U.S. patent number RE31,887 [Application Number 06/157,288] was granted by the patent office on 1985-05-14 for moisture-vapor-permeable pressure-sensitive adhesive materials.
This patent grant is currently assigned to T. J. Smith & Nephew Limited. Invention is credited to Martin E. Hodgson.
United States Patent |
RE31,887 |
Hodgson |
May 14, 1985 |
Moisture-vapor-permeable pressure-sensitive adhesive materials
Abstract
This invention relates to a moisture-vapor-permeable
pressure-sensitive adhesive material for use on animal skin and
nails, e.g. a surgical drape, suture strip or sheet, adhesive
dressing, bandage, plaster, strapping tape, decorative nail
covering, or decorative cosmetic product. The adhesive material
comprises a backing material and a pressure-sensitive adhesive on
at least substantially the whole of the body adhering portion of at
least one surface of said backing material, both said backing
material and said adhesive being moisture-vapor-permeable and
unaffected by water and at least one of said backing material and
said adhesive comprising a synthetic polymer and .Iadd.both said
backing material and said adhesive .Iaddend.being continuous and
nonpermeable to liquid water, said adhesive material having a
moisture vapor permeability of at least 300 g/sq. meter/24
hours/40.degree. C./80 percent RH.
Inventors: |
Hodgson; Martin E. (Harlow,
GB2) |
Assignee: |
T. J. Smith & Nephew
Limited (Kingston-upon-Hull, GB2)
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Family
ID: |
27259063 |
Appl.
No.: |
06/157,288 |
Filed: |
June 6, 1980 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
839436 |
Jul 7, 1969 |
03645835 |
Feb 29, 1972 |
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Foreign Application Priority Data
|
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Jul 9, 1968 [GB] |
|
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32588/68 |
Oct 22, 1968 [GB] |
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50045/68 |
Dec 20, 1968 [GB] |
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60756/68 |
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Current U.S.
Class: |
428/355EN;
428/343; 428/424.4; 428/424.6; 602/54; 128/849; 428/424.2; 602/52;
428/355AC |
Current CPC
Class: |
A61F
13/023 (20130101); C09J 7/26 (20180101); A61K
8/8152 (20130101); A61L 15/58 (20130101); A61Q
3/00 (20130101); A61L 15/58 (20130101); C08L
33/26 (20130101); C08L 33/14 (20130101); C08L
33/06 (20130101); C08L 29/10 (20130101); A61L
15/58 (20130101); C08L 29/10 (20130101); A61L
15/58 (20130101); C08L 33/08 (20130101); C08L
27/06 (20130101); A61F 13/105 (20130101); Y10T
428/24802 (20150115); Y10T 428/28 (20150115); Y10T
428/2852 (20150115); Y10T 428/2878 (20150115); Y10T
428/1424 (20150115); Y10T 428/2891 (20150115); Y10T
428/3158 (20150401); Y10T 428/31855 (20150401); Y10T
428/31573 (20150401); Y10T 428/31576 (20150401); Y10T
428/31786 (20150401) |
Current International
Class: |
A61L
15/16 (20060101); A61L 15/58 (20060101); A61Q
3/00 (20060101); A61L 24/00 (20060101); A61K
8/72 (20060101); A61F 13/02 (20060101); A61K
8/81 (20060101); C09J 7/02 (20060101); C08L
27/06 (20060101); C08L 27/00 (20060101); B32B
007/10 (); B32B 027/40 (); A61F 013/02 (); A61L
015/06 () |
Field of
Search: |
;428/343,355,424.2,424.4,424.6 ;128/132D,132R,156 |
References Cited
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Other References
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.
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Article from Biomedical Business International..
|
Primary Examiner: Thomas; Alexander S.
Attorney, Agent or Firm: Jacobs & Jacobs
Claims
We claim:
1. A moisture-vapour-permeable pressure-sensitive adhesive material
for use on .[.animal.]. .Iadd.human .Iaddend.skin .[.and nails,.].
comprising a .Iadd.continuous .Iaddend.backing material.[.,.].
.Iadd.which is on unreinforced thermoplastic polyurethane film
.Iaddend.and a .Iadd.continuous .Iaddend.pressure sensitive
adhesive on at least substantially the whole of the body-adhering
portion of at least one surface of said .Iadd.continuous
.Iaddend.backing material, both said .Iadd.continuous
.Iaddend.backing material and said .Iadd.continuous
.Iaddend.adhesive being .[.moisture-vapour-permeable, and
unaffected by water.]. .Iadd.oxygen-permeable, synthetic polymers
which are moisture vapour permeable, unaffected by water
.Iaddend..[.and at least one of said backing material and said
adhesive comprising a synthetic polymer and being continuous.]. and
.[.nonpermeable.]. .Iadd.non-permeable .Iaddend.to liquid water
said adhesive material having a moisture vapor permeability of at
least .[.300.]. .Iadd.500.Iaddend.g/sq. meter/24hours/40.degree.
C./80.degree. percent RH. .[.2. A pressure-sensitive adhesive
material as claimed in claim 1, which has a moisture vapor
permeability of at least 500 g./sq. meter/24 hours at 40.degree. C.
and 80 percent RH..]. .[.3. A pressure-sensitive adhesive material
as claimed in claim 1, which is oxygen-permeable..]. .[.4. A
pressure-sensitive adhesive material as claimed in claim 1, wherein
the backing material is continuous and the
adhesive is not continuous..]. 5. A pressure-sensitive adhesive
material as claimed in claim 1, which is .[.in the form of.]. a
surgical drape.[., suture strip or sheet, adhesive.]. .Iadd.or
wound .Iaddend.dressing.[., bandage, plaster, strapping tape,
decorative nail covering, or decorative
cosmetic product.].. 6. A moisture-vapour-permeable
pressure-sensitive adhesive material for use on .[.animal.].
.Iadd.human .Iaddend.skin .[.and nails,.]. comprising a
.Iadd.continuous .Iaddend.backing material .Iadd.which is on
unreinforced thermoplastic polyurethane film .Iaddend.and a
.Iadd.continuous .Iaddend..[.pressure-sensitive.]..Iadd.pressure
sensitive .Iaddend.adhesive .Iadd.selected from the group
consisting of polyvinyl ethyl ethers and acrylic ester copolymers
containing hydrophilic groups .Iaddend.on at least substantially
the whole of the body-adhering portion of at least one surface of
said .Iadd.continuous .Iaddend.backing material, both said
.Iadd.continuous .Iaddend.backing material and said
.Iadd.continuous .Iaddend.adhesive being
.[.moisture-vapour-permeable .[.and.]. .Iadd.synthetic polymers
which are .Iaddend.unaffected by water and .[.at least said
adhesive comprising a synthetic polymer and being continuous and
nonpermeable.]. and .Iadd.are non-permeable .Iaddend.to liquid
water, said adhesive material having a moisture .[.vapor.].
.Iadd.vapour .Iaddend.permeability of at least .[.300.].
.Iadd.500.Iaddend.g/sq. .[.meter.]. .Iadd.meter.Iaddend./24
hours/40.degree. C./80 percent RH. percent RH. .[.7. A
pressure-sensitive adhesive as claimed in claim 6 wherein the
adhesive is a polyvinyl ethyl ethers or an acrylic ester copolymer
containing hydrophilic groups..]. .[.8. A pressure-sensitive
adhesive material as claimed in claim 6 wherein the backing
material is noncontinuous..]. .[.9. A pressure-sensitive adhesive
material as claimed in claim 8 wherein the backing material is a
microporous film of plasticized polyvinyl chloride or nonwoven
fabric..]. .[.10. A pressure-sensitive adhesive material as claimed
in claim 9, wherein the nonwoven fabric is based on cellulose or
synthetic polymer fibers which may be crimped and/or laid down in
such a manner as to give an elastic fabric..]. .[.11. A
pressure-sensitive adhesive material as claimed in claim 10,
wherein the fabric comprises extruded composite
synthetic fibers or a spun-bonded polyester fabric..]. 12. A
moisture-vapour-permeable pressure-sensitive adhesive material for
use on animal skin and nails.[.,.]. comprising a backing material
.Iadd.which is an unreinforced thermoplastic polyurethane film
.Iaddend.having a pressure-sensitive adhesive on at least
substantially the whole of the body-adhering portion of at least
one surface of said backing material, both said backing material
and said adhesive being moisture-vapour-permeable and unaffected by
water and both said backing material and said adhesive comprising a
synthetic polymer and being continuous and nonpermeable.].
.Iadd.non-permeable .Iaddend.to liquid water, said adhesive
material having a moisture vapor permeability of at least 300
g./sq. meter/24 hours/ 40.degree. C./80 percent RH. .[.13. A
pressure-sensitive adhesive material as claimed in claim 12 wherein
the backing material comprises a copolymer obtainable by
copolymerizing an hydroxy alkyl acrylate or methacrylate with an
alkoxy alkyl acrylate or methacrylate and optionally with a minor
amount of a further monomer..]. .[.14. A pressure-sensitive
adhesive material as claimed in claim 12, wherein the backing
material comprises a homopolymer of ethoxy ethyl methacrylate or
methoxy ethyl methacrylate or a copolymer of methyl methacrylate
with ethoxy ethyl methacrylate or methoxy ethyl methacrylate..].
.[.15. A pressure-sensitive adhesive material as claimed in claim
12 wherein the backing material comprises a thermoplastic
polyurethane film..]. 16. A pressure-sensitive-adhesive material as
claimed in claim 12, wherein the adhesive .Iadd.is
.Iaddend..[.comprises.]. a polyvinyl ethyl ether. 17. A
pressure-sensitive adhesive material as claimed in claim 12 which
is .[.in the form of a nail cover,.]. a medical or surgical
dressing.[.,.]. .Iadd.or .Iaddend.a surgical drape.[., a suture
strip, an elastic adhesive bandage or a strapping tape.].. .[.18. A
pressure-sensitive adhesive material as claimed in claim 12, which
is in the form of a nail cover and the backing material has a
thickness of from 1 to 3 mils..]. .[.19. A pressure-sensitive
adhesive material as claimed in claim 17 which is in the form of a
nail cover and in which the adhesive is applied in an amount of
from 5 to 75 grams per square meter..]. .[.20. A pressure-sensitive
adhesive material as claimed in claim 12 wherein the backing
material comprises a copolymer obtainable by reacting an alkoxy
alkyl acrylate or methacrylate with a different alkoxy alkyl
acrylate or methacrylate, no monomers other than alkoxy alkyl
acrylates or methacrylates or polymers formed therefrom being
present in the reaction mixture..]. .[.21. A pressure-sensitive
adhesive material as claimed in claim 20, wherein the backing
material comprises a copolymer of ethoxyethyl methacrylate and
methoxy ethyl methacrylate..]. .[.22. A pressure-sensitive adhesive
material as claimed in claim 21, wherein the backing material
comprises a 50/50, 60/40 or 70/30 copolymer of MEMA/EEMA..]. .[.23.
A pressure-sensitive adhesive material as claimed in claim 20
wherein the adhesive comprises a polyvinyl ethyl ether..]. .[.24. A
pressure-sensitive adhesive material as claimed in claim 20 which
is in the form of a suture strip and which is wholly or partially
reinforced with woven or nonwoven fabrics..]. .[.25. A
pressure-sensitive adhesive material as claimed in claim 13 wherein
said hydroxy alkyl acrylate or said methoacrylate comprises hydroxy
ethyl methacrylate, hydroxy propyl acrylate, or hydroxy propyl
methacrylate, and wherein said alkoxy alkyl acrylate or
methacrylate comprises ethoxy ethyl methacrylate or methoxy ethyl
methacrylate..]. .[.26. A pressure-sensitive adhesive material as
claimed in claim 17 in which the backing material is reinforced by
a nonwoven
material..]. .Iadd.27. A pressure-sensitive adhesive material as
claimed in claim 1 which is a surgical drape..Iaddend. .Iadd.28. A
pressure-sensitive adhesive material as claimed in claim 1 which is
an adhesive dressing..Iaddend. .Iadd.29. A pressure-sensitive
adhesive material as claimed in claim 12 which is a medical
dressing..Iaddend. .Iadd.30. A pressure-sensitive adhesive material
as claimed in claim 12 which is a surgical dressing..Iaddend.
.Iadd.31. A pressure-sensitive adhesive material as claimed in
claim 12 which is a surgical
drape..Iaddend. .Iadd.32. A pressure-sensitive adhesive as claimed
in claim 1 wherein the adhesive is a polyvinyl ethyl
ether..Iaddend. .Iadd.33. A pressure-sensitive adhesive as claimed
in claim 1 wherein the adhesive is an acrylic ester copolymer
containing hydrophilic groups..Iaddend. .Iadd.34. A pressure
sensitive adhesive material as claimed in claim 16 which is a wound
dressing or surgical drape..Iaddend. .Iadd.35. A pressure sensitive
adhesive material as claimed in claim 12 wherein the adhesive is an
acrylic polymer..Iaddend. .Iadd.36. A pressure sensitive adhesive
material as claimed in claim 12 wherein the adhesive is an acrylic
ester copolymer containing hydrophilic groups..Iaddend.
Description
The present invention relates generally to adhesive materials for
use on animal bodies particularly human bodies. Examples of such
materials are: adhesive bandages, plasters, dressings, surgical
drapes, and decorative cosmetic products.
Where adhesive materials are to be used on parts of animal bodies
e.g., human bodies, it is desirable to have an adhesive material
which is permeable to water vapor, but which is not permeable to
liquid water, micro-organisms and particles of dirt. These
conditions are desirable in order to provide the desired covering
without causing maceration due to occlusion of water from
transepidermal water loss from the body. Many methods have been
tried in order to obtain the results set out above. Methods at
present in use involve the use of perforated, porous or microporous
backing material having a porous or pattern spread adhesive layer.
Such constructions however do not provide a barrier to low surface
tension aqueous solutions, e.g., washing-up liquid (which will also
allow bacteria to penetrate). Furthermore large holes in the
material are not bacteriaproof and small holes are subject to being
blocked by grease etc. Special processes are also needed to produce
such materials.
According to the present invention there is provided a
moisture-vapor-permeable pressure-sensitive adhesive material for
use on animal skin and nails, comprising a backing material having
a pressure-sensitive adhesive on at least substantially the whole
of the body-adhering portion of at least one surface of said
backing material, both said backing material and said adhesive
being moisture vapor permeable and unaffected by water and at least
one of said backing material and said adhesive comprising a
synthetic polymer and being continuous and nonpermeable to liquid
water, said adhesive material having a moisture vapor permeability
of at least 300 g./sq. meter/24 hours/40.degree. C./80 percent
relative humidity (R.H.).
For the synthetic polymer used to form the continuous backing
material and/or the continuous adhesive to have the properties
desired it should not be highly crystalline, should not have a high
proportion of hydrogen bonding and should include hydrophilic
groups.
Evidences from various sources indicate that the average body loss
of water through the skin excluding visible sweat is in the region
of 250 g./sq. meter/24 hours. Areas such as the palm of the hand
and soles of the feet have a high water loss in the region of 500
g./sq. meter/24 hours.
It follows that a permeability of at least 300 g./sq. meter/24
hours/40.degree. C./80 percent R.H. is required for most areas but
a figure of 500 is preferred especially for wound dressings and
surgical drapes.
The adhesive may be applied as an allover spread (continuous or
discontinous) to one surface of the backing material or the
adhesive may be applied to body-adhering portions only to form for
example a window dressing, i.e., one in which the wound-covering
area of the backing material is not coated with adhesive.
It is clear that either the backing material or the adhesive, or
both, may be continuous and nonpermeable to liquid water. All such
arrangements have a number of common advantages, for example the
moisture vapor permeability feature allows the skin etc., to
breathe thereby preventing maceration and the impermeability to
liquid water feature prevents ingress of water and egress of wound
exudate where the material is used on a wound. The feature that
both the adhesive and the backing material are unaffected by water
allows the dressing to be immersed in water without adverse effect.
Each of the three different embodiments of the invention, however,
has its own particular advantages and the arrangement used for any
particular purpose should be selected bearing in mind these
advantages. For example, in embodiments where only the backing
layer is continuous and impermeable to water, dirt and water are
prevented from passing through the backing layer to the adhesive
which may then allow the water and dirt to reach the body. The
arrangement where only the adhesive is impermeable to water will
prevent wound exudate from passing through the adhesive. The
arrangement where both the adhesive and the backing material are
continuous and impermeable to water is particularly preferred since
this has the advantages given above for the arrangement where only
one of the backing material and adhesive is continuous. Furthermore
the manufacture of this embodiment is simplified since each of the
layers may be produced in a continuous manner. Also the possibility
of pinholes in the backing layer and the adhesive coinciding is
less when two continuous layers are used since any such pinholes
present are accidental. Furthermore strike-through of adhesive
through the backing layer is prevented.
The expression "continuous" as used throughout the present
specification, including the claims, is intended to mean that the
material is such that it contains no discontinuities which are
visible, either by the naked eye or under an optical microscope,
and are such that water vapor passes through such materials by
inter molecular diffusion. The polymer may be visualized as a
tangled mass of polymer chains with approximately molecular sized
holes between them. At normal temperatures there is considerable
segmental mobility and the holes are continually forming and
disappearing as a result of thermal motion. Diffusion of a
penetrant takes place as a succession of "jumps" from hole to
hole.
The diffusion of a gas or vapor through such a continuous material
does not depend on the fluid properties of the gas or vapor but on
the structures of the gas or vapor and the continuous material and
chemical affinity of one for the other.
In the specification, including the claims the expression
"unaffected by water" when used to describe the backing material
and/or the adhesive is intended to mean that the backing material
and/or adhesive does not on contact with water lose those
properties which would effect its performance as a backing or
adhesive, e.g., (a) the adhesive does not lose adhesion or cohesion
due to solution and does not swell to cause the dressing etc., to
come off and, (b) the backing does not lose its tensile strength,
disintegrate or become tacky.
Where reference is made to moisture vapor permeability it is
intended that such measurements are carried out by the Payne cup
method, carried out as follows.
Ten ml. of distilled water are added to the cup. A 11/4inch
diameter sample of the material to be tested is clamped above the
opening from the cup. Where an adhesive is being tested this should
first be coated onto a highly permeable backing for support. The
arrangement is then placed in an air-circulating oven at
temperatures of 40.degree. C. and relative humidity of 20 percent
for 24 hours. There is therefore a difference between the relative
humidity inside the cup and the relative humidity outside the cup.
The loss of water from the cup is found by weighing. The moisture
vapor permeability is expressed as g./sq. meter/24 hours/40.degree.
C./80 percent R. H. for the particular material.
The expression "pressure-sensitive adhesive" as used throughout the
specification, including the claims, is intended to mean an
adhesive which is inherently tacky, viscoelastic and cohesive in
its normal dry state. Clearly the adhesive used must be capable of
adhering to that part of the body to which it is to be
attached.
Where reference is made to adhesive being on "substantially the
whole of the body-adhering portion of the backing material" it is
not intended to exclude the possibility of the adhesive being
discontinuous to an extent sufficient to provide the body-adhering
portion with an average m.v.p. of at least 300.
The adhesive materials of the invention should be nontoxic,
nonirritant, conformable and should maintain their properties over
a range of conditions and time. The backing material should be
nontacky under conditions of use.
The adhesive materials may be used on any part of the human body,
e.g., for surgical, dermatological or cosmetic use. Some examples
of specific uses of the adhesive material of the invention are as
surgical drapes, suture strips and sheets, adhesive dressings,
bandages, plasters, decorative nail coverings, solid eye liners,
wrinkle producers (for theatrical make up) etc.
The adhesive materials of the present invention may result in the
following advantages:
1. Prevent occlusion of moisture under the structure which can
injure the skin or nail.
2. Allow oxygen through from the outside. This is important to
healing of wounds.
3. Prevent ingress of liquid water.
4. Prevent ingress of bacteria.
5. Are unaffected by water.
Some degree of isotropic elasticity in the backing material is
desirable for some applications. This is however not essential, and
nonelastic backing materials such as cretane may be used, if
desired.
Continuous adhesives may be formed from polymers containing
hydrophilic groups such as hydroxyl, carboxyl, amine, amide, ether
and alkoxy providing that the adhesives are not soluble or highly
swollen in water.
However, water-soluble or water-swellable polymers can be added to
pressure sensitive formulations provided they are compatible and do
not cause the adhesives to be affected by water (for example a
polyvinylmethyl ether may be added to a polyvinylethyl ether
adhesive or a hydroxy propyl acrylate homopolymer may be added to a
compatible pressure-sensitve adhesive); other water-soluble or
water-swellable polymers which may be used are cellulose esters,
polyvinyl alcohol and other hydrophilic materials. Similarly
water-soluble monomers can be used in water-insensitive
copolymers.
Examples of materials which may be used as the continuous adhesive
are blends of vinyl ether or acrylic polymers, with or without the
addition of tackifying resins. Hydroxy acrylate polymers may also
be used in suitable formulations.
Preferred water-impermeable adhesives are polyvinyl ethyl ethers
and certain acrylate ester copolymers containing hydrophilic
groups.
The polyvinyl ethyl adhesives may be obtained in a wide range of
viscosities. A particularly preferred polyvinly ethyl ether
adhesive is a composition comprising the following ingredients:
______________________________________ Amount (Parts by weight
except Ingredient. where stated).
______________________________________ Bakelite EDBC (see below) 50
Bakelite EHBM (see below) 100 (solution as received) Kelrez ZR 142
(see below) 25 Antioxidant (Nonex WSL) 3 60-80 petroleum ether 300
mls. ______________________________________
Polyhydroxy propyl acrylate is a tacky rubbery polymer which may be
converted into a pressure-sensitive adhesive composition by
copolymerization. The homopolymers generally cross-link during
polymerization but linear polymers may be obtained by solvent
polymerization provided the concentration of monomer is low.
Suitable acrylate ester copolymer adhesives found so far are
Acronal KR 2156 (B.A.S.F) and D.260 (Shawinigan). Blends of acrylic
and polyvinyl ethers found to be useful as adhesives include (a) a
mixture of 50 parts by weight Acronal 40D (B.A.S.F.) and 50 parts
by weight Lutanol M 40, and (b) a mixture of 100 parts by weight
Gantrez M 574, 50 parts by weight Gelva D 260 and 25 parts by
weight of Kelrez ZR 142.
Where a continuous adhesive is used, the adhesive may be applied to
the backing material in solution, aqueous dispersion, as a hot
melt, or by a transfer process, using known techniques, e.g.,
knife, roller-coating or curtain coating methods. In practice the
transfer process has been found to be particularly convenient. The
adhesive solution is spread on release-coated paper, and almost
dried before contacting the backing material under sufficient
pressure to ensure good contact. The release paper is then removed.
Other methods may however prove to be more practicable in
commercial use.
Any suitable adhesive may be used where the adhesive is to be
discontinuous. The discontinuities should not be too big, i.e., the
adhesive layer should contact the skin etc., over most of the area
of the dressing.
The adhesive can be made porous by foaming, leaching out soluble
fillers, pattern spreading, e.g., as shown in British Pat. No.
819,635 spraying or selective layer perforating.
Where the backing material is continuous any material which is
continuous and is water-vapor-permeable but liquid water
impermeable may be used, although for many uses other properties,
e.g., conformability and oxygen permeability, are desirable.
Useful materials include cast films of thermoplastic polyurethane
and other polymers containing nonbound (free to interact with
water) hydrophilic groups e.g., --OH, --COOH, --NH.sub.2, --NH,
alkoxy and ether etc.,) provided they are unaffected by water, as
defined above.
Preferred continuous backing materials are:
I. A copolymer obtainable by copolymerizing an hydroxy alkyl
acrylate or methacrylate with an alkoxy alkyl acrylate or
methacrylate and optionally with a minor amount of a further
monomer.
Copolymers of this type are described in G.B. application No.
50,044/68.
If desired more than one hydroxyalkyl acrylate or methacrylate
and/or more than one alkoxy alkyl acrylate or methacrylate may be
used as monomers.
Preferably the minor amount of further monomer is no more than 10
percent by volume based on the total volume of monomers.
Preferred further monomers are acrylic acid methacrylic acid
acrylamide, mono- and di- acrylates of glycols and poly glycols,
(e.g. glycerol and polyalkylene glycols), mono- and
di-methacrylates of glycols and polyglycols (e.g., glycerol and
polyalkylene glycols, glycidyl acrylates and glycidyl
methacrylates).
The further monomer or monomers may be present as an impurity in
the major constituents of the reaction mixture or may be
specifically added, e.g., to provide for cross-linking.
The preferred hydroxy alkyl acrylates and methacrylates are hydroxy
ethyl methacrylates (HEMA), hydroxyl propyl acrylate (HPA) and
hydroxy propyl methacrylate (HPMA).
Preferred alkoxy alkyl acrylates and methacrylates are ethoxy ethyl
methacrylate (EEMA) and methoxy ethyl methacrylate (MEMA).
The properties of these copolymers will vary depending on the
proportions of the various ingredients used to make up the
copolymer. In general copolymers with a high proportion of alkoxy
alkyl acrylate or methacrylate (e.g., EEMA) give flexible, high
moisture-vapor-permeable non-water-swellable films at 20.degree. C.
whereas a high proportion of a hydroxy alkyl methacrylate (e.g.,
HEMA) will give high moisture-vapor-permeable brittle,
water-swellable films (properties at 20.degree. C.). For example, a
copolymer made up from 80 percent by volume EEMA and 20 percent by
volume (HEMA is flexible and is not affected by water, whereas a
copolymer made up from 50 percent by volume EEMA and 50 percent by
volume HEMA is brittle and is swollen by water.
Copolymers including more than 30 percent hydroxyl ethyl acrylate
or methacrylate are affected by water and are thus not included as
materials which can be used as backing materials in the present
invention.
These copolymers may be prepared by copolymerizing an hydroxyalkyl
acrylate or methacrylate with an alkoxy alkyl acrylate or
methacrylate and optionally with a minor amount of a further
monomer. A free radial initiator, for example, tertiary butyl
peroctoate may be used. The reaction may be performed in a solvent
such as ethyl acetate, industrial methylated spirits, ethanol,
methanol, dimethyl formamide. The reaction is performed in an inert
atmosphere under reflux for 8 hours. The copolymer may be
precipitated by pouring into a nonsolvent such as petroleum
ether.
Alternatively, the above reaction may be taken to near completion
by refluxing, e.g., for 24 hours, to give a solution of the
copolymer. Films may be formed from the solution of the copolymer
by casting a solution of the copolymer onto a smooth surface, for
example release-coated silicone paper or cast polypropylene, drying
and stripping the film off the smooth surface. To improve strength
characteristics the copolymers may be self-cross-linked by heating
or may be cross-linked by the addition of a cross-linking agent or
a catalyst. A copolymer of 80 percent by volume EEMA and 20 percent
by volume HEMA may be partially self-cross-linked by heating at
120.degree. C. for 11/2 hours or longer in air atmosphere.
II. Homopolymers of alkoxy alkyl acrylates or methacrylates (linear
or cross-linked) or from copolymers of one or more (preferably one)
alkoxy alkyl acrylate or methacrylate with one or more (preferably
one) alkyl acrylate or methacrylate.
The moisture vapor permeability is reduced as the proportion of
alkyl acrylate or methacrylate is increased. Care should therefore
be taken to ensure that, in the final product, the moisture vapor
permeability is at least 300 by careful selection of the
proporation of alkyl acrylate or methacrylate, the thickness of the
backing material and the nature and thickness of the adhesive.
Preferred monomers are ethoxy ethyl methacrylate (EEMA); methoxy
ethyl methacrylate (MEMA); methyl methacrylate (MMA).
III. A copolymer obtainable by reacting an alkoxy alkyl acrylate or
methacrylate with a different alkoxy alkyl acrylate or
methacrylate. Copolymers of this type are described in our GB
application No. 60,754/68. Although it is preferred that no
monomers other than alkoxy alkyl acrylates or methacrylates or
polymers formed therefrom are present in the reaction mixture, up
to 10 percent of further monomers (see list above under I) may be
present.
What reference is made to no monomers other than alkoxy alkyl
acrylates or methacrylates or polymers being present, it is to be
understood that the reaction mixture may include very small amounts
of the free acids as impurities.
These copolymers may be produced by copolymerizing in an inert
atmosphere an alkoxy alkyl acrylate or methacrylate with a
different alkoxy alkyl acrylate or methacrylate.
The reaction may be performed in the presence of a free-radical
initiator, for example, tertiary butyl peroctoate.
The reaction may be performed in the absence of a solvent or in the
presence of a solvent, e.g., ethyl acetate, toluene, methanol or
dimethyl formamide.
The copolymer may be precipitated by pouring into a nonsolvent such
as petroleum ether. Alternatively the reaction may copolymer. Films
may be formed from a solution of the copolymer by casting
completion by heating drying for a suitable length of time e.g.,
for 24 hours, to give a solution of the copolymer by casting the
solution onto a smooth surface, for example, release-coated
silicone paper or cast polypropylene, drying and stripping the film
from the smooth surface. The properties of the films and coatings
of the copolymer of the invention depend on the type and proportion
of the monomers. For example, copolymers of ethoxy ethyl
methacrylate (EEMA) and methoxy ethyl methacrylate (MEMA) and
containing a high proportion of MEMA will tend to be stiff and
brittle at temperatures in the region of 5.degree. C. whereas
similar copolymers containing a large proportion of EEMA will be
flexible.
IV. Thermoplastic polyurethane films. Suitable films can be made by
extrusion or preferably by solvent casting. Suitable materials, and
their production are described in U.S. Pat. No. 2,871,218. Estane
5701 and 5702 (B. F. Goodrich Co.) have been found to be
particularly satisfactory. Estane 5702 has been found to be the
most useful of these materials.
This material is best cast as a tetrahydrofuran or acetone
solution.
Properties of a 1-mil thick film of Estane 5702 are:
MVP 1,620 g.s.m./24 hr.
O.sub.2 permeability 4,880 cc./m..sup.2 /Atmos./24 hr.
Tensile strength (p.s.i.) 5,300
Elongation 730 percent
Modulus at 300 percent extension (p.s.i.) <500
Hardness (Durometer A) 70
Low-temperature brittleness point (.degree.F.) <-100
Where the backing material is not continuous any material having
high moisture vapor permeability may be used provided it is not
affected by water. In addition it is desirable for such backing
material to be such that it acts as a screen for larger particles
of solid materials such as dirt.
Examples of materials which may be used to form noncontinuous
backing material are microporous films of plasticized polyvinyl
chloride (process for making such microporous film of p.v.c. is
described in U.K. specification No. 884,232), and certain nonwoven
and woven and knitted porous fabrics. Fabrics which may be used as
the backing material include nonwoven fabrics based on cellulose or
synthetic polymer fibers which may be crimped and/or laid down in
such a manner as to give an elastic fabric. A preferred type of
fabric having the desirable properties of omnidirectional stretch
combined with high porosity and high strength even when wet, is
that type of fabric based on extruded composite synthetic fibers
sold under the trade mark "Heterofil" by Imperial Chemical
Industries Limited.
Several of the spun-bonded polyester fabrics marketed as "Reemay"
fabrics by DuPont and similar fabrics by Bondina Ltd. are similarly
suitable.
In some cases the adhesive may be applied directly to the backing
materials. In other cases however a water-vapor-permeable tie
coating continuous or discontinuous may be needed to obtain
adequate keying between the adhesive and the backing material. For
example acrylic and plasticized PVC films may be coated with some
adhesives directly, without need for a primer coat, e.g., where the
adhesive used is a polyvinyl ethyl ether a tie coating is not
usually required. However when using a backing material which
includes Nylon a primer coat is required in order to obtain
adequate keying between the adhesive and backing material when wet.
A suitable primer has been found to be a butadiene/vinyl-pyridine
latex solid under the trade name "Gentac."
In some instances, when using a noncontinuous backing material the
exposed surface of the backing material has been found to "fluff
up" badly, as well as becoming soiled. Also there is a tendency for
the adhesive to strike through the backing material, adding to the
soiling problem. This may be overcome by applying a thin coat of a
flexible and extensible material on the exposed surface of the
backing material. In addition to consolidating the surface, this
coating could also provide release properties useful when the
product is used in a roll form, e.g., for bandaging and strapping.
Suitable material which may be used are conventional release coats
such as polystearyl methacrylate.
Where the material is to be used as a surgical dressing, a pad may
be attached to the adhesive-coated surface of the material.
The dressing pad when used is of conventional type and may, if
desired, be made in situ by flocking vertically orientated fibers
onto the adhesive surface.
Preferably a protector is provided to cover the adhesive which
protector may be removed from the material immediately prior to
use.
The protector, when used, may be a smooth-release-coated paper,
e.g., a silicone-release-coated paper, but other thin suitable
films inert to the adhesive may be employed.
The continuous portion of the material of the invention preferably
has a high oxygen permeability especially where the material of the
invention is to be used as a wound dressing.
Where the adhesive material of the invention is being stored in
such a manner that the adhesive can come into contact with the
backing material, e.g., if stored in the form of a reel,
precautions must be taken to ensure the adhesive does not strongly
adhere to the backing material. For example, the backing material
may be provided with a release coating or a protector may be
applied over the adhesive surface. This release coating may also
serve to reduce soiling of the film in use.
If desired the backing film or adhesive layer or both may be given
a pattern of thinner areas, e.g., by embossing, to enhance the
vapor and gas permeability of the layers.
One of the preferred uses of the present invention is in decorative
cosmetic products, e.g., nail covers, eye liners, beauty spots,
stage effects, e.g., wrinkle producers (attach to skin in stretched
state).
the preferred backing films for use in nail covers are copolymers
of EEMA/HEMA (provided the amount of HEMA does not exceed 30
percent; EEMA/HPMA: MEMA/EEMA: copolymers of MEMA with other
monomers e.g., MEMA/HEMA; EEMA/MMA and homopolymers of MEMA.
Particularly preferred are 80/20 (volume percent) and 75/25 (volume
percent) copolymers of EEMA/HEMA: 90/10 (volume percent) and 80/20
(volume percent) copolymers of EEMA and MMA; and 80/20 (volume
percent) copolymer of EEMA/HPMA; 50/50, 60/40 and 70/30 MEMA/EEMA
copolymers; 90/10 (volume percent) and 80/20 (volume percent)
copolymers of MEMA/HEMA and cross-linked versions of these
polymers. The film thickness is preferably from 1 to 3 mils.
The preferred adhesives for use in connection with the nail coves
are polyvinyl ethyl ether based adhesives, continuous film
adhesives and foamed porous adhesives. The adhesive is preferably
applied in an amount of from 5 to 75 grams per square meter. Nail
covers are preferably glossy although they can have a matt finish.
The films and/or adhesive may be pigmented or dyed. The films may
having printing on them.
The nail covers are conveniently made up as a kit of two sets of
six individual nail covers mounted in a range of sizes on a
stiff-release-coated card.
The nail covers are removed from the nails by peeling or wiping
with a special solvent. The material state to be preferred for nail
covers are also preferred for other decorative cosmetic
products.
Another particularly preferred use of the present invention is in
forming adhesive medical and surgical dressings including first aid
dressings and ward dressings.
The absorbent pad is generally placed centrally on the adhesive
face of the material and the whole is preferably covered by a film
or release coated paper protector. If desired, the dressings may be
placed in a sterile pack, e.g., one sterilized by ethylene oxide or
by irradiation.
The preferred backing films and adhesives include those given in
respect of the nail covers.
Other preferred backing materials are continuous thermoplastic
polyurethane films, e.g., the Estanes (B. F. Goodrich) particularly
Estane 5702 and 5701, and elastic fabrics coated with such
materials or with poly EEMA. Preferred discontinuous backing
materials are microporous p.v.c., spun-bonded nonwoven fabrics,
elastic woven fabrics and knitted fabrics.
Another preferred use of the present invention is in surgical
drapes. These are large flexible sheets which are provided with a
continuous layer of adhesive on at least a part only of one
surface.
Where only a part of one surface is coated, the adhesive-coated
area may be varied with the design of the drape and a film or
release-coated protector is generally applied to the
adhesive-coated area. This protector is removed when it is desired
to use the drape. Generally two uncoated margins are provided to
enable the protector to be easily removed. Alternatively, the
coated margins may be covered by a releasable protector strip. The
drapes may be packaged as a roll in a sterile pack and the shape of
the drape may be varied to suit particular parts of the body.
Preferred materials, including both the backing material and the
adhesive, are the same as those given for the nail covers. Another
preferred backing material is a polyurethane film.
If desired, a bacteriostat may be incorporated into the surgical
drape to prevent growth of infectious bacteria on its surface.
If desired, part of the surgical drape may be reinforced, for
example the backing film may be reinforced with a light-weight
spun-bonded nonwoven fabric to prevent the film tearing or
splitting, if particular strength is required.
The surgical drapes of the present invention have a number of
advantages as set out below:
1. Moisture vapor and oxygen permeable, waterproof and bacteria
proof.
2. They may be left in position on the body for long periods which
if considered desirable, enables
a. the drape to be adhered over the proposed area of operation and
the incision line marked on the drape during the preoperative
period.
b. the incision to be made accurately through the drape, the drape
prevents wound infection from the surrounding area and the cut
edges reinforce the wound edges.
c. the incision to be closed by surface suture strips and, if
necessary, covered by an adhesive dressing (e.g., ward dressing)
adhering to the surface of the drape and the whole assembly to be
left in contact with the body surface until the incision is
healed.
It may be convenient for the drape to be transparent to enable the
wound to be observed during healing.
The drapes preferably have a matt surface to prevent light
reflection especially for use in an operating theater.
Surgical drapes must be highly conformable to skin otherwise after
an incision has been made the retraction of the skin from the
incision would cause the drape to lift and allow blood etc., to
pass between the drape and the skin. The backing material is
preferably antistatic.
Another use of the present invention is in suture strips. At
present wounds either caused by accident or caused during surgical
treatment are generally closed by stitching. The present invention,
however, provides small flexible strips which may be used to
prevent a wound from opening up.
The strips should have sufficient rigidity and cohesive properties
to achieve the desired result. The suture strips may be mounted on
a release-coated paper or film strip and packaged in a sterile
pack, such as a film or coated paper peel pack. The size and shape
of the suture strips may, of course, be varied as desired. The
following three forms have, however, been found to be of particular
use.
1. Thin strips, e.g., one-eighth of an inch.times.3 inch mounted in
multiples of 5 or 10 on release-coated rectangular strip.
2. Rectangular strips, e.g., one-fourth of an inch.times.2 inch
with a central absorbent pad, nonadherent strip or a central
reinforced area either mounted in groups on a release-coated sheet
or individually wrapped with a protective facing.
3. A "butterfly" shape, i.e., wide ends and narrow waist either
mounted in groups on a release-coated sheet or individually wrapped
with a protective facing.
Preferred backing materials for use in the production of the suture
strips are the same as those given for the surgical dressings.
Preferred adhesives are polyvinyl ethyl ethers.
The suture strips may be wholly or partially reinforced with woven
or nonwoven fabrics, for example spun-bonded fabrics such a Reemay
(as sold by E. I. Dupont de Nemours) I.C.I.). fabrics formed from
Heterofil fibers (as marketed by I.C.I.). A fabric reinforcement
may be present in any layer of the suture strip, for example on the
uncoated film surface.
The suture strips preferably have a small amount of elasticity to
aid closure of the wound. The strip is adhered to one side of the
wound and is then held under tension while adhering to the other
side of the wound.
The suture strips of the present invention have a number of
advantages as set out below.
1. The moisture vapor and gas permeability properties enable the
strips to be left in position for as long as 10 days without
irritation and trauma of the skin.
2. Waterproof properties prevent removal by external water or wound
exudate.
3. The strips may be used for tissue grafts.
Another particular preferred use of the present invention is in
elastic adhesive bandages and strapping tapes. These products
comprise lengths of the adhesive material described above and are
generally in the form of reels. Since in some cases the adhesive
will tend to adhere strongly to the backing material when in reel
form, it is desirable to use either a release coat on the backing
material or a protector on the adhesive.
The preferred continuous backing materials for strapping tapes are
films of copolymers of EEMA/HEMA; EEMA/HPMA; EEMA/MMA MEMA/HEMA and
EEMA/MEMA reinforced by woven or nonwoven fabrics. Preferred
discontinuous backing materials for strapping tapes include woven
and nonwoven fabrics with good tensile strength.
The preferred backing materials for elastic bandages are knitted
fabrics, e.g., knitted nylon, fabrics containing elastic threads,
and high-twist cotton fabrics (elastic bandages) which may be
coated with poly-ethoxy ethyl methacrylate or thermoplastic
polyurethane.
The preferred adhesive is polyvinyl ethyl ether.
The backing material for the elastic bandages preferably has a high
degree of stretch with good recovery properties whereas when used
as a strapping tape the backing material is preferably more rigid,
although it must still be flexible.
The main advantage with the bandages and strapping tapes is that
they are waterproof yet moisture vapor and gas permeable thus
allowing the bandages or tapes to be adhered to the skin without
irritation or trauma developing .
IN THE DRAWINGS
FIG. 1 is a graph showing, for one form of the adhesive material of
the invention, the relationship between moisture vapor permeability
and thickness of backing material and amount of adhesive;
FIG. 2 is a diagrammatic sketch of an adhesive material in
accordance with the invention,
FIG. 3 is a diagrammatic sketch of a nail cover in accordance with
the invention,
FIG. 4 is a diagrammatic sketch of a number of nail covers mounted
on a single mounting,
FIG. 5 is a diagrammatic sketch of an adhesive medical or surgical
dressing in accordance with the invention,
FIG. 6 is a diagrammatic sketch of a suture strip in accordance
with the invention,
FIG. 7 is a diagrammatic sketch of a surgical drape in accordance
with the invention.
FIG. 1 is described in connection with Example 16.
In FIG. 2 an adhesive material is shown comprising a backing
material 2, which may or may not be continuous and an adhesive 4
which may be continuous or discontinuous on one surface of the
backing material 2. At least one of the backing material and the
adhesive is continuous. As shown in FIG. 2 a protector, removable
for use is provided for the adhesive although this is optional. By
making the backing from an elastic material, an elastic bandage or
tape may be obtained. The adhesive material of FIG. 2 is in the
form of an adhesive tape.
In FIG. 3 there is shown a nail cover 14 of the invention. The nail
cover includes a backing material, an adhesive and a protector 6 as
in the material of FIG. 1 and has a cuticle-contacting curved
portion 8 and a body portion 10. The protector is removed and the
cover applied to the nail. The material used should be such that
the cover will conform to the curvature of the nail. When the cover
has been applied to the nail the squared end of the portion 10 is
trained to the desired length and shape. If desired the nail covers
may be produced as a set (see FIG. 4) mounted on a common mounting
the mounting 12 replaces the protector. The individual nail covers
14 on the mounting 12 are of cuticle-contacting portions of the
covers one of varying radii and six covers are provided for each
hand to enable selection of the current radius cuticle-contacting
portion to be selected. The covers are removed from the mounting
for use. A strip of a protective material 16 which is subsequently
removed may be provided on each nail cover 14 to enable it to be
easily removed from the mounting 12 and for ease of handling.
FIG. 5 shows an adhesive medical or surgical dressing of the
invention. This comprises a backing material 2 and an adhesive 4 as
in the arrangement of FIG. 1. A dressing pad 18 is situated roughly
centrally of the dressing on the adhesive side. A protector is
provided to cover the pad and adhesive. The protector is removed
when the dressing is required for use.
FIG. 6 shows a suture strip of the invention. This comprises a
narrow strip of pressure-sensitive adhesive material including a
backing material 2 and an adhesive 4. A fabric reinforcement 20 is
provided on the uncoated side of the backing material. A protector
6 covers the adhesive side and is removed when the strip is to be
used to prevent a wound from opening up.
FIG. 7 shows a surgical drape of the invention comprising a backing
material 2 and an adhesive 4. The incision line is marked on the
drape as at 22. A removable protector 6 is provided by adhesives to
facilitate removal of the protector 6.
Material similar to those shown in FIGS. 2 to 7 may be used for
various other purposes. For example by using different shaped
adhesive materials comprising a backing and an adhesive other
decorative cosmetic products such as beauty spots and eye liners
may be formed. Also by using an elastic backing material a wrinkle
producer for stage effect may be obtained. The material is
stretched adhered to the skin and allowed to contract causing a
wrinkle effect.
The invention will now be described with reference to the following
examples. In these examples where reference is made to moisture
vapor permeabilities the units are g./sq. meter/24 hrs./40.degree.
C./80 percent RH.
EXAMPLE 1
One surface of a backing material in the form of a lightweight
fabric (weight 1 oz./sq.yd) formed from "Heterofil" fibers based on
Nylon was given a primer coat of "Gentac" and adhesive composition
A (described below) was then applied to the primer coated surface
of the fabric in an amount of 75 g./sq. meter. The moisture vapor
permeability of the adhesive material so produced was 500.
The adhesive coated material was made into first aid dressings but
cutting to an appropriate size and applying a pad to part of the
adhesive surface. The dressing gave satisfactory results and did
not produce skin maceration due to having too low a moisture vapor
permeability.
EXAMPLE 2
One surface of a backing material in the form of a lightweight
fabric (weight 1 oz./sq.yd.) formed from Heterofil fibers based on
Nylon was given a primer coat of "Gentac" and adhesive composition
B (described below) was then applied to the primer-coated surface
of the fabric in an amount of 70 g./sq. meter. The moisture vapor
permeability of the adhesive material so produced was 835.
The adhesive-coated material was made into first aid dressings by
cutting to an appropriate size and applying a pad to part of the
adhesive surface. The dressing gave satisfactory results and did
not produce skin maceration due to having too low a moisture vapor
permeability.
EXAMPLE 3
An adhesive composition was prepared by dissolving a copolymer
(Shawinigan D 260) of acrylic esters in a solvent system consisting
of toluene/Hexane/ethyl acetate. This adhesive was knife-coated on
to a microporous poly vinyl chloride foil having a moisture vapor
permeability of 4,500. Dry coating weight was 50 g./sq.m. Dressings
made from this showed a moisture vapor permeability of 550 and
adhered well to skin.
No skin maceration developed in user trials.
EXAMPLE 4
The moisture vapor permeability of the adhesive of Example 3 was
increased by the addition of a poly methyl vinyl ether. (Lutanol
M40).
A 50/50 blend on a solids basis was knife-coated on to microporous
P.V.C. foil at a dry coating weight of 75 g./sq.m. Dressings made
from this had a moisture vapor permeability of 780. The dressings
performed well in user trials, although adhesives based on methyl
vinyl ethers alone were not expected to possess sufficient water
resistance for this purpose.
EXAMPLE 5
Adhesive composition C (described below) was knife-coated on to
microporous P.V.C. foil at a dry coating weight of 72 g./sq.m.
This gave dressings having moisture vapor permeability higher than
that given by a similar formulation based on ethyl vinyl ethers
without the poly hydroxy propyl acrylate (HPA), e.g., a moisture
vapor permeability 555 was increased to 667 by this addition of
HPA.
EXAMPLE 6
A cast film 0.0025 inch thick and consisting of a copolymer of 80
percent by volume EEMA and 20 percent by volume HEMA with its
casting paper still attached was spread with a solvent-based
polyvinyl ethyl ether pressure-sensitive adhesive (adhesive
composition A). The amount of adhesive was 16 grams per square
meter. The adhesive was then dried in an oven and the coated film
mounted on to a release-coated paper protector. The casting paper
was then removed and the laminate made into a kit of individual
nail covers. The film alone had a moisture vapor permeability of
1,400, the adhesive a moisture vapor permeability of 3,000 and the
completed nail cover a moisture vapor permeability of 960.
A trial showed that the nail covers performed adequately and did
not cause damage to the nail.
EXAMPLE 7
A first aid dressing was made up using a 0.002-inch cast film
(copolymer of 20 percent by volume HEMA and 80 percent by volume
EEMA) and the film coated with 30 grams per sq. meter of a
polyvinyl ethyl ether adhesive (adhesive composition A). A
protector consisting of a low-release silicon-coated parchment (No.
E1952 as marketed by Leonard Stace Ltd.) was applied to the
adhesive surface of the dressing which had a moisture vapor
permeability of 690.
EXAMPLE 8
A surgical drape was made up by coating a 0.002-inch thick cast
film (20 percent by volume HEMA 80 percent by volume EEMA copolymer
with 16 grams per square meter of a polyvinyl ethyl ether adhesive
(adhesive composition A). The marginal edges on two opposed
parallel sides were left unspread. A silicone-release-coated paper
was applied to the adhesive as a protector. The moisture vapor
permeability of the surgical drape (excluding the protector) was
1,080.
EXAMPLE 9
A 1.6 oz. per square yard spun-bonded nonwoven fabric (Reemay type
2415) was laminated to an 0.002-inch thick cast film (copolymer of
20 percent by volume HEMA and 80 percent by volume EEMA). The film
side was then coated with 90 grams per square meter of a polyvinyl
ethyl ether adhesive (adhesive coposition A) and a release-coated
card was then applied to the adhesive surface. The resulting
laminate was split into one-eighth of an inch by 3 inch strips
which were then packed in a peel pack to be used as suture strips.
The suture strips had a moisture vapor permeability of 340.
EXAMPLE 10
A cast film 0.0025 of an inch thick and consisting of a copolymer
made by copolymerizing a mixture 50 percent by volume EEMA and 50
percent by volume MEMA with its casting paper still attached was
spread with a solvent-based polyvinyl ethyl ether
pressure-sensitive adhesive (adhesive composition A). The amount of
adhesive was 16 grams per square meter. The adhesive was then dried
in an oven and the coated film mounted on to a release-coated paper
protector. The casting paper was then removed and the laminate made
into a kit of individual nail covers. The nail covers (excluding
the protector) had a moisture vapor permeability of 940.
Nail covers in accordance with this example were given to 20
volunteers and used for 72 hours or more.
Examination of the nails showed that no significant nail damage
occurred when compared with a conventional nitrocellulose lacquer
used as a control. The nail covers had an excellent appearance and
did not cause any irritation.
EXAMPLE 11
A first aid dressing was made up using a 0.002-inch cast film (of a
copolymer obtained by copolymerizing a mixture of 50 percent by
volume MEMA and 50 percent by volume EEMA) and the film coated with
30 grams per sq. meter of a polyvinyl ethyl ether adhesive
(adhesive composition A). A protector consisting of a low-release
silicone-coated parchment (No. E 1952 as marketed by Leonard Stace
Ltd.) was applied to the adhesive surface of the dressing.
The dressing (excluding protector) had a moisture vapor
permeability of 780.
EXAMPLE 12
A surgical drape was made up by coating a 0.002-inch thick cast
film (of a copolymer obtained by copolymerizing a mixture of 50
percent by volume MEMA 50 percent by volume EEMA) with 16 grams per
sq. meter of a polyvinyl ethyl ether adhesive (adhesive composition
A). The marginal edges on two opposed parallel sides were left
unspread. A silicone-release-coated paper was applied to the
adhesive as a protector. The drape (excluding protector) had a
moisture vapor permeability of 1080.
EXAMPLE 13
A 1.6 oz. per square yard spun-bonded nonwoven fabric (Reemay type
2415) was laminated to an 0.002-inch thick cast film (of a
copolymer obtained by copolymerizing a mixture of 50 percent by
volume MEMA and 50 percent by volume EEMA). The film side was then
coated with 90 grams per square meter of a polyvinyl ethyl ether
adhesive (adhesive composition A) and a release-coated card was
then applied to the adhesive surface. The resulting laminate was
split into one-eighth of an inch by 3 inch strips which were then
packed in a peel pack to be used as suture strips. The suture
strips (excluding protector) had a moisture vapor permeability of
350.
EXAMPLE 14
Adhesive composition D (see below) was knife-coated onto a
silicone-coated release paper, to give a dry coating weight of 60
g.s.m. After drying, a spun-bonded fabric (Reemay 2415) was
laminated to the adhesive and the release paper stripped away.
Small dressing pads were placed on the adhesive, and first aid
dressings cut out.
The dressings had a moisture vapor permeability of 1,100, adhered
satisfactorily to human skin, and did not cause skin maceration or
irritation.
EXAMPLE 15
Adhesive composition E (see below) was knife-coated onto a release
paper to give 40 g.s.m. dry coating weight. The dry adhesive w was
transferred by lamination to a nonwoven spun-bonded polyester
fabric having an appreciable degree of stretch and recovery (No.
1520 by Bondina Ltd).
This was then cut into strips 3 inches wide by 3 yards long and
rolled up with a silicone paper interleaf for use as adhesive
compression bandages. These bandages had a M.C.P. of 110 units.
EXAMPLE 16
Adhesive materials were prepared from a backing material of a
polymer obtained by copolymerizing a 50/50 mixture of EEMA/MEMA and
adhesive composition A (see below). The accompanying drawing shows
the moisture vapor permeability of these various films in the form
of a graph (log/log scale) in which moisture vapor permeability
(along the ordinate or y-axis) is plotted against mass of adhesive
(along the abscissa or x-axis) (g./sq. meter for the adhesive alone
(line A), the adhesive on 0.001-inch (line B); 0.0015-inch (line C)
0.002-inch (line D); 0.0025-inch (line E) and 0.0030-inch (line F)
backings.
EXAMPLE 17
A self-cross-linking acrylic ester copolymer in ethyl acetate
solution (Acronal KR 2156 supplied by BASF) was reverse-roll-coated
onto a 1-mil thick polyurethane film (Estane 5702 solution cast) to
give a dry coating weight of 60 g.s.m.
The polyurethane film, with the wet coating of adhesive solution
was passed through a hot-air-drying tunnel at 75.degree. C. which
caused the adhesive to foam up as it dried.
At the reel up, a siliconized paper interleaf was laminated to the
adhesive, passing through nip rollers applying sufficient pressure
to burst much of the foam (50 p.s.i. on the actuating cylinders of
a Dixon coater model 160, 12 inch wide).
Samples of film/adhesive tested for MVP gave a figure of 820.
Similar film coated with Acronal KR 2156, but not foamed, gave an
MVP figure of 550 units.
EXAMPLE 18
A surgical drape was made up by coating a 0.0032-inch
(.+-.0.0002-inch) thick cast film of a copolymer obtained by
copolymerizing a mixture of 50 percent by volume MEMA and 50
percent by volume EEMA with 50 g./sq. meter of adhesive composition
A. The marginal edges on two opposed parallel sides were left
unspread. A silicone-release-coated paper was applied to the
adhesive as a protector. The surgical drape (excluding protector)
had the following properties.
______________________________________ Moisture vapor permeability
525 .+-. 25 Tensile strength 2.2 .+-. 0.3 lb./in Yield point 1.7
.+-. 0.1 lb./in. Elongation at break 300 .+-. 40%
______________________________________
EXAMPLE 19
Example 10 was repeated using a 0.0021-inch (.+-.0.0002-inch) film
and an adhesive spread of 18 g./sq. meter.
The moisture vapor permeability of the film alone was 1,800 and of
the film coated with adhesive was 1,050.
EXAMPLE 20
A 0.011-inch microporous plasticized PVC film was given 60 g.s.m.
coating of adhesive composition A by transfer from a
silicone-release-coated paper. The coated film was made up into
small first aid dressings and used in a clinical trial on
volunteers for healing cuts, abrasions and blisters on the fingers.
Of the 500 dressings used only 3 showed signs of maceration,
attributed to lifting and ingress of water. In all other cases the
wound healing was satisfactory over the periods of inspection
varying from 5 hours to 3 days.
The dressings had a moisture vapor permeability of 600.
It will be appreciated that the materials used in the examples are
for illustration only and many other materials could be used, e.g.,
the 50/50 EEMA/MEMA copolymer used in Examples 12 to 15 could be
replaced by say a 70/30 MEMA/EEMA or 60/40 MEMA/EEMA copolymer.
The following are adhesive compositions used in many of the above
examples.
ADHESIVE COMPOSITION A
______________________________________ Bakelite EDBC 50 parts by
weight Bakelite EHBM 100 parts by weight (of solution as received)
Kelrez ZR142 25 parts by weight Antioxidant (Nonex WSL 3 parts of
weight 60-80 petroleum ether 300 ml.
______________________________________
The Bakelite EDBC and the Bakelite EHBM were mixed together in a
two-blade mixer and the Nonex WSL and Kelrez ZR 142 was added as a
25 percent solution in a portion of the petroleum ether. When the
mass had been thoroughly mixed it was diluted to working viscosity
using the rest of the petroleum ether.
This polyvinyl ethyl ether adhesive has an oxygen permeability,
when coated as a 0.0126-inch layer (70-74 g./sq. meter) on a
microporous P.V.C. base, of 5,000 cc./sq. meter/24 hours/atms.
ADHESIVE COMPOSITION B
An adhesive composition was prepared by dissolving in 60 to 80
petroleum ether solvent, the following ingredients:
______________________________________ Bakelite EHBM 1 part by
weight Bakelite EDBC 1 part by weight (of solution received) Kelrez
ZR 142 0.5 parts by weight
______________________________________
ADHESIVE COMPOSITION C
This adhesive was prepared from the following ingredients:
______________________________________ Parts by weight
______________________________________ Bakelite EDBC 30 Bakelite
EHBM 85.2 Kelrez ZR 142 15.35 Poly hydroxy propyl acrylate 33.35
Ethanol 130 60/80 petroleum ether to 40% solids.
______________________________________
ADHESIVE COMPOSITION D
An adhesive was made up to the following formulation:
______________________________________ parts by weight
______________________________________ Acronal 40D 50 Lutonal M40
(aq.) 50 ______________________________________
This adhesive had the following properties
______________________________________ Williams plasticity
K.sub.2.sup.40 273 Peel adhesion to steel at 60 g.s.m. (T0
B.S.2.110)530 g/cm. width
______________________________________
Moisture vapor permeability at 60 g.s.m. (on film with water vapor
permeability of 1915); 1075.
ADHESIVE COMPOSITION E
An adhesive was made up to the following formulation:
______________________________________ Parts by weight
______________________________________ Gantrez M 574 100 Gelva D
260 20 Kelrez ZR 142 25 ______________________________________
The following test results were obtained at 60 g.s.m. coating
weight:
______________________________________ Williams plasticity
K.sub.2.sup.40 120 Moisture permeability (on film of M.V.P. 1919)
752 ______________________________________
The following are descriptions of some of the materials referred to
in the general description and in the examples.
Bakelite Resin EHBM is a poly (vinyl ethyl ether) high-viscosity
resin having 25 percent non-volatiles in hexane, a reduced
viscosity at 20.degree. C. of 4.0.+-.0.5; a plasticity of 1.6 to
2.0 mm.; a flashpoint <20.degree. F.; a specific gravity of C.
7,299 and a weight per gallon of 6.07 lbs.
Bakelite Resin EDBC is a poly (vinyl ethyl ether) low-viscosity
resin having 98 percent nonvolatiles; a reduced viscosity at
20.degree. C. of 0.3.+-.0.1; a specific gravity at 20.degree. C. of
0.973 and a weight per gallon of 8.12 lbs.
Kelrez ZR142 is a zinc resinate formed by the interaction of zinc
oxides with the resin acids in partially dimerized Colophony,
contains 9.6 percent zinc and has a melting point of 160.degree. to
165.degree. C.
Acronal 40 D is an aqueous dispersion of acrylic polymers (50
percent solids) sold by B.A.S.F.
Lutonal M40 (aq.) is a soft polymer of methyl vinyl ether dissolved
in water (50 percent solids) sold by B.A.S.F.
Gantrez M574 is a solution of polymethyl vinyl ether sold by
General Aniline and Film Corporation.
Gelva D260 is a solution of copolymers of acrylic alkyl esters sold
by General Aniline and Film Corporation.
Gentac is a butadiene/vinyl-pyridine copolymer latex.
NONOX is a phenol condensate.
ESTANE is a linear polyrethane elastomer.
REEMAY is a nonwoven fabric formed from a polyester spun-bonded
filament.
HETEROFIL is a staple fiber of filament comprising a polymeric core
and outer layer of a polymer of lower melting point than that of
the inner layer. The polymer is a polyamide in the case of both the
core and the outer layer and the core and outer layer may both be
derived from the same monomer but will have different molecular
weights in order to produce the different melting points.
The EEMA used in Examples 8 to 15 contained 2-ethoxy ethyl
methacrylate for the most part together with a very small
proportion of acid as an impurity.
The HEMA used in Examples 8 to 11 contained 2-hydroxy ethyl
methacrylate for the most part, together with a small amount of
di-ethylene glycol monomethacrylate, ethylene glycol dimethacrylate
and methacrylic acid as impurities.
The EEMA/HEMA copolymer film of Example 10 has an oxygen
permeability transmission rate when measured according to B.S.
2,782; 1,965 method 514 A, was found to be 5,000 ml./sq.meter/24
hours/Atms./thou. thickness.
The poly hydroxy propyl acrylate was prepared by polymerizing
hydroxy propyl acrylate in ethanol using benzoyl peroxide catalyst
to give a solid rubbery polymer soluble in ethanol.
The moisture vapor permeabilities of a number of the continuous
backing materials used in accordance with the present invention are
given below:
______________________________________ Moisture vapor permeability
Thickness g./sq.m./24 hrs at 40.degree. C. Film (.times. 0.001")
& 80% RH) ______________________________________ EEMA 4.5 880
EEMA/HEMA 2.5 1400 (80:20) EEMA/Methyl 2.5 1020 Methacrylate
(80:20) MEMA 4.3 1140 MEMA/Methyl 2.0 1650 Methacrylate (90:10)
MEMA/HEMA 1.5 2460 (90:10) MEMA/EEMA 2.1 1800 (50:50) MEMA/HEMA 2.7
1650 (70:30) ______________________________________
* * * * *