PRIORITY

This application claims priority from United States Provisional Patent Application No. 61/333,040 filed on 10 May 2010 and United States Provisional

Patent Application No. 61/424,638 filed on 18 December 2010, the entire contents of both provisional applications being herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to footwear and in particular to footwear devices that provide orthopaedic support for an impaired lower limb.

The invention has been developed primarily as a modular device for providing orthopaedic support to the ankle and/or foot of a person and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use. In particular, the invention has application in the field of modular shoes generally.

BACKGROUND OF THE INVENTION

The following discussion of the prior art has been provided in order to place the invention in an appropriate technical context and allow the advantages of it to be more fully appreciated. However, any discussion of the prior art throughout the specification should not be considered as an express or implied admission that such prior art is widely known or forms part of common general knowledge in the field. Strong healthy mobile limbs, particularly the legs and feet, are important for maintaining a healthy and active lifestyle. However, many people suffer from problems related to their legs and feet arising from a physical injury or as a result of a medical condition such as diabetics, stroke victims and those suffering from polio and arthritis. For such patients, it is necessary to provide some form of orthopaedic support to the lower limb in order to assist in the rehabilitation process.

Devices have hitherto been developed to provide orthopaedic support for patients suffering from impaired lower limbs. However, known devices of this type have suffered from a number of inherent disadvantages or limitations, including in connection with the inability to adapt readily to changes in the physical condition of an impaired limb as it improves over time. Such devices are typically cumbersome and therefore prevent the patient from wearing their normal shoes on the foot to which the supportive device applied. This is particularly disadvantageous for those patients who are required to wear the supporting device for long periods of rehabilitation, in some case being up to 18 months or longer, as the appearance of the impaired limb and exposed supporting device typically draws undesirable attention to the patient, particularly at the workplace, formal events or other social occasions.

It is an object of the present invention to overcome or substantially ameliorate one or more of these disadvantages of the prior art, or at least to provide a useful alternative.

SUMMARY OF THE INVENTION

According to a first aspect of the invention, there is provided an orthopaedic footwear device for an impaired lower limb, the device including: a sole module having a first surface for supporting a foot of the impaired lower limb and an opposed second surface for engaging the ground; and

an upper module securable to the sole module and having an opening for receiving the foot, the upper module having at least one selectively interchangeable portion releasably attached to the sole module for covering at least a portion of the received foot, wherein at least one of the sole module and the upper module is configured to provide orthopaedic support to the impaired lower limb.

In some preferred embodiments, the entire upper module is releasably attached to the sole module and can be selectively interchanged with another upper module of a different form. Preferably, the upper module includes two or more portions. In certain preferred embodiments, each portion of the upper module is releasably attached to the sole module such that the upper module can be

disassembled for reconfiguration, as desired.

The interchangeable portion is preferably arranged at a toe end of the sole module and extends towards a heel end of the sole module. Preferably, the interchangeable portion is arranged to cover at least a portion of a forefoot of the foot. The interchangeable portion is preferably adapted to form a vamp of the upper module.

It will be appreciated by those skilled in the art that a variety of

interchangeable portions can be made to provide a particular style and/or to perform a particular function. In various embodiments, the interchangeable portion can be configured to provide the appearance of, for example, a leather shoe, a casual shoe, a sand shoe, a walking shoe, a running shoe or a protective shoe or boot (e.g. steel capped toe). Preferably, the interchangeable portion is formed of leather, suede, textile, rubber, plastic or other suitable material, or combinations thereof.

In some embodiments, the interchangeable portion can be configured so that the upper module encloses a different volume in which the forefoot is received. That is, for example, the interchangeable portion can be configured to enclose a larger volume for receiving a larger or bulkier foot (e.g. higher, wider and/or longer).

Similarly, the interchangeable portion may be configured to reduce the volume enclosed by the upper module and the sole module. In certain embodiments, the interchangeable portion can also be configured to receive at least a part of a lower limb orthosis or brace applied to the foot. In such embodiments, the interchangeable portion can be configured to suit the material from which the orthosis is formed (e.g. rigid or flexible).

In some embodiments, the variation in enclosed volume can be achieved by, for example, changing one or more of the internal height, width and length of the interchangeable portion. As will be described in greater detail below, the ability to select a particular interchangeable portion advantageously allows the orthopaedic device to be used throughout a rehabilitation program during which the size and/or type of orthosis or brace worn by the user is changed to cater for improvements or other changes in the lower limb of the user.

It will of course be appreciated that the interchangeable portion is not limited to the styles and functions listed above, and could advantageously be configured to any desired configuration for a particular application or use of the orthopaedic device. Preferably, an attachment means is provided for attaching the interchangeable portion of the upper module to the sole module. In some embodiments, the attachment means includes a plurality of receiving formations (e.g. apertures, sockets, cavities, female sockets, etc) in the sole module for receiving and engaging correspondingly located plug-type elements (e.g. plugs, studs, protrusions, male members, etc) extending from the interchangeable portion. In other preferred forms, the receiving formations can be formed in the interchangeable portion and the plug- type elements can be formed in the sole member. Preferably, the attachment means is configured to enable the interchangeable portion to be snap-lockingly attached to the sole member. In one preferred embodiment, the attachment means is in the form of a plurality of press-studs or buttons. In some embodiments, the attachment means includes securing elements such as mechanical fasteners (e.g. screws). The securing elements can preferably be used as an auxiliary securing means used in combination with the snap-locking elements.

In some preferred embodiments, the upper module includes a heel cover attached to the heel end of the sole module for covering the heel of the foot. The cover is preferably releasably mounted to the sole module such that it can be readily disassembled and replaced (or exchanged), as necessary.

The heel cover is preferably formed to be generally U-shaped so as to surround the heel.

Preferably, the heel cover is hingedly mounted to the heel end of the sole module for movement between a closed position and an open position in which the opening in the upper is increased to facilitate insertion and removal of the foot from the space enclosed by the sole module and the upper module. In some preferred embodiments, the heel cover is secured to the sole module by one or more fastening elements (e.g. screws), wherein the heel cover is rotatable about the fastening element(s) between the closed and open positions.

Preferably, a retaining mechanism is provided for securely retaining the heel cover in the closed position. The retaining mechanism preferably includes a tongue slidably mounted to the heel end of the sole member for movement between an extended locking position and a depressed (or retracted) unlocked position.

Preferably, the retaining mechanism includes a biasing element for biasing the tongue to the extended locking position. The biasing element is preferably in the form of a spring, for example, a compression (coil) spring.

In some embodiments, the heel cover has an opening or cut-out for receiving a portion of the retaining element such that when the retaining element is in its extended position the retaining element interferes with the heel cover to inhibit movement thereof and thus retain the heel cover in the closed position. The retaining element preferably can be depressed against the action of the biasing element to be spaced from the heel cover so as not to interfere with the heel cover and thereby allow movement thereof to the open position.

In certain preferred embodiments, the upper includes a midfoot portion for covering the top of the midfoot between the interchangeable portion and the heel cover, the midfoot portion being arranged intermediate the interchangeable portion and the heel cover. Preferably, an upper periphery of the midfoot portion and an upper periphery of the heel cover together define the opening in the upper module.

Preferably, the midfoot portion is adapted to form a midfoot brace for providing orthopaedic support to the midfoot region of the foot. Preferably, the midfoot brace is securely fixed to the heel end of the sole. In some embodiments, the midfoot brace is secured to the heel end of the sole by one or more fastening elements such as, for example, screws. Preferably, the fastening elements are releasable for enabling removal of the midfoot brace so that the midfoot can be replaced or exchanged.

The midfoot brace preferably includes a first side portion and a second side portion extending from opposite sides of the heel end of the sole and supporting respective sides of the midfoot. In some preferred embodiments, the distal ends of the first side portion and second side portion are not connected to one another so as to allow for relative movement between the respective first and second side portions, in use.

In some embodiments, the interchangeable portion is configured to cover the midfoot brace for enhancing the aesthetic appearance of the upper module when the interchangeable portion is attached to the sole member.

Preferably, the upper includes a mounting formation for mounting a lower limb orthosis to the upper. The mounting formation is preferably associated with the heel cover. In embodiments where the heel cover is hingedly mounted to the sole module, the mounting formation is preferably joined to the heel cover such that movement of the heel cover between the open and closed positions causes a corresponding movement of the lower limb orthosis. Preferably, the mounting formation is in the form of one or more flanges joined to the heel cover. In other preferred forms, the lower limb orthosis is integrally formed with the heel cover to provide an interchangeable one piece unit releasably connectable to the sole end of the sole module. The lower limb orthosis is preferably releaseably mounted to the mounting formation such that the lower limb orthosis is selectively interchangeable.

Preferably, the lower limb orthosis has at least one portion which is shaped to facilitate close-fitting engagement about a portion of the lower limb. In certain embodiments, a securing means is provided for securing the orthosis to the lower limb so as to provide a predetermined degree of orthopaedic support to the limb. In some embodiments, the securing means includes one or more straps, preferably adjustable straps (e.g. Velcro straps).

In some preferred embodiments, the lower limb orthosis is configured to be an ankle-foot orthosis (AFO). Advantageously, the AFO may have a length (or height) so as to extend from the mounting formation up to a predetermined position on the limb of the user. For example, the AFO may be a high-leg AFO extending from the mounting formation up to a point on the lower limb just below the knee area. In other forms, the AFO may be a mid-leg AFO extending up to the calf area of the limb, or to a point between the calf and the ankle. In yet other forms, the lower limb orthosis may support the foot only.

It will therefore be appreciated by those skilled in the art that the lower limb orthosis mounted to the mounting formations of the upper can be selected to address a particular or current physical condition of the impaired lower limb. As such, as the condition of the impaired limb improves over time it is possible to select and mount a lower limb orthosis which is most appropriate to the current physical condition of the impaired limb. For example, a practitioner may prescribe that a high-leg AFO be employed for the initial treatment phase, which could then be replaced with a mid- leg AFO for the next treatment phase. The mid-leg AFO could subsequently be substituted with a foot orthosis as the limb further improves over time.

The lower limb orthosis can also be changed, not only as the leg improves, but to provide support for a particular area of the limb so as to, for example, reduce the weight bearing on a particular area, and/or to promote a desired posture.

It will further be appreciated by those skilled in the art that the lower limb orthosis is not limited to ankle-foot orthosis (AFO) and could, for example, additionally incorporate support for the knee.

Preferably, the lower limb orthosis, the midfoot brace and the first surface of the sole module are adapted to work in combination to provide the desired orthopaedic support bracing for the impaired lower limb. In certain other preferred embodiments, the midfoot brace is adapted to work in combination with a separate lower limb orthosis applied to the lower limb for providing the desired orthopaedic support.

In some preferred embodiments, the sole includes a heel plate and a main sole section connected to the heel plate, the heel plate being arranged at the heel end of the sole module and the main sole section extending from the heel plate towards the toe end of the sole module. The first foot supporting surface of the sole module is preferably formed in part by an upper surface of the heel plate and in part by an adjacent upper surface of the main sole section. The upper surface of the heel plate and the upper surface of the main sole section are substantially flush across the join.

Preferably, the heel plate has a substantially flat upper surface for supporting the heel of the foot. The upper surface of the main sole section is preferably contoured for close-fitting engagement with the foot and to thereby enhance the comfort of the user. In certain forms, the contours substantially complement the contours of the surface of the foot which is supported. In other forms, one or more regions of the upper surface of the main sole section have a weight distributing contour so as to be spaced from the supported foot for reducing the weight bearing forces on predetermined parts of the supported foot.

Preferably, the heel plate is formed of a substantially rigid material. In other embodiments, the heel plate can be configured to provide some degree of cushioning and/or flexibility for the heel, in use.

The main sole section is preferably adapted to be flexible such that the main sole section can flex, in use. Preferably, the main sole section is formed of two or more layers. In some preferred embodiments, the main sole section includes a primary layer defining the upper surface of the main sole section and a secondary layer mounted adjacent to, or against, an opposed surface of the primary layer, the secondary layer being configured to provide desired orthopaedic support characteristics of the sole including, for example, predetermined characteristics of cushioning, support (e.g. weight bearing profile) and/or flexibility for the midfoot and forefoot.

Preferably, the sole module includes means for modifying a configuration of the main sole section for changing one or more characteristics of the main sole section to suit a current physical condition of the foot. The means for modifying a configuration of the main sole section is preferably associated with the secondary layer of the main sole section. Preferably, the modifying means enables one or more of the width, length and contours of the main sole section to be altered. In one preferred embodiment, the modifying means includes a plurality of discrete members connected to the secondary layer of the main sole section, each discrete member being releasably received in a corresponding opening in the secondary layer. Preferably, each discrete member is independently interchangeable. The secondary layer is preferably formed of a flexible material such that the secondary layer deforms (e.g. stretches) to accommodate the size and/or shape of the discrete members inserted into the openings. Each opening in the secondary layer is preferably a circular through passage. In some forms, each discrete member is circular in cross-section and sized to fit snugly within the respective opening. It will be appreciated that the openings need not all be the same size, and that a range of different sized openings may be formed in the secondary layer.

The discrete members are preferably provided as a set of discrete members of various sizes, shapes, heights and densities. The set of discrete members preferably includes discrete members of various cross- sectional profiles including, for example, regular profiles, irregular profiles, circular, oval and elliptical.

Preferably, the primary layer of the sole section has a second side surface from which a plurality of spigots project, each spigot being arranged to substantially align with one of the openings in the secondary layer. Each discrete member preferably has a blind bore for mounting the discrete member on an associated spigot. Preferably, the distal end of each spigot is enlarged to provide a press fit between the spigot and the associated discrete member for retaining the discrete member on the spigot. The discrete members are preferably arranged about, along or otherwise adjacent to a periphery of the main sole section. In some preferred embodiments, the sole module includes a sole plate for providing additional orthopaedic support, the sole plate being mounted to the ground engaging surface of the sole module. Preferably, the sole plate has a mounting plate for mounting the sole plate to the heel plate. The heel plate preferably has a channel formation in which the mounting plate is mounted.

Preferably, the sole plate has a cantilever arm extending from the mounting plate towards the toe end, the cantilever arm being configured to limit the amount of flex in the main sole section, in use. Preferably, the cantilever arm is arranged to be substantially centred in the ground engaging surface such that the cantilever arm is surrounded by the discrete members of the modifying means.

The cantilever arm is preferably shaped and/or sized to provide a

predetermined amount of flex in the main sole section. Preferably, the cantilever arm has a narrow waist adjacent to the mounting plate and a wider body extending from the waist.

In some embodiments, the length or thickness of the cantilever arm is set to provide the desired supporting characteristics. In certain forms, the cantilever arm is curved to generally follow the overall contour of the main sole section.

The orthopaedic supporting characteristic of the sole plate, particularly that of the cantilever arm, can also be set by the material from which it is formed. In certain embodiments, the sole plate is made from one of carbon fibre, Kevlar, plastic, rubber, metal or a composite thereof. It will of course be appreciated that the sole plate is not limited to the materials listed above and could be formed from any suitable material. The sole plate may also be configured to enhance the durability of the sole module, particularly by forming at least part of the ground engaging surface.

Preferably, the cantilever arm forms part of the ground engaging surface.

In some preferred embodiments, the main sole section has a third layer mounted against the secondary layer such that the third layer defines at least a part of the ground engaging surface. Preferably, the third layer has a plurality of through holes which are arranged to overlie corresponding openings in the secondary layer. Each hole in the third layer is preferably concentrically aligned with a corresponding opening in the second layer.

In certain embodiments, the third layer is generally U-shaped so as to extend around the periphery of the main sole section such that the cantilever arm is arranged in the centre open section of the U-shaped layer. In some preferred embodiments, at least a part of the wider body of the cantilever arm, the third layer and the heel plate define the ground engaging surface. In various preferred embodiments, at least a part of the wider body of the cantilever arm and the third layer lie in substantially the same plane.

Preferably, the sole plate includes a tail member extending rearwardly from the mounting plate, the tail member being adapted to provide a spring back force for facilitating lifting of the impaired lower limb, in use. In some preferred

embodiments, the tail member extends from the mounting plate such that a distal end of the tail member is positioned to strike the ground first during a normal walking action, whereby the tail member elastically deflects to load the tail member upon striking the ground (and under the weight of the user) such that it subsequently returns to its rest position under the action of the loaded spring back force as the sole member is raised by the user during the walking motion.

In some preferred embodiments, a trim element extends around the edge of the sole module. In certain embodiments, the trim element and the third layer of the main sole section are integrally formed as a one piece unit. In other embodiments, the trim element, the third layer of the main sole section and midfoot brace are integrally formed as a one piece unit.

Preferably, the trim element is secured to the sole module by fasters such that it can be readily disassembled, as required.

According to another aspect of the invention, there is provided a therapeutic footwear device for use with a lower limb orthosis, the device including:

a sole module having a first surface for supporting a foot of a user wearing the lower limb orthosis and an opposed second surface for engaging the ground; and an upper module having an opening for receiving the foot and at least a portion of the lower limb orthosis, the upper having at least one selectively interchangeable portion releasably attached to the sole module for covering at least a portion of the received foot and the lower limb orthosis.

According to yet another aspect of the invention, there is provided a footwear device including:

a sole module having a first surface for supporting a foot and an opposed second surface for engaging the ground; and

an upper module having an opening for receiving the foot, the upper module having at least one selectively interchangeable portion releasably attached to the sole for covering at least a portion of the received foot. BRIEF DESCRIPTION OF THE DRAWINGS

A preferred embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 is a schematic perspective view of a first embodiment of an orthopaedic footwear device for an impaired lower limb according to the invention;

Figure 2 is an exploded side view of the device of Figure 1 showing the various modules of the device;

Figure 3 is an exploded perspective view of the orthopaedic footwear device from above;

Figure 4 is an exploded perspective view of the orthopaedic footwear device from below;

Figure 5 is an exploded view showing the sole module, upper module and heel cover of the orthopaedic footwear device;

Figure 6 is an exploded view of a second embodiment orthopaedic footwear device according to the invention using a high-leg ankle foot orthosis(AFO);

Figure 7 is an exploded view of the device of Figure 6 using a mid-leg AFO;

Figure 8 is an exploded view of the device of Figure 6 using a foot bracing orthosis;

Figure 9 is a perspective view of the device of Figure 8 assembled with the foot bracing orthosis and ready for the use;

Figure 10 shows an embodiment of a sole module of the orthopaedic footwear device; Figure 11 shows an embodiment of an interchangeable portion of the upper module of the orthopaedic footwear device;

Figure 12 shows an embodiment of an ankle-foot orthosis for use with the orthopaedic footwear device;

Figure 13 is a side view of the orthopaedic footwear device;

Figure 14 is an exploded view the device of Figure 13;

Figure 15 is side view of the device of Figure 13 with an interchangeable cover portion and heel cover attached to the sole module for providing the device with the appearance of a casual shoe; and

Figure 16 is side view of the device of Figure 13 with an interchangeable cover portion and heel cover attached to the sole module for providing the device with the appearance of a leather shoe.

PREFERRED EMBODIMENT OF THE INVENTION

Referring to the drawings, the invention provides an orthopaedic footwear device 1 for an impaired lower limb (Figures 11 and 12) having a lower leg 2, ankle 3 and foot 4.

The device 1 includes a sole module 5 having a first surface 6 for supporting the foot 4 of the impaired lower limb and an opposed second surface 7 for engaging the ground.

An upper module 8 is securable to the sole module 5 and has an opening 9 for receiving the foot 4. The upper module 8 has at least one selectively interchangeable portion in the form of a front cover 10. The front cover 10 is releasably attached to a toe end 11 of the sole module 5 and extends towards a heel end 12 of the sole module 5 for covering the forefoot and midfoot of the foot 4.

As will be described in greater detail below, the sole module 5 and the upper module 8 are configured to work in combination to provide orthopaedic support to the impaired lower limb.

The device 1 includes an attachment means in the form of a plug and socket system for attaching the interchangeable front cover 10 to the sole module 4. As most clearly shown in Figure 14, the plug and socket system includes a plurality of plugs 13 protruding from the front cover 10 and correspondingly arranged sockets 14 in the sole module 5 for receiving and releasably engaging the respective plugs 13. The plug and socket system enables the front cover to be readily snap locked to the sole member and readily disassembled so that the front cover may be changed to one which provides a different aesthetic appearance.

Again referring to Figure 14, the upper module 8 also includes a heel cover 15 hingedly attached to the heel end 12 of the sole module 5 by a pair of screws 16. As most clearly shown in Figure 3, the heel cover 15 is generally U- shaped so as to surround and cover the heel of the foot 4, in use. The screws 16 enable the heel cover 15 to be readily disassembled and interchanged.

The hinged connection of the heel cover 15 allows movement of the heel cover 15 between a closed position as shown in solid lines in Figure 13 and an open position as shown in dashed lines in Figure 13. In the open position, the opening 9 in the upper module 8 is increased to facilitate insertion and removal of the foot 4 from the space enclosed by the sole module 5 and the upper module 8. Referring to Figures 3 and 5, a retaining mechanism in the formed a slidable locking tongue 17 is provided for securely retaining the heel cover 5 in the closed position, as required for normal use when the patient is walking. The locking tongue 17 is slidably mounted to the heel end 12 of the sole module 5 for movement between an extended locking position and a depressed (or retracted) unlocked position. The locking tongue 17 is biased to an extended locking position by a compression spring (not shown).

As most clearly shown in Figure 4, the heel cover 15 has a cut-out 18 for receiving a tip 19 of the locking tongue 17 such that when the locking tongue is in its extended locking position the tip 19 is received in the void formed by the cut-out 18 such that the tip 19 interferes with the heel cover 15 to inhibit movement thereof and thus retain the heel cover 15 in the closed position.

When it is desired to open the heel cover 15, the user can simply depress the tip 19 of the tongue 17 against the action of the compression spring. Depressing the tip 19 causes the tongue to slide out of the cut-out 18 to be spaced from the heel cover 15 so as not to interfere with the heel cover. In this depressed position of the tongue 17, the heel cover 15 is free to be rotated about the screws 16 to the open position. It will be appreciated that the abilitly to move the heel cover to the open position will greatly aid a patient when they desire to insert or remove their impaired foot in or from the footwear device 1.

The upper module 8 includes a midfoot portion in the form of a midfoot brace 20 for providing orthopaedic support to the midfoot region of the foot 4. The midfoot brace 20 is securely fixed to the heel end 12 of the sole module 5. Again the midfoot brace 20 is preferably secured to the heel end of the sole by one or more fastening elements such as screws 21 for enabling removal of the midfoot brace so that the midfoot brace can be replaced or exchanged to alter the nature of the orthopaedic support provided to the midfoot region of the foot, as required.

In the embodiment illustrated in Figures 1 to 5, the midfoot brace 20 includes a first side portion 22 and a second side portion 23 extending from opposite sides of the heel end 12 of the sole module 5 for supporting respective sides of the midfoot. The distal ends 24 of the first side portion and second side portion are not connected to one another so as to allow for relative movement between the respective first and second side portions whilst the user is walking.

The interchangeable front cover 10 is configured to cover the midfoot brace 20 for enhancing the aesthetic appearance of the upper module when the front cover is attached to the sole member. A separate aesthetic cover (not shown) may be used to cover the heel cover 15 to complete the aesthetic appearance of a normal shoe provided by the front cover 10.

As shown in Figure 14, a lower limb orthosis 25 is integrally formed with the heel cover 15. The integrally formed heel cover 15 and lower limb orthosis 25 is releasably attached to the sole module 5. Again, this interchangeable characteristic enables different types of orthosis 25 to be used over the course of a rehabilitation programme to account for changes in the condition of the impaired limb.

The lower limb orthosis 25 has at least one portion 26 which is shaped to facilitate close-fitting engagement about a portion of the lower limb. Securing means in the form of adjustable Velcro straps are provided to hold the orthosis 25 in bracing engagement with the limb to provide a predetermined degree of orthopaedic support to the limb. It will therefore be appreciated by those skilled in the art that the lower limb orthosis 25 in combination with the midfoot brace 20 and supporting surface 6 of the sole module 5 can be configured to act as ankle-foot orthosis (AFO), yet have the aesthetic appearance of a standard shoe from the front cover 10. Advantageously, the AFO may have a length (or height) so as to extend from the mounting formation up to a predetermined position on the limb of the user. Due to the modular nature of the orthopaedic device, this height can be readily adjusted over the course of a rehabilitation program, whilst the aesthetic appearance of a standard shoe is maintained. Figure 6 shows an example of a high-leg AFO having a height so as to extend up to a point on the lower leg just below the knee area of the patient. Figure 7 shows an example of a mid-leg AFO extending up to the calf area of the limb, and Figure 8 shows a lower limb orthosis which is configured to support the foot only, rather than extending up the lower leg of the patient.

It will therefore be appreciated by those skilled in the art that the lower limb orthosis formed with the upper can be selected to address a particular or current physical condition of the impaired lower limb. As such, as the condition of the impaired limb improves over time it is possible to select and mount a lower limb orthosis which is most appropriate to the current physical condition of the impaired limb. For example, a practitioner may prescribe that a high-leg AFO be employed for the initial treatment phase, which could then be replaced with a mid- leg AFO for the next treatment phase. The mid-leg AFO could subsequently be substituted with a foot orthosis as the limb further improves over time. The lower limb orthosis can also be changed, not only as the leg improves, but to provide support for a particular area of the limb so as to, for example, reduce the weight bearing on a particular area, and/or to promote a desired posture.

It will further be appreciated by those skilled in the art that the lower limb orthosis is not limited to ankle-foot orthosis (AFO) and could, for example, additionally incorporate support for the knee.

Referring to the embodiment illustrated in Figures 2, 3 and 4, the sole module 5 includes a rigid heel plate 27 and a main sole section 28 connected to the heel plate. The heel plate 27 is arranged at the heel end of the sole module 5 and the main sole section 28 extends from the heel plate 27 towards the toe end 11 of the sole module 5. The upper surface of the main sole section is contoured for close-fitting engagement with the foot and to thereby enhance the comfort of the user and/or the orthopaedic support provided by the sole module.

As most clearly shown in Figure 2, the main sole section 28 is formed of a primary layer 29 defining the upper surface of the main sole section and a secondary layer 30 mounted adjacent to, or against, an opposed surface of the primary layer. The secondary layer is configured to provide desired orthopaedic support characteristics of the sole including, for example, predetermined characteristics of cushioning, support (e.g. weight bearing profile) and/or flexibility for the midfoot and forefoot.

Again referring to Figures 1 to 5, the sole module 5 includes means for modifying a configuration of the main sole section 28 for changing one or more characteristics of the main sole section 28 to suit a current physical condition of the foot. The means for modifying a configuration of the main sole section 28 is associated with the secondary layer 30 of the main sole section 28 and includes a plurality of independently interchangeable discrete members 31 releasably received in corresponding openings 32 in the secondary layer 30.

The discrete members 31 are provided as a set of discrete members of various sizes, shapes, heights and densities whereby changing one or more discrete members 31 with a discrete member of a different size or density enables one or more of the width, length and contours of the main sole section to be altered.

The secondary layer 30 is formed of a flexible material such as rubber to enable it to deform (e.g. stretch) to accommodate the size and/or shape of the discrete members snugly inserted into the openings. For example, if a circular discrete member is swapped for an oval shaped member this may achieve a widening of the main sole member which could be advantageously used to provide more space around an inflamed bunion.

To facilitate mounting and retaining of the discrete member, each discrete member has a blind bore 33 for enabling press-fitting onto spigots 34 with enlarged ends projecting from the underside of the primary layer 29 of the sole.

As best shown in Figures 2 and 3, the heel plate 27 has a channel 35 in which a mounting plate 36 of a sole plate 37 is arranged for mounting the sole plate to the heel plate. The sole plate 37 provides additional orthopaedic support and durability to the ground engaging surface of the sole module. The sole plate has a cantilever arm 38 extending from the mounting plate 36 towards the toe end 11 and is curved to limit the amount of flex in the main sole section whilst the patient is walking.

The main sole section has a third layer 39 mounted against the secondary layer such that the third layer defines at least a part of the ground engaging surface. The third layer has a plurality of through holes which are concentrically arranged with the corresponding openings in the secondary layer to allow passage of the discrete members 31. The third layer is generally U-shaped so as to extend around the periphery of the main sole section such that the cantilever arm is arranged in the centre open section of the U-shaped layer.

The sole plate 37 includes a tail member 40 extending rearwardly from the mounting plate 36. The tail member is adapted to provide a spring back force for facilitating lifting of the impaired lower limb during a normal walking motion. The tail member 40 extends from the mounting plate such that a reinforced distal end 41 of the tail member 40 is positioned to strike the ground first during the normal walking action, whereby the tail member elastically deflects to load the tail member upon striking the ground under the weight of the user such that it subsequently returns to its rest position under the action of the loaded spring back force as the sole member is raised by the user during the next stride.

A trim element 42 extends around the edge of the sole module 5 to complete the aesthetic effect of a standard shoe. In the embodiment illustrated in Figures 1 to 5, the trim element 42 is integrally formed with the midfoot brace 20 and the third layer 39 of the main sole section.

Accordingly, it will be appreciated by those skilled in the art that a variety of interchangeable portions can be made to provide the appearance of a particular style of shoe whilst the device performs a particular orthopaedic function. In various embodiments, the interchangeable portion can be configured to provide the appearance of, for example, a leather shoe, a casual shoe, a sand shoe, a walking shoe, a running shoe or a protective shoe or boot (e.g. steel capped toe). Accordingly, the present invention, at least in its preferred embodiments, provides a safe, robust, effective and easy to use modular orthopaedic footwear device for bracing an impaired lower limb. The modular construction of the device advantageously provides the user with the option to readily disassemble the device, or a part of the device, for modifying the orthopaedic support bracing to best suit the current physical condition of the impaired limb.

The ability to readily dissemble the device also advantageously renders changes in the style and physical appearance of the device. Such changes are particularly advantageous by those patients who require orthopaedic support for their lower limb over extend periods of time, as the device can be worn in various situations with a different interchangeable portion to provide the least conspicuous appearance yet still provide the necessary orthopaedic support.

Preferred forms of the invention enable various types of lower limb orthosis to be used to treat the current physical condition of the limb, allowing changes to the bracing of the limb to be made over time as the condition of the limb improves.

The device therefore provides significant advantages to those suffering from an injury to a lower limb or to those suffering from undesirable postural conditions arising from diabetes, arthritis, polio or the like. In particular, the use of preferred embodiments of the present device can be advantageously used to rehabilitate or otherwise correct the posture of a patient. In these and other respects, the invention in its preferred embodiments represents a practical and commercially significant improvement over the prior art. Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may embodied in many other forms.