Note: Descriptions are shown in the official language in which they were submitted.
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METHODS USING REPOSITIONABLE INSTRUCTIONS
AND KITS CONTAINING SAME
Field of Invention
This invention relates to multiple step health care procedures. More
specifically, this invention relates to a method of performing multiple step
health care procedures using a pre-printed repositionable instruction sheet.
Background of the Invention
The health care industry continues to develop more and more
advanced materials and methods for carrying out procedures to improve the
physical well-being of patients. As technologies in this field advance, the
procedures to be carried out by the health care provider become more and
more complex and diverse, including multiple steps that must be performed
in certain sequential order or in certain time frames. Instructions are
generally provided with each kit for performing certain health care
procedures, which instructions are generally provided on small pre-printed
sheets .
U.S. Patent No. 5,178,419 to Bolnick et al. discloses a label form for
use in drug testing and methods for applying same. This patent describes a
multi-segment label set form, which in one embodiment has a first label
segment with a permanent adhesive backing layer and second and third label
segments having temporary adhesive backing layers. The label segments are
provided with information to identify the patient participating in the test, thedrug being tested and other study information.
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Summary of the Invention
The present invention provides a method for performing a multiple-
step health care procedure, which method comprises use of a pre-printed
instruction sheet having instructions for a plurality of steps of said health
care procedure pre-printed on the sheet. The sheet is provided with a
repositionable adhesive applied in an amount effective for repositionably
adhering said sheet to an intended substrate.
The present invention also provides a kit for a multiple-step health
care procedure. The kit comprises health care materials and at least one
repositionable pre-printed instruction sheet having instructions for use of
said health care materials in a plurality of steps of a health care procedure
pre-printed on the sheet.
Brief descriPtion of the Drawing
The Figure shows a plan view of a repositionable pre-printed
instruction sheet of the present invention.
Detailed Descri~tion
The present invention finds particular utility in multiple step
procedures carried out in the health care industry and especially for
procedures that are carried out in a clean environment. In these
environments, it is desirable to provide instructions that may be placed at
locations convenient for viewing by the health care practitioner without the
requirement of using special clips or other holding devices to hold the
instruction sheet. It is also desirable to have instructions that are
disposable, to avoid sterilization difficulties. Instructions are useful becausesimilar procedures may be carried out using any one of a number of different
manufacturer's products, and each product will often involve a slightly
different protocol as compared to
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others in the same general class. Thus, the present invention is ideally
suited for dental and orthodontic procedures and medical office procedures
that require multiple steps.
The practitioner may place the respositionable pre-printed instructions
at a location convenient for viewing during the procedure, such as on the
headrest or arm of the patient chair, on the instrument table, or any other
convenient location. The repositionable adhesive of the pre-printed
instructions provides hands-off review of the instructions while at the same
time providing easy removal of the pre-printed instructions following
completion of the procedure without fear of damaging the substrate to
which the instructions were attached. The disposable nature of such
instructions eliminates sterilization procedures that would be required for
reusable instructions.
The present invention provides particular advantage in a clean or
sterile environment, because the hands-off review capability allows the
health care practitioner to maintain a clean field or, alternatively, a sterile
field without having to stop during a procedure to handle the instructions.
The present invention is particularly useful in the context of teaching
environments, such as universities and where a new material is being used
for the first time.
One example of a health care procedure that particularly benefits from
the use of the present invention is the use of a dental adhesive. A
multiplicity of different dental adhesives are currently available in the market,
each using their own specific technique. A complete dental adhesive system
may comprise an etchant or conditioner, one or more primer solutions, one
or more adhesive components and a restorative material to be bonded to the
tooth and
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possibly other materials as well. Additionally, polymerization initiators may
be added to one or more of these solutions as a separate step, or one or
more components may be provided with a photoinitiator which necessitates
the use of a curing light to initiate polymerization of the adhesive. Some of
5 these materials may be rinsed off of the tooth, while others should be kept
as dry as possible. Some components should be applied in only a thin layer,
while other components should be applied in multiple layers in order to
maximize effectiveness of the adhesive bond. The dental practitioner, when
faced with such an array of different products and different techniques, may
10 easily become confused and apply the components in the wrong order, in
inappropriate amounts, omit a step or not provide sufficient time for curing,
drying, etching, and the like.
In another aspect of the present invention, some dental materials may
be used in a number of different applications. Technique guides for each of
these applications may be advantageously provided with the materials so
that alternative procedures may be easily and conveniently performed by the
dental professional.
Specific techniques benefitting from the use of repositionable
instructions include bonding of various diverse materials to tooth structure,
such as amalgam fillings, porcelain, metal articles, bridges, veneers, dental
composites and the like. Other dental procedures wherein the present
invention has particular utility include application of fluoride treatments,
application of sealing compositions, bleaching teeth, taking dental
impressions, placement of provisional tooth restorations, the use of
electronic anesthesia and the like.
Repositionable preprinted instructions may find utility in the dental lab
as well, in carrying out
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procedures such as preparation of prosthetic devices such as porcelain
crowns, inlays, onlays, veneers, dentures, bridges and the like. Included in
such procedures are the intermediate steps carried out by the dental lab in
fabrication of the ultimate article, such as preparation of investment
materials and the like. Other dental lab procedures include fabrication of
dental appliances, orthodontic appliances, mouthguards and the like. A third
category of dental lab procedures is the preparation of dental models.
Other health care procedures also may benefit from the present
invention, such as preparing an orthopedic cast or splint, placing an artificialligament or bone replacement structure, operative procedures utilizing unique
surgical drapes or wound disinfection techniques, surgical stapling
procedures, placement of electronic implants such as cardiac pacemaker and
the like. Medical laboratories particularly may find the present invention
useful for providing convenient instructions for performing various diagnostic
tests, for example on blood, urine and bodily fluids, tissues and by-products.
One example of such a test particularly suited for use of the present
invention is the home pregnancy test, which contains instructions unfamiliar
to the user and which is usually performed in the bathroom where
counterspace may be limited.
The pre-printed instructions may describe the entire procedure to be
performed, or may relate only to a particular step or steps that benefit from
convenient repositionable instructions. It will be understood that the
instructions may optionally be placed in a location convenient for viewing by
the patient for use in carrying out certain tasks during the health care
procedure .
The present invention also provides a kit for a multiple-step health
care procedure. The kit comprises
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health care materials and at least one repositionable pre-printed instruction
sheet having instructions for use of said health care materials in a plurality of
steps of a health care procedure pre-printed on the sheet. Preferably, the kit
comprises a plurality of repositionable pre-printed instruction sheets in the
form of a pad. In this embodiment, the health care professional is provided
with a convenient fully disposable instruction sheet that can be discarded
after a single use, with a new sheet being available for use with the next
patient.
The kit preferably contains pre-printed repositionable instructions,
together with multiple components of a dental adhesive system.
Alternatively, the kit may contain the instructions with only one or two key
materials used in a health care procedure, such as a kit comprising a dental
adhesive material and a dental restorative material. Other key materials are,
for example, a dental glass ionomer or a luting cement.
As used herein, "repositionable" refers to the ability to be repeatedly
adhered to and removed from a substrate without substantial loss of
adhesion capability and without damage to the intended substrate upon
removal. Most preferably, the pre-printed instructions of the present
invention may be adhered to and removed from a 20 pound white bond
xerographic quality paper substrate for three cycles with no more than 75%
loss of peel adhesion. In another aspect, the present invention is removable
from a substrate when it has been adhered to the substrate over a long
period of time. Thus, preferably the adhesive used in the present invention
does not develop excessive adhesion build-up over time.
To show repositionable adhesion to the intended substrate, a pre-
printed instruction sheet having a repositionable adhesive is applied to 20
pound white
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bond xerographic quality paper for 5 cycles, with the paper being adhered to
the pre-printed instructions for 24 hours for each cycle. Preferably, the pre-
printed instruction sheet is removed from the paper at about 12 inches per
minute and at 180 degree peel. After completion of the 5 cycles the pre-
printed instruction sheet will support its own weight when suspended from a
vertical or the underside of a horizontal white bond 20 pound xerographic
quality paper substrate. Preferably, the pre-printed instruction sheet has
sufficient shear and peel adhesion strength that it may be adhered to the
underside of a white bond 20 pound xerographic quality paper substrate at
any angle desired, including the underside of a substrate having a 45 degree
angie position. The pre-printed instruction sheet has sufficient adhesion on
its first application to a vertical white bond 20 pound xerographic quality
paper substrate that it will hold its own weight (i.e not fall off of the
substrate) for at least 24 hours.
Removability of the repositionable pre-printed instruction sheet
without damage to the substrate is evaluated by applying a pre-printed
instruction sheet having repositionable adhesive to 20 pound white bond
xerographic quality paper and applying pressure with three passes of a 5 kg
roller to ensure full adhesive contact. The pre-printed instruction sheet is
removed from the paper at a rate of about 12 inches per minute and at 180
degree peel with no tear or damage to the substrate paper.
As note above, the pre-printed instructions of the present invention
are capable of being repositionably adhered to any desired substrate. A
repositionable adhesive as described herein is provided on the instruction
sheet for this purpose. This adhesive preferably is provided on the opposite
side of the sheet from the pre-printed instruction, but may
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optionally be provided at any appropriate location on the sheet. The entire
back side surface of the sheet may be coated with repositionable adhesive,
but preferably the repositionable adhesive is provided as a strip in an amount
sufficient to support the weight of the pre-printed sheet when applied to a
5 vertical surface.
A repositionable adhesive may be provided through any of a number
of recognized modes of providing a repositionable adhesive. Ideally,
depending on the substrate, the removable adhesive must provide sufficient
tack (or quick stick) to quickly fix the adhesive to the desired substrate,
10 sufficiently low peel strength to prevent damage of the surface when the
adhesive is removed, and have the appropriate cohesive strength to control
the transfer of adhesive to the substrate. Cold flow of the adhesive on a
surface should be avoided, because this leads to an undesirable building of
peel strength over time.
Preferably, the adhesive is an acrylate- or methacrylate-based
adhesive system comprising infusible, solvent dispersible, solvent insoluble,
inherently tacky, elastomeric copolymer microspheres as disclosed in U.S.
Pat. No. 3,691,140. Alternatively, this adhesive composition may comprise
hollow, polymer, acrylate, infusible, inherently tacky, solvent insoluble,
solvent dispersible, elastomeric pressure-sensitive adhesive microspheres as
disclosed in U.S. Pat. No. 5,045,569.
Preferably, the repositionable adhesive utilized herein comprises
between about 60-100% by weight of hollow, polymeric, acrylate,
inherently tacky, infusible, solvent-insoluble, solvent-dispersible, elastomericpressure-sensitive adhesive microspheres having a diameter of at least 1
micrometer, and between about 0-40% by weight of a non-spherical
polyacrylate
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adhesive. These hollow microspheres are made in accordance with the
teaching of European Patent Application 371,635. The non-spherical
polyacrylate adhesive may be any conventional pressure-sensitive adhesive.
Examples of such adhesives are polymers made from the "soft" monomers
such as n-butyl acrylate, isooctyl acrylate, or the like, or copolymers made
from a soft component, such as isobutylene, n-butyl acrylate, isooctyl
acrylate, ethyl hexyl acrylate, or the like; and a polar monomer such as
acrylic acid, acrylonitrile, acrylamide, methacrylic acid, methyl methacrylate
or the like. Non-spherical polyacrylate adhesives are commercially available,
for example, as the Rohm and Haas RhoplexTM line of adhesives. Preferably,
the non-spherical polyacrylate adhesive is present in the repositionable
adhesive at an amount of about 10-35% by weight. When the
repositionable adhesive additionally comprises a non-spherical polyacrylate
adhesive, improved anchorage of the total adhesive to the pre-printed
instruction sheet is observed, resulting in less adhesive residue being left on
the substrate after removal. Also, tacky microsphere-containing
repositionable adhesives comprising non-spherical polyacrylate adhesive
exhibit excellent shear adhesion properties, even for highly textured vertical
surfaces. These advantageous adhesive properties are obtained with
excessive adhesion to substrates such as painted walls that would result in
peeling of the paint off of the wall when the film adhesive composite is
removed .
Repositionable adhesives are also known in which microspheres
contained in the adhesive are non-tacky. A disclosure of this type of
adhesive is provided in U.S. Pat. No. 4,735,837 to Miyasaka.
A repositionable adhesive may be provided by addition of components
to conventional adhesive
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formulations to modify their tack and flow characteristics. U.S. Patent No.
4,599,265 (Esmay) discloses an adhesive having a high degree of cohesive
strength that has low tack and maintains peelability from a variety of
ordinary substrates. U.S. Patent No. 4,737,559 (Kellen et al.) describes a
PSA formulation in which the viscous flow, and resultant adhesion buildup,
is controlled through the addition of a small amount of a free radically
polymerizable photocrosslinker.
Another means for providing a repositionable adhesive through the
reduction of the adhesive contact area is accomplished by the deposition of
a discontinuous or patterned film on a backing. W0 85/04602 (Newing et
al.) describes pressure-sensitive adhesive articles comprising a plurality of
discontinuous adhesive segments in a pattern on at least a portion of at least
one side of a carrier or backing, covering from about ten to about thirty
percent of the total surface area of that carrier material. European Patent
Application 276,557 (Fry) describes a repositionable pressure-sensitive sheet
material comprising a sheet material bearing on one surface a discontinuous
non-repetitive adhesive coating covering about 10 to about 85 percent of
the surface in the form of individual adhesive islands. U.S. Patent No.
4,889,234 (Sorenson et al.) discloses a discontinuous patterned adhesive
label structure in which the level of adhesion is varied according to area of
adhesive coverage on the label, the pattern in which the adhesive is coated,
and the full coverage adhesive characteristics of the materials used.
European Patent Application 279,579 (Tanuma et al.) describes pressure-
sensitive adhesive sheets comprising, in one embodiment, a continuous
adhesive layer having "irregular sections" (i.e., ".. the pressure-sensitive
-10-
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adhesive layer is uneven..."). The uneven adhesive layer, according to the
application, is imparted through a variety of pressing, molding, and
embossing methods.
Optimal repositionable adhesives used in the present pre-printed
instruction sheet provide very little adhesive transfer to the substrate to
which the pre-printed instruction sheet is adhered upon removal of the
sheet. When the adhesive used contains tacky microspheres, the following
test may be performed to determine the amount of microsphere transfer:
An area of coated sheet material is marked and observed using an
optical microscope. The number of microspheres within the area are
counted and this number designated "Y". The marked area of the coated
sheet is then adhered to KromekoteTM paper, a commercially available paper
for the printing industry, for a few seconds and then removed. The marked
area is again observed with an optical microscope, and the number of
microspheres remaining in the area are counted and this number designated
"Z". Percent microsphere transfer is defined as 100 times the ratio of the
difference between the number of microspheres initially present (in the
marked area of the coated sheet) after coating and the number of
microspheres remaining in the marked area after each adhesion and removal
from the paper substrate (Y - Z) to the number of microspheres initially
present in the area just after coating.
Percent transfer = 1 OO(Y-Z)
y
Preferably, the repositionable adhesive of the present invention has a
microsphere transfer of no more than 25%.
When the repositionable adhesive does not contain microspheres, a
similar measurement may be performed by determining the weight of
adhesive transferred to a
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substrate from a pre-printed instruction sheet having a known amount of
adhesive coated thereon. As above, it is desirable to have no more than
about 25% of adhesive transferred to the substrate, regardless of the nature
of the adhesive.
Detailed Descri~tion of the Drawing
Turning now to the Figure, pre-printed instruction sheet 10 is
preprinted with instructions 12, 13 and 14 for carrying out the multiple
10 steps for application of a dental adhesive system to a tooth. Repositionable
adhesive (not shown) is provided on the opposite side of sheet 10 from pre-
printed instructions 12, 13 and 14 to provide repositionable adhesion of
sheets 10 to an intended substrate.
