodiments or implementations calculated to achieve the same purposes may be substituted for the embodiments shown and described without departing from the scope of the present invention. Those with skill in the art will readily appreciate that embodiments may be implemented in a very wide variety of ways. This application is intended to cover any adaptations or variations of the embodiments discussed herein. Therefore, it is manifestly intended that embodiments in accordance with the present invention be limited only by the claims and the equivalents thereof.
The present application claims priority to U.S. Provisional Patent Application No. 60/914,299, filed Apr. 26, 2007, entitled “Adhesive Overbandage,” the entire disclosure of which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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60914299 | Apr 2007 | US |