U.S. patent application number 10/476487 was filed with the patent office on 2004-07-15 for dressing holder and a combination of a foot bed and such a dressing holder.
Invention is credited to Kohler, Peter, Lindh, Kjell, Lindh, Leif, Netz, Pelle.
Application Number | 20040134103 10/476487 |
Document ID | / |
Family ID | 20284131 |
Filed Date | 2004-07-15 |
United States Patent
Application |
20040134103 |
Kind Code |
A1 |
Kohler, Peter ; et
al. |
July 15, 2004 |
Dressing holder and a combination of a foot bed and such a dressing
holder
Abstract
A dressing support (1) is comprised of a flexible, resilient
spacing sheet, which is stuck firmly to the patient and has an
opening for receiving an ulcerated area. A compress (9) is applied
in the opening (2). A foot bed (30) includes a recess (32) which is
complementary to the support (1) and which receives said support
when the foot rests on the foot bed, said support being stuck to
the bottom or plantar surface of the foot.
Inventors: |
Kohler, Peter; (Stocksund,
SE) ; Netz, Pelle; (Stockholm, SE) ; Lindh,
Leif; (Danderyd, SE) ; Lindh, Kjell; (Lidingo,
SE) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Family ID: |
20284131 |
Appl. No.: |
10/476487 |
Filed: |
November 7, 2003 |
PCT Filed: |
May 15, 2002 |
PCT NO: |
PCT/SE02/00920 |
Current U.S.
Class: |
36/71 |
Current CPC
Class: |
A61F 13/069 20130101;
A61F 15/004 20130101; A61F 13/067 20130101 |
Class at
Publication: |
036/071 |
International
Class: |
A43B 019/00 |
Foreign Application Data
Date |
Code |
Application Number |
May 16, 2001 |
SE |
0101725-0 |
Claims
1. A dressing support which includes a flexible sheet that has a
first main surface which is intended to be stuck adhesively (8) to
the skin of a patient, and a smooth or slippery second main surface
opposite to said first main surface, wherein said sheet has a
through-penetrating opening (2) and, when applied, is arranged to
form spacing means between a surface area of the patient's skin
surrounded by said opening (2) and an underlying support surface
which subjects the patient to load via said sheet, characterised by
a compress (9) placed in the opening (2).
2. A dressing support according to claim 1, characterised in that
the defining edge of said sheet opening is bevelled (68), said
bevel preferably lying on the first main surface.
3. A dressing support according to claim 1 or 2, characterised in
that said sheet includes a springy, resilient layer (6) and a
relatively thin load-distributing layer (5).
4. A dressing support according to claim 3, characterised in that
the outermost surface layer (5) of said sheet has a smooth or
slippery outer surface and includes one or more secondary openings
(51); and in that said sheet includes inwardly of the outermost
surface layer a soft, flexible elastomeric layer (4) which is
intended to penetrate elastically through said secondary openings
when said sheet is subjects to load, so as to form exposed
anti-slip studs (61).
5. A dressing support according to any one of claims 1-4,
characterised in that said sheet has an associated cover (7, 7')
which can be loosely applied over the opening (2); and in that the
cover is preferably sunken into the outer part of the opening
(2).
6. A dressing support according to any one of claims 1-5,
characterised in that said sheet has a plane form that corresponds
essentially to the sole of the patient's foot.
7. A dressing support according to any one of claims 1-6,
characterised in that said sheet includes markings (3) which
provide references for locations at which the sheet can be cut to
obtain a desired shape and form.
8. A dressing support according to any one of claims 1-7,
characterised in that subsequent to cutting said sheet the sheet
will have a net area that corresponds to at least three times the
area of the opening (2).
9. A dressing support according to any one of claims 1-8,
characterised in that the thickness of the sheet decreases towards
the outer edge of said sheet.
10. A dressing support according to any one of claims 1-4, 6-9,
characterised in that the sheet has the plane form of a circular
part having radially and outwardly projecting strip parts, wherein
the opening (2) is disposed centrally in said central part.
11. A foot bed (30) that is configured complementary to the
underside of a foot and that includes a recess in alignment with an
ulcerous area or a tactile area on the underside of the foot,
characterised in that the upper side of the foot bed includes a
recess (32) which is generally complementary to a dressing support
(1) according to any one of claims 1-9, as applied to the underside
of a patient's foot, wherein the through-penetrating opening (2) of
the dressing support accommodating said compress (9) forms the
recessed or sunken area of the foot bed when the patient's foot and
the dressing support firmly adhered to said foot rest on the foot
bed with the dressing support accommodated in the recess (32).
12. A dressing support according to claim 11, characterised in that
the recess is generally complementary to the dressing support and a
stocking or sock placed on the foot over the dressing support.
Description
[0001] The present invention relates to a dressing support of the
kind defined in the preamble of the independent Claim directed to
the dressing support.
[0002] The invention also relates to a foot bed in combination with
the inventive dressing support, in accordance with the preamble of
the independent Claim directed to the combination.
[0003] Diabetics are prone to skin sores, particularly on the
underside or soles of their feet. Such sores do not heal easily,
due to the poor circulation and the impaired activity of the
sufferer. According to one conventional method, sores of this
nature are healed by providing a relatively spacious shoe and
placing in the shoe a foot bed which is generally complementary to
the sole of the patient's foot. There is provided in the foot bed
at the location of the sore a recess which can also accommodate a
dressing placed over the sore on the patient's foot. The
bandage/dressing and the sore are relieved of pressure, when the
patient wears the correct treatment shoe. The patient is able to
move freely while wearing the shoe, since only those parts of the
foot that withstand load are subjected to pressure against the foot
bed, whereas the dressing and the sore are subjected to no load at
all. The dressing may have the form of a compress on which there
may be applied some appropriate medicament and which is applied to
the patient's foot over the sore and changed when necessary.
[0004] One problem with this solution is that patients are often of
the opinion that a treatment shoe fitted with a foot bed is not
particularly attractive aesthetically, and consequently prefer not
to wear the shoe, and fail to take the trouble and the time to put
the shoe on when indoors or when walking short distances or making
short errands. Another problem is that on special occasions
patients wear more attractive shoes which are not fitted with a
pressure-relieving foot bed. As a result, the sore is subjected to
pressure via the compress, therewith seriously impairing the
healing process or delaying said process. The problem is
accentuated, by the fact that diabetics normally have impaired
tactility on the soles of their feet and consequently are unable to
feel troublesome pain caused by pressure on the sore.
[0005] When changing a compress or dressing, another problem often
resides in the failure to give the new compress the same size,
thickness and positioning on the foot as the preceding compress,
from which the foot bed is designed or modelled. There is
consequently a risk that the sore will be subjected to load, since
the shape and size of the compress do not coincide with the
original form of the foot bed.
[0006] A further problem is that even when the compress is
positioned correctly initially, this position can be disturbed when
the foot is inserted into or removed from the foot bed placed in
the treatment shoe.
[0007] Accordingly, one object of the invention is to eliminate
these problems, either completely or partially.
[0008] A further object of the invention is to provide a dressing
support that covers either part of the foot or the whole of the
foot and that can be firmly adhered to the patient's foot and
functions to relieve pressure on the sore even in the absence of a
foot bed, and that the specially produced compress/dressing that
fits in the support will always have the same size and shape. When
changing the dressing support, it shall be replaced with a support
of the same size and in accordance with indications placed
precisely in accordance with the former compress/dressing so as to
fit in the foot bed.
[0009] A further object of the invention is to provide a foot bed
which is adapted to a patient's foot and which includes a recess
corresponding to the dressing support.
[0010] These objects are achieved either totally or partially by
means of the present invention.
[0011] The invention is defined in respective accompanying
independent Claims.
[0012] Further embodiments of the invention are set forth in the
accompanying dependent Claims.
[0013] A central part of the invention relates to a dressing
support that can be used to relieve pressure on a sore or on a
sensitive skin surface of a patient and also to firmly secure a
dressing on the patient and to enable a compress/dressing to be
changed while the dressing support is seated firmly on the patient,
i.e. stuck to the patient's skin.
[0014] The dressing support can be applied to the underside of a
patient's foot such as to prevent direct contact between the
underlying foot supporting surface and a sore or a sensitive area
on the underside of the foot. The dressing support suitably has the
form of a resilient pressure-distributing sheet or strip of
material that includes a through-penetrating opening in which a
compress/dressing can be placed without serious danger of loading
the surface that shall be relieved of pressure should the patient
support his/her weight on the underlying surface via the dressing
support. The foot bed can probably be excluded in certain
instances, e.g. when the dressing support covers the whole of the
underside of a patient's foot and includes one or more
through-penetrating compress/dressing-accommodating openings.
[0015] It will be understood, however, that the inventive dressing
support also finds use in the treatment of other skin areas or skin
surfaces of a patient, where there is a risk of sores forming in
local areas as a result of pressure, for instance bedsores, e.g.
above the sacrum.
[0016] The dressing support is intended for one-time use only and
basically has the form of sheet material (in different sizes and
with different sized holes for compresses/dressings) e.g. a
flexible pressure-distributing material (for example, gelatine
material, polyurethane, EVA or like materials). The sheet is
provided with a skin-friendly adhesive and is intended and designed
to remain stuck to the patient over a continuous period of time of
up to several weeks. If the support is removed, it cannot be
replaced since otherwise the support might be wrongly positioned.
The dressing support includes a through-penetrating opening for
accommodating a compress/dressing and forms a spacing means which
prevents the sore beneath the compress in the support opening from
being subjected to pressure/load. A medicament can be applied
locally to the compress/the dressing when necessary. The dressing
constantly has the same shape and size and can be replaced via the
opening in the support with the support stuck firmly to the
patient.
[0017] The opening receiving the compress/dressing can be sealed
with adhesive tape, for instance. The outer surface of the
sheet-like support is preferably slippery so as to reduce the risk
of the support being displaced by forces acting in the plane of the
support. The side of the support that lies proximal to the
underlying foot-supporting surface, e.g. the floor, may be provided
with a stiff layer that distributes the load or pressure points and
therewith reduces the risk of local pressures on the patient's foot
sore. This layer will preferably be flexible so as to adapt to the
shape of the surface area of the patient on which the dressing
support shall be stuck.
[0018] By producing the dressing support in several standard
designs, and by providing the support with graphic markings and
constructing the support so that it can readily be brought to the
correct size by cutting pieces from the dressing support, for
instance whilst guided by said graphic markings, a fresh dressing
support can be applied in a precisely correct position when
changing the support, with the aid of markings provided on the body
part to this end, and the size of the opening can be adjusted.
[0019] When the dressing support has been securely adhered to the
underside of a patient's foot with the opening in the support
positioned over a sore or a tactile area on the underside of the
foot, a foot bed can be cast or moulded on a conventional way, with
the foot and the applied dressing support as a model.
[0020] When the patient with the dressing support applied to
his/her foot inserts his/her foot into the treatment shoe, the foot
bed and the dressing support will together provide a comfortable
support surface for the whole of the foot in the treatment shoe,
with the exception of the opening in the dressing support.
[0021] In those cases when the dressing support covers the whole of
the foot with pressure-relieving openings for sores or tactile skin
areas, the adaptation of a normal shoe may suffice.
[0022] When the patient removes the treatment shoe, the dressing
support carrying the dressing will remain on his/her foot,
wherewith the dressing support will prevent direct contact between
the walking surface and the sore as the patient walks without the
treatment shoe/foot bed.
[0023] The fact that the exposed side of the dressing support is
slippery reduces the risk of the support being disturbed on the
foot of the wearer as he/she inserts her foot in or on to the foot
bed in the treatment shoe.
[0024] When the foot to which the support is applied shall be
inserted into a sock or stocking, the slippery outer surface of the
support affords the advantage of reducing the risk of displacement
of the support relative to the foot and also facilitates insertion
of the foot carrying the support into the sock.
[0025] As will be understood, the foot bed may be formed on the
basis of the foot to which a dressing support has been applied
being clothed with a sock/stocking.
[0026] The slippery/smooth outer layer of the support may include
one or more secondary openings, and the support may include a soft
elastic rubber-like layer nearest the outer layer that includes
said secondary openings. As load is exerted on the dressing
support, parts of the rubber layer will penetrate plastically out
through the secondary openings and therewith form anti-slip
elements, which are particularly useful when a patient that has a
dressing support applied to his/her foot walks on a slippery floor
without wearing a sock or stocking.
[0027] The invention will now be described by way of example with
reference to the accompanying drawing.
[0028] FIG. 1 is a plan view of one example of an inventive
dressing support.
[0029] FIG. 2 is a sectional view taken on the line I-I in FIG.
2.
[0030] FIG. 3 is a schematic vertical sectioned view of a treatment
shoe fitted with a foot bed.
[0031] FIG. 4 is a view of the upper side of the foot bed.
[0032] FIG. 5 is a plan view of the underside of a patient's foot
to which a dressing support has been applied.
[0033] FIG. 6 is a schematic section view taken on the line VI-VI
in FIG. 4.
[0034] FIG. 7 is a schematic section view taken on the line VII-VII
in FIG. 5.
[0035] FIG. 8 is a schematic cross-sectional view of a dressing
support.
[0036] FIG. 1 illustrates a standardised sheet-like dressing
support 1, which includes an opening 2 whose area corresponds at
most to one-third of the area of the support 1. The support 1 also
includes graphic markings 3 in the form of indications that
facilitate cutting of the support to a desired size.
[0037] A support 1 intended for a patient's foot may include a
roundish central part 11 having a diameter of, e.g., 5 cm and
including a central opening 2 having a diameter of 2.5 cm.
Strip-like parts 12 connect with diametrically opposed parts of the
round portion 11. The strip parts 12 have a length of about 7 cm.
The side 4 of the support that is intended to lie proximal to the
patient, may be formed from a load-distributing, soft plastic sheet
which is firmly fastened to adhesive tape 8 or the like used to
secure the support 1 to the patient. The exposed side of the
support 1 is formed from a load-distributing, relatively rigidly
flexible sheet 5 of material, which has a slippery exposed outer
surface. A compress (9), possibly provided with a local medicament,
is placed in the space defined by the opening 2. Tear-off adhesive
tape 7 or the like may be adhered to the sheet 5 over the openings
(2).
[0038] A dressing support 1 is placed on the underside 20 of a
patient's foot 21 (FIG. 5) in a position in which the opening 2 is
in alignment with a sore 23 on the underside 20 of the foot. The
strip parts 12 are cut so that the support 1 will not extend beyond
the plane contour of the underside of the foot, and the support 1
is now stuck firmly to the underside 20 of the foot, for instance
with double-sided adhesive tape.
[0039] A foot bed 30 (FIG. 2) is now produced in a conventional
fashion, by using as a model the underside 20 of the foot 21 with
the support 1 firmly affixed thereto. The actual foot bed 30
includes a recess 32 whose plane contour corresponds to the plane
contour of the fitted support 1, and has a depth corresponding to
the thickness of said support. The underside of the foot bed 30 is
given a form that will enable it to be correctly fitted in a
treatment shoe. (FIG. 3), which is preferably designed to
facilitate the insertion and removal of a patient's foot to which a
support 1 has been applied.
[0040] Because the underside 5 of the support 1 is slippery, there
is less danger of the support 1 being displaced relative to the
foot 21 as a result of friction against, e.g., the foot bed 30 when
putting on the shoe 40.
[0041] The adhesive tape 7 (or alternatively a cover 7' (FIG. 8)),
which preferably also has a slippery outer surface, can be readily
pealed or torn off to enable the compress in the opening 2 in the
support part 11 to be replaced whilst the support 1 remains firmly
stuck to the patient's foot 21.
[0042] The support 1 includes an intermediate layer 6 of flexible
material, for instance a formable plastic layer.
[0043] A patient who has removed his/her foot from the shoe 40 with
the support 1 attached is able to walk on a floor surface with less
danger of the sore 23 being subjected to pressure loads from the
floor, since the support 1 functions as a spacing means.
[0044] The inventive dressing support finds general use as a means
for preventing direct contact between a tactile surface area of a
patient's skin or a skin sore and an underlying supportive surface,
and can, of course, be given other configurations than that shown
in FIG. 1. The embodiment illustrated in FIG. 1 is particularly
suitable for protecting foot sores or sensitive areas of a
patient's skin and can be provided in a few standard designs which
together enable the majority types of foot sores of typical sizes
and in typical places to be treated. It will be understood that
several supports 1 can be applied to a patient's foot.
Alternatively, a complete sole that includes several openings.
[0045] For example, a dressing support may have more than one
opening 2 and can, of course, also retain its basic function,
namely that of forming a spacing means which surrounds a sore or a
tactile area and which provides favourable transfer of load between
an adjacent underlying support surface and an area on the patient
that surrounds the sore or the tactile area.
[0046] An inventive dressing support can thus be used beneficially
by, for instance, rheumatics or neuropatients for reasons other
than those associated with diabetes, for instance the presence of a
sensitive growth on the underside of the foot and that can be
supported with the aid of a dressing support, possibly without the
dressing, wherewith the foot and the dressing support affixed
thereto can be received in a correspondingly shaped bed in a shoe
in the same way as that described above.
[0047] In one embodiment of the invention, the outer edge of the
dressing support 1 may be chamfered, bevelled 69 or thinned so that
the outer edge part of the applied dressing support will taper
gently so as to lie flush with the patient's skin, i.e. in the
absence of any protrusion.
[0048] The defining edge of the opening 2 may also be bevelled 68,
said bevel 68 preferably lying nearest the patient so as to provide
pressure relief in the area around the edge of the opening. As an
alternative to the tape 7, there can be used a cover 7' which can
be fitted loosely into the opening in the proximity of the outer
surface of the sheet-like. The cover 7' is suitably sunken in the
opening, so as to reduce the risk of the cover transferring
pressure loads to the patient and/or to a dressing located in the
opening.
[0049] The outer layer 5, which is relative rigid, has a number of
openings 51 that enable the soft elastic material in the layer 4 to
protrude out through said openings 51 so as to form friction studs
61 when the support 1 is compressed between the patient's foot and
an underlying surface, such as a floor, for example. The studs 61
reduce the risk of the support sliding on a slippery undersurface
when subjected to load.
* * * * *