In the treatment of severe trauma to the Achilles tendon, such as complete or partial ruptures, the treatment con- ventionally prescribed comprises inflexible, or rigid, immobilisation of the ankle joint for six to eight weeks in a position in which the foot is typically slightly forwardly inclined whereby the strain on the Achilles tendon is reduced. Prior to the immobilisation surgery can be performed to stitch together the Achilles tendon; however, some practitioners recommend treatment without surgery.

In an article in"Clinical Orthopaedics and Related Re- search"No. 308, pp 155-165, titled"A New Treatment of Ruptured Achilles Tendons", by René Cetti, Lars Onsberg Henriksen and Kurt Skovgaard Jacobsen, a so-called mobile plaster case is described that comprises a plaster case on the lower leg with a stirrup element underneath the foot to carry the full weight with a lower portion to support the heel onwards to the central part of the plan- tar arch and with an upper portion for supporting the top part of the metatarsus.

The foot support element is rigidly integral with the re- mainder of the case, but configured to enable the patient to move his toes freely and to exercise a certain degree of plantar flexion, ie downwardly oriented bending of the forefoot, whereas the dorsal flexion, ie the oppositely oriented, upward tilting of the ankle joint, is prevented

beyond a position of 20° of plantar flexion. This is a position in which the Achilles tendon is somewhat short- ened compared to normal upright position on a plane, horizontal support. According to this article a much- improved course of treatment is obtained by the fact that the foot is allowed a certain degree of movability, mean- ing that the patient is able to stimulate blood circula- tion and perform a certain training of the foot prior to removal of the plaster.

US patent disclosure 5,176,623 teaches an orthopaedic support brace comprising a lower leg support intended for being clamped in place around the lower leg of the pa- tient, a foot support configured for supporting around the foot and a pivotal joint configured such that the foot support is able to pivot relative to the lower leg support about an axis corresponding more or less to the pivotal axis of the ankle joint. The disclosure features a means for locking the pivotal joint in a number of dif- ferent angulations thereby enabling the patient to use the support as needed and permitting him to train the movability of the ankle joint following release of the lock fitting without having to dismount the support brace. Usually such angle is described on the basis of a 0-position corresponding to the position of the ankle joint in normal upright position. To each side of the brace the locking means comprises a screw that is screwed into a groove wherein toothed elements enable selection of different angulations ranging from-30° to +30° at 10°- intervals. All turning forces that occur during walking are transferred to the locking mechanism which is there- fore loaded during walking. With this prior art device it is therefore critical that the locking device is in cor- rect engagement when the patient tries to lean on his leg

since any attempt to walk on the device will influence the foot support against tilting relative to the lower leg support.

The prior art device is configured with a view to treat- ing trauma to joints in general-in the embodiment shown ankle joint trauma, but they are not configured with a view to specific treatment of eg trauma to the Achilles tendon. It should be noted in particular that use of this device while taking steps during walking, a rolling move- ment of the walking sole of the foot element occurs that corresponds to normal walking, wherein this rolling is ended by a toe or forefoot"set-off"which triggers an activation of the Achilles tendon. This is undesirable in connection with the treatment of trauma to the Achilles tendon, and it follows that this device is unsuitable for the treatment of disorders, such as trauma to the Achil- les tendon, wherein toe set-off must not occur.

WO 97/49359 discloses an orthopaedic case wherein only a brace mounted on the lower-leg support is used as support during walking, which means that the walking is performed entirely without the foot support entering into contact with the support. Obviously this device means that walk- ing can be performed without straining the Achilles ten- don, but it has been found that walking with such brace is often unsteady and it is also perceived as unnatural by the patient.

It is the object of the present invention to suggest an orthopaedic brace that ensures an optimal treatment of trauma related to the lower leg, in particular the Achil- les tendon, the ankle joint or the foot.

A first aspect of the present invention is based on the realization that the known orthopaedic support braces are configured with a view to"general"application, ie that they can be used for a number of different disorders or traumatic conditions and therefore they exhibit a high degree of variability that is not optimal for the indi- vidual user in the individual case. As described above, the orthopaedic support brace known from US patent dis- closure 5,176,623 is configured with a locking means that allows on the one hand movement, tilting of the ankle joint, in the dorsal and plantar directions, and on the other hand can be locked in a number of predetermined po- sitions with a give angulation between the lower-leg sup- port and the foot support. Since the prior art device can be adjusted to a number of different fixed angulations, there is also a risk that the patient will unintention- ally lock the case in an angle that is not the one pre- scribed by the practitioner in charge.

Correspondingly the present invention provides an ortho- paedic brace that, for a first embodiment, allows a lock- ing means to be locked only within a very narrow angular range of less than 10°, preferably less than 5°, in ac- cordance with the desired treatment.

Conveniently the means for locking the locking means com- prise a latch element that can be shifted back and forth between an open position and a number of locked positions within the selected angle interval that ensures partly ready operation partly a sensible indication of the cor- rect positioning of the latch element.

According to a preferred embodiment of the present inven- tion this problem has been solved by a locking means with

only two positions: a locked position with a single, pre- determined angle and an open position in which the foot support can be moved relative to the lower leg support within a predetermined angle interval. Such locking means ensures optimal operational comfort for the patient with only two possible positions and, likewise, it ensures that neither the locked angle nor the possible angular movement deviates from the prescriptions of the practi- tioner in charge.'Predetermined'in this context is used to denote that the patient is unable to change the pre- scribed parameters, but that the brace can be configured such that said parameters can be adjusted by the practi- tioner or can be adjusted during manufacture of the brace. However, this is not necessary and in order to ob- tain the most simple brace, said parameters can be perma- nently fixed for the given brace that can then be avail- able in different types, eg with regard to the magnitude of the locked angle. A convenient embodiment can feature a locked angle corresponding to 20° of plantar flexion and an angular range that allows 20° of plantar flexion, ie allows the foot to flex down to 40° of plantar flex- ion. A further convenient embodiment may feature a locked angle corresponding to the 0°-position and an angle in- terval that allows 20° of plantar flexion, ie allows the foot to flex downwards corresponding to 20° of plantar flexion.

The means for locking the locking means can conveniently comprise a latch element that can be shifted back and forth between a locked and an open position, and that en- sures on the one hand easy operation, and on the other hand a sensible indication of the correct position of the latch element.

Hereby a very convenient brace is obtained that is suit- able for treating trauma to the Achilles tendon, and wherein the patient benefits from adequate mobility and yet, following controlled opening of the locking means, adequate opportunity for training the Achilles tendon and the foot joint while simultaneously the oscillating move- ment of the foot joint is still limited so as to avoid any risk of the Achilles tendon overstretching.

In normal conditions, this brace will be used such that a locking means is to be set to a fixed position when the patient is to walk and in a release position when the pa- tient wishes to move his foot joint to train the Achilles tendon. Training is normally exercised with the leg in its unloaded state, eg. in a sitting position.

The above-described locking means can also advantageously be used in connection with other orthopaedic braces fea- turing a leg element, a foot element and a hinge device that permits the foot support to be moved relative to the lower-leg support.

A further aspect of the present invention relies on the realization that a convenient configuration of the walk- ing sole can ensure both an approximately natural walking posture and a protection against loading of the Achilles tendon upon foot set-off with the forefoot or the toes.

More specifically this is ensured by an embodiment of the present invention wherein the walking sole is configured for allowing partial rolling during walking, but wherein the walking sole has an expanse that ensures that the rolling is discontinued before it reaches a set-off with forefoot or toes. When the patient notices that the natu- ral rolling seizes, a set-off with the foot as a whole

will follow, ie a set-off with the lower leg and the foot as a unit. The term"walking sole"as used herein is in- tended to designate the surface that is or may be, during normal use, in contact with the support, as opposed to the walking sole element on which the walking sole is ar- ranged.

It is known in many other contexts to use a walking sole that does not extend below the forefoot. For instance, both EP-A-0 693 275 and EP-A-0 248 964 describe foot braces for relief of the forefoot in connection with forefoot-related disorders. In both instances the braces concerned can only be carried by the foot and therefore they do not prevent the Achilles tendon from being strained. Since a relief of the Achilles tendon is not relevant in the treatment of forefoot-related disorders either, there is accordingly no indication that a walking sole limited to the area behind the forefoot can advanta- geously be used in an orthopaedic brace of the type known from eg US patent No. 5,176,623.

Correspondingly, the present invention provides an ortho- paedic brace comprising: a leg element configured for be- ing clamped around the lower leg of a patient; a foot element configured for supporting around the foot of the patient and that also comprises a walking sole with a front and rear maximal expanse in the longitudinal direc- tion of the foot; a hinge device that secures the foot element relative to the leg element and that permits the foot element to pivot about an axis that corresponds sub- stantially to the axis of the ankle joint when the brace is worn by a patient; and a releasable locking means that can be activated to prevent the turning of the foot ele- ment, wherein the walking sole has a front maximal ex-

panse located in the area between the ankle and the fore- foot when the brace is worn by a patient. The walking sole has a rear maximal expanse that is preferably deter- mined to be within the area delimited between the ankle and the rear edge of the heel.

According to a first preferred embodiment the walking sole is substantially planar or slightly curved, or it comprises a planar or slightly curved middle area with upwardly curved front and back regions. The term "slightly curved"used in this context describes an curved surface with a radius of curvature of 300-550 mm, preferably 450-550 mm.

According to an alternative preferred embodiment the foot support as such is configured such that it supports only underneath the heel and onwards to an area behind the toes in such a manner that the patients is able to freely move his toes and thus also, to a limited extent, the Achilles tendon. In this configuration the patient has adequate opportunity to train his toes within a rela- tively narrow interval of movements that is adapted such as to fully ensure that the Achilles tendon in not influ- enced too much. Thus this configuration allows the pa- tient to choose between two movement intervals: a narrow one with the foot support locked and a wider one when the foot support is released for pivoting within the deter- mined interval. However, it may be desirable that the foot support extends in the entire length of the foot in order to hereby obtain full support underneath the foot.

Further characteristic features and advantages of the in- vention will appear from the description that follows of

embodiments thereof and that refers to the drawings wherein: Figure 1 is a vertical, lateral view of an orthopaedic brace wherein the foot support is fixated in a position in which it inclines 20° forwards; Figure 2 is a front view of the orthopaedic brace corresponding to the one shown in Figure 1; Figure 3 is a vertical, lateral view of an orthopaedic brace wherein the foot support is fixated in a position corresponding to a 0°-inclination; Figure 4 is a front view of the orthopaedic brace corre- sponding to Figure 3; Figure 5 is an exploded assembly drawing of a hinge with locking means, seen from the outside; Figure 6 is an exploded assembly drawing of a hinge with locking means corresponding to Figure 6, seen from the inside; Figure 7 is an explanatory sketch of a locking means in locked position; and Figure 8 is an explanatory sketch of a locking means as shown in Figure 7, in an open position.

Now follows a description of the orthopaedic brace in part with reference to a patient's foot and lower leg as positioned in the brace, the spatial relation between the brace and the foot and lower leg of the patient, however, being unequivocal, there exists to the person skilled in the art an unequivocal correlation between the brace and the foot and lower leg of the patient, and consequently

the brace can unequivocally be described with reference to said foot or lower leg. Additionally it applies that said relations apply when the patient is in a normal up- right posture with the brace in place.

All figures are schematical and not necessarily to scale and they show only the details that are essential to the understanding of the invention, whereas other details have been omitted for the sake of clarity. All figures use the same reference numerals to designate the same or corresponding elements.

Firstly, reference is made to figures 1 and 2 that show assembly views of the brace in position, like when it is fitted around lower leg and foot. The brace, designated as a whole by the reference numeral 1, consists of a leg element 2, a foot element 3 and a hinge device 4 with a locking means.

In the embodiment shown the leg element is configured with two stanchions 5, an inner and an outer one, that are at the top and the front provided with a shaped, for- wardly curved shin shell 6 that can be made of plastics and is configured to establish a comfortable and firm support relative to the front of the lower leg of the pa- tient. To the stanchions and level with the shin shells 6, the backs are provided with an adjustable inner strap 7 that is manufactured from a flexible material and con- figured to be openable and closable and adjustable in length, eg by means of burr-locking straps (Velcro@) to enable it to conveniently support around the back side of the patient's lower leg, and slightly underneath the up- per strap 7 a corresponding lower strap 12 is provided for further bracing against the lower leg of the patient.

According to an alternative embodiment (not shown) the

shin shell 6 and the upper strap 7 can be replaced by a single strap that is conveyed all the way around the lower leg, and likewise the lower strap 12 can also be conveyed all the way around the lower leg.

Corresponding to the lower part of the leg element 2 im- mediately above the hinge device, the front features a forwardly curved ankle support 13 that is configured for imparting a firm and comfortable support against the front of the patient's lower leg immediately above the ankle. The ankle support 13 can be configured either as a shaped component or as a flexible strap.

The foot element 3 consists of a foot shell 16 with an inner and an outer lateral element connected to a foot sole 17, the top face of which is, as it is, supporting the foot, and the under side of which is provided with a walking sole element 19 featuring a walking sole 20. Each of the lateral elements is connected to a respective stanchion 5 by means of a hinge device 4 configured with a locking means. Depending on the mechanical properties of the brace with regard to rigidity, the brace can be configured with locking means on the one or both hinge devices. The shown embodiment features locking means on both sides. The embodiment shown of a foot element has an adjustable arch element or top element 18 that is, in the embodiment shown, fixated in the correct position by means of a top element strap 15 of for instance burr- locking strap (Velcro@). This measure enables improved adaptation to the foot of the individual patient. Accord- ing to an alternative embodiment (not shown) the arch element 18 and the strap 15 can be substituted by one single strap in direct contact with the topside of the foot.

The walking sole element 19 has such height that it en- sures that normal walking can be performed without the foot shell or the toes-in case they are not supported by the foot sole-enter into contact with the ground. As will appear from Figures 1 and 3 the height as well as the shape of the walking sole element are determined by the selected, locked angle between foot and lower-leg element. The walking sole as such can be planar, substan- tially planar, curved or-as shown-planar with up- wardly curved frontmost and rearmost edges.

The walking sole has a frontmost and a rearmost maximal expanse in the longitudinal direction of the foot. Both the frontmost and the rearmost expanse, ie the length and the positioning of the walking sole can be varied with a view to obtaining different desired properties, eg with a view to performing walking and support function in up- right position for the determined angle between foot and leg element. The solution thus selected will thus depend on an actual choice. As described above, the expanse of the walking sole is of major significance for the walking procedure, and in accordance with the invention it is im- portant that the walking sole has a frontmost maximal ex- panse that is determined essentially within the area de- limited between the ankle and the forefoot; an area that is also designated the middle foot or the arch. The walk- ing sole has a rear maximal expanse that is determined within the area defined between the ankle and the rear of the heel. In the embodiment corresponding to Figure 1, the walking sole has a frontmost maximal expanse corre- sponding to the front part of the middle foot, corre- sponding approximately to the heads of the metatarsal

bones. In the embodiment corresponding to Figure 3 the walking sole has a frontmost maximal expanse correspond- ing to the central portion of the middle foot, corre- sponding approximately to the middle section of the meta- tarsal bones.

Preferred embodiments of the present invention may have the following exemplary objects: For a fixed angle posi- tion of 20° and with a total foot sole length of 200-300 mm (projected onto horizontal) the walking sole can have a frontmost maximal expanse that is 20,30,40,50,60, 70 or 80 mm in front of the axis of rotation of the hinge (projected onto horizontal). For a fixed angular position of 0° and with a total foot sole length of 200-300 mm the walking sole can have a frontmost maximal expanse that is 70,80,90,100 or 110 mm in front of the ro- tational axis of the hinge.

In addition to the shown preferred embodiments of the present invention the fixed angle position can be se- lected to be eg within the range of from-10 to 40° with preferred increments of 5°.

In addition to the shown preferred embodiments of the present invention the predetermined angle interval can be selected to be for instance 25 or 30° ei- ther in the dorsal or the plantar direction or to each side relative to the selected fixed angle position.

The explanation given above that the walking sole has a frontmost and rearmost expanse does not imply that the walking sole is necessarily configured as a single unin- terrupted face; it may also be perceived configured as separate frontmost and rearmost walking sole faces.

Figures 3 and 4 show an orthopaedic brace wherein the foot support is fixated in a position corresponding to a 0°-inclination, and therefore the walking sole is posi- tioned further back towards the heel.

Reference is now made to Figures 5 and 6 that show a hinge device 4 with a locking means. The hinge device consists of a foot portion 20 and a leg portion 21 mounted pivotally on a shaft 22 arranged through the bores 40 and 41 on the foot part and the leg part, re- spectively. The two hinge parts can be mounted on the foot element or the leg element, respectively, or they can be configured as integral parts thereof, eg by injec- tion moulding as will appear from Figure 7. The foot ele- ment comprises a guide pin 23, and the leg element com- prises a recess 24 in the form of a curved elongated opening in which the guide pin has been arranged and can be moved when the foot element is turned relative to the leg element about the shaft 22 mounted through the two hinge parts. The length of the recess determines the lim- its to the angulation, if any, between the two elements.

In the embodiment shown, the hinge device comprises two elements, an inner element 25 and an outer element 30 ar- ranged on the inside and the outside, respectively, of the foot element and the leg element, respectively, and that serve on the one hand to keep the hinge together and to control it. The elements are prevented from turning by the two hinge parts being configured with recesses that completely or partially correspond to the configuration of the respective element. The inner element 25 comprises a first bore 26 through which the shaft 22 is mounted; the shaft is configured with a flange for abutment against the element. The inner element also comprises a

second 27 and a third 28 bore whereby the guide pin 23 can be secured to the inner element corresponding either to the second or the third bore by means of an attachment means 29, eg a screw or a rivet. The outer element 30 comprises a bore 31 in which an attachment element 32 ar- ranged through the shaft can be secured thereby holding the hinge together. As will appear from the figure the foot portion 20 and the leg portion 21 as well as the outer element 30 is provided with recesses in the form of slightly curved elongate openings. The recess 33 in the foot element serves exclusively to enable mounting of the guide pin 23 in a given one of the two bores 27,28. The significance of this will be described below. The recess 34 in the outer element permits, as described above, that the guide pin can be moved therein when the foot element is turned relative to the leg element about the shaft 22.

Obviously, it is the smallest expanse of the recesses 24,34, in their respective longitudinal directions that determine the possible angular movement. A convenient embodiment would therefor consist in the recesses 34 con- stituting the movement-limitation, and in the outer ele- ment 30 being made of a material that is resistant to the load imposed by the guide pin when this is conveyed from impact to impact while carrying out angular movements.

The internal and external elements are preferably made of metal.

As will appear from Figures 5 and 6 the outer element comprises a set of flanges 35 that serve to convey a con- trol element or a locking means 36 such that in its lon- gitudinal axis it can be conveyed linearly back and forth relative to the outer element and thus the hinge device.

According to a (not shown) alternative embodiment the flanges 35 can be configured as an integral part of the

leg portion 21, which enables that the outer element 30 is configured as a planar element. As will appear from Figure 6, the locking means 36 is provided with an angu- lar groove 37 comprising a locking groove 38 arranged parallel with the longitudinal axis of the locking means and a guide groove 39 arranged substantially perpendicu- lar to the locking groove 38. The outer element and the locking means preferably comprise means that ensure that the locking means is secured in its locked position and cannot be opened inadvertently, eg by means of a snap de- vice (not shown).

The functioning of the locking means will now be de- scribed with reference to Figures 7 and 8. In Figure 7 the locking means is shown in its locked position where the guide pin is secured in the locking groove 38 thereby preventing angular turning of the hinge. From Figure 8 it will appear that the locking means has been conveyed to the right, away form the shaft 22 of the hinge, to an open position whereby the guide pin 23 is now located in the guide groove 39 of the angle groove thereby permit- ting the hinge to turn about its axis. Since the guide groove is not normally configured to absorb forces from the guide pin, the guide groove 39 should have such ex- panse that the guide pin can be moved freely in the guide groove. As described above, the outer element 30 should be configured for absorbing the forces from the guide pin. When the patient has finished his angle movements the brace is conveyed back to its predetermined locked position, and the locking means is displaced into place whereby the guide pin 23 will again be situated in the locking groove 38 of the locking means. The locking means can be provided with the text"OPEN"and an indication of

direction to open the lock in the form of an arrow sym- bol.

As described both in the introductory part and immedi- ately above, a preferred embodiment of the brace features a single, lockable, predetermined angle between foot ele- ment and leg element, but in view of the fact that dif- ferent angles can be expedient depending on the patient and the relevant trauma, it will-from a manufacturing point of view-be convenient if both the fixed angle and the angle variation could be set or selected during as- sembly of the various parts of the brace. For instance, the fixed angle between foot element and leg element can be determined by the hinge being, as described above, configured such that the guide pin can be secured corre- sponding to two or more fixed angle positions. The maxi- mal magnitude of the angle variation can be determined exclusively with the magnitude of the recess 34 in the outer element 30 which presupposes, however, that the re- cess 24 in the leg portion and the guide portion 39 in the locking means is configured with a view to allowing the maximal angle variation. It will therefore also be an option to the practitioner in charge or the like to per- form an adjustment of the brace and thereby determine a particular angle position and a particular angle interval for the brace prior to it being handed out to the patient who will, via the locking means, only have these prede- termined adjustments at his disposal.

Albeit the above relates to specific embodiments of the invention, the present description is intended to serve to exemplify a few possible options for exercising the invention that do not, however, constitute any limitation to the scope of the invention that is determined exclu-

sively by the appended patent claims. For instance, it is an option that the hinge device secures the locking as well as the angle-variation limitation in numerous ways.

For instance, the described angle groove can be config- ured eg as a T-groove whereby the foot element in the unlocked position can be moved both upwards and downwards relative to the locked position. It is also possible to advantageously employ this invention in the treatment of other illnesses or disorders associated to the foot, the ankle or the lower leg and that require that, during treatment, the ankle joint is fixated in a locked posi- tion. Also in case of other such illnesses and disorders the foot is able to move to a certain degree by use the brace according to the invention thereby enabling the pa- tient to stimulate blood circulation and exercise a cer- tain training of foot, ankle or lower leg, prior to final removal of the brace.