APPARATUS ATTACHABLE TO SKIN TO COMMUNICATE TARGETED AREA

Abstract

An adhesive cover and method of use in which the cover is well-suited to effectively cover a temporary tattoo utilized in radiation therapy treatments. The cover includes a transparent, flexible layer with an optional rigid layer releasably adhered thereto. The first, flexible layer has a lower adhesive surface, an upper low-adhesion surface and a predefined peripheral edge. The second, rigid layer has a lower surface releasably adhered to the upper low-adhesion surface of the first layer, an opposing upper exposed surface, and a peripheral edge cooperative with the predefined peripheral edge of the first layer to preserve the integrity of the first layer during handling and application. The second layer is removed from the first layer only after the first layer is adhered to a patient's skin.

Claims

1. An apparatus that is releasably attachable to a portion of a patient's skin to communicate a targeted area of the patient's skin and ensure that radiation is directed to an appropriate area of the patient, the apparatus comprising: a carrier substrate defining a releasable surface thereon; and at least one cover comprising a relatively flexible and substantially transparent layer defining a substantially transparent central portion and having an adhesive lower surface releasably superimposed on a continuous portion of the releasable surface of the carrier substrate, an upper surface located on an opposite side of the flexible and substantially transparent layer relative to the lower surface, and a configuration enabling it to be 1) removable from the releasable surface of the carrier substrate without substantially wrinkling; and 2) attachable to the patient's skin with the adhesive lower surface adhesively engaging the skin substantially without wrinkling and in a position with the lower and upper surfaces of the central portion overlying the targeted area of the patient's skin to ensure that radiation is directed to an appropriate area of the patient.

2. An apparatus as defined in claim 1, wherein the flexible layer includes printing, printed matter or indicia allowing information to be communicated.

3. An apparatus as defined in claim 2, wherein the upper surface of the flexible layer includes the printing, printed matter or indicia thereon.

4. An apparatus as defined in claim 2, wherein the flexible layer is substantially transparent and the printing, printed matter or indicia is substantially opaque.

5. An apparatus as defined in claim 1, wherein the cover includes a second layer superimposed on the flexible and substantially transparent layer.

6. An apparatus as defined in claim 5, wherein the second layer is configured to facilitate manual gripping of the cover and applying of the cover to the patient's skin.

7. An apparatus as defined in claim 5, wherein the second layer is firmer than the flexible and substantially transparent layer to at least substantially maintain its shape under its own weight and the weight of the flexible and substantially transparent layer.

8. An apparatus as defined in claim 7, wherein the second layer is releasably adhered to the upper surface of the flexible and substantially transparent layer.

9. An apparatus as defined in claim 7, wherein the second layer is substantially opaque.

10. An apparatus as defined in claim 7, wherein the flexible and substantially transparent layer defines a thickness within a range of about 1/50 mm to about 1/25 mm, and the second layer defines a thickness within a range of about 1/50 mm to about 2/25 mm.

11. An apparatus as defined in claim 1, wherein the flexible and substantially transparent layer defines a substantially circular shape, a substantially oval shape, a substantially rectangular shape, a substantially curvilinear shape, or a substantially rectilinear shape.

12. An apparatus as defined in claim 1, wherein a maximum width or diameter of the flexible and substantially transparent layer is within a range of about 10 mm to about 40 mm.

13. An apparatus as defined in claim 12, wherein the maximum width or diameter of the flexible and substantially transparent layer is within a range of about 20 mm to about 30 mm.

14. An apparatus as defined in claim 5, wherein the second layer is separated into at least two portions.

15. An apparatus as defined in claim 5, wherein the second layer defines a seam that divides the second layer into separable portions.

16. An apparatus as defined in claim 1, wherein substantially the entirety of the flexible and substantially transparent layer is transparent.

17. An apparatus that is releasably attachable to a portion of a patient's skin to communicate a targeted area of the patient's skin and ensure that radiation is directed to an appropriate area of the patient, the apparatus comprising: first means defining a substantially transparent central portion, an adhesive lower surface, and an opposing upper surface, for manually manipulating the first means substantially without wrinkling and attaching the first means to the patient's skin with the adhesive lower surface adhesively engaging the skin substantially without wrinkling and in a position with the lower and upper surfaces overlying the targeted area of the patient's skin to ensure that radiation is directed to an appropriate area; and second means defining a continuous surface underlying the first means for releasably supporting the first means thereon and allowing manual removal of the first means therefrom substantially without wrinkling.

18. An apparatus as defined in claim 17, wherein the first means is a relatively flexible layer defining the lower surface including an adhesive thereon and the upper surface, wherein the lower surface of the first layer is releasably engageable by the adhesive with the patient's skin in a position overlying the targeted area of the patient's skin and is substantially transparent.

19. An apparatus as defined in claim 17, further comprising third means superimposed on the first means and firmer than the first means for manually gripping the first and third means while substantially maintaining the shape of the first and third means under their own weight, manually adhesively and removably attaching the first means to the patient's skin in a position overlying the targeted area of the patient's skin substantially without wrinkling thereof, and manually gripping the third means and removing the third means from the first means adhered to the patient's skin.

20. An apparatus as defined in claim 17, wherein the first means further includes printing, printed matter or indicia thereon allowing information to be communicated.

21. An apparatus as defined in claim 20, wherein the printing, printed matter or indicia is substantially opaque.

22. An apparatus that is releasably attachable to a portion of a patient's skin to communicate a targeted area of the patient's skin and ensure that radiation is directed to an appropriate area of the patient, the apparatus comprising: a carrier substrate defining a releasable surface thereon; and at least one cover comprising a relatively flexible and substantially transparent layer defining a transparent central portion, and including an adhesive lower surface releasably superimposed on a continuous portion of the releasable surface of the carrier substrate, an upper surface located on an opposite side of the flexible and substantially transparent layer relative to the lower surface, printing, printed matter or indicia thereon allowing information to be communicated, and a configuration enabling the flexible and substantially transparent layer to be 1) removable from the releasable surface of the carrier substrate substantially without wrinkling; and 2) attachable to the patient's skin with the adhesive lower surface adhesively engaging the skin substantially without wrinkling and in a position with the lower and upper surfaces of the central portion overlying the targeted area of the patient's skin to ensure that radiation is directed to an appropriate area of the patient.

23. An apparatus as defined in claim 22, wherein the printing, printed matter or indicia is substantially opaque and communicates information.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1 is an exploded perspective view of a tattoo cover and a carrier strip in accordance with an illustrative embodiment of the present invention;

[0029] FIG. 2a is a plan view of the tattoo cover of FIG. 1 illustrating with broken lines exemplary curvilinear seams in a layer of the tattoo cover;

[0030] FIG. 2b is a plan view of the tattoo cover of FIG. 1 illustrating with broken lines exemplary seam dispositions in a layer of the tattoo cover;

[0031] FIG. 3 is a cross-sectional view of the tattoo cover of FIG. 1 taken along line 3-3 of FIG. 2b and removed from the carrier strip;

[0032] FIGS. 4a, b, c and d are schematic views showing a method of applying the tattoo cover according to an illustrative aspect of the present invention;

[0033] FIG. 5 is a schematic illustration showing a number of tattoo covers placed on a patient so as to aid in properly positioning the patient for a radiation treatment;

[0034] FIG. 6 is a schematic illustration of a number of tattoo covers provided on a sheet carrier strip according to another aspect of the present invention;

[0035] FIG. 7 is a schematic illustration of a number of tattoo covers provided on a rolled carrier strip according to still another aspect of the present invention;

[0036] FIG. 8 is a perspective view of a tattoo cover and a carrier strip according to another exemplary embodiment of the present invention;

[0037] FIG. 9 is a perspective view of a tattoo cover and a carrier strip according to still another exemplary embodiment of the present invention; and

[0038] FIG. 10 is a perspective view of a tattoo cover and a carrier strip according to a further exemplary embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0039] Referring to the drawings and, in particular, FIG. 1, a tattoo cover in the form of an adhesive composite in accordance with an illustrative embodiment of the present invention is shown and generally represented by reference numeral 10. The cover 10, as shown, is generally circular in shape, which shape is well suited for contouring with a patient's body or anatomical surface thereof. However, other shapes (e.g., oval, rectangular, etc.) equally may be used. The cover 10 includes two layers, a first layer 12 releasably adhereable to a carrier strip 14, and a second layer 16 releasably adhereable to the first layer 12.

[0040] The first layer 12 is preferably conformable to anatomical surfaces so as to flexibly move in a complementary fashion with an anatomical surface. Although the first layer 12 may be formed from a variety of different materials and/or composites, particularly well suited materials for use in forming the first layer 12 include elastomeric polyurethane, polyester films or the like. These materials provide the preferred properties of resiliency, high moisture vapor permeability and at least substantial transparency. An example of a suitable commercially available material for use in forming the first layer 12 is 3M 9841 polyurethane available from Minnesota Mining & Manufacturing, which is a thin hypoallergenic, fluid resistant, transparent material conformable to various anatomical surfaces. The first layer 12, as shown, is defined by two substantially planar surfaces; a skin-contacting first lower surface 18 with an adhesive associated therewith and an opposing first upper surface 20, and a first peripheral edge 22 preferably defining a first substantially circular disc shape. The first layer 12, as illustratively shown via broken lines in FIG. 3, may also be a composite of two or more layers in which the lower surface of the first layer 12 is defined by a layer providing certain material characteristics while the upper surface of the first layer 12 is defined by another layer providing the same or different material characteristics.

[0041] The adhesive suitable for use with the first lower surface 18 can be any of the conventional adhesives typically used in skin-contacting applications. Examples of such adhesives are disclosed in U.S. Pat. Nos. Re. 24,906, 3,389,827, 4,112,213, 4,310,509, 4,323,557, and 4,737,410, each of which is hereby incorporated by reference. Suitable adhesives for use in the present invention, including for instance those elaborated on in the above-identified references, preferably transmit moisture vapor at a rate greater than or equal to that of human skin. The skin-contacting surface 18 is associated with the carrier strip 14, during non-use (FIGS. 6 and 7), so as to be protected thereby. The carrier strip 14 may be formed from any of a variety of materials. For example, suitable materials include paper based products (e.g., Kraft paper), polypropylene, polyethylene, polyester or any combination of these materials. The carrier strip 14 can be provided with a release coating (e.g., a silicone release material).

[0042] The first upper surface 20 of the first layer 12 is suitable for printing so as to allow information to be communicated thereon. For example, product information may be provided so as to allow for ready recognition of the product source (e.g., a trademark). The first upper surface 20 is preferably adhesive free. However, in alternative aspects of the present invention, the first upper surface 20 may be provided with a low-adhesion coating such as, for example, a solution of polyvinyl n-octadecyl carbamate as disclosed in U.S. Pat. No. 2,532,011, which is hereby incorporated by reference. It will be readily understood by those skilled in the pertinent art from the present disclosure that any of a variety of other coatings suitable for providing appropriate low-adhesion properties or a low-adhesion bond equally may be used in accordance with the present invention.

[0043] The second layer 16, which is preferably substantially stiffer than, or relatively rigid in comparison to, the first layer 12, cooperates with the first layer 12 so as to maintain the integrity thereof during both handling and application. Suitable materials for use in forming the second layer 16 include, but are not limited to, polyethylene/vinyl acetate copolymer-coated papers and polyester or polyurethane films. An example of a particularly suitable commercially available material for use in forming the second layer 16 is 3M 9842 polyurethane available from Minnesota Mining & Manufacturing. Those skilled in the pertinent art will readily recognize from the present disclosure that any of a variety of other materials and/or combinations thereof equally may be utilized in forming the second layer 16. For instance, as illustratively shown via broken lines in FIG. 3, the second layer 16, like the first layer 12, may be a composite of two or more layers in which a lower surface of the second layer 16 is defined by a layer providing specific material characteristics while an upper surface of the second layer 16 is defined by another layer providing the same or different material characteristics.

[0044] The second layer 16, as shown, is defined by two substantially planar surfaces; a second lower surface 24 releasably adhered to the first upper surface 20 of the first layer 12 and an opposing exposed second upper surface 26, and a second peripheral edge 28 preferably defining a second substantially circular disc shape. The second peripheral edge 28, as shown, is substantially coincident or co-terminus with the first peripheral edge 22 of the first layer 12. In addition, the second layer 16 is divided into two portions 30, 32 that cooperate to define a seam 34 extending diametrically across the second layer 16 such that the second layer 16 is breakable or easily bent about or along the seam 34 to enable each of the portions 30, 32 to be separately released from the first layer 12. The seam 34, in one aspect of the present invention, traverses the center of the second layer 16 so that the two portions 30, 32 are substantially equally sized and shaped. In other aspects of the present invention, the seam 34 is offset with respect to the center of the second layer 16. Additionally, although the seam 34 is preferably a straight line, it need not be. For example, the seam 34, in another aspect of the present invention, can have curvilinear characteristics associated therewith, such as the exemplary curvilinear shapes illustrated in broken lines in FIG. 2a. A curvilinear or non-linear seam 34 may be used to provide further support to the first layer 12 as such seams are less likely to allow the two portions 30, 32 of the second layer 16 to fold about the seam. Furthermore, in still other aspects of the present invention, the second layer 16 can be provided with any of a number of additional seams, as shown typically in broken lines in FIG. 2b, so as to divide the second layer 16 into any of a number of distinct portions.

[0045] The second lower surface 24 of the second layer 16 is, in a preferred aspect of the present invention, provided with a low-adhesion coating such as, for example, the solution of polyvinyl n-octadecyl carbamate disclosed in U.S. Pat. No. 2,532,011, previously incorporated by reference, for effectuating an appropriate bond between the first upper surface 20 of the first layer 12 and the second lower surface 24 of the second layer 16. It will be readily apparent to those skilled in the pertinent art from the present disclosure that any of a variety of other coatings suitable for providing appropriate low-adhesion properties equally may be used. In addition, as previously noted, in alternative aspects of the present invention, the first upper surface 20 of the first layer 12 may also be provided with an adhesive of some sort as desired to accomplish different objectives.

[0046] The second upper surface 26 of the second layer 16, like the first upper surface 20 of the first layer 12, may be suitable for printing so as to allow information (e.g., user instructions) to be communicated thereon.

[0047] Referring now to FIG. 3, the second layer 16 provides rigidity to the first layer 12 after the first layer 12 has been removed or separated from the carrier strip 14 (FIG. 1). As shown, the first layer 12 has a thickness “T1” (e.g., about 0.02 mm to about 0.04 mm) and the second layer 16 has a thickness “T2” (e.g., about 0.02 mm to about 0.08 mm). The thicknesses T1 and T2 associated with the respective first and second layers 12 and 16 each may be modified for different applications or purposes as desired. The peripheral edge 28 of the second layer 16, as also shown, preferably corresponds to the peripheral edge 22 of the first layer 12 so as to be substantially co-terminus. Thus, both the first layer 12 and the second layer 16 preferably have substantially the same cross-sectional width or diameter “W” (e.g., preferably within the range of about 10 mm to about 40 mm, and most preferably within the range of about 20 mm to about 30 mm). Accordingly, in a preferred aspect of the present invention, the second layer 16 is sufficiently rigid so as to allow one to handle the entire cover 10 by grasping about the peripheral edge of the second layer 16 without compromising the integrity of the first layer 12. Thus, the cover 10, in a preferred aspect of the present invention, may be effectively handled prior to and during the application thereof without the use of additional structures (e.g., tabs, handles, etc.), which may tend to complicate the process of manufacturing the adhesive composite of the cover.

[0048] It is noted that those skilled in the pertinent art will readily recognize alternative ways in which to facilitate the handling and application of the cover 10. Thus, although the foregoing substantially co-terminus dual-layered cover is preferable for providing a small, compact adhesive composite that may be easily manufactured and/or formed, other configurations also may be used and fall within the scope of the present invention. For example, any part of the peripheral edge 22, 28 associated with either or both of the two portions 30, 32 of the second layer 16 can be modified to extend beyond the peripheral edge 22 of the first layer 12 so as to provide means for holding the cover 10 after removal from the carrier strip 14 without contacting the adhesive associated with the first lower surface 18 of the first layer 12. Alternatively, either of the two portions 30, 32 of the second layer 16 can be modified to extend beyond the seam 34 so as to overlap at least a part of the other of the two portions 30, 32 and thereby provide means to grip and/or remove the portion from the first layer 12.

[0049] The bond between the second lower surface 24 of the second layer 16 and the first upper surface 20 of the first layer 12 is preferably stronger than the bond between the first lower surface 18 of the first layer 12 and the carrier strip 14. This differential preferably ensures that the second layer 16 remains adhered to the first layer 12 when the cover 10 is removed from the carrier strip 14.

[0050] With reference to FIGS. 4a through 4d, applying the cover 10 to an anatomical surface 36 involves first removing the cover 10 from the carrier strip 14 while leaving the first layer 12 and second layer 16 intact. As shown in FIG. 4a, the removed cover 10, after removal from the carrier strip 14, can be held at or about the periphery thereof while being placed over the anatomical surface 36 at a desired location 38. As shown in FIG. 4b, once in place, pressure can be applied to ensure good adhesion between the first layer 12 and the anatomical surface 36. After the cover 10 is appropriately adhered to the anatomical surface 36, each portion 30, 32 of the second layer 16 is removed from the first layer 12 as shown in FIGS. 4c and 4d to leave the first layer 12 securely adhered to the surface 36 and thereby provide a protective barrier at the desired location 38. Thus, the integrity of the first layer 12 in maintained, via the relative rigidity of the second layer 16, during both handling and application. That is, the first layer 12 is prevented from becoming folded, wrinkled or otherwise compromised by the second layer 16 while being removed from the carrier strip 14 and while being placed on and adhered to the surface 36. Consequently, an improved adhesion is achieved between the first layer 12 and the surface 36 as wrinkles, creases, punctures and/or other adhesion imperfections are substantially reduced or eliminated.

[0051] Thus, it will be readily understood by those having skill in the pertinent art from the present disclosure that the exemplary cover and corresponding method of applying such as provided herein, is well suited for use in radiation therapy treatments. More particularly, the cover and method of the present invention are well suited for use in keeping temporary tattoos on patients for an extended period of time during radiation therapy treatments. For example, as shown in FIG. 5, during the simulation step of a radiation treatment or at any time subsequent thereto, after one or more treatment fields 40 have been established and the patient properly positioned, via any number of temporary tattoos 42, and the results verified, any one or more of the temporary tattoos can be covered via cover 10 in, for example, the manner previously described with respect to FIGS. 4a through 4d. By so doing, the temporary tattoo may be preserved for a predefined period of time (e.g., about 4 or more weeks) through daily bathing and physical activity.

[0052] Accordingly, in practice, a radiation therapist or facility may preserve the temporary tattoos 42 through the entire therapy treatment by utilizing the cover 10 to protect the temporary marks 42 used in positioning the patient so that one or more treatment fields 40 are consistently and properly maintained among different treatment sessions. The covers 10 can be replaced as needed at any time during the therapy treatment (e.g., at week three of a six week treatment) so as to optimize the protective effect provided by such covers. The improved adhesion accomplished between the cover 10 and the anatomical surface 36 when the cover 10 is applied according to the above-described application process results or stems from the first layer 12 being maintained in an extended, relatively rigid state via the second layer 16 during handling and application over the temporary tattoo 42. The transparent or substantially transparent nature of the first layer 12 enables the radiation therapist to readily observe the tattoo 42 and thus allows for the radiation treatment to be conducted according to convention.

[0053] As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above described and other embodiments of the present invention without departing from the scope of the invention as defined in the appended claims. For example, FIGS. 6 and 7 depict different product forms of the cover. FIG. 6 illustrates an exemplary sheet carrier strip 44 suitable to accommodate a predefined number of covers 10. The upper surface of the strip 14 defines a low-friction or releasable surface to allow the covers 10 to be manually gripped and removed therefrom. FIG. 7, on the other hand, illustrates an exemplary product roll or a rolled carrier strip 46 also with a predefined number of covers 10 accommodated thereon. Like the strip 14, the upper surface of the strip 46 carrying the covers 10 defines a low-friction or releasable surface that allows the covers 10 to be manually gripped and removed therefrom. In accordance with another aspect of the present invention, the covers 10 provided on the carrier strip 14 or 46, or other type of carrier strip or substrate, may not include a relatively rigid second layer as described above. For example, if the first substantially transparent layer is sufficiently small and defines a suitable peripheral shape, the transparent layer may be manually engageable and removable from the carrier, and capable of being applied to the desired anatomical surface without wrinkling, without including a second relatively rigid layer overlying the first relatively flexible, transparent layer. In one such embodiment, the covers are substantially circular in shape, and define a diameter within the range of about 10 mm to about 40 mm, and preferably within the range of about 20 mm to about 30 mm. Because of the relatively small diameter of such covers, and the curvilinear shape, the cover can exhibit sufficient rigidity to allow it to be manually gripped and removed from the carrier, and applied to a desired anatomical surface, without wrinkling. Although the currently preferred shape of such covers is circular, other shapes equally may be employed. Preferably, however, such cover defines a substantially continuous curvilinear peripheral shape to facilitate the manual engagement and application of the cover to the desired anatomical surfaces without wrinkling, and to prevent the cover from being accidentally caught or snagged after application to the anatomical surface and removed therefrom either in whole or in part. Additionally, the cover 10, as illustrated in FIGS. 8 and 9, can have any of a variety of different pre-cut shapes and/or sizes including, for example, an oval shape as shown in FIG. 8, or a rectangular shape as shown in FIG. 9. As can be seen, in the embodiments of FIGS. 8 and 9, the covers are provided on single cover carriers or backings, rather than being provided with plural covers on a common backing. Still further, the cover 10 can be continuously linear such as shown in FIG. 10 so as to be cut to length as desired. In another embodiment of the present invention, the linear covers are pre-cut, and are sufficiently small so that they can be provided without a second, relatively rigid layer. In this embodiment, the pre-cut, linear or substantially linear-shaped covers are provided on a common carrier backing or strip, which may be provided in roll form or otherwise, or provided on single-cover carriers or backings. The linear covers without the relatively rigid second layers define a width within the range of about 10 mm to about 20 mm, and a length of about 10 cm or less. As with the relatively small circular or curvilinear covers described above, such linear-shaped covers are sufficiently small that they can be manually gripped and removed from the backing or carrier and applied to the anatomical surface of interest without wrinkling. In other embodiments of the present invention, the covers provided with a second relatively rigid layer include on a peripheral or marginal edge portion of such layer a manually engageable tab extending outwardly from the substantially transparent layer to facilitate manually gripping the cover and applying same to the anatomical surface area of interest. Still further, any of numerous different materials and/or adhesives that are currently known, or that later become known, equally may be used to make the covers and the backings or carriers of the covers of the present invention. Accordingly, this detailed description of the currently preferred embodiments of the present invention is to be taken in an illustrative as opposed to a limiting sense.