U.S. patent number 3,630,194 [Application Number 05/039,754] was granted by the patent office on 1971-12-28 for orthopedic bandage.
This patent grant is currently assigned to Johnson & Johnson. Invention is credited to Franklin Boardman.
United States Patent |
3,630,194 |
Boardman |
December 28, 1971 |
**Please see images for:
( Certificate of Correction ) ** |
ORTHOPEDIC BANDAGE
Abstract
This orthopedic bandage for immobilizing or supporting portions
of the body comprises a flexible carrier such as cotton gauge
supporting a solid, water-soluble vinyl monomer selected from the
group consisting of diacetone acrylamide and N-isopropyl acrylamide
and mixtures thereof. Other monomers and fillers including
polymeric and reactive substances may optionally be added to
achieve particular properties or results. The bandage is preferably
prepared for use by dipping in water in the presence of a catalyst
for initiating polymerization of the vinyl monomer and then
wrapping the body portion to be immobilized. In the preferred
practice the initiator is a part of the bandage and may either be
mixed with the monomer or coated on the surface of the bandage.
Inventors: |
Boardman; Franklin
(Englishtown, NJ) |
Assignee: |
Johnson & Johnson
(N/A)
|
Family
ID: |
21907186 |
Appl.
No.: |
05/039,754 |
Filed: |
May 22, 1970 |
Current U.S.
Class: |
602/8 |
Current CPC
Class: |
A61F
13/04 (20130101); A61L 15/12 (20130101); A61L
15/12 (20130101); C08L 33/24 (20130101) |
Current International
Class: |
A61F
13/04 (20060101); A61L 15/00 (20060101); A61L
15/12 (20060101); A61l 015/07 () |
Field of
Search: |
;128/90,155,89
;260/89.7R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Koren; Samuel
Assistant Examiner: Yahwak; G. M.
Claims
Having described the invention, what is claimed is:
1. An orthopedic bandage comprising a flexible carrier having
adhered thereto a dry cast-forming composition comprising at least
about 9 percent by weight of a solid, water-soluble vinyl monomer
selected from the group consisting of diacetone acrylamide,
N-isopropyl acrylamide, and mixtures thereof.
2. The orthopedic bandage of claim 1 wherein said cast-forming
composition includes about 20 to 60 percent by weight, based on
total monomer, of N-t-butylacrylamide.
3. The orthopedic bandage of claim 1 wherein said cast-forming
composition includes sufficient polymerization initiator to
polymerize said water-soluble vinyl monomer in the presence of
water.
4. The orthopedic bandage of claim 3 wherein said polymerization
initiator comprises a mixture of oxidizing and reducing agents.
5. The orthopedic bandage of claim 3 wherein said polymerization
initiator includes a buffer component to control acidity.
6. The orthopedic bandage of claim 3 wherein said polymerization
initiator comprises ammonium persulfate and ferrous sulfate.
7. The orthopedic bandage of claim 3 wherein said polymerization
initiator comprises ammonium persulfate and sodium sulfite.
8. The orthopedic bandage of claim 7 wherein said polymerization
initiator includes a buffering quantity of sodium bicarbonate.
9. The orthopedic bandage of claim 3, including an encompassing,
substantially moistureproof container therefor.
10. The orthopedic bandage of claim 1 wherein said cast-forming
composition includes about 20 to 60 percent by weight, based on
total monomer, of a nonirritating, solid monomeric derivative of
acrylic and methacrylic acid.
11. The orthopedic bandage of claim 1 wherein said cast-forming
composition includes up to about 70 percent by weight, based on
said composition, of a solid filler.
12. The orthopedic bandage of claim 11 wherein said solid filler
comprises a polymeric filler.
13. The orthopedic bandage of claim 11 wherein said solid filler is
a water-soluble polymeric filler selected from the group consisting
of poly (ethylene oxide), methyl cellulose, carboxymethyl
cellulose, hydroxy ethyl cellulose polyacrylamide or mixtures
thereof.
14. The orthopedic bandage of claim 11 wherein said solid filler is
a water-insoluble polymeric filler selected from the group
consisting of cellulose acetate, poly (methyl methacrylate), poly
(diallyl phthalate), polycaprolactone, copolymers of ethylene and
maleic anhydride, copolymers of styrene and maleic anhydride or
mixtures thereof.
15. The orthopedic bandage of claim 12 wherein said polymeric
filler comprises cellulose acetate.
16. The orthopedic bandage of claim 12 wherein said polymer filler
comprises methyl methacrylate polymer.
17. The orthopedic bandage of claim 11 wherein said filler
comprises a water-insoluble inorganic salt.
18. The orthopedic bandage of claim 17 wherein said water-insoluble
inorganic salt comprises calcium sulfate.
19. The orthopedic bandage of claim 17 wherein said water-insoluble
inorganic salt comprises calcium carbonate.
20. An orthopedic bandage comprising a flexible fabric carrier
having adhered thereto a cast-forming composition comprising about
20 to 64 percent by weight, based on said composition, diacetone
acrylamide, about 10 percent to 48 percent by weight, based on said
composition, of N-t-butylacrylamide and about 20 to 50 percent by
weight, based on said composition. of cellulose acetate.
21. The orthopedic bandage of claim 20 wherein said cast-forming
composition includes a catalytic quantity of initiator for
polymerizing said diacetone acrylamide.
22. A packaged orthopedic bandage comprising a substantially
moistureproof container having enclosed therein a flexible fabric
carrier having adhered thereto a dry cast-forming composition
comprising at least about 9 percent by weight of diacetone
acrylamide and a catalytic quantity of initiator for polymerizing
said diacetone acrylamide.
23. The packaged orthopedic bandage of claim 22 wherein said
container comprises an aluminum foil package.
24. A method of forming a rigid orthopedic cast for body members
comprising the steps of:
a. providing an orthopedic bandage comprising a flexible fabric
carrier supporting a dry, cast-forming composition comprising at
least about 9 percent by weight of a solid, water-soluble vinyl
monomer selected from the group consisting of diacetone acrylamide,
N-isopropyl acrylamide, and mixtures thereof;
b. immersing said bandage in a aqueous medium in the presence of a
polymerization initiator for said vinyl monomer;
c. wrapping said orthopedic bandage in a plurality of layers around
the body member to be immobilized; and
d. allowing said vinyl monomer to polymerize.
25. The method of claim 24 wherein said polymerization initiator is
present on said bandage prior to immersion thereof.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the field or orthopedic bandages which
are used to form casts for immobilizing and supporting parts of the
body such as fractured limbs to permit undisturbed healing. More
specifically, it relates to an improved polymeric orthopedic
bandage which can be prepared and applied using conventional
techniques associated with well-known plaster of Paris casts but
has a number of improvements thereover including reduced weight,
and greater penetrability by X-ray.
While the present invention is described herein with particular
reference to orthopedic bandages for immobilizing portions of the
body, it should be understood that the invention is not limited
thereto. It can be employed to form hard casts for a variety of
uses, particularly where various desirable attributes of a
polymeric cast can be advantageously employed, as will be apparent
to those skilled in the art.
2. Description of the Prior Art
Plaster of Paris on fabric or gauze bandage has been used almost
exclusively in the preparation of surgical casts designed to
immobilize and support portions of the body, e.g., a leg, arm,
wrist, neck, and the like. Plaster of Paris is inexpensive,
convenient and ready to use after simply dipping in water.
Moreover, practically all physicians, particularly orthopedic
specialists, have long worked with the plaster of Paris medium and
are very familiar with its application. Once having mastered the
art of working with plaster of Paris, they are reluctant to learn
the different techniques associated with other media.
Notwithstanding, plaster of Paris has certain shortcomings. It is
relatively heavy and can be damaged by wetting with water. It is
also substantially opaque to X-rays, thus sometimes requiring that
a cast be removed to ascertain, for example, whether a fracture has
satisfactorily healed.
Past efforts to find substitutes for all or a portion of the
plaster of Paris in orthopedic casts have been largely
unsuccessful, in part because they required the mastering of new
techniques and were less convenient to use and suffered from other
shortcomings. For example, some substitute casts were substantially
impervious to transmission of water vapor and thus perspiration. As
another example the use of thermoplastic sheets have been
unacceptable because molding temperatures are too high. If an
insulating medium is introduced between the thermoplastic material
and the skin, the ability to mold or shape the thermoplastic
material satisfactorily to the part to be immobilized is
compromised.
Previous attempts to use resin structures have also proved largely
unsuccessful. For example, the technique disclosed in U.S. Pat. No,
3,027,336, involves the application of the resin in the form of a
paste which is inconvenient to prepare and represents a wide
departure from the simple and convenient water-dipping technique
associated with plaster of Paris, which is so widely accepted and
popular. Moreover, it requires the presence of a pore-forming agent
to achieve porosity. Similarly, the technique of U.S. Pat. No.
3,089,486, involves the inconvenient impregnation of a
polymer-imbued bandage with a liquid, curable monomer component
immediately before or after the bandage is placed on the body
member.
It is therefore a general object of the present invention to
provide an orthopedic bandage which can be applied in substantially
the same manner as plaster of Paris casts and yet avoids many of
the disadvantages associated therewith, including opaqueness to
X-ray and poor water resistance. It is another general object to
provide a plastic orthopedic cast which avoids many of the
shortcomings of prior art plastic casts, including low water vapor
transmission.
It is a more specific object to provide an improved orthopedic
bandage from a polymerizable monomer which can be activated by
simply immersing the same in an aqueous medium. It is another
object to provide a plastic-based orthopedic bandage from a
water-soluble polymerizable monomer which is solid at room
temperature and substantially nonirritating in both the monomeric
and polymeric forms. It is another object to provide a
plastic-containing orthopedic cast which doesn't heat up
excessively when curing the same. Still another object is to
provide a plastic component for orthopedic casts which is
polymerizable under conditions normally encountered by doctors in
applying all-plaster casts.
These and other objects of the present invention will become
apparent as a detailed description proceeds.
SUMMARY OF THE INVENTION
These objects are achieved by an orthopedic bandage comprising a
flexible carrier supporting a cast-forming composition comprising a
solid, water-soluble vinyl monomer selected from the group
consisting of diacetone acrylamide, N-isopropyl acrylamide, and
mixtures thereof. As described in detail hereinafter, to this
cast-forming composition may optionally be added certain other
monomers or comonomers which are solid at room temperature and
nonirritating to the skin and certain fillers, including certain
polymeric fillers and water-insoluble insoluble inorganic
salts.
The orthopedic bandage so formulated is prepared for use by
contacting it with an aqueous medium, preferably hot tapwater, in
the presence of catalytic amounts of a polymerization initiator or
catalyst whereby the vinyl monomer is polymerized. The
polymerization catalyst may be added to the aqueous medium itself,
or it may be incorporated into the cast-forming composition, In the
latter case, the bandage must be kept dry and out of contact with
moisture-laden air. Because two-ingredient catalyst systems are
normally employed, one catalytic component may be incorporated in
the cast-forming composition and the other catalytic component may
be added to the water at the time of dipping, thus minimizing the
sensitivity of the composition to water or moisture-laden air.
If the catalyst is incorporated in its entirety in the cast-forming
composition, as preferred, the physician need only dip the bandage
in water in order to initiate polymerization and prepare the
bandage for use. This simple procedure substantially duplicates, of
course, the conventional techniques employed in connection with
plaster of Paris casts. If the entire catalyst is not incorporated
in the cast-forming composition, the physician need only add any
missing catalytic component to the water in which the bandage is
immersed. Further details of the invention are set forth in the
following subsections.
THE FLEXIBLE CARRIER
The flexible carrier may be any suitable support capable of
carrying the vinyl monomer prior to the polymerization thereof and
otherwise compatible to its intended use, the particular carrier
per se not being part of the present invention. It should
preferably be somewhat stretchable, conformable and inexpensive. In
general, the same flexible carriers employed in connection with
plaster of Paris casts may be used in the present invention.
Preferred carriers include open-mesh fabrics such as cotton gauze,
cotton crinoline and other natural and synthetic bandage materials
well known to those skilled in the art. For example, the carrier
may be a cotton gauze having 10 to 50 warp and 10-50 weft threads
to the square inch, some or all of the threads optionally being
resilient or elastic.
The carrier may either be woven or nonwoven and may also be
manufactured in whole or part from plastic or glass fibers. The
plastics may include, for example, polyethylene, polypropylene and
various polyester or polyamide fibers, e.g., Dacron, nylon and the
like. The carrier may also be prepared from porous foams such as
polyester and polyether polyurethane foams. Other materials will be
apparent to those skilled in the art in the light of the present
disclosure.
The Water-Soluble Solid Monomer
Because it is desired that the orthopedic bandage of the present
invention be a dry bandage, the vinyl monomer employed therein must
be solid at room temperature. In addition, since the bandage is to
be prepared for use by simply dipping in aqueous medium,
polymerization of the monomer and the catalyst system for
initiating the same must lend itself to activation by contact with
water. Still further, the monomer must be substantially
nonirritating to the skin, both in a monomeric and polymeric
form.
These stringent requirements are met by diacetone acrylamide and
N-isopropyl acrylamide and mixtures thereof. Diacetone acrylamide
is preferred at present because of its lower cost. Casts made, in
accordance with the present invention, of polymers of diacetone
acrylamide are also porous and thus will transmit perspiration, a
distinct advantage in the cast field, as patients will readily
testify.
A more precise chemical identification of the diacetone acrylamide
employed in the practice of the present invention is N-(1,1
-dimethyl- 3 -oxobutyl-acrylamide. It can be purchased commercially
and is presently available, for example, from the Lubrizol
Corporation, Wickliffe, Ohio, a corporation of Ohio. In this
connection, see, for example, U. S. Pat. No. 3,458,478 , issued
July 29, 1969, and assigned to The Lubrizol Corporation.
The amount of vinyl monomer of the flexible support may approximate
levels employed in plaster of Paris orthopedic bandages. The vinyl
monomer may be present in the amounts of about 50 to 800 percent of
the weight of the support, typically about 200 to 500 percent.
Techniques for controlling the amount of monomer are briefly
discussed hereinafter in connection with methods of manufacture and
the solvents used therein.
The Polymerization Initiator
A conventional redox initiator system used in emulsion
polymerization may be used to catalyze polymerization of the vinyl
monomer and hardening of the bandage. These initiators are mixtures
of oxidizing and reducing agents generally in the proportions of
about 1 to 1 by weight, which react substantially immediately with
each other when dissolved in water. Accordingly, both cannot be
mixed in aqueous solution until polymerization is to be
initiated.
Examples of oxidizing agents are ammonium persulfate, potassium
persulfate, hydrogen peroxide, t-butyl hydroperoxide, ferric
chloride, hydroxylamine, cobalt (III) chloride, and potassium
permanganate. Examples of reducing agents are ferrous sulfate,
sodium sulfite, sodium dithionite, ferrous chloride, sodium
formaldehyde sulfoxylate, oxalic acid, cobalt (II) chloride, and
hydrazine. A catalyst concentration of about 0.5 to 5 percent by
weight, based on water, is preferred although higher
concentrations, e.g., about 5 to 10 percent, may also be used.
Although the oxidizing and reducing agents, making up the initiator
system are generally used in a weight ratio of 1 parts oxidizing
agent to 1 part reducing agent, this ratio can be varied
substantially with effective results still being obtained, for
example, with 1 part of either the oxidizing agent or the reducing
agent being present with 9 parts of the other.
Both the oxidizing and reducing agents are necessary for
polymerization. Both initiators may be added to the water before
dipping, or one of the two may be incorporated in the bandage at
the time of its manufacture and the other added to the dipping
water.
Alternatively, catalytic amounts of both initiators may be
incorporated in the bandage at the time of manufacture. Thus, the
physician need only dip the bandage in water to prepare it for use.
A specific example of a preferred catalyst system employed in this
embodiment is ammonium persulfate and sodium sulfite. As already
indicated, with both catalysts present, precautions should be taken
to avoid contact with water- or moisture-laden air. As aqueous
solutions of initiator tend to become acidic on standing, in the
preferred practice a nontoxic, nonirritating buffer, such as sodium
bicarbonate, sodium citrate, sodium acetate, disodium phosphate or
the like, is added to avoid possible later irritation resulting
from such acidification. Thus, a preferred accelerator is a
three-part system containing, for example, potassium persulfate,
sodium sulfite and sodium bicarbonate in approximately equal
proportions by weight.
The temperature of the dipping solution has a profound effect on
the hardness of the final cast. The hotter the water, the faster
hardening will occur. Water at 120.degree. - 130.degree. F. is
recommended. Water below 110.degree. F. should preferably not be
used, since polymerization of the monomer in the bandage after
dipping may be inhibited. Temperatures of 120.degree. - 140.degree.
F. are readily available in hot tapwater.
Other Ingredients
Other ingredients may also be incorporated into the bandage to act
as monomeric supplements, binders, fillers, polymerization rate
controllers, and the like. For example, it has been found
advantageous to add N-t-butylacrylamide along with the diacetone
acrylamide or N-isopropyl acrylamide as a reactive monomer.
N-t-butylacrylamide is not soluble in water and cannot be used in
the water system by itself but only in conjunction with diacetone
acrylamide or N-isopropyl acrylamide.
Other solid monomers or comonomers may also be added, e.g., the
following nontoxic derivatives of acrylic and methacrylic acid:
Inorganic Salts (Sodium, Calcium, etc.)
4,4' -Isopropylidene-diphenol esters
N-vinylsuccinimide
N-vinylphthalimide
P-Vinyl Benzamide
Vinyl Naphthalene
N-vinylcarbazole
The common vinyl monomers (styrene, methyl methacrylate, methyl
acrylate, vinyl acetate, vinyl chloride, ethylene, and acrylamide)
are excluded from consideration since they are either not solid at
room temperature or they are known to be capable of irritating the
skin.
To bind the diacetone acrylamide and N-isopropyl acrylamide (and
any other monomers or comonomers) to the flexible carrier, and to
prevent their loss in the dipping water upon contact therewith, a
thin film of adhesive may be added to the ingredients at the time
of manufacturing the bandage. For example, a binder may be formed
by evaporation of a latex, e.g., Rhoplex B- 15, a latex product of
Rohm and Haas Company, and UCAR-TCX- 8960, a latex product of Union
Carbide Corporation. Care should be taken, however, to avoid
contact with water in the presence of initiator. Accordingly, where
a latex is used as the binder system, the water should be removed
before imparting the initiator.
In addition to, or in place of, the binder, various types of
fillers may be used, including polymeric fillers and
water-insoluble inorganic salts. Fillers reduce the amount of more
costly monomer required. They also control the rate of water
entering the bandage and thus the rate of reaction. By thus slowing
the rate of reaction and increasing the bulk, the temperature rise
from the polymerization reaction is reduced and moderated,
minimizing any discomfort to the patient.
Almost any nontoxic, nonirritating polymer can be used as a filler.
Preferably, they should coat out as a binder for the vinyl monomer,
i.e., the diacetone acrylamide or N-isopropyl acrylamide. The
binding action holds the monomer on the flexible carrier and
minimizes undesired leaching into the dipping water. As examples of
fillers one may use substantially water-insoluble fillers such as
cellulose acetate, poly(methyl methacrylate), poly(diallyl
phthalate), polycaprolactone, copolymer of ethylene and maleic
anhydride, and copolymers of styrene and maleic anhydride; as
water-soluble fillers one may use, for example, poly(ethylene
oxide), methyl cellulose, carboxymethyl cellulose, hydroxy ethyl
cellulose and polyacrylamide. The water-soluble fillers are
generally preferred as they give more rapid wetting times.
Inorganic fillers may be added to improve the ease of wrapping of
the bandage. In particular, they render the bandage less sticky
and, as aforementioned, moderate any temperature rise. Calcium
sulfate or calcium carbonate are preferred, but other commercial
fillers (e.g., bentonite, silica, etc.) can also be used. The
presence of such inorganic fillers is not necessary , whereas the
presence of a polymer filler is considered quite desirably.
When calcium sulfate hemihydrate, e.g., plaster of Paris, is
employed as a filler, a hybrid system results. The monomer
polymerizes and the plaster of Paris takes up water to form calcium
sulfate dihydrate. Advantageously, neither the rate of
polymerization of the monomer or hydration time of the plaster of
Paris is unduly modified by the presence of the other reactive
component. The presence of the polymer renders the cast far less
opaque to X-ray than an all-plaster cast, and otherwise imparts the
advantageous features of the polymer.
Of the total solids on the flexible carrier, the monomer or
comonomer components comprise between about 30 and 100 percent by
weight of the total and the filler comprises between about 0 to 70
percent. The preferred ranges are about 50 to 80 percent monomer
and 20 to 50 percent filler.
The monomer component itself should comprise at least about 30
percent by weight, based on total monomer, of diacetone acrylamide
or N-isopropyl acrylamide or mixtures thereof, preferably about 40
to 80 percent, the balance being other monomeric or comonomeric
components hereinabove set forth, e.g., N-t-butylacrylamide.
Accordingly, at least about 9 percent of the total solids must
consist of diacetone acrylamide or N-isopropyl acrylamide or
mixtures thereof.
The filler component itself may contain anywhere between 0 and 100
percent by weight, based on total filler, of polymer, the remainder
being inorganic salt. The preferred range of polymer content in the
filler is about 50 to 100 percent.
Further information on ingredients and proportions thereof are set
forth hereinafter in the description of methods of manufacture and
in the specific examples.
Packaging
When both initiators are incorporated in the cast-forming
composition at the time of its manufacture, the orthopedic bandage
must be maintained in a dry state until the time of use, as
previously discussed. Accordingly, in order to prevent premature
polymerization of the vinyl monomer, the bandage is packaged,
preferably in roll form, in a moisture-resistant container which
may be readily opened at the time of use.
In a preferred embodiment wherein the initiators are incorporated
in the orthopedic bandage, the bandage is sealed in an aluminum
foil package which may be readily torn open for use. Various
alternative containers may also be employed, as those skilled in
the art will readily recognize.
Methods Of Manufacture and the Solvent Employed Therein
The bandage of the present invention may be manufactured by various
techniques, as is exemplified by the methods of preparation of
preferred forms thereof. In one specific embodiment, a cotton gauze
bandage is impregnated with diacetone acrylamide,
N-t-butylacrylamide, cellulose acetate, ammonium persulfate and
sodium sulfite, the latter two ingredients being the initiators. As
aforementioned, a buffer such as sodium bicarbonate is preferably
included also. The impregnation is accomplished by dissolving the
ingredients in a suitable solvent. The bandage is passed through
the solution and then between metering rolls or knives to achieve
the desired level of impregnation. The solvent is evaporated
therefrom by conventional techniques, e.g., heating, blowing air
thereover, and the like.
The resulting orthopedic bandage is then sealed in an aluminum foil
package to avoid contact with moisture-laden air. At the time of
use the package is torn open, and the bandage is momentarily dipped
in hot tapwater then lightly squeezed after removal. It is
immediately wrapped around the body portion to be immobilized in a
plurality of layers and allowed to set, becoming slightly warm
(e.g., about 110.degree. F.) for about 15 minutes in the process.
After cooling to about room temperature (another 10-30 minutes or
so), the cast has hardened sufficiently for the desired
immobilization.
When initially incorporating the diacetone acrylamide or
N-isopropyl acrylamide into the flexible carrier, a variety of
solvents may be employed, depending upon the presence and nature of
other ingredients and whether the catalyst system is included. The
solvent must be easily evaporated below the maximum temperature to
which the monomer can be warmed without polymerizing. For diacetone
acrylamide, this temperature is its melting point, i.e., 57.degree.
C. Both methylene chloride (boiling point of 40.degree. C.) and
acetone (boiling point of 56.degree. C.) are preferred solvents.
Other solvents that could be used are water, methyl acetate, ethyl
acetate, diethyl ether, chloroform, carbon tetrachloride,
tetrahydrofuran, benzene, and toluene. Since the rate of
evaporation of a solvent can be speeded by blowing air across the
bandage, solvents with boiling points above 57.degree. C. may be
used as well.
The choice of concentration of monomer and polymer in the solvent
is determined by the viscosity of the final solution. The viscosity
is in turn determined by the molecular weight range of polymer
used; the greater the molecular weight, the greater the viscosity.
Highly viscous solutions are undesirable, since the final bandage
coating is thick, and the bandage is hard to wrap. Very thin
solutions yield very thin coatings of the bandage with an
insufficient supply of deposited monomer.
The cast-forming composition may also be incorporated into the
support without the use of a solvent, as will become apparent from
the specific examples hereinafter set forth. The use of a solvent
is, however, the preferred technique at present.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be more clearly understood from the
following detailed description of specific embodiments, read in
conjunction with accompanying drawings, wherein:
FIG. 1 is a schematic illustrated production of a preferred
embodiment of the orthopedic bandage of the present invention;
and
FIG. 2 is a schematic illustrating the simple steps of using the
bandage produced in FIG. 1 to form a cast to immobilize a human
forearm.
DESCRIPTION OF PREFERRED EMBODIMENT
Referring to FIg. 1, the starting material is a roll of open-mesh
cotton gauze bandage 10 which is passed through impregnating
solution 12 in vessel 14 by means of direction changing rollers 16,
18 and 20. Impregnating solution 12 comprises diacetone acrylamide,
N-t-butylacrylamide, cellulose acetate, ammonium persulfate and
sodium sulfite in an acetone solvent, illustrative proportions
being indicated in example 6 set forth hereinafter. If a buffer is
included, e.g., sodium bicarbonate, it is preferably present in the
same weight proportion as the ammonium persulfate or sodium
sulfite.
Leaving impregnating solution 12, the impregnated web 22 passes
between metering knives 24 and 26 or equivalent metering rolls (not
shown), which control the level of solution on the web. Web 22 then
passes around direction changing roller 28 and across a series of
supporting rollers 30, where it is subjected to slight warming from
a row of infrared lamps 32 and rapid air currents exhausted via
exhaust fan hood 34. As a result, the acetone solvent is driven
off, leaving a dry bandage containing the cast-forming composition
which is accumulated as orthopedic bandage roll 36.
Since the dry bandage contains polymerizable monomers as well as a
catalyst system for initiating polymerization in the presence of
water, the dry bandage is packed in a moistureproof sealed
container in zone 37. An inexpensive and effective container for
such purposes may be an aluminum foil package which can be readily
torn open at the time of use.
In FIG. 2, a packaged orthopedic bandage of the present invention
is illustrated as bandage roll 40 in aluminum foil package 42 which
is hermetically sealed. At the time of use, package 42 is torn open
and the entire roll 40 or a desired length 44 thereof is dipped in
a vessel 46 containing hot tapwater 48 (e.g., about 120-130.degree.
F.). Following dipping the bandage is lightly squeezed to remove
excess water and then promptly applied to the body portion to be
immobilized, as illustrated by cast 50 on forearm 52.
Because the bandage is conformable and requires no barrier between
itself and the skin, it can be closely fitted to the body portion
and rapidly built up in a plurality of smooth layers into an
integral cast. The cast rapidly cures, with temperatures never
reaching excessively painful levels, and becomes hard within less
than an hour of its initial application.
The present invention will be more clearly understood from the
following specific examples of formulations used in preparing
orthopedic bandages, as well as test results obtained when using
such orthopedic bandages.
EXAMPLES
Example 1
A paste consisting of 50 parts by weight of diacetone acrylamide
and 20 parts by weight of UCAR Latex TCX-8960 was spread with a
spatula on a gauze bandage measuring 1 yard long and 3 inches wide.
The bandage was hung dried by standing overnight. The dried bandage
was rolled and dipped in a solution of 2 l parts by weight of
ammonium persulfate and 2 parts by weight of sodium sulfite in 100
parts by weight of water. The solution was made up just prior to
dipping of the bandage.
The bandage was removed from the solution a few seconds after
immersion and wrapped around a 1-inch diameter dowel or pipe
covered with aluminum foil. The bandage became sticky, warm, but
not hot a few minutes after wrapping. Fifteen minutes after the
wrapping the bandage was no longer sticky. After an hour the cast
was hard and cool. The crushing strength of the cast measured the
next day was 250 pounds as shown on a Dillon Dynamometer.
Example 2
A paste consisting of 400 parts by weight of plaster of Paris, 100
parts by weight of diacetone acrylamide, 220 parts by weight of
water, 4 parts by weight of ammonium persulfate, and 4 parts by
weight of sodium sulfite was spread on a cotton gauze bandage 1
yard long and 3 inches wide. The bandage was wrapped around a
wooden stick, 1 inch in diameter, bearing an aluminum foil cover
with a thermometer placed between foil and stick.
The bandage hardened 9 minutes after wrapping. The maximum
temperature recorded on the thermometer at any time was 78.degree.
F. After 45 minutes the cast was removed from the stick. The cast
could barely be deformed by hand pressure at this time. The maximum
strength of the cast, recorded 6 days later, was 285 pounds as
recorded on a Dillon Dynamometer.
Example 3
A gauze bandage, 10 yards by 4 inches, is impregnated with a
solution of 150 parts by weight of diacetone acrylamide, 75 parts
by weight of Plexiglas VS- 100 poly (methyl methacrylate) (Rohm and
Haas Company, Philadelphia, Pennsylvania), and 25 parts by weight
of Hydrocal plaster of Paris (Unites States Gypsum Company) in 400
parts by weight of methylene chloride. The bandage is dried in
circulating air at 100.degree. F., rolled up and inserted in a
sealable container.
A bandage 5 yards by 4 inches cut from the above coated bandage is
dipped in a solution of 8 parts by weight of sodium sulfite and 8
parts by weight of ammonium persulfate in 300 parts by weight of
water of about 115.degree. F. The bandage is removed immediately
from the solution, squeezed lightly, and wrapped around a patient's
limb. The bandage becomes warm, maintaining a temperature of
110.degree. F. for 15 minutes and then cooling to room temperature,
at which point the cast is hard to the touch.
A similar bandage can be prepared by substituting N-isopropyl
acrylamide for diacetone acrylamide and using the same reagents and
parts by weight as in the above example. A similar bandage can also
be prepared by substituting cellulose acetate for the poly (methyl
methacrylate) and omitting the plaster of Paris completely.
Example 4
Two bandages (5 yards by 4 inches) weighing about 20 parts each are
coated with a solution prepared from 150 parts by weight of
diacetone acrylamide, 75 parts by weight of Plexiglas VS-100 poly
(methyl methacrylate) and 75 parts by weight of Hydrocal plaster of
Paris in 470 parts by weight of methylene chloride. Upon
evaporation of the solvent, 88 parts of coating are deposited on
each bandage.
These orthopedic bandages are activated by dipping in hot tapwater
containing catalytic quantities of an initiator, e.g., ammonium
persulfate and sodium sulfite. The activated bandage is then
promptly applied to a limb to form a plastic cast.
Example 5
Cylindrical casts were prepared from orthopedic bandages similar to
those of examples 3 and 4. A cylindrical cast 4 inches long with a
2-inch inside diameter, weighing about 0.31 pounds showed a
crushing strength on a Dillon Dynamometer of about 145 pounds 1
hour after wrapping, about 250 pounds 24 hours after wrapping, and
about 450 pounds 1 week after wrapping. The strength-to-weight
ratio varied from about 470, 1 hour after wrapping, to about 1,450,
1 week after wrapping.
The transmission of perspiration is a requirement in any proposed
orthopedic cast. Flat, rectangular casts were, therefore, prepared
from orthopedic bandages similar to those of examples 3 and 4 for
measurement of moisture-vapor-transmission. The results obtained
with casts having 5, 10 and 23 plies are as follows:
---------------------------------------------------------------------------
Vapor Transmission of Water Grams of water per No. Of plies 100
in..sup.2 per 24 hours
__________________________________________________________________________
5 31 10 9 23 8
__________________________________________________________________________
The ability of these solid, apparently opaque plastic casts, to
transmit water vapor is considered remarkable. Most polymers would
transmit no water at all.
Example 6
An impregnating solution was prepared from 30 parts by weight of
E-398- 10 cellulose acetate (Eastman Chemical Products, Inc.), 113
parts by weight of diacetone acrylamide, 37 parts by weight of
N-t-butylacrylamide, 20 parts by weight of ammonium persulfate and
20 parts by weight of sodium sulfite in 400 parts of acetone. Two
cotton gauze bandages, each measuring 2 yards by 4 inches and
weighing about 10 parts by weight, were impregnated with the
solution and dried. Each of the resulting orthopedic bandages
weighed about 80 parts, thus indicating a solids pickup from the
solution of about 70 parts by weight.
The bandages were dipped in 300 milliliters of water at about
140.degree. F. and wrapped around a core. During polymerization
temperatures reached about 140.degree. F. at the core.
Example 7
Patches of orthopedic bandages containing diacetone acrylamide and
prepared as indicated in examples 3, 4 and 6 where no buffer was
used with the activator, were taped on human males and females in a
routine testing procedure for the skin irritation potential of the
new cast. With the exception of two possible allergenic responses
to the bandages, no irritation was evident.
This tests repeated on the two allergenic patients, however, this
time using a buffered accelerator solution, the buffer used being
sodium bicarbonate. No irritation was observed with the one
patient. The other showed some irritation, but when tested was
found to show the same degree of irritation to sodium bicarbonate
alone.
Animal test s were performed by injecting mice and guinea pigs with
extracts of polymerized bandage prepared in accordance with the
present invention. No irritation was observed in mice, while a
positive sensitizing reaction was observed in guinea pigs, which
was considered to be of little significance. No irritation was
observed after application of unpolymerized bandage on strip wounds
on rabbits. The bandages is, therefore, considered safe for use on
humans.
From the above description, it is apparent that the objects of the
present invention have been achieved. While only certain
embodiments have been illustrated, many alternative modifications
will be apparent from the above description to those skilled in the
art. These and other alternatives are considered within the spirit
and scope of the present invention and coverage thereof is intended
by the claims of any patents based on this application and any
continuations or divisions thereof.
* * * * *