U.S. patent application number 17/121611 was filed with the patent office on 2021-04-22 for apparatus attachable to skin to communicate targeted area.
The applicant listed for this patent is BEEKLEY CORPORATION. Invention is credited to Mark Broyles.
Application Number | 20210113392 17/121611 |
Document ID | / |
Family ID | 1000005275947 |
Filed Date | 2021-04-22 |
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United States Patent
Application |
20210113392 |
Kind Code |
A1 |
Broyles; Mark |
April 22, 2021 |
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.
Inventors: |
Broyles; Mark; (Plainville,
CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BEEKLEY CORPORATION |
Bristol |
CT |
US |
|
|
Family ID: |
1000005275947 |
Appl. No.: |
17/121611 |
Filed: |
December 14, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15694027 |
Sep 1, 2017 |
10864124 |
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17121611 |
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13225804 |
Sep 6, 2011 |
9750652 |
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15694027 |
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12855145 |
Aug 12, 2010 |
8012295 |
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13225804 |
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11121253 |
May 3, 2005 |
7781041 |
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12855145 |
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60629482 |
Nov 19, 2004 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 15/00 20130101;
Y10T 428/14 20150115 |
International
Class: |
A61F 15/00 20060101
A61F015/00 |
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
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of co-pending
U.S. patent application Ser. No. 15/694,027, filed Sep. 1, 2017,
now U.S. Pat. No. 10,864,124 issued on Dec. 15, 2020, which is a
continuation application of Ser. No. 13/225,804, filed Sep. 6,
2011, now U.S. Pat. No. 9,750,652 issued on Sep. 5, 2017, which is
a divisional application of U.S. patent application Ser. No.
12/855,145, filed Aug. 12, 2010, now U.S. Pat. No. 8,012,295 issued
Sep. 6, 2011, which is a divisional application of U.S. patent
application Ser. No. 11/121,253, filed May 3, 2005, now U.S. Pat.
No. 7,781,041 issued Aug. 24, 2010, claiming priority on U.S.
Provisional Application Ser. No. 60/629,482, filed Nov. 19, 2004,
all of which are hereby incorporated by reference in their
entireties.
FIELD OF THE INVENTION
[0002] The present invention relates generally to adhesive
composites. More particularly, the present invention relates to an
adhesive composite providing improved means for handling and
application to a surface. The invention is particularly
advantageous for use in covering targeting marks or tattoos used in
radiation therapy treatments.
BACKGROUND INFORMATION
[0003] Adhesive composites including transparent dressings and the
like are well known and of countless variety. However,
notwithstanding that which is known, there has yet to be provided
an adhesive composite that is particularly well suited for covering
the temporary marks or tattoos used in radiation therapy
treatments.
[0004] The first step when an individual requires radiation
treatment, after an initial consultation with a radiation
oncologist, is a planning session, called a "simulation." The
purpose of the simulation is to determine the areas where the
radiation will be delivered, called radiation treatment fields, and
to plan the treatments. This session is generally conducted by a
radiation oncologist, aided by one or more radiation therapists and
often a dosimetrist, who performs calculations necessary in the
treatment planning. The simulation may last anywhere from fifteen
minutes to an hour or more, depending on the complexity of the
treatment.
[0005] During simulation, a patient lies on a table and a machine
or a "simulator" is used to establish the treatment fields. The
dimensions and movements of the simulator closely match that of a
linear accelerator. The simulator, rather than being used to
deliver radiation treatment, is a tool that allows the radiation
oncologist and therapist to observe the area to be treated. The
simulation may, for example, be guided by fluoroscopy or CAT scan
to observe the patient's internal anatomy. The table can be raised
and lowered and rotated around a central axis. The lights are
usually dimmed while the treatment fields are being set. Temporary
marks are made on the patient's skin with magic markers, paint
pens, or other suitable means (e.g., carbolfushin). These marks are
very important as they enable precise and consistent positioning of
the patient so as to ensure that the treatment radiation is
properly directed to the appropriate treatment area, and the
radiation therapist uses them each session as a guide during the
radiation treatment. The treatment plan and treatment fields
resulting from the simulation session are verified and radiation
treatment is started only after the radiation oncologist and
therapists have rechecked the treatment field and calculations, and
are thoroughly satisfied with the setup.
[0006] Sometimes, after a few treatments, tiny permanent dots
called tattoos are used in place of the temporary marks. Other
times, permanent tattoos are used initially but due to changing
circumstances (e.g., a need to modify the treatment field)
temporary marks are subsequently employed. The use of permanent
tattoos is particularly advantageous in radiation treatments that
extend over weeks as the radiation therapist is able to set up the
treatment fields each day with precision, while the patient is
allowed to wash and bathe without worrying about obscuring the
treatment fields. However, although the permanent tattoos consist
of only small pinpricks with a small amount of ink, appearing like
a small freckle, there remain instances in which temporary marks
are preferable instead of permanent tattoos. Examples of such
instances include: (i) when a patient refuses permanent tattoos;
(ii) when a facility prefers not to tattoo children; (iii) when the
treatment field is highly visible (e.g., the patient's neck or
face); (iv) when the skin color makes visibility of the tattoos
difficult; and (v) when a facility prefers to use temporary tattoos
or marks for an initial number of treatments (e.g., when it is
likely that a second treatment field setup is foreseeable). In
addition, when it is necessary to employ match lines to match old
and new treatment fields, or field borders to distinguish the
treatment fields, or radiation boost lines or other similarly
notable markings, temporary marks are preferable over permanent
tattoos.
[0007] A significant advantage associated with the use of temporary
tattoos is that the number of such tattoos used need not be limited
as do permanent tattoos. Hence, the temporary tattoos provide
greater ease, flexibility and freedom in use. Another possible
advantage associated with using temporary tattoos as opposed to
permanent tattoos is found in that the temporary tattoos can be
shaped or sized as needed to facilitate effectively defining the
treatment field without the negative consequence of permanently
blemishing a patient's skin. The challenge when using temporary
tattoos is in keeping them in place on the patient's skin over an
extended period of time (e.g., over a typical 6 week radiation
treatment). Radiation therapists and facilities, in an effort to
address this challenge, currently cover the temporary tattoos using
adhesive composites (e.g., Tegaderm.TM.), tape, wound spray,
stickers, or the like. For example, radiation therapists often use
Tegaderm, which is commercially available in the form of framed
sheets of predefined dimension (e.g., approx. 2''.times.3''
sheets). In order to be more effectively used, these framed
Tegaderm sheets are manually cut and/or otherwise shaped by the
radiation therapist. This cutting/shaping process can be time
consuming and inefficient as the Tegaderm, once the frame
associated therewith is compromised, becomes difficult to handle
and/or otherwise manipulate. The Tegaderm, which is very thin,
often wrinkles or folds over itself so that effective application
is significantly inhibited. Along these lines, the drawbacks
associated with conventional covering techniques are found in the
handling of the covering materials, the application of the covering
materials and/or the reliability or the lack of durability
associated with the covering materials. To date, there has yet to
be found a reliable and effective tattoo cover and/or method for
keeping temporary tattoos and the like on patients for an extended
period of time. Accordingly, the present invention is proposed to
address one or more of these and other shortcomings associated with
the prior art.
SUMMARY OF THE INVENTION
[0008] The present invention is directed to an adhesive composite
cover and method of application thereof that addresses one or more
of the above-noted shortcomings by providing improved means for the
handling and application of a cover to an anatomical surface. The
cover is particularly well suited to effectively cover a temporary
tattoo utilized in radiation therapy treatments.
[0009] In accordance with one aspect, the present invention is
directed to an apparatus that is releasably attachable to a portion
of a patient's skin having thereon a temporary tattoo or other
marking for covering the marking and allowing the underlying
marking to be visible therethrough. The apparatus comprises a
carrier substrate defining a releasable surface thereon; and at
least one cover. The cover comprises a relatively flexible and
substantially transparent first layer having an adhesive lower
surface releasably superimposed on the releasable surface of the
carrier substrate, an upper surface located on an opposite side of
the first 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 overlying the marking
and allowing the underlying marking to be visible therethrough.
[0010] In accordance with another aspect, the cover, according to a
beneficial feature of the present invention, includes a
transparent, first relatively flexible layer with a second,
relatively rigid or stiff layer releasably adhered thereto. The
second layer is sufficiently firm to maintain its shape under its
own weight and the weight of the first layer attached thereto. The
first layer has a lower adhesive surface, an upper low-adhesion
surface and a predefined peripheral edge. The second 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 so as to be substantially co-terminus
therewith.
[0011] In an advantageous aspect of an embodiment of the present
invention, the second layer is divided into at least two distinct
portions by a seam that extends from a first point at the
peripheral edge to a second point also at the peripheral edge so
that the second layer is separable along or about such seam to
facilitate or enable each of the portions to be separately removed
from the first layer. In one aspect of such embodiments of the
present invention, the first point and the second point are
diametrically opposed and divide the second layer into two
substantially equal portions. The second layer, in a preferred
feature of the present invention, is sufficiently rigid to enable
one to hold the cover about the respective peripheral edges thereof
without compromising the integrity of the first layer. In another
aspect of the present invention, the cross-sectional width of both
the first layer and the second layer are at least substantially the
same so as to be substantially co-terminus about the respective
peripheral edges thereof.
[0012] In accordance with another aspect, the present invention
involves a method for applying an adhesive composite cover to an
anatomical surface. In accordance with a preferred embodiment of
the present invention, the method comprises the steps of: [0013]
(i) providing an adhesive composite accommodated by a carrier
strip, the adhesive composite including at least two substantially
co-terminus layers, a first relatively conformable transparent
layer with an adhesive lower surface, an opposing non-adhesive or
relatively low-adhesive upper surface, and a first peripheral edge,
and a second relatively rigid layer releasably adhered to the upper
surface of the first layer, the second layer defining a second
peripheral edge; [0014] (ii) removing the adhesive composite from
the carrier strip; [0015] (iii) handling the adhesive composite by
holding it about the second peripheral edge; [0016] (iv) placing
the adhesive composite over an anatomical surface at a desired
location with the second layer continuously adhered to the first
layer; [0017] (v) applying pressure to the adhesive composite via
the second layer to ensure proper adhesion; and [0018] (vi)
removing the second layer from the first layer to leave the first
layer securely adhered to the anatomical surface and thereby
provide a protective barrier at the desired location.
[0019] Another advantageous aspect of the present invention is
directed to a method for conducting a radiation treatment
simulation. According to a preferred embodiment of the present
invention, the method comprises the steps of: [0020] (i)
positioning a patient with respect to a simulation machine suitable
to establish one or more treatment fields; [0021] (ii) setting at
least one treatment field via the simulation machine; [0022] (iii)
utilizing one or more marks made on the patient's skin, such as
temporary tattoos, to properly position the patient for treatment;
and [0023] (iv) covering the one or more marks with a transparent,
relatively flexible layer that is continuously supported by a
relatively rigid layer during handling and application. The method
may further comprise separating the relatively rigid layer from the
substantially transparent, relatively flexible layer only after
such flexible layer is fully adhered to the patient's skin.
[0024] According to a beneficial aspect of the present invention,
the first, relatively flexible layer has an adhesive
skin-contacting surface, an opposing low-adhesion surface, and a
first peripheral edge with the relatively flexible layer having a
second, relatively rigid layer releasably adhered thereto via the
low-adhesion upper surface. The relatively rigid layer defines a
second peripheral edge that advantageously cooperates with the
first peripheral edge of the relatively flexible layer to preserve
the integrity of the first layer during handling and application.
That is, the relatively rigid layer, according to a preferred
feature of the present invention, is in continuous contact with the
relatively flexible layer during handling so as to facilitate
applying the cover free from wrinkles, folds and/or other
compromising effects.
[0025] In accordance with another aspect, the present invention is
directed to 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 comprises a carrier substrate
defining a releasable surface thereon and least one cover. The
cover comprises 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.
[0026] In accordance with another aspect, the present invention is
directed to 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 comprises a carrier substrate
defining a releasable surface thereon and at least one cover. The
cover comprises 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.
[0027] These and other aspects and advantages of the currently
preferred embodiments of the present invention will become more
readily apparent in view of the following detailed description and
accompanying drawings.
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.
* * * * *