U.S. patent number RE34,753 [Application Number 07/737,405] was granted by the patent office on 1994-10-04 for orthopedic rigid splint-plate orthosis.
Invention is credited to Jorge A. Groiso.
United States Patent |
RE34,753 |
Groiso |
October 4, 1994 |
Orthopedic rigid splint-plate orthosis
Abstract
An orthopedic rigid splint-plate orthosis comprises a
splint-plate which is provided in one of a combination of different
shapes and sizes corresponding to different body members which may
have to be treated. The splint-plate has at one of its edges a
non-stretchable linking ribbon which at the end thereof opposite to
the end joined to the plate includes locking means which are
complementary with corresponding locking means provided in the edge
of the plate opposite to that edge joined with the ribbon. The
plate is provided presterilized and isolated inside an impervious
bag which may be filled with boiling water to make the rigid
splint-plate soft, whereafter the water is drained and the softened
plate applied and moulded to the body member and then left to
harden back to its rigid state. For use in an operating theatre,
the bag with the plate may be closed inside a second bag and
sterilized with gas or radiation; thereafter, the plate may be
softened by submerging the sealed outside bag in hot water.
Inventors: |
Groiso; Jorge A. (Buenos Aires
1112, AR) |
Family
ID: |
3478446 |
Appl.
No.: |
07/737,405 |
Filed: |
July 29, 1991 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
934120 |
Nov 24, 1986 |
04852556 |
Aug 1, 1989 |
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Foreign Application Priority Data
Current U.S.
Class: |
602/7; 602/14;
602/22; 602/30 |
Current CPC
Class: |
A61F
5/028 (20130101); A61F 5/0585 (20130101) |
Current International
Class: |
A61F
5/058 (20060101); A61F 5/02 (20060101); A61F
5/04 (20060101); A61F 005/00 () |
Field of
Search: |
;602/5,6,7,12,14,20,21,23,27,28,29,30 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Hafer; Robert A.
Assistant Examiner: Hanlon; Brian E.
Attorney, Agent or Firm: Ostrolenk, Faber, Gerb &
Soffen
Claims
I claim:
1. A method for immobilizing an injured body member comprising:
(a) opening .[.the.]. .Iadd.a .Iaddend.bag in a combination
comprising a splint-plate .Iadd.and the bag, with the splint plate
.Iaddend.inside .[.a water.]. .Iadd.the bag, the bag being liquid
.Iaddend.impervious.Iadd., .Iaddend.aseptically closed .[.bag.].,
mechanically resistant to the weight of the splint-plate and
thermally resistant to temperatures at or below the boiling point
of water, the splint-plate comprising a rigid thermoplastic plate
pre-cut to conform to a specific body member .[.and provided with
fastening means attached thereon.].;
(b) pouring a liquid into the opened bag, the liquid being at a
temperature at or below the boiling point of water and above the
softening point of the thermoplastic splint plate;
(c) allowing the splint-plate to remain in the liquid until the
splint-plate softens;
(d) removing the softened splint-plate from the bag;
(e) applying the softened splint-plate to a body member and molding
it to fit the body member; and
(f) securing the splint-plate in place around the body member
.[.with the fastening means.]..
2. The method according to claim 1.Iadd., .Iaddend.wherein the
softened splint-plate is removed from the bag by cutting the bottom
of the bag to allow the liquid to drain from the bag.
3. The method according to claim 1.Iadd., .Iaddend.wherein the
splint-plate is secured in place using at least one non-stretchable
linking strip, one end of the strip being connected to the
splint-plate and the other end of the strip being provided with a
locking means which is engageable with a complementary locking
means attached to the splint-plate. .Iadd.
4. The method according to claim 1, wherein the step of securing
comprises securing the splint-plate in place around the body member
with a fastening means attached to the splint-plate. .Iaddend.
.Iadd.5. A combination for immobilizing an injured body member
comprising an orthopedic splint-plate, a liquid-impervious,
aseptically closed bag holding the splint-plate, the bag being
mechanically resistant to the weight of the splint-plate and
thermally resistant to temperatures at or below the boiling point
of water, said bag being provided for receiving a hot liquid
therein at or below the boiling point of water thereby to soften
the splint-plate, the splint-plate comprising a rigid thermoplastic
plate pre-cut to conform to a specific body member, the
thermoplastic plate being deformable to conform to the body member
after heating to a temperature at or below the boiling point of
water, and becoming rigid on the body member upon subsequent
cooling, said splint-plate further comprising a plurality of holes
therethrough which permit the circulation of air from one face of
the splint-plate to its other face. .Iaddend. .Iadd.6. The
combination according to claim 5, further comprising fastening
means attached to the thermoplastic plate for securing the plate to
the body member. .Iaddend. .Iadd.7. The combination according to
claim 5, wherein the bag has a V-shaped bottom part which can
easily be cut to discharge the contents of the bag. .Iaddend.
.Iadd.8. The combination according to claim 6, wherein the
fastening means comprises at least one non-stretchable locking
strip, one end of the strip being provided with a locking means
which is engageable with a complementary locking means attached to
the splint-plate. .Iaddend. .Iadd.9. The combination according to
claim 5, wherein the splint-plate has a face intended to contact
the body member
comprising padding. .Iaddend. .Iadd.10. A combination for
immobilizing an injured body member comprising an orthopedic
splint-plate, a liquid-impervious, aseptically closed first bag
holding the splint-plate, the bag being mechanically resistant to
the weight of the splint-plate and thermally resistant to
temperatures at or below the boiling point of water, the
splint-plate comprising a rigid thermoplastic plate pre-cut to
conform to a body member and being deformable to conform to the
body member after being heated in the bag to a temperature at or
below the boiling point of water and becoming rigid on the body
member upon subsequent cooling, and further comprising a second bag
disposed about and sealing the first bag so that the second bag
containing the first bag with the splint-plate may be submerged in
a hot liquid to soften the splint-plate without contact of the hot
liquid with said first bag and splint plate, said bags being
permeable to sterilizing gas for sterilizing the splint-plate, but
impermeable to the hot liquid and to microbes.
.Iaddend. .Iadd.11. A combination for immobilizing an injured body
member comprising an orthopedic splint-plate, a liquid-impervious,
aseptically closed bag holding the splint-plate, the bag being
mechanically resistant to the weight of the splint-plate and
thermally resistant to temperatures at or below the boiling point
of water, the splint-plate comprising a rigid thermoplastic plate
pre-cut to conform to a body member, the thermoplastic plate being
deformable to conform to the body member after being heated in the
bag to a temperature at or below the boiling point of water and
becoming rigid on the body member upon subsequent cooling, said bag
being permeable to sterilizing gas for sterilizing the
splint-plate, but impermeable to hot liquid and to microbes.
.Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the invention
The present invention relates to an orthopedic rigid bandage-plate
orthosis or splint useful for medical applications, especially
those applications in which some parts of the human body have to be
secured against movement during a predetermined therapeutic
treatment period. This includes treatment for foot deviations such
as various foot, metatarsus aductus, overlapping toes, pes talus
and bunions; sprained and fractured fingers and toes; sprained
ankles; trigger finger; post-operative immobilization for neck,
foot and hand surgery; genu valgum; torticollis; scoliosis;
thoracic trauma; and provisional immobilization. Other uses may be
those related to aesthetic and plastic surgery, and those in the
veterinary field.
2. Description of prior art
Splints made of plastic-like materials are well-known in the art.
One kind of splint is provided in rigid form and has to be
moistened in water in order to be softened and wound around the
human body member to be protected.
Another kind of rigid orthosis comprises a thermoplastic material
plate provided in the form of a large sheet, from which each splint
has to be cut in the proper shape according to the injured human
body member. Once cut, the plastic rigid splint must be perforated
and binding ribbons riveted thereto. It is then sufficiently heated
in a skillet, pan or other adequate means to transform the
thermoplastic .[.materialito.]. .Iadd.material into .Iaddend.a soft
state, whereafter the orthosis may be duly applied to and wrapped
around the pertinent body member. Thereafter, the ribbons are wound
around the splint and tied using a special adhesive to keep the
splint in place until it cools and reverts to its normal rigid
state.
In emergency situations, the time and expertise necessary to cut
the rigid bandage-plate in the proper shape and the need to prepare
it represent important drawbacks. If trained personnel for cutting
this plate happen to be unavailable, when the emergency situation
arises, it is very probable that incorrectly cut splints may be
obtained.
Another drawback of the prior art method and means is due to the
investment and cost of obtaining and keeping the large sheet
material from which the relatively small plates are cut from time
to time. Furthermore, there are left-overs from the cut material
which constitute significant wastes thereof.
Other drawbacks and disadvantages result from the initial lack of
sterilization of the thermoplastic sheet and the need of
significant accessories such as the skillet or pan, stove or
heater, drill, riveter, special adhesive, etc. The initial lack of
sterilization may be dangerous if the cut plate is not heated
sufficiently, e.g. when the water is warmed but not boiled, and
furthermore, is inadmissable in operating theatres. In fact, when
sterilization is needed, an additional step is required using gas
or radiation for sterilizing the splint.
These drawbacks generally limit the availability and use of these
splints to hospitals and clinics and preclude widespread storage
and use in private consulting-rooms.
BRIEF SUMMARY OF THE INVENTION
Therefore, an object of the present invention is to provide
orthosis means which may be bought individually, costing a fraction
of the investment required by prior art means.
Another object of the present invention is to provide orthosis
means which may be applied without the need of accessory means,
i.e. skillet, heater, tools or separate ribbons and adhesive.
Another object of the present invention is to provide orthosis
means which eliminate the waste of leftovers.
Another object of the present invention is to provide orthosis
means which drastically reduce the time and expertise necessary for
preparing the splint, such that it may be swiftly applied by the
doctor himself.
Another object of the present invention is to provide orthosis
means which may be widely available and used in any type of medical
establishment, large or small, including private consulating
rooms.
Another object of the present invention is to provide orthosis
means which are assuredly sterilized.
Another object of the present invention is to provide orthosis
means which may be easily and safely used in operating
theatres.
In order to overcome the above cited drawbacks and to realize said
objects, the present invention provides orthopedic rigid
splint-plate orthoses which are particularly adapted to different
human body parts which may have to be therapeutically treated, such
that each splint-plate may form a rigid protection which can be
directly moulded on the skin of the patient without any risk of
burning thereof. The splint-plate is made of thermoplastic
material, the composition and thermoplastic characteristics of
which are well-known in the art. See for example U.S. Pat. No.
4,600,618 issued Jul. 15, 1986. The rigid splint-plate is provided
within a bag made of a plastic material having good resistance to
hot water. The splint is provided in the bag, said splint having
already been cut in a specific shape and size, with at least one
fixing strip or ribbon attached at one edge of the splint. The free
end of the strip has locking means which match complementary
locking means on the opposite edge of the splint or on the free end
of a second strip attached thereto.
The splints of the present invention are provided in the bags, said
splints having already been sterilized the bags, and are made
available in different shapes and sizes, such that an individual
practitioner need only stock a small quantity of easily storable
splint packets.
When needed, a bagged splint of the proper size is taken from the
cupboard or appropriate storage means, and subjected to a heating
operation while still inside the bag, so that the state of the
splint-plate is changed from rigid to soft. Thereafter, the thence
soft splint-plate is removed from the bag and moulded by hand on
the body part to be treated. Then the ribbon is wrapped around the
soft splint to keep it in place until it has hardened.
Consequently, in emergency situations, the rigid splint of the
present invention is immediately available and easily usable and,
therefore, the patients run no risks due to time-delays and lack of
personnel. The rigid splints, in accordance with the present
invention, will have the correct shape for the corresponding human
body part, since they will be manufactured and precut by dedicated
personnel skilled in this art. The advantages of this are that the
proper splint will be simply selected and correctly located for the
pertinent human body part, even by non-skilled personnel, due to
its predetermined correct shape, and thus leftovers are eliminated.
Sterilization of the splint is optional, and .Iadd.it
.Iaddend.should only taken out of the bag once it has been heated
to its soft state. The .[.split.]. .Iadd.splint .Iaddend.is thus
isolated from contamination during storage time, which may be quite
long in small establishments. Furthermore, all contact with
preparation tools is eliminated, as is the need for special
accessories to prepare the splint. Sterilization is optional; in
fact, an individual physician may simply use hot water from his
coffee maker to heat the splint prior to application, since boiling
water is indeed not necessary if the splint is just to be
softened.
According to a preferred embodiment, the present invention provides
orthopedic splint-plate, orthoses, each comprising a thermoplastic
material splint-plate having a shape corresponding to the body
member to be treated, the plate having at one of its edge a linking
strip or ribbon made from a non-stretchable material joined thereto
at one of its ends. At its opposite end, the linking strip includes
locking means complementary with locking means provided on the
plate, at an edge opposite to said one edge of the plate joined to
the strip. The rigid plate is provided isolated in an impervious
material bag which is aseptically closed, which bag is mechanically
resistant to the weight of the splint-plate as well as thermally
resistant to the temperature of hot water up to and including
boiling point. Prior to application, the bag is cut open at one end
and hot fluid poured in to soften the splintplate. Once the
thermoplastic plate is soft, the heating fluid is emptied and the
plate is removed from the bag. Thenceforth, the plate is ready to
be applied to a body.
Alternatively, to ultimately preserve sterilization of the splint,
the closed bag may be submerged in hot fluid to soften the plate
inside and opened only for removal of the then-softened plate. For
post-surgery use in an operating theatre, the original sealed bag
with the plate inside may be placed inside an additional bag which
is sealably closed and subjected to radiation or gas for
sterilizing it and its contents.
In addition, the rigid splint-plate orthosis of the present
invention may be provided with a foam padded surface which is
intended to be in contact with the skin of the patient. The foam
pad may be of thermoplastic material. The plate may be gridded with
holes to facilitate skin breathing as well as saving material and
providing a lighter splint.
The present invention further features a method for immobilizing an
injured body member part during a treatment period, which method
comprises the steps of providing a rigid splint-plate comprised of
thermoplastic material and thermally resistant bag means containing
said splint-plate, the thermoplastic splint-plate having
complementary fastening means located at opposite sides thereof,
subjecting said plate to a hot fluid to heat and relatively soften
it whilst still inside the bag means, removing the softened
splint-plate from said bag means and said hot fluid, applying said
soft splint-plate to at least a part of said injured body member
and manually moulding it to substantially conform to the shape of
said body member part, locking the soft splint-plate plate in place
with said fastening means and waiting for said thermoplastic
splint-plate to revert to its rigid state, whereby said rigid
splint-plate firmly grips and immobilizes said injured body member
part.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective general view of the rigid splint-plate
orthosis of the invention, wherein the splint-plate is located
within a bag ready for sale.
FIG. 2 shows the bag of FIG. 1 with the rigid splint-plate removed
therefrom.
FIG. 3 illustrates the definite shape of the splint of FIGS. 1 and
2, once moulded, wrapped around and fastened to an (unillustrated)
body member.
FIG. 3A shows the splint of FIG. 3 applied, for example, to correct
a bunion.
FIGS. 4 shows another way, from among many other possibilities, of
using the orthosis of the present invention.
.Iadd.FIG. 5 shows the invention having a second bag. .Iaddend.
In the several Figures, the same reference numerals indicate the
same parts of the rigid splint-plate orthosis.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Consider first FIGS. 1 and 2. Reference numeral 1 generally
indicates the orthopedic rigid splint-plate orthosis of the
invention consisting of a thermoplastic splint-plate 2, which in
accordance with a particular use has one of several shapes and
sizes, and a bag 9 which is made from an impervious material.
Splint-plate 2 includes a ribbon or strip 3, which is made from a
non-stretchable and thermally resistant material. The strip 3 is
joined, at one of its ends 4, to the splint-plate 2, by means of
any suitable joining means 8, such as a pair of stainless rivets.
The other end 5 of the strip 3 includes locking means 6 which are
complementary with corresponding locking means 7 located in the
splintplate 2. The locking means 6 and 7 may be of any suitable
nature, such as typical hook and loop means. In any case, the
locking means 6, 7 and the joining means 8 must be capable of
firmly retaining the splint-plate around the body member of the
patient, at least until the plate 2 is rigid.
As stated above, the splint-plate 2 is originally provided and
stored within the bag 9 to keep it sterilized. This bag 9 may be
made from a plastic material, laminar or not, but, in any case, the
bag must be capable of resisting the weight of the splint-plate 2
as well as the temperature of hot water, which is poured inside the
bag 9 or in which the bag is submerged, in order to cause the plate
2 to adopt a soft state. Preferbly, the bag 9 has a pentagonal-like
shape, in order to define a tip 10 which may be cut to allow
discharge of the water after heating. Obviously, the bag 9 may have
any other kind of configuration which allows discharge of the water
upon requirement. In any case, the splint-plate .[.orthesis.].
.Iadd.orthosis.Iaddend./and bag 9 will preferably be aseptic in its
interior.
When preparing the orthopedic rigid splint-plate orthosis 1 of the
present invention for use, the physician, assistant or less skilled
operator cuts the upper part of the bag 9 and pours the boiling
water inside the bag 9. He then waits between one and two minutes
to let the splint-plate 2 warm into a soft state. Once the
splint-plate 2 is soft, the end 10 of the bag 9 is cut to function
like a funnel allowing the discharge of the hot water. When
practically all the water is discharged, the necessary part of the
bag will be cut in order to permit removal of the splint-plate 2,
which may then be placed directly over the skin of the patient in
the region to be treated.
The necessary shape of the splint-plate, as illustrated in FIGS. 3,
3A and 4, is obtained by pressing with the fingers on the soft
plate 2. Once the plate 2 is cooled, it reverts back to its
original rigid state, where it will grip itself around the member
of the patient and the strip 3 will perform an accessory fastening
function. An adhesive strip may be used for the strip 3. The entire
preparation and casting operation takes only a few minutes or so
and requires no special instrumentation nor hardly any skill.
Another important feature of the present orthosis is that, during
the therapeutic period or treatment, any necessary zone of the
plate 2 may be reheated and remoulded on the body of the patient,
in order to correct the position of the splint 2, as well as to
relieve any excess pressure exerted in such zones.
The use of the present invention in an operating theatre differs
somewhat, insofar that initially the sealed bag 9 is enclosed in a
second .[.(not illustrated).]. .Iadd.9A shown in FIG. 5.Iaddend.,
which is sealed and sprayed with ethylene oxide gas. The molecular
apertures of the plastic material used for the bags, e.g., nylon ar
large enough for the gas molecules to pass through and too small
for the microbes; hence, all contents of the bags are effectively
sterilized until the bag is opened. Of course, other forms of gas
or radiation may be employed. When needed, the pair of closed bags
is submerged in hot water and, once the plate 2 has softened, the
circulating nurse cuts open the outside bag and the scrub nurse
then opens the inside bag 9. Into neither of the two bags is hot
water poured.
Another feature of the rigid splint-plate 2 of the present
invention is that the splint-plate 2 may be lined with a foam pad
.[.(not illustrated).]. .Iadd.2B .Iaddend.on an inner face thereof,
which lined face is intended to be in contact with the skin of the
patient. This pad surface is intended to avoid hurting the skin of
the patient, as well as to make the rigid splint 2 more
comfortable. This pad surface may be perforated and may comprise a
thermoplastic material. .Iadd.Also, the plate may be gridded with
holes 2A to facilitate skin breathing as well as saving material
and providing a lighter splint. .Iaddend.
Although the essential features of the invention have been brought
out by means of a preferred embodiment, the invention is not
limited to this embodiment and extends on the contrary to all
alternative forms within the purview of the appended claims.
* * * * *