Note: Descriptions are shown in the official language in which they were submitted.
W097/49359 PCT~K97/00276
AN ORTHOPEDIC BANDAGE
The present invention relates to an orthopaedic bandage,
e.g. for use as a part of the treatment of trauma to the
- 5 Achilles tendon.
In the treatment of severe trauma to the Achilles tendon,
such as ruptures, a usual prescribed treatment comprises
rigid immobilisation of the ankle joint for a period of
from six to eight weeks in a position where the foot in-
clines slightly forward whereby the pull on the Achilles
tendon is reduced. Prior to the lmmobilisation surgery
may be performed to suture the Achilles tendon; however
some treating consultants recommend treatment without
surgical intervention.
In an article from "Clinica~ Orthopaedics and Related Re-
search" No. 308, pp 155-165, titled "A New Treatment of
Ruptured Achilles Tendons" the author René Cetti, Lars
Onsberg Henriksen and Kurt Skovgaard Jacobsen describe a
so-called mobile plaster encasement comprising a plaster
bandage on the lower leg with a stirrup portion below the
foot to carry the full weight, with a bottom portion to
support the heel to a point centrally of the arch and
with a top portion to support the top side of the median
foot.
The foot support portion is rigidly integrated with the
remaining part of the bandage but configured to allow the
patient to freely move his toes and to permit a certain
plantar flexion, i.e. downward bending of the fore part
of the foot whereas the dorsal flexion, i.e. the oppo-
sitely oriented tipping of the ankle joint, is prevented
~eyond a position of 20~ of plantar flexion. This is a
position in which the Achilles tendon is somewhat short-
ened relative to the normal flat standing position on a
CA 022~8784 1998-12-18
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¦ PCT -'or ~ pllcation
July 9, 1998 2 P~/~ ~7/ ~76
planar support. According to this article a substantially
improved cou-se of treatment is obtained in that the foot
is allowed ~ certain freedom of movement whereby the
patient may ,timulate blood circulation and exercise some
rehabilitation of the foot prior to removal of the
plaster.
DE 2701203 relates to a bandage for treatment of talipes
equinus. The bandage comprises a walking support in the
form of a U-shaped brace and a flexible foot support
mounted on the walking support. As the foot support is
flexible this bandage is not appropriate for use in
connection with the treatment of trauma to the Achilles
tendon.
US patent No. 5,176,623 teaches an orthopaedic supporting
bandage comprising a support for the lower leg intended
for being tightly secured around the lower leg of the
patient, a foot support intended for supporting around
the foot, and a pivot joint arranged to allow the foot
support to pivot relative to the lower leg support about
an axis which is presumably to correspond to a certain
degree to the axis of pivoting of the ankle joint. The
patent teaches a means for locking the pivot joint in a
number of different angular settings whereby the patient
is allowed to use the support in accordance with his
needs, and has the option of rehabilitating the
movability of his ankle joint following release of the
locking fitting. The locking means comprises two screws
which are screwed into grooves where crests allow
selection between different angular positions at 10~
intervals. In case of this known device it is critical
that the locking means is correctly engaged when the
patient attempts to stand up on this leg, because any
attempt at walking on the device will influence the foot
support to tip relative to the lower leg support. All
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0 g~7_ ~99~
turning forces that occur during walking are transmitted
to the locking mechanism which is consequently under load
during walking. Moreover use of this prior art device
while taking steps during walking will produce a rolling
motion on the foot portion; at the end of which rolling
motion a toe set-off is produced, which means that the
Achilles tendon is activated. This is unacceptable in
connection w,th the treatment of trauma to the Achilles
tendon. Therefore this device is
CA 022~8784 1998-12-18 AMENDEDSHEET
W097/49359 PCT~K97/00276
unsuitable for the treatment of ailments, such as trauma
to the Achilles tendon, where toe set-offs are not to oc-
--cur. Release of the foot support relative to the lower
leg support also presupposes the use of tools and there-
~5 fore practice has proved this device unsuitable for reha-
bilitation purposes in its mounted state. Accordingly,
the device is used exclusively for rigid treatment.
According to the invention an orthopaedic bandage as fea-
tured in claim 1 is provided.
Usually, the use of this bandage is such that the lockingmeans is set to its fixated position when the patient is
to walk, in its release position when the patient desires
to rehabilitate his foot joint. Usually, rehabilitation
is performed with the leg in its unloaded state, e.g.
while sitting. When the patient walks, his weight is
transferred partly to the lower leg support, partly to
the foot support.
Hereby a very convenient bandage is obtained which is
suitable for treatment of trauma to the Achilles tendon
where the patient has adequate mobility and yet, follow-
ing controlled release of the locking means, he is able
to rehabilitate his Achilies tendon and his foot joint as
he pleases while, simultaneously, the pivoting movement
in the foot joint is restrictured so as to eliminate the
danger that the Achilles tendon is stretched too far. It
is considered to be most convenient if the pivoting move-
ment in the dorsal direction is restricted to 20~ ofplantar flexion. A suitable pivoting range for the reha-
bilitation may be from 20~ to 40~ of plantar flexion. The
requirements to the strength in the locking device are
less than the those to the prior art. Besides, the lock-
ing is not so critical for the walking since, in all cir-
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W097/49359 PCT~K97/00276
cumstances, the pivoting movement is limited to an range
where the Achilles tendon is not stretched too far.
According to one embodiment the foot support itself is so
arranged that it only supports below the heel and onwards
to centrally below the arch and across the median foot
whereby the patient is allowed to freely move his toes
and whereby a certain plantar flexion of the fore part of
the foot is permitted, whereas the option of performing
dorsal flexion of the foot relative to the foot support
is narrowly restricted. In this embodiment the patient
has a adequate opportunity of rehabilitating his toes and
foot within a relatively narrow range of movements which
is adapted to fully ensure that his Achilles tendon is
not stretched too far. This embodiment allows the patient
to choose between to movement ranges, a narrow one with
the foot support locked and a wider one with the foot
support released for pivoting within the predetermined
range. However, it may be desirable that the foot support
extends in the entire length of the foot in order to
hereby obtain full support of the foot from below.
According to convenient embodiments the locking means is
provided with means for securing the holder in each of
the two positions, viz. release position and fixation po-
sition, since the holder is arranged in such a manner
that, under the influence of gravity, it will have a ten-
dency to move towards the fixation position. This embodi-
ment provides a stable functioning of the holder and at
the same time adequate security that the locking engage-
ment is not unintentionally released, e.g. as a conse-
quence of thrust-like impacts which may occur during
walking.
The means for securing the holder may conveniently com-
prise a spring-biased, displaceable element with a tip or
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a rounded portion which may engage with two respective
indentations whereby easy operation and perceptible indi-
- cation of the correct positioning of the holder are ob-
tained.
According to a convenient embodlment of the invention,
the orthopaedic bandage is so configured that the means
for restricting the pivoting of the foot support are
themselves pivotally embedded whereby the pivoting range
may be shifted to different angular ranges. This may be
brought about e.g. by the guide pin being provided on a
separately pivotal element and thus excentrically rela-
tive to the rotationai axis of the separately pivotal
element. Hereby the bandage may be adjusted to the vari-
ous requirements of treatment as to the securing of thefoot relative to the lower leg.
Further characteristics and advantages of the invention
will appear from the following description of embodiments
thereof given with reference to the drawings, wherein:
Figure 1 is a vertical side view of an orthopaedic
bandage where the foot support is fixated in
a position in which it inclines 20~ forwards,
Figure 2 illustrates the same as Figure 1, but wherein
the lock is released and the foot support in-
clines 35~ forwards,
Figure 3 is a sectional view seen from the back and
along the line A-A in Figure 1,
Figure 4 illustrates the walking support, seen from
the back,
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Figure 5 illustrates the foot-shell seen from the
side, from the back and from above, respec-
tively,
5 Figure 6 illustrates the ankle-shell seen from the
side, from the back and from above, respec-
tively,
Figure 7 illustrates the locking panel seen from the
side, from the back and in a planar section
view from above, respectively,
Figure 8 is an enlarged-scale view of a detail of the
bandage for illustration of the locking means
in the fixation position,
Figure 9 illustrates a detail corresponding to Figure
8 but having the locking means in the release
position and with the foot support tipped
into the 35~ position,
Figure 10 is a vertical side view of an orthopaedic
bandage in which the foot support is fixated
in a position on which it inclines 20~ for-
wards,
Figure 11 is a vertical side view of an orthopaedic
bandage where the foot support is fixated in
a position in which it inclines 0~ forwards,
Figure 12 is a vertical side view of an orthopaedic
bandage wherein the foot support is in a po-
sition in which it inclines 20~ forwards and
is not fixated,
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W097/493S9 PCT~K97/00276
Figure 13 is a vertical side view of an orthopaedic
bandage wherein the foot support is in a po-
sition in which it inclines 40~ forwards and
is not fixated,
Figure 14 is a back view of the bandage shown in Fig-
ures 10 through 13,
Figure 15 is a side view, a top view and a front view
of the foot element in the embodiment shown
in Figures l0 through 13,
Figure 1~ is a side view, an end view and a top view of
a lateral board for mounting on the foot ele-
ment shown in Figure 15,
Figure 17 shows an element for angular setting mounted
in connection with the lateral board of the
foot element, one from the front and from the
side,
Figure 18 illustrates an ankle element seen from the
side, from the back and from above,
Figure 19 is a sectional view of the element for angu-
lar setting in a position corresponding to
the one shown in Figure 10,
Figure 20 is a side view of the position of the element
for angular setting, corresponding to Figure
10,
Figure 21 is a sectional view of the element for angu-
lar setting in a position corresponding to
the one shown in Figure 11,
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Figure 22 is a side view of the position of the element
for angular setting corresponding to Figure
11,
Figure 23 is a sectional view of the element for angu-
lar setting in a position corresponding to
the one shown in Figure 12,
Figure 24 is a side view of the position of the element
for angular setting corresponding to Figure
12,
Figure 25 is a sectional view of the element for angu-
lar setting in a position corresponding to
the one shown in Figure 13, and
Figure 26 is a side view of the position of the element
for angular setting corresponding to Figure
13.
All views of the Figures are schematic and not necessar-
ily to scale, and they show only details that are essen-
tial to the understanding of the invention whereas other
details have been omitted for the sake of clarity. In all
figures identical reference numerals are used to desig-
nate identical or corresponding elements.
Reference is first made to Figures 1, 2, and 3 that show
assembly views of the bandage in a position like the one
it occupies when worn around the lower leg and foot. The
bandage, which is, as a whole, designated by the refer-
ence numeral 1, is supported by the walking support 2
which has the approximate shape of a U-brace with a
transversal element 3 at the bottom and two upright ele-
ments 5 so configured and adapted that the lower leg maybe positioned between said upright elements.
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W097/49359 PCT~K~7/~276
At the top and to the front, the upright elements 5 are
- provided witn a shaped, forwardly arched shinbone-shell
that may be made of plastics and configured to provide a
comfortable ~nd steady bracing re~ative to the front of
the patient's lower leg. In level with the shinbone-shell
6, the backs of the upright elements are provided with an
adjustable g1rth 7 made of a flexible material and which
is configured to be opened and closed and its length ad-
justed to conveniently support around the back of the pa-
tient's lower leg. Slightly below the upper girth 7 a
corresponding lower girth 12 is provided for further sup-
porting the back of the patient's lower leg.
Slightly further down the upright elements, the front is
provided with a forwardly arched ankle-shell 13 which is
a shaped component configured to provide steady and com-
fortable support against the front of the patient's lower
leg immediately above the ankle. Further down the foot-
shell 16 is seen which is pivotally suspended relative tothe upright elements 5 by the pivoting pin 19. Opposite
the ankle-shell 13, the fixation panel 21 is seen. The
fixation panel is shown in Figure 1 in its lowermost po-
sition and in which position it secures the foot-shell in
a position with 20~ of plantar flexion, i.e. the foot has
an 20~ forward inclination relative to the position it
will occupy when the subject stands on a planar support.
Figure 2 illustrates a fixation panel 21 in its uppermost
position in which it releases the pivoting of the foot-
shell about the guide pin 20. In Figure 2, the foot-shell
occupies a position of 35~ of plantar flexion.
It will appear from Figure 3 how the sides of the foot-
shell are innermost positioned so as to be able to sup-
port on the sides of the foot, the ankle-shell is outside
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1 0
the foot-shell, and the walking support has the outermost
position at a small distance from the ankle-shell.
Figure 4 depicts the walking support 2 itself, which con-
sists of a rectangular profile, e.g. of aluminium bent to
be substantially U-shaped with the transversal element 3
at the bottom and two upright elements 5. On its under-
side, the transversal element is provided with a sole 4
which may be of rubber or some other suitable walking ma-
terial. The sole is not shown in Figure 4, but it willappear from Figure 1. The upright elements extend sub-
stantially parallel at the bottom and further upwards it
is has a slightly outward angulation in order to provide
adequate adaptation to the lower leg. On each of the up-
right elements an upper locking groove 10 is provided anda lower locking groove 11 having a purpose which will be
described below. Besides, the upright elements are pro-
vided with mounting holes for securing the remaining de-
tails of the finished bandage.
Reference is now made to Figure 5 for a description of
the foot-shell 1~, in Figure 5a shown from the side, in
Figure 5b from the back and in Figure 5c from above. The
foot-shell is made of e.g. a plastics material and is so
arranged that the foot may be inserted between the sides
above the arch portion 17 and below the inclined top ele-
ment 18. The foot may be advanced until the arch portion
17 supports the heel and the rear half of the foot from
below to a point centrally on the arch. The top element
18 abuts on the top side of the foot, but it is so suita-
bly short that it does not prevent upwardly bending of
the toes. To each side of the foot-shell, holes are ar-
ranged for a pivoting pin and a guide pin, which will be
subject to more detailed description below. The foot-
shell may be made of a form-stable material, such as ABS
plastics (acrylonitril-butadiene-styrene plastics).
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WOg7/49359 PCT~K97/00276
1 1
Reference is now made to Figure 6 for a description of
the ankle-shell 13, in Figure 6a shown from the side, in
Figure 6b shown from the back and in Figure 6c shown from
above. The ankle-shell comprises a plastics object bent
to such a shape that it fits around the front of the an-
kle just above the ankle joint. To each side of the an-
kle-shell a circular hole 14 is provided intended for
passage of a pivoting pin, and a sector hole 15 intended
for a guide pin to be described later. The ankle-shell
may be made of a material corresponding to the material
used for the foot-shell.
Reference is now made to Figure 7 which shows the fixa-
tion panel 21 in Figure 7a in a side view, in Figure 7bin a rear view, and in Figure 7c in a planar sectional
view, respect:ively. The fixation panel comprises a block
of material in which a dovetail notch or the like is pro-
vided in the form of guides 22 as will appear most
clearly from the sectional view in Figure 7c. The guide
22 is dimensioned to allow the fixation panel to be
shifted downwards over an upright element 5 of the walk-
ing support and such that the fixation panel 21 is se-
cured by the walking support. In the fixation panel 21 a
hole is also arranged in an inward orientation towards
the edge of an upright element 5 when arranged in the
guide 22. The narrowed entry portion of the dovetail
notch forms the holding groove 23 where the distance be-
tween the edges correspond to the width of the guide pin
20, as will be explained in further detail below. The
fixation panel is made of a form-stable material, such as
aluminium.
Reference is now made to Figures 8 and 9 that illustrate
a section of the bandage for further illustrating the co-
operation between walking support, foot-shell, ankle-
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.. _ . . . .
WOg7/49359 PCT~K97/00276
12
shell, and fixation panel. Figure 8 illustrates these de-
tails in a position where the fixation panel forms a
locking engagement relative to the foot-shell, whereas
Figure 9 shows a situation in which the engagement of the
fixation panel is loosened. Figure 8a shows the detail in
a lateral view and Figure 8b the same in a sectional view
from the back. In the same manner Figure 9a illustrates
the detail in a lateral view and Figure 9b in a sectional
view seen from the back.
These figures will show how the plvoting pin 19 comprises
a pin tightly secured to the upright element 5 of the
walking support and with a collar and bushing, respec-
tively, for securing foot-shell and ankle-shell in close
contact with each other and at a small distance from the
walking support. Moreover, the guide pin 20 is illus-
trated, which is somewhat shorter than the pivoting pin
19 and comprises a pin securely attached to the foot-
shell and conveyed through the sector hole 15 in the an-
kle-shell. The guide pin protrudes outside the ankle-
shell, but not so far as to touch the upright element 5
of the walking support. Figure 8 also illustrates the
fixation panel 21 with a locking unit 29 comprising a
spring-biased locking ball which is, in the view shown in
Figure 8, in engagement with the lower locking notch 11
on the walking support. In this position the holding
groove 23 engages with the guide pin 20 from both sides
and thereby completely prevents pivoting of the foot-
shell relative to the walking support.
In Figure 9 the fixation panel 21 is shifted upwards com-
pared to the position in Figure 8, and so far that the
spring-biased ball element in the locking unit 24 is in
engagement with the upper locking notch 10 on the walking
support whereby the panel is secured in this position.
Hereby the guide 20 goes clear of the holding grooves 23
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W097/49359 PCT~K97/00276
13
of the fixation panel. In this situation it is possible
for the foot-shell to pivot about the pivoting pin 19 to
the extent allowed by the engagement between guide pin 20
and the sector hole 15.
The sector hole 15 is an arched groove with a centre of
curvature at the centre of the pivoting pin of a width
correspondinc~ to the guide pin and having an angular ex-
tent adapted to give room for pivoting of the foot-shell
about the pLvoting pin 19 from 20~ to 35~ of plantar
flexion. In the preferred embodiment the foot-shell occu-
pies a position of 20~ of plantar flexion in the locked
position. It would be obvious to the person skilled in
the art to configure the embodiment for other pivoting
directions and ranges.
Figures 10 tllrough 13 illustrate a further embodiment of
the bandage according to the invention in which elements
are provided that are intended for adjustment of the
range for the pivoting interval to different angular
ranges, and wherein it is also possible to fixate the
foot portion in a horizontal position. Thus, this embodi-
ment makes ii possible to perform a pivoting movement in
the angular range of 0-20~ of plantar flexion and in an-
other settinq to perform a pivoting movement within therange of 20-40~ of plantar flexion. It should be noted
that in this embodiment the foot support extends in the
full length of the foot in order to hereby support the
entire foot. This is desirable in connection with a vari-
ety of treatments.
The means 8 for adjusting the angular range of the pivot-
ing intervals will appear in part from Figure 14 which is
a rear view of the bandage according to the invention.
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14
Figure 15 illustrates an embodiment of a foot element
which has, as opposed to the foot-shell shown in Figure
5, an adjustable instep element or top part 18 which is,
in the embodiment shown, fixated in the correct position
by means of a top part girth 25 of a burr-locking band
(Velcro~). This measure allows for improved individual
fitting to the foot of the actual patient. This measure
may also be implemented by the bandage shown in Figures
1-9 .
Figure 16 describes a lateral board for mounting in con-
nection with the foot element. The connection to the foot
element is established in the lowermost edge area of the
lateral board. In the lateral board, two recesses 27,28
are provided where the one 27 serves to receive a shaft
about which the foot element is to be pivoted, and the
other 28 serves to receive an element 8 for angular set-
ting, as will be described in the following.
Figure 17 describes an element 8 for angular setting and
comprising an engagement portion and a shaft portion 9
for mounting in the recess 28 in the lateral board. A
guide pin is provided excentrically relative to the part
mounted through the recess 28 in the lateral board. This
guide pin is moved, as was the case with the embodiment
shown in Figures 1-9, in a sector hole 15 in an element
which is fixated relative to the walking support, where
the sector hole 15 outwardly delimits the movements of
the guide pin 20.
Figure 18 describes an ankle element 13 which has, like
shown in Figure 6, a sector hole 15 for receiving a guide
pin 20 and for delimiting the range of pivoting thereof.
Figures 19-26 are views, some being sectional and some
side views where the elements not immediately visible are
CA 022~8784 1998-12-18
W097/49359 PCT~K97/00276
also shown, in which the element for angular setting of
different positions generates various limitations to the
pivoting movement. Release positions are also shown
(Figures 23-26) and locking positions (Figures 19-22) for
- 5 the locking means, respectively. In the locking position,
the locking means slides down over the guide pin 20 and
secures this so as to prevent angular rotation.
Although specific embodiments of the invention have been
described above, the present description is only to be
considered as exemplary of a few of the alternative ways
in which to realise the invention, but not as a limita-
tion of the scope of the invention which is determined
exclusively by the appended patent claims. In this con-
text it is possible to configure a bandage according tothe invention by ailowing the guide pin be securely at-
tached relatlve to the lower leg support and at the same
time allow the element comprising the sector hole to be
pivotal along with the foot element. Hereby the locking
means may accordingly be configured for engaging with the
element comprising the sector hole, e.g. by means of a
pin which is caused to engage with a cut-out in this ele-
ment intendeci therefor.
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W097/4g359 PCT~K97/00276
16
R e f e r e n c e n u m e r a 1 s
1. Bandage
2. Walking support
5 3. Transversal element
4. Sole
5. Upright element
6. Shin-shell
7. Girth, upper
108. Element for angular setting
9. Shaft portion
10. Locking notch, upper
11. Locking notch, lower
12. Girth, lower
15 13. Ankle-shell
14. Circular hole in ankle-shell
15. Sector hole in ankle-shell
16. Foot-shell
17. Arch portion
20 18. Top portion
19. Pivoting pin
20. Guide pin
21. Fixation panel
22. Guides
25 23. Holding grooves
24. Locking unit
25. Top portion girth
26. Lateral board
27. Recess
30 28. Recess
CA 02258784 1998-12-18