U.S. patent application number 10/337410 was filed with the patent office on 2003-11-20 for method and apparatus for putting a tubular compressive orthosis of knitted elastic textile material, such a stocking, tights, or a sock, onto a limb.
Invention is credited to Gardon-Mollard, Christian.
Application Number | 20030216676 10/337410 |
Document ID | / |
Family ID | 9523523 |
Filed Date | 2003-11-20 |
United States Patent
Application |
20030216676 |
Kind Code |
A1 |
Gardon-Mollard, Christian |
November 20, 2003 |
Method and apparatus for putting a tubular compressive orthosis of
knitted elastic textile material, such a stocking, tights, or a
sock, onto a limb
Abstract
The method comprises the following steps: a) enveloping the limb
(22), over a length corresponding at least to the length of the
orthosis (18), in a flexible sleeve (10) of material having a low
coefficient of friction and great strength in traction and
resistance to tearing, the limb possibly having dressings or
bandages present thereon; b) the orthosis is put on over that
portion of the limb which is enveloped by the sleeve, with this
being performed manually, causing the orthosis to slide over its
entire length on the sleeve interposed between the orthosis and the
limb; and c) once the orthosis has been put on and put into place,
the interposed sleeve is extracted by traction, the sleeve sliding
between the orthosis and the limb which then come mutually into
contact as the sleeve is extracted.
Inventors: |
Gardon-Mollard, Christian;
(Chamalieres, FR) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Family ID: |
9523523 |
Appl. No.: |
10/337410 |
Filed: |
January 7, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10337410 |
Jan 7, 2003 |
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09622907 |
Dec 22, 2000 |
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6523729 |
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09622907 |
Dec 22, 2000 |
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PCT/FR99/00454 |
Mar 2, 1999 |
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Current U.S.
Class: |
602/76 |
Current CPC
Class: |
A47G 25/907 20130101;
A61F 13/08 20130101 |
Class at
Publication: |
602/76 |
International
Class: |
A61L 015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 2, 1998 |
FR |
98/02487 |
Claims
1/ A method of putting a tubular compressive orthosis (18) such as
a stocking, tights, or a sock of knitted elastic textile material
onto a limb, optionally with dressings or bandages present on the
limb, the method being characterized by the following steps: a) the
limb is enveloped, over a length corresponding at least to the
length of the orthosis, in a flexible sleeve (10) of a material
that presents a low coefficient of friction and high strength in
traction and against tearing; b) the orthosis is put on over that
portion of the limb which is enveloped by the sleeve, with this
being performed manually, causing the orthosis to slide over its
entire length on the sleeve interposed between the orthosis and the
limb; and c) once the orthosis has been put on and put into place,
the interposed sleeve is extracted by traction, the sleeve sliding
between the orthosis and the limb which then come mutually into
contact as the sleeve is extracted.
2/ The method of claim 1 in which the orthosis is open at both its
distal and its proximal end, the sleeve being extracted via the
distal opening by being pulled out in the vicinity of said opening
(FIG. 7).
3/ The method of claim 1 in which the orthosis is closed at its
distal end and open at its proximal end, the sleeve being extracted
via the proximal opening by pulling outwards in the vicinity of
said opening, and then withdrawing the sleeve extracted in this way
by causing it to pass around the limb, over the orthosis (FIG.
6).
4/ A device for putting a tubular compressive orthosis (18) of
knitted elastic textile material onto a limb (22) by a method
according to any one of claims 1 to 3, the device being
characterized by a flexible sleeve (10) of material that presents a
low coefficient of friction and high traction strength, and
dimensioned in such a manner as to enable the limb to be enveloped
over a length that corresponds at least to the length of the
orthosis.
5/ The device of claim 4, in which the flexible sleeve is a sleeve
of cloth, in particular a cloth coated in a substance having a low
coefficient of friction.
6/ The device of claim 4, in which the flexible sleeve is tubular
and open at at least one of its ends.
7/ The device of claim 4, in which the flexible sleeve has two
thickness of material (14, 16) turned one inside the other by
invagination.
8/ The device of claim 4, in which the flexible sleeve is secured
at one of its ends to the distal end of the orthosis via a
releasable link (20).
9/ The device of claim 4, in which the flexible sleeve is provided
at one of its ends with at least one reinforced element
constituting a strap or handle (12) for grasping and pulling.
Description
[0001] The invention relates to the field of tubular compressive
orthoses made of a knitted elastic textile material, i.e. of the
"elasticated stocking" type.
[0002] In the meaning of the present invention, such orthoses can
have various shapes. For example, compressive orthoses for one or
both lower limbs can be in the form of a stocking proper (covering
the thigh and the calf), of tights (covering both lower limbs and
the abdomen up to the waist, in a single piece), one-legged tights
(tights provided with one leg only, for applying compression to
only one of the lower limbs), or indeed socks (covering only the
calf).
[0003] The invention also applies to compressive orthoses for the
upper limbs.
[0004] The invention is therefore not limited to a particular
article, but relates to all kinds of tubular compressive orthosis
(i.e. excluding bandages) such as those described above.
[0005] To enable high compression to be applied to the limb(s),
such orthoses are made of an elastic material, typically a knit of
very tight texture, thereby giving rise to various
difficulties.
[0006] In particular with orthoses of the stocking or tights type,
one of the difficulties lies in putting it on over the foot and the
ankle (where the orthosis is most difficult to put on and where
compression at its strongest), with the risk of the orthosis being
badly placed, particularly at the instep and the heel, which are
zones where it is always rather difficult to put on an orthosis,
particularly with increasing orthosis pressure.
[0007] This difficulty in putting on an orthosis is generally made
worse by the fact that such orthoses are prescribed for treating
circulatory diseases which often affect patients who are elderly,
clumsy, sometimes suffering from a motor handicap, and suffering
from arthritic phenomena that deform the hands and the feet, etc.,
i.e. people whose mobility is generally rather limited.
[0008] Furthermore, with post-surgical indications, after vein
surgery, an orthosis can be made more difficult to put on by the
dressings present on the leg after surgery, which dressings are
often of the "American dressing" type, i.e. very absorbent and
therefore very thick, thus getting in the way of putting on an
orthosis even though it is essential to avoid moving them. An
orthosis can also be difficult to put on because the patient being
under general anesthetic, so the patient cannot contract muscles
voluntarily to provide active resistance while the orthosis is
being put on; under such circumstances, it is important to avoid
forcing the passive joints of the patient.
[0009] This difficulty in putting on compressive orthoses is an
obstacle that is known both to patients and to carers, and numerous
types of device have been proposed for making it easier, generally
when the orthosis is a stocking, and most such devices comprise
metal and/or rigid structures that are complex to operate.
[0010] FR-A-2 340 708 describes one such device, in the form of a
rigid Turkish slipper cut open at the toes; that accessory does
indeed make it easier to pass the stocking over the foot, but it
provides no help of any kind with putting it on over the remainder
of the limb, which operation remains very difficult when the limb
carries dressings and the patient is immobilized under
anesthetic.
[0011] An object of the invention is to propose a method and
apparatus that are simple to use for putting an orthosis of the
above-specified type onto a limb.
[0012] It will also be seen that the putting-on device of the
invention is not expensive to make, which means that a discardable
device can be provided for single use only, which is particularly
advantageous for use with orthoses that are for treatment of a
venous ulcer, since the device which might into contact with the
wounds and the serosities could be a vector for germs if it were to
be used with other patients. It will also be seen that in this
particular indication, the single-use device can be integrated in
the orthosis so as to make it easier to put on, and be detachable
therefrom subsequently, thus enabling a carer to use a one-piece
product that is suitable for putting on directly, and whose element
that serves for putting-on purposes only can be separated and
discarded after use.
[0013] More precisely, the method of the invention is characterized
by the following steps: a) the limb is enveloped, over a length
corresponding at least to the length of the orthosis, in a flexible
sleeve of a material that presents a low coefficient of friction
and high strength in traction and against tearing; b) the orthosis
is put on over that portion of the limb which is enveloped by the
sleeve, with this being performed manually, causing the orthosis to
slide over its entire length on the sleeve interposed between the
orthosis and the limb; and c) once the orthosis has been put on and
put into place, the interposed sleeve is extracted by traction, the
sleeve sliding between the orthosis and the limb which then come
mutually into contact as the sleeve is extracted.
[0014] If the orthosis is open at both its distal and its proximal
ends, then the sleeve is extracted via the distal opening by being
pulled outwards in the region of this opening. If the orthosis is
closed at its distal end and open at its proximal end, then the
sleeve is extracted via the proximal end by being pulled outwards
through said opening, and it is then withdrawn by passing the
sleeve as extracted in this way around the limb, over the
orthosis.
[0015] The invention also provides a device for implementing the
method, the device being characterized by a flexible sleeve of
material that presents a low coefficient of friction and high
traction strength, and dimensioned in such a manner as to enable
the limb to be enveloped over a length that corresponds at least to
the length of the orthosis.
[0016] The flexible sleeve can be made of cloth, in particular a
cloth that is coated in a material having a low coefficient of
friction. It is advantageously tubular and open at at least one of
its ends. It may optionally comprise two thicknesses of material
turned inside out, one on the other, by invagination.
[0017] In a particular embodiment that is particularly adapted to
single use, one of the ends of the sleeve is secured to the distal
end of the orthosis via a separable link.
[0018] To make the sleeve easier to extract, it can be provided at
one of its ends with at least one reinforcing element forming a
strap or a handle for taking hold of and pulling.
[0019] Other characteristics and advantages of the invention will
appear on reading the following description of various embodiments
given with reference to the accompanying drawings.
[0020] FIGS. 1, 2, and 3 show three possible embodiments of a
putting-on device of the invention.
[0021] FIGS. 4 and 5 show two possible variants of a putting-on
device of the invention associated with an orthosis intended more
particularly for treating venous ulcer pathologies.
[0022] FIGS. 6 and 7 show the successive steps in the method of the
invention respectively with the device being withdrawn from the top
and with the device being withdrawn from the bottom.
[0023] The putting-on device of the invention is constituted by a
flexible and deformable sleeve which is formed in this example by a
piece of cloth suitable for surrounding and containing the limb
(leg or arm) that is to receive the orthosis, and covering it on
all sides.
[0024] By way of example, the sleeve can be made as a single piece
of cloth wound around the limb, however it is preferably made in
the form of a tubular article, i.e. one of the sides of the piece
of cloth is sewn to an opposite side thereof so as to define a
closed outline having a sleeve opening into which the limb is
inserted. This opening which corresponds to the proximal end of the
limb after the sleeve has been put on, is referred to below as the
"top end".
[0025] The sleeve is thus open at its top end; it can also be open
at its bottom end so as to make it possible, optionally, to allow
the distal end of the limb to project therethrough, or on the
contrary it can be closed at said bottom end, in which case the
sleeve is in the form of a sack or bag. It will be understood below
from the description of how the method of the invention is
implemented, that a sleeve having two open ends (the variant shown
in the various figures) is applicable to putting on any type of
orthosis, whereas a sleeve having a single open end is applicable
only to putting on an orthosis of the "open-foot" type.
[0026] The shape of the sleeve (referenced 10 in the figures) can
be approximately cylindrical as shown in FIG. 1 (for putting on
stockings and socks, for example) or it can be elongate and
slightly tapering (for putting on stockings or orthoses that go up
above the knee), as shown in FIG. 2.
[0027] An accessory 12 is advantageously provided for being taken
hold of and pulled, which accessory is in the form of a strap,
handle, tag, loop, etc. so as to help the patient or the carer
remove the putting-on device more easily after the orthosis has
been put into place (see below).
[0028] The device is either a single piece, i.e. constituted by a
single thickness of cloth, or else a double piece as shown in FIG.
3, i.e. made up of two thicknesses 14, 16 with one thickness of
cloth being turned over onto itself or "invaginated" like the
finger of a glove being taken off, thereby making it even easier to
put the compressive orthosis into place and to remove the
device.
[0029] The material from which the sleeve is made is a material
having a low coefficient of friction and great resistance to
breakage (in traction and in tearing).
[0030] The concepts of "low coefficient of friction" and "great
resistance to traction and tearing" are relative and mean that the
method as described below must be capable of being performed in
satisfactory manner by hand without help from any additional
accessory, and without displacing the orthosis once it has been put
into position, and without tearing the device while it is being
extracted.
[0031] The mechanical properties required for this purpose can vary
as a function of the more or less compressive nature of the stitch
of the orthosis (compressive classes III or IV requiring greater
traction force, and thus material that is stronger), on the
structure of the stitch and the material of the orthosis, since
certain characteristics (e.g. covering, incorporated elastane
fiber, or incorporated elasto-diene fiber) can have an effect on
the coefficients of friction of the orthosis relative to the skin
and relative to the device.
[0032] By way of example, a particularly suitable material is
Stabilkote 4, which is a cloth used in particular in sail-making.
This material is made by weaving 30 denier warp and weft threads of
6.6 nylon polyamide, by impregnation using a melamine resin, and by
coating in polyurethane. Such a cloth weighs 42.+-.2 grams per
square meter (g/m.sup.2); it is therefore very lightweight but
nevertheless highly resistant to tearing; by being coated in
polyurethane it is given a coefficient of friction that is very low
relative to the skin, relative to the surface of dressings or
bands, relative to the knit of a compressive orthosis, and relative
to itself.
[0033] On reading the present description, it will be understood
that the simplicity in the design and the use of the flexible
sleeve of the invention are the result in particular of the cloth
sliding over itself, i.e. that the tube can be invaginated over a
certain length prior to being placed on the leg that is to receive
the orthosis. This manipulation can further be simplified for the
user by means of a system of different colors (e.g. red to be put
inside blue).
[0034] The size of the device must include a diameter that is large
enough to enable it to be put onto the limb, typically a leg,
which, in association with venous ulcer disease, can present one or
more ulcers on which compresses or American dressings have been
placed for medical purposes. This dimension can be at least 25 cm
to 30 cm minimum diameter to cover all of the usual situations,
assuming that the device is cylindrical in shape; if the device is
conical in shape, then its dimensions are adapted to various sizes
of calf, and of thigh if the device is to go above the knee.
[0035] It does not matter if the device is oversized, particularly
if it needs to accommodate the thickness of any dressings that
might be present on the limb. Such excess size will give rise to
folds being formed in the device while the orthosis being put into
place, however, as will be understood from the following detailed
description of the method, these folds are far from harmful, since
the coefficient of friction of the material of the device when
rubbing against itself is very low, thereby making it even easier
to extract.
[0036] In particular, such overdimensioning can make it easier to
invaginate the distal end of the device, with, for example, the
bottom (distal) third thereof being invaginated over the middle
third, while the top (proximal) third serves essentially to exert
traction for removing the device as a whole.
[0037] With certain diseases, such as ulceration of the legs,
generally giving rise to large amounts of infection and trophic
lesions, the device must be for single use only, i.e. discardable.
Given its very low cost, both in material and in manufacture, such
single use is entirely realistic.
[0038] Under such circumstances, the device can advantageously be
secured to the orthosis as shown in FIGS. 4 and 5. In these
figures, reference 18 designates an orthosis, in particular a
discardable orthosis for compressing the leg following a venous
ulcer, of the kind described in WO-A-97/47262 (Innothra Topic
International), to which reference can be made for further details.
The single or double attached device 10 is sewn at 20 to the bottom
end (distal end adjacent to the foot) of the orthosis 18 using a
broad overcast stitch or a thread that can be cut, and at a
sufficient distance from the toe to make it possible to detach the
device after the orthosis has been put into place merely by cutting
the stitches. Other methods of connection, e.g. high frequency
welding, could naturally be envisaged providing they make it easy
for the orthosis and the device to be separated once the orthosis
has been put on.
[0039] Furthermore, for a universal article that can be used with
any type of compressive orthosis (thigh-stocking, socks, tights),
with open or closed foot portions, the device can be made
"openable" at one of its end by various means such as fastener
straps, adhesive, press-fasteners, laces, zip fasteners, etc.
[0040] Various embodiments of the device are possible, depending on
whether it is desired to remove the device from the top (the loops
12 are then situated on its proximal end, as shown in FIG. 4), or
from the bottom (the loops are then situated at its distal end, as
in FIG. 5).
[0041] The various steps in the method of the invention for putting
on an orthosis are described below with reference to FIGS. 6 and 7
which relate to two possible variants:
[0042] FIG. 6 relates to the case where the device, which is of the
type shown in FIG. 2, is extracted from the top (proximal end), as
must be the case with an orthosis of the kind shown which is in the
form of a stocking that closes over the toes (this example is not
limiting and the method can equally well be used for putting on any
type of stocking, socks, tights, etc. whether open or closed at the
foot or the ankle); in this variant the device is most
advantageously invaginated initially as explained above, e.g. with
the distal third invaginated in the middle third; and
[0043] FIG. 7 shows the case of the device being withdrawn from the
bottom (distal end) which implies that the orthosis must be open at
its distal end, at the foot or the ankle; FIG. 7 relates to putting
on an orthosis of the kind shown in FIG. 5 with an attached device,
but this example is not limiting and the method is equally
applicable to putting on any type of orthosis that is open at the
foot or the ankle, with or without an attached device.
[0044] The first step, shown at (a) in FIGS. 6 and 7 consists in
putting the device 10 into place on the limb 22, possibly with
dressings thereon. In FIG. 7, where the orthosis 18 attached to the
device, the orthosis is initially turned inside-out, i.e. with its
inside face that is to be come into contact with the limb facing
outwards.
[0045] The orthosis is then turned progressively the right way out
(as at 24 in FIG. 7) and slid onto the leg (arrows 26, 28, 30),
with this sliding being made easier by the very low coefficient of
friction of the material of the device 22, so it is very easy for
the patient or the carer to put on the orthosis using two hands,
without it being necessary to use any particular accessory or to
have help from a third person.
[0046] This leads to the situation shown in (b) in FIGS. 6 and 7,
where the orthosis 18 is in place on the leg, with the device 10
being interposed between the leg and the orthosis.
[0047] When the orthosis is attached to the device as in FIG. 7, it
is then necessary to cut or remove the thread 20 connecting the
orthosis to the device (arrow 32) in order to separate these two
elements.
[0048] The following step, shown at (b) and (c) in FIGS. 6 and 7
consists in extracting the device 10 by pulling on one of its ends,
either its proximal end (extraction via the top, FIG. 6, with this
extraction being made much easier by the device being invaginated)
or from the distal end if that is possible (extraction from the
bottom, FIG. 7); this traction can be exerted in particular by
pulling on the loops 12 (arrows 34).
[0049] Given the very low coefficient of friction of the device
relative to the skin and also relative to the cloth of the
orthosis, the device is easy to extract completely (arrows 36, 38).
However, because of its high coefficient of friction on the skin,
and because of the constriction force due to the elasticity of the
knit, the orthosis 18 does not move relative to the limb during
this operation of extracting the device, and it therefore retains
the position that was given to it on being put on.
[0050] In FIG. 6, where the device is extracted from the top, it is
subsequently removed from the leg by being passed over the orthosis
18 as shown at (d) (arrow 40); naturally, to make this operation
possible, the device must firstly be open at both ends, and
secondly it must be of a diameter that is large enough to enable it
to be passed over the top of the thigh.
* * * * *