WO2024038252A1

WO2024038252A1 - A footwear adapter and orthosis for attaching to footwear

Info

Publication number: WO2024038252A1
Application number: PCT/GB2023/052089
Authority: WO
Inventors: Paul Fryer
Original assignee: Xothotics Limited
Priority date: 2022-08-17
Filing date: 2023-08-07
Publication date: 2024-02-22
Also published as: WO2024038253A1

Abstract

The present disclosure relates to a footwear adapter for attachment to an orthosis, and orthosis for attaching to footwear. The footwear adapter comprises an attachment portion, wherein the attachment portion is configured to be at least partially embedded into an external surface of an item of footwear such that the footwear adapter does not substantially protrude beyond the external surface of the item of footwear, and wherein the attachment portion is configured to engage with an orthosis for a human user. The orthosis comprises a leg support, wherein the leg support comprises an attachment portion configured to engage with an item of footwear worn by the user.

Description

A footwear adapter and orthosis for attaching to footwear

Field of the invention

The present disclosure relates to a footwear adapter and orthosis for attaching to footwear, in particular an orthosis configured to detachably couple to footwear via the footwear adapter.

Background

An orthosis is an externally applied device used to influence the structural and functional characteristics of the neuromuscular and/or skeletal system.

Orthoses may include, but are not limited to, paralysis orthoses, relief orthoses, and soft braces. Paralysis orthoses may be used both for paralyses with complete functional failure of muscles or muscle groups, as well as for incomplete paralysis. They are intended to correct or influence functional limitations or to replace functions that have been lost as a result of the paralysis. Relief orthoses are used both in degeneration and after injuries to joints. Soft braces may be used to protect the joints from excessive loads, for example following light injury or for injury protection.

Orthoses may also be used to provide support to the human body and can be used for performance enhancement.

Ankle-foot orthoses (AFO) refer to orthoses that span the ankle and foot. Existing anklefoot orthoses commonly use a rigid plate which is arranged underneath at least a portion of the user’s foot in use. The rigid plate may be placed into a shoe or otherwise integrated as a part of an orthotic medical “boot”.

The rigid plate may inhibit, or significantly reduce, the user’s flexibility of their foot in use. This may also interfere with the user’s foot proprioception. This can result in impaired balance and control of ambulation, even resulting in increased incidence of trips and falls due to reduced proprioceptive input.

Existing medical orthotic boots, such as Walker boots, can also be heavy, bulky, and cumbersome.

Summary of the invention

Aspects of the invention are as set out in the independent claims and optional features are set out in the dependent claims. Aspects of the invention may be provided in conjunction with each other and features of one aspect may be applied to other aspects.

In a first aspect of the invention there is provided an orthosis for providing support to a human user. The orthosis comprises a leg support, wherein the leg support comprises an attachment portion configured to engage with (or “couple to”) an item of footwear worn by the user. The provision of the attachment portion may be advantageous to allow the orthosis to load transfer with the item of footwear directly, reducing loading on the user’s leg, ankle, and/or foot. Furthermore, attachment of the orthosis to the item of footwear may avoid the need for a rigid plate arranged under the user’s foot to transfer the load from the orthosis to the item of footwear, as instead the load may be transferred through the attachment portion. This may be advantageous compared to existing underfoot platebased solutions as the user maintains flexibility in their foot in the footwear during use. This may improve balance, control of ambulation, and mobility as the user is able to flex their foot in the shoe and accommodate to uneven ground, unlike when the foot is interfaced with a rigid plate. Avoiding the need for a rigid plate arranged under the user’s foot to transfer the load from the orthosis to the item of footwear may also be advantageous for user comfort. Current solutions relying on a hard, rigid plate with a vertical support being inserted into a shoe that was never designed to receive such an arrangement can be incredibly uncomfortable for the user, and often leaves the user at increased risk of sores. Discomfort and sores are a key factor in users stopping use of orthoses completely and not adhering to recommend rehabilitation plans which can be detrimental to a user’s recovery and/or mobility. In addition, attachment of the orthosis to an item of footwear may reduce movement and slippage of the orthosis in use. This may be advantageous to reduce the incidence of trips and falls.

Attachment of an orthosis to an item of footwear may also be advantageous to avoid requiring specialist footwear orthoses, such as a Walker boot, which can be heavy, bulky, and cumbersome. Even when specialist footwear orthoses are not required and a rigid plate may be inserted into a regular item of footwear, users of such orthotic devices are often required to buy two pairs of any shoe in different sizes, as the orthosis tends to require a larger shoe size relative to the user’s normal shoe size in order to allow the orthosis to fit within the shoe, alongside the user’s foot. Furthermore, as regular shoes are not designed to have a rigid plate with an upright installed into them, they can have a relatively short life as the rigid plate can quickly wear through the parts of the shoe. This can be a long-term cost inhibitor to the user and severely limits the types of shoes that it is possible to use a rigid plate with. By contrast, attachment of an orthosis to an item of footwear as described with reference to embodiments of the present invention may be advantageous to allow the user to selectively attach an orthosis to an item of footwear, without requiring multiple sizes of footwear to be purchased. This also reduces the amount of environmental waste generated either by requiring shoes of different sizes to be purchased, as is the case for conventional rigid plate orthoses, or requiring specialist footwear orthoses to be purchased, often only for use during a finite recovery period.

The attachment portion may be configured to detachably engage with the item of footwear worn by the user. This may be advantageous to facilitate use of a single orthosis with a variety of footwear, for example wherein the user can interchange different items of footwear with the orthosis, for example depending on preference or terrain, etc. This avoids the need for multiple specialist footwear orthoses. Detachable engagement may also be advantageous to adapt footwear based on the users need for the orthosis support, for example the orthosis may be coupled to the item of footwear during activities where the user requires support, such as during sports or injury rehabilitation, and detached from the footwear when support from the orthosis is no longer required, for example during less intense activity or following injury recovery.

In some examples, the attachment portion may be configured to engage with a portion of the heel of the item of footwear worn by the user, optionally wherein the attachment portion is configured to detachably engage with a portion of the heel. However, the skilled person will understand that the attachment portion may be configured to engage with a portion of any other external surface of an item of footwear.

In some examples, the attachment portion may comprise a substantially semi-circular engagement portion configured to detachably engage with a corresponding substantially semi-circular engagement portion in the heel of the item of footwear worn by the user

The attachment portion may comprise an interlocking structure, the interlocking structure being configured to (i) interlock with a corresponding interlocking structure in the heel of the item of footwear worn by the user in an engaged configuration, and (ii) disengage with the corresponding interlocking structure in the heel of the item of footwear worn by the user in a released configuration. This may be advantageous to reversibly secure the orthosis to the item of footwear in order to prevent uncontrolled disengagement between the orthosis and item of footwear.

The interlocking structure may comprise an engagement protrusion configured to reversibly interlock with a receiving slot in the item of footwear worn by the user. Alternatively, the interlocking structure may comprise a receiving portion configured to reversibly interlock with an engagement protrusion of the item of footwear.

In some examples, the interlocking structure may comprise a clip.

The engagement protrusion may be biased into the engaged configuration. For example, the engagement protrusion may be a resiliently deformable material such that the engagement protrusion is configured to be biased into the engaged configuration.

Alternatively, or in addition to the interlocking structure, the leg portion may be configured to detachably engage with the item of footwear via at least one magnet. The attachment portion may be configured to detach from the item of footwear via rotation of the footwear in the plane of the sole of the footwear, or in the plane of the engagement portion, to disengage the at least one magnet, for example akin to ski bindings.

The leg support may comprise an ankle support. This may be advantageous to provide support to the ankle of the user, for example by transferring load between the ankle support and footwear in use, thus reducing loading on the user’s ankle. Optionally, the leg support may consist of an ankle support, wherein the ankle support comprises the attachment portion. The orthosis may further comprise a torso support, wherein the torso support and the leg support are coupled via a joint. This may be advantageous to transfer load between the item of footwear and the torso of the user, thus reducing loading onto the leg of the user. Coupling the torso support and leg support via a joint may be advantageous to promote the user’s mobility by allowing for a range of motion between the torso support and leg support. For example, the orthosis may comprise an exoskeleton comprising a torso support and a leg support, coupled via a joint. An example exoskeleton is described in more detail in GB2212021.6.

In another aspect of the invention, there is provided a footwear adapter for attachment to an orthosis, comprising an attachment portion, wherein the attachment portion is configured to be at least partially embedded into an external surface of an item of footwear. The attachment portion is configured to engage with an orthosis for a human user.

The provision of the attachment portion may be advantageous to allow the orthosis to couple to and transfer load with the item of footwear directly, reducing loading on the user’s leg and/or foot. Furthermore, attachment of the orthosis to the item of footwear may avoid the need for a rigid plate arranged under the user’s foot to transfer the load from the orthosis to the item of footwear, as instead the load may be transferred through the attachment portion directly into the item of footwear. This may allow the user to maintain proprioceptive input and flexibility of their foot in use through the footwear as no rigid plate is required. In addition, attachment of the orthosis to an item of footwear may reduce movement and slippage of the orthosis in use. The footwear adapter may also be advantageous to avoid requiring specialist footwear orthoses, such as a Walker boot, which can be heavy, bulky, and cumbersome.

The orthosis may comprise a leg support configured to support at least a portion of the leg of a user.

The attachment portion may be configured to detachably engage with the orthosis for a human user. Detachable engagement via the footwear adapter may be advantageous to facilitate adapting footwear based on the users need for the orthosis support, for example the orthosis may be coupled to the item of footwear via the footwear adapter during activities for which the user requires support, such as during sports or injury rehabilitation, and detached from the footwear when support from the orthosis is no longer required, for example during less intense activity or following injury recovery.

The footwear adapter may be configured to be at least partially embedded in the item of footwear such that footwear adapter does not extend beyond the profile of the item of footwear. For example, the footwear adapter may not protrude beyond the profile of the item of footwear compared to the profile of the item of footwear without the footwear adapter installed. This may be advantageous to avoid any bulky or cumbersome attachment protrusions which may otherwise increase risk of injury when the item of footwear and footwear adapter are worn without being coupled to an orthosis. As such, this may facilitate the item of footwear being worn with and without the orthosis, as required.

The footwear adapter attachment portion may be configured to be at least partially embedded into an external surface of a heel of an item of footwear. For example, footwear adapter may be configured to be at least partially embedded in the heel such that footwear adapter does not extend beyond the profile of the heel of the item of footwear. However, the skilled person will understand that the attachment portion may be at least partially embedded into any other external surface of an item of footwear, including but not limited to, the midsole, outsole, heel counter, or vamp of an item of footwear.

The attachment portion may be configured to be at least partially embedded in a plane parallel to a sole of the item of footwear, preferably below the insole of the item of footwear. For example, the attachment portion may be at least partially embedded in the at least one of the midsole, outsole, and heel. This may be advantageous to transfer load between the orthosis and the item of footwear below the user’s foot in order to reduce loading through the user’s foot in use, thus providing support to the user. This may also be advantageous to utilize the shock-absorption properties of the sole of the item of footwear to reduce the impact of loading whilst in use, such as during walking.

The footwear adapter may be configured to be permanently embedded within an item of footwear, for example wherein the footwear adapter is secured to the item of footwear by adhesive, bonding, or any other suitable fastening means. The footwear adapter may be configured to be retrofitted into an item of footwear. Alternatively, the footwear adapter may be integrated into the item of footwear during manufacture of the footwear.

The attachment portion may comprise an engagement portion configured to detachably engage with a corresponding engagement portion of the orthosis. For example, the engagement portion of the footwear adapter may be substantially semi-circular such that the engagement portion is configured to substantially align with an external surface of a heel of the item of footwear. In some examples, the substantially semi-circular engagement portion comprises a semi-circular slot. In other examples, the substantially semi-circular engagement portion may comprise a semi-circular flange.

The attachment portion may, additionally or instead, comprise an interlocking structure, wherein the interlocking structure is configured to interlock with a corresponding interlocking structure of the orthosis in an engaged configuration and disengage with the corresponding interlocking structure of the orthosis in a released configuration. This may be advantageous to reversibly secure the footwear adapter to the orthosis in order to prevent uncontrolled disengagement between the orthosis and item of footwear.

In some examples, the interlocking structure comprises a receiving slot configured to detachably engage with an engagement protrusion of the orthosis.

Alternatively, or in addition, the footwear adapter attachment portion may comprise at least one magnet configured to magnetically engage with at least a portion of an orthosis.

The footwear adapter may additionally comprise a load bearing insole, such as a carbon fibre insole. The load bearing insole may be configured to be arranged within the item of footwear. The attachment portion of the footwear adapter may be configured to couple to the load bearing insole. For example, the attachment portion of the footwear adapter may be configured to be mechanically secured to the load bearing insole through the sole and/or heel of the item of footwear.

In another aspect, there is provided, an item of footwear for attachment to an orthosis, the footwear comprising the footwear adapter as described above, wherein the footwear adapter is at least partially embedded into the item of footwear.

The footwear adapter may be configured to be permanently embedded within an item of footwear, for example wherein the footwear adapter is secured to the item of footwear by adhesive, bonding, or any other suitable fastening means. The footwear adapter may be configured to be retrofitted into the item of footwear. Alternatively, the footwear adapter may be integrated into the item of footwear during manufacture of the footwear.

In some embodiments, the item of footwear comprises a heel, wherein the attachment portion of the footwear adapter is at least partially embedded into the heel of the footwear. However, the skilled person will understand that the attachment portion may be at least partially embedded into any other external surface of an item of footwear, including but not limited to, the midsole, outsole, heel counter, or vamp.

The attachment portion may be configured to be at least partially embedded in a plane parallel to a sole of the item of footwear, preferably below the insole of the item of footwear. For example, the attachment portion may be at least partially embedded in the at least one of the midsole, outsole, and heel.

The item of footwear may additionally comprise a load bearing insole, such as a carbon fibre insole. The load bearing insole may be configured to be arranged within the item of footwear. The attachment portion of the footwear adapter may be configured to couple to the load bearing insole. For example, the attachment portion of the footwear adapter may be configured to be mechanically secured to the load bearing insole through the sole and/or heel of the item of footwear.

Preferably, the item of footwear may be a shoe, such as but not limited to a boot.

In another aspect there is provided a kit comprising the orthosis as described in relation to the first aspect of the invention, and the footwear adapter as described in relation to the second aspect of the invention. In such examples, the leg portion of the orthosis is configured to detachably engage with the footwear adapter. In some examples, the kit may comprise an item of footwear wherein the footwear adapter is at least partially embedded into the item of footwear, such as that described in relation to the third aspect of the invention.

In some examples, the kit may further comprise a load bearing insole, such as a carbon fibre insole.

Drawings

Embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

Fig. 1 shows an example ankle support, for example for use as or part of an orthosis, the ankle support coupled to a footwear adapter for a shoe.

Fig. 2A shows an example coupling mechanism for a footwear adapter and an example ankle support in an uncoupled configuration, such as the footwear adapter and ankle support of Fig. 1.

Fig. 2B shows an alternative view of the footwear adapter and ankle support of Fig. 2A, also in the uncoupled configuration.

Fig. 2C shows the coupling mechanism of the footwear adapter and ankle support of Figs. 2A and 2B whilst being coupled together.

Fig. 2D shows a cross section view of the footwear adapter and ankle support coupling mechanism of Figs. 2A to 2C in an engaged configuration.

Fig. 3A shows an example footwear adapter, such as the footwear adapter of Fig. 1 , installed in a shoe, wherein the example footwear adapter of Fig. 3A comprises an alternative coupling mechanism to that shown in Figs. 2A to 2D.

Fig. 3B shows the footwear adapter and shoe of Fig. 3A coupled to an ankle support, such as the ankle support of Fig. 1 .

Fig. 4A shows a front view of an example exoskeleton on a human user, wherein the exoskeleton is coupled to an item of the user’s footwear.

Fig. 4B shows a side view of the example exoskeleton of Fig. 4A on a human user.

Fig. 4C shows a back view of the example exoskeleton of Figs. 4A-4B on a human user.

Fig. 5A shows a perspective view of an example footwear adapter, such as the footwear adapter of Figs. 1 and 2, installed in a shoe, coupled to an example ankle support.

Fig. 5B shows a cross section view of the coupling mechanism between the footwear adapter installed in the shoe and ankle support of Fig. 5A in an engaged configuration.

Fig. 5C shows a cross section view of the footwear adapter of Fig. 5A installed in the shoe, comprising a carbon fibre insole.

Fig. 5D shows a perspective view of the carbon fibre insole installed into the shoe of Fig. 5C.

Fig. 6A shows a side view of an example footwear adapter, such as the footwear adapter of Figs. 1 and 2, installed in a boot, coupled to an example support.

Fig. 6B shows a perspective view of the example footwear adapter and boot of Fig. 6A in an uncoupled configuration with the example support of Fig. 6A.

Fig. 6C shows a rear view of the example footwear adapter and boot of Figs. 6A and 6B in a coupled configuration with the example support of Figs. 6A and 6B.

Fig. 6D shows a perspective view of the example footwear adapter and boot of Figs. 6A to 6C in a coupled configuration with the example support of Figs. 6A to 6C.

Fig. 6E shows a cross section view of the coupling mechanism between the footwear adapter installed in the boot and the support of Figs. 6A to 6D in an engaged configuration.

Fig. 6F shows another cross section view of the footwear adapter installed in the boot of Figs. 6A to 6E, comprising a carbon fibre insole installed in the boot.

Embodiments of the claims relate to a footwear adapter and orthosis for attaching to footwear, in particular an orthosis configured to detachably couple to footwear via the footwear adapter. It will be appreciated from the discussion above that the embodiments shown in the Figures are merely exemplary, and include features which may be generalised, removed or replaced as described herein and as set out in the claims.

Fig. 1 shows an example ankle support 114 and footwear adapter 120.

The ankle support 114 comprises a pair of side members 604, configured to be positioned either side of the ankle of a user in use. In the example shown in Fig. 1 , the side members 604 are substantially vertical. The pair of side members 604 are coupled at the distal end by a substantially horizontal member 610. The horizontal member 610 is curved such that it is configured to fit around the back of the heel of a user’s item of footwear, for example the user’s heel of a user’s shoe as shown in more detail in Fig. 3B.

The distal end of the ankle support 114, comprising the horizontal member 610, is coupled to the footwear adapter 120.

In the example shown in Fig. 1 , the proximal end of each side member 604 is coupled to a lower leg support 112, such as a brace or orthosis. The coupling is to the lower leg support 112 is by a pivot 608. The pivot 608 is configured to allow movement of the foot and shoe, or other item of footwear, relative to the lower leg support 112. This may be advantageous to facilitate ankle mobility and flexibility relative to the lower leg support 112 The proximal end of each side member 604 is slightly curved in the anterior direction such that the pivot 608 sits forwards of the footwear adapter 120.

The ankle support 114 is preferably made of metal, such as aluminium. Optionally, the metal is anodised, such as anodised aluminium. However, the skilled person will understand that other materials may be used. In some examples, the ankle support 114 is manufactured via 3D printing. However, the skilled person will understand that other methods of manufacture can be used.

The horizontal member 610 at the distal end of the ankle support 114 comprises a rail 606.

The footwear adapter 120 comprises a plate 600. The plate 600 has a substantially semicircular or semi-ellipse shape. A slot 602 is arranged around the curved perimeter of the plate 600. In this example, the plate 600 is metal, however the skilled person will understand that other types of materials may be used. The plate 600 may be manufactured by way of 3D printing, however the skilled person will understand that other methods of manufacture may be used.

The rail 606 of the ankle support 114 is configured to fit within the slot 602 of the footwear adapter 120. As such, the curved edge of the plate 600 is configured to be concentric with the curved horizontal member 610 of the ankle support 114. Each end of the rail 606 may also be tapered (not shown). The tapered ends may advantageously guide the rail 606 into the slot 602 to facilitate ease of coupling between the rail 606 and slot 602.

The ankle support 114 may also comprise a reversible coupling mechanism (not shown), wherein the coupling mechanism is configured to reversibly secure the footwear adapter 120 to the ankle support 114, for example by reversibly securing the rail 606 within the slot 602 of the footwear adapter 120. Two example reversible coupling mechanisms are shown in more detail in Figs. 2A to 2D and Fig. 3A, respectively.

The plate 600 is sized to be at least partially embedded in the sole of a user’s shoe, wherein at least a portion of the slot 602 is arranged along an external surface of the shoe. An example footwear adapter 120 installed in a heel of a shoe is shown in more detail in Fig. 3A.

Figs. 2A and 2B show an example coupling mechanism for a footwear adapter and an example ankle support, such as the footwear adapter and ankle support of Fig. 1 , in an uncoupled configuration. In this example, the coupling mechanism is a clip, wherein the footwear adapter and an ankle support are configured to clip together by an interlocking structure.

The footwear adapter 120 comprises a receiving portion 202 configured to receive a corresponding engagement portion 204 of the ankle support 114. An internal surface of the receiving portion 202 comprises an interlocking protrusion 206 to provide an interlocking structure, wherein the protrusion 206 is configured to interlock with the engagement portion 204 of the ankle support 114. As shown in Fig. 2B, in this example the footwear adapter interlocking protrusion 206 is arranged on the internal upper surface of the receiving portion 204. The interlocking protrusion 206 comprises a ledge on the furthest side from the mouth of the receiving portion 204 and a tapered profile towards the mouth of the receiving portion 202.

The corresponding engagement portion 204 of the ankle support 114 extends inwardly from the curved horizontal member 610, to form an engagement protrusion. The engagement portion 204 comprises a fixed base 208 coupled to a lever member 210 at a proximal end. In this example, the fixed base 208 and lever member 210 are formed from a single piece of resilient material, such as a resilient metal. The fixed base 208 is coupled to the rail 606, as shown in Fig. 2C.

The lever member 210 also comprises an aperture 212. The aperture is arranged such that the aperture is configured to engage with the interlocking protrusion 206 of the footwear adapter 120 in the engaged configuration.

The curved horizontal member 610 further comprises an aperture 612 configured to receive the distal end of the lever member 210 which extends through the aperture 612. The height of the aperture 612 is greater than the thickness of the lever member 210 such that the aperture 612 is configured to permit a range of vertical movement of the lever member 210 within the aperture 612. The portion of the lever member 210 which protrudes from the posterior external surface of the curved horizontal member 610 forms an actuator portion 214.

In use, the engagement portion 204 is inserted into the receiving slot 202, as shown in Fig. 2C, such that the ledge of the interlocking protrusion 206 of the receiving portion 202 is engaged with the aperture 212 of the engagement portion 204. A cross section of the engaged configuration is shown in Fig. 2D. The lever member 210 is biased into the engaged configuration as a result of its resilient material properties.

To disengage, the actuator portion 214 is depressed such that the aperture 212 of the engagement portion 204 is disengaged from the interlocking protrusion 206. The engagement portion 204 may then be removed from the receiving portion 202 of the footwear adapter 120 to uncouple the footwear adapter 120 and ankle support 114.

Figs. 5A and 5B show an example footwear adapter 120, such as the footwear adapter of Figs. 1 and 2, installed in a shoe 900, coupled to an example ankle support 114. The shoe 900 comprises a sole 708 arranged along the bottom surface, opposite to the vamp 706 of the shoe. The back portion of the sole 708 comprises the heel 702, arranged adjacent to the heel counter 704 at the rear of the shoe 700.

The footwear adapter 120 is installed into the heel 702 of a shoe 900. In the example shown, the receiving slot 202 of the footwear adapter 120 is configured to align with the posterior surface of the heel portion 702 of the shoe 900, adjacent to the heel counter 704.

In the example shown in Fig. 5A, the ankle support 114 is similar to that shown in Figs. 1 and 2. The ankle support 114 of Figs. 5A to 5C comprises a pair of side members 604, curved in the anterior direction such that the pivot 608 sits forwards of the footwear adapter 120 and is configured to be positioned anterior of the ankle of a user in use. The pair of side members 604 are coupled at the distal end by a substantially horizontal member 610. The horizontal member 610 is curved such that it is configured to fit around the back of the heel 708 of a user’s shoe 900.

In this example, the distal end of the lever member 210 of the protrusion portion 204 extends over the back of the curved horizontal member 610.

The distal end of the lever member 210 is arranged such that it is configured to permit a range of vertical movement of the lever member 210 relative to the curved horizontal member 610. The distal portion of the lever member 210 which protrudes above the posterior external surface of the curved horizontal member 610 forms an actuator portion 214.

In use, the engagement portion 204 is inserted into the receiving slot 202, as shown in Fig. 5B, such that the ledge of the interlocking protrusion 206 of the receiving portion 202 is engaged with the aperture 212 of the engagement portion 204. The lever member 210 is biased into the engaged configuration as a result of its resilient material properties.

As shown in Fig. 5C, the shoe 900 further comprises a carbon fibre shoe insole 1000. The insole 1000 may be secured to the heel insert 120 through the sole of the shoe 708, for example via a plurality of screws 110 or other mechanical fastenings. The screws 110 may be recessed within the carbon fibre insole 1000 to avoid the screw heads causing discomfort to the foot of the user in use. The carbon fibre insole 1000 advantageously improve the load-bearing performance of the item of footwear, for example to prevent or reduce buckling of the sole of the footwear under loading. The carbon fiber shoe insole 1000 is preferably flexible to allow the user to maintain flexibility of their foot during use. This may improve balance, control of ambulation, and mobility as the user is able to flex their foot and the insole and accommodate to uneven ground by proprioceptive input, unlike when the foot is interfaced with a rigid plate.

The shoe 900 may also comprise a second insole 1020, wherein the second insole 1020 is arranged over the carbon fibre insole 1000 such that, in use, the second insole 1020 may be arranged between the carbon fibre insole 1000 and the user’s foot. The second insole 1020 may advantageously provide cushioning to enhance the comfort of the user when wearing the shoe 900. The second insole 1020 has been omitted in Fig. 5D to show the carbon fibre insole 1000.

Fig. 3A shows an alternative example coupling mechanism for a footwear adapter 120. As before, the plate 600 has a substantially semi-circular or semi-ellipse shape with a slot 602 arranged around the curved perimeter of the plate 600. In this example, at least a portion of the slot 602 is magnetic, preferably comprising a plurality of magnets 620 as shown in Fig. 3A. The magnets 620 are preferably arranged such that their polarity is in an alternating pattern around the slot 602.

In this example, the plate 600 is metal, comprising a plurality of neodymium magnets 620, however the skilled person will understand that other types of magnets may be used. The plate 600 may be manufactured by way of 3D printing, however the skilled person will understand that other methods of manufacture may be used. In such examples, the rail 606 of the horizontal member 610 at the distal end of the ankle support 114 may be configured to be magnetic. For example, the rail 606 may be metal, comprising a plurality of neodymium magnets, however the skilled person will understand that other types of magnets may be used, or alternatively the rail 606 may be made from a magnetic material.

The rail 606 comprises magnets arranged such that their polarity is in an alternating pattern around the horizontal member 610, wherein the alternating pattern is opposite to that of the magnets 620 of the slot 602.

In use, the footwear adapter 120, and corresponding shoe, is offered up to the ankle support 114 such that the curved edge of the plate 600 is configured to be concentric with the curved horizontal member 610 of the ankle support 114. The polarity of the alternating magnets of the slot 602 and rail 606 therefore align and magnetically attract to each other, thus holding the footwear to the orthosis in the correct position.

The footwear adapter 120 and corresponding shoe 700, are configured to detach from the ankle support 114 by rotating in the plane of the sole 708 of the shoe so that the alignment of the magnets is changed such that they now oppose each other, and the footwear adapter 120 is repelled from the ankle support 114 and released.

Fig. 3A also illustrates an example item of footwear, in this case a shoe 700, comprising a footwear adapter portion 120. The shoe 700 comprises a sole 708 arranged along the bottom surface, opposite to the vamp 706 of the shoe. The back portion of the sole 708 comprises the heel 702, arranged adjacent to the heel counter 704 at the rear of the shoe 700.

The plate 600 is embedded within the heel 702 such that the slot 602 is accessible by an external surface of the shoe 700. The slot 602 is arranged around the heel 702 of the shoe, proximate to the heel counter 704. The plate 600 is configured such that it does not substantially protrude beyond the profile of the heel 702 of the shoe 700.

The footwear adapter portion 120 may be retrofitted into the heel 702 of the shoe 700, or a shoe may be manufactured comprising the plate 600 embedded within the heel 702.

Fig. 3B shows the shoe 700 comprising the footwear adapter 120 in magnetic engagement with the ankle support 114. The pair of side members 604 are positioned opposite sides the shoe 700, close to the heel counter 704. The horizontal member 610 is arranged around the back of the heel 702 of the shoe 700. The pivot 608 sits forwards of the magnetic shoe engagement portion 120 and heel counter 704 of the shoe 700.

The ankle support 114 is configured to receive the vertical load from the leg support 112. The footwear adapter 120 is configured to take the vertical load from the ankle support 114 and transfers the vertical load into the sole 708 of the shoe 700, which ultimately transfers the vertical load to the ground.

The ankle support 114 is also configured to create a suspension shock absorbing joint, using the sole 708 of the shoe 700 to provide a ‘spring’. Optionally, a flexible carbon fibre insole may also be inserted into the shoe 700 (not shown). The carbon fibre insole may also be used in conjunction with the sole 708 to create the suspension shock absorbing joint.

Whilst the magnetic coupling mechanism of Fig. 3A is described herein as an alternative to the clip mechanism of Figs. 2A to 2D, the skilled person will understand that in other embodiments an orthosis and corresponding footwear adapter may be configured to couple together using a combination of interlocking structures, such as a clip, and magnetic coupling means.

Figs. 4A to 4C show an example orthosis for attaching to footwear, wherein the orthosis is an exoskeleton 100 as worn by a human user H. The exoskeleton 100 comprises a torso support 102 and a leg support 106, coupled via a hip joint 104.

The torso support 102 comprises a back brace that at least partially encloses the upper and mid-section of the torso. In this example, the back brace comprises a substantially carbon fibre structure. The torso support 102 further comprises a pair of underarm supports 118, arranged on opposite lateral sides of the torso support. Each underarm support 118 comprises a deformable moulding, for example a silicon moulding. The deformable mouldings may be advantages to protect the axillary nerve of the user H in use.

The torso support 102 may additionally comprise at least one ratchet strap (not shown). Preferably, each ratchet strap comprises a magnetic attachment means. This may be advantageous to secure the torso support to the torso of the user H and prevent the torso support H collapsing forward.

Optionally, the torso support 102 may further comprise a hip shield 116. The hip shield 116 comprises a rigid part arranged on the opposite side (or contralateral side) of the exoskeleton 100 to the hip joint 104. The hip shield 116 is partially arranged in a parasagittal plane of the human body, at the height of the hip of the user H. In this example, the hip shield 116 is integral to the torso support 102, however in other examples the hip shield 116 may be detachable.

The torso support 102 also comprises a hinge (not shown) on the posterior surface of the torso support 102, adjacent to the back of the user H. The hinge is arranged parallel to the craniocaudal axis of the user H, preferably in the sagittal plane. In this example, the hinge portion comprises Kevlar and flexible epoxy to permit bending of the hinge portion whilst maintaining shear loading between the carbon fibre segments of the torso support 102 on either side of the hinge.

The hip joint 104 is arranged on the ipsilateral side of the exoskeleton as the leg support 106.

The leg support 106 further comprises an upper leg brace or orthosis 108 and a lower leg brace or orthosis 112. The upper leg orthosis 108 and the lower leg orthosis 112 are coupled together by a knee joint 110. The upper leg orthosis 108 and the lower leg orthosis 112 each comprise at least one ratchet strap (not shown). Preferably, each ratchet strap comprises a magnetic attachment means.

The upper leg orthosis 108 and lower leg orthosis 112 each comprise a pair of carbon fibre supports. Each carbon fibre support of the pair is arranged in a parasagittal plane, on opposite sides of the leg. Both the upper leg orthosis 108 and lower leg orthosis 112 further comprise carbon fibre cross bracing between the pair of carbon fibre supports.

An ankle support 114 is coupled to the distal end of the lower leg orthosis 112. An example ankle support 114 is shown in more detail in Fig. 6.

As shown in Figs. 4B-4C, the exoskeleton 100 optionally further comprises a buttock support portion 122. The buttock support portion 122 comprises a curved plate configured to encompasses the lower and mid buttock of the user H from the midpoint of the back at the gluteal sulcus to the upper front of the thigh at the top of the rectus femoris muscle with the lower edge following the line of the gluteal sulcus. In this example, the buttock support portion is made from carbon fibre.

The torso support 102 is configured to enclose at least a portion of a user H’s torso and capture the vertical load of the user H’s upper body. In particular, the pair of underarm supports 118 are configured to capture the vertical load of the user H’s upper body. The hinge portion of the torso support 102 is configured to provide a clam shell for easy donning of the exoskeleton 100.

The buttock support portion 122 is also configured to capture vertical load, in particular vertical load from the mid body. This may reduce, and in some examples eliminate, load capture at the base of the axilla of the user H (under the armpits) which can be uncomfortable and damaging to the axillary nerve of the user.

Both the torso support 102 and buttock support portion 122 are configured to transfer the captured vertical load to the hip joint 104.

The upper leg orthosis 108 is configured to at least partially encompass the thigh of user H. The upper leg orthosis 108 is also configured to transfer the load from the hip joint 104 to the knee joint 110.

The knee joint 110 is configured to rotate such that the upper leg orthosis 108 is moveable relative to the lower leg orthosis 112. The knee joint 110 is also configured to transfer the load from the upper leg orthosis 108 to the lower leg orthosis 112.

The lower leg orthosis 112 is configured to at least partially encompass the calf of user H. The lower leg orthosis 112 is also configured to transfer the load from the knee joint 110 to the ankle support 114.

The ankle support 114 is configured to attach to an item of footwear via a footwear adaptor (not shown). In Figs. 4A to 4B, the item of footwear is a boot 800. The ankle support 114 may detachably engage to the item of footwear via a footwear adapter in any suitable way, including but not limited to as described in relation to any of Figs. 1 to 3B. As shown in Figs. 4A to 4B, the ankle support 114 is coupled to a posterior external surface of the boot 800, for example at or proximate to the heel of the boot 800.

The torso support 102, the leg support 106 and, optionally, the buttock support portion 122 are configured to rotate about a common axis of the hip joint 104. The degrees of rotation are constrained independently of each other allowing specific degrees of rotation of (i) the torso support 102 relative to the hip joint 104, (ii) the buttock support portion 122 to the hip joint 104, and (iii) the upper leg support 108 to the hip joint 104.

The rachet straps are configured to adjust and fasten the respective portion around the user’s anatomy.

The optional hip shield 116 is configured to encompass the hip and a portion of the upper thigh on one side of the user H’s body. The hip shield 116 is configured to inhibit outward lateral movement of the hip relative to the torso support 102. This may be by advantageous to reduce hip swing during ambulation.

In use, the torso support 102 and buttock support portion 122 capture the vertical load of the user H’s upper and mid body and transfer the load to the hip joint 104.

The hip joint 104 transfers the total load to the leg support 106, from the upper leg orthosis 108, via the knee joint 110, to the lower leg orthosis 112. The example shown in Figs. 4A-4C comprises a single hip joint 104 and a single leg support 106, wherein the hip joint 104 is arranged on the ipsilateral side of the exoskeleton 100 as the leg support 106. However, the skilled person will understand, that other example exoskeletons may provide two leg supports 106 and two hip joints 104, wherein each leg support is coupled to a respective hip joint. Such a configuration may be particularly advantageous for use by individuals with double lower limb amputations, or patients who are unable to have a bilateral hip replacement, for example due to age. In examples comprising two hip joints 104, the second hip joint may replace the hip shield 116, or each hip joint may instead be coupled to or integrated within a hip shield, for example wherein the hip shield is in the same parasagittal plane as the respective hip joint.

The embodiments shown in Figs. 4A to 4C relate to an exoskeleton, however the skilled person will understand that any other orthosis for providing support to a human user may be used.

For example, in another embodiment, the orthosis may comprise a load-bearing ankle brace or orthosis for attaching to footwear coupled to a lower leg brace or orthosis, such as lower leg orthosis 112, configured to enclose at least a portion of the user’s lower leg. The orthosis may be made at least partially of carbon fibre, for example comprising rigid carbon fibre portions secured with a ratchet strap that wraps around the lower leg. The lower leg orthosis may be configured to provide a clam shell for ease of donning, including a flexible hinge portion. The flexible hinge portion may comprise a flexible material capable of shear loading, such as Kevlar with flexible epoxy.

The hinge portion may be arranged parallel to the longitudinal axis of the lower leg brace, for example wherein the hinge portion is arranged along the outer side of the lower leg brace. This may be advantageous to improve conformity of the lower leg orthosis to the user’s shin.

An ankle joint, such as the ankle joint 608 in as shown in Fig. 1 , is coupled to either side of the lower leg brace, configured to be arranged on opposite sides of the user’s ankle in use. This may be advantageous to allow movement and flexibility of the ankle of the user in use, in particular allowing for a normal human range of movement in the ankle of the user, for example advantageously allowing the ankle to be bent whilst seated and standing, and during walking. The ankle joint may further comprise a suspension shock absorbing joint. This may be advantageous to reduce the impact of loading, for example whilst in use, such as during walking. The ankle support comprises a footwear engagement portion configured to engage with an item of footwear via a footwear adaptor, such as the footwear adaptor shown in any of Fig. 1 to 3B. The ankle joint 608 may be arranged above footwear engagement portion, for example proximate to the vamp of the shoe. By capturing at least a portion of the vertical force from walking and transferring it to the user’s shoe via the shoe engagement portion, bypassing the user’s own ankle, such a load-bearing ankle brace or orthosis could be used in the treatment of weak, injured, or arthritic joints in the ankle or foot.

Preferably, an ankle joint, such as the ankle joint 608 in as shown in Figs. 5A to 5C, is coupled to either side of the lower leg brace, configured to be arranged anterior to the user’s ankle in use. For example, the ankle joint 608 may be configured to be positioned in between anterior to the user’s ankle and posterior to the user’s toes in use. This may be advantageous to provide a turning moment, caused by the ankle joint 608 being anterior to the anatomical ankle joint of the user, which is transferred to the carbon fibre insole or footplate 1000. The carbon fibre insole 1000 is configured to store energy in the walking phase under load which is returned as energy to the user later in the walking phase.

In another example embodiment and use case the orthosis may consist of a load-bearing ankle brace or orthosis for attaching to footwear.

In any of the examples and embodiments discussed herein, a carbon fibre shoe insole may additionally be inserted into the item of footwear to improve the load-bearing performance of the item of footwear, for example to prevent or reduce buckling of the sole of the footwear under loading. For example, a carbon fibre insole is shown inside the item of footwear in Figs. 5B to 5D, and 6E to 6F. A carbon fiber shoe insole may be advantageous to reduce or prevent buckling of the shoe under loading. The carbon fiber shoe insole is preferably flexible to allow the user to maintain flexibility of their foot during use. This may improve balance, control of ambulation, and mobility as the user is able to flex their foot and the insole and accommodate to uneven ground by proprioceptive input, unlike when the foot is interfaced with a rigid plate.

Figs. 6A to 6F show an example footwear adapter 120, such as the footwear adapter of Figs. 1 and 2, installed in a boot 1100, and coupled to an orthotic leg support 1200. Whilst a boot 1100 is shown in Figs. 6A to 6F, the skilled person will understand that any other item of footwear may be used, for example such as a shoe.

The footwear adapter 120 is installed into the outsole heel 702 of a boot 1100. In the example shown, the receiving slot 202 of the footwear adapter 120 is configured to align with the posterior surface of the heel portion 702 of the boot 1100, adjacent to the heel counter 704. As shown in Fig. 6B, the footwear adapter 120 does not substantially protrude from the profile of the heel portion 702 of the boot 1100.

The distal end of the orthotic leg support 1200 which is configured to be arranged at the inferior end of the orthotic leg support 1200 in use, comprises a pair of side members 1204 coupled by a curved rear portion 1205. The curved rear portion 1205 is curved such that it is configured to fit around the back of the heel 702 of the boot 1100. The distal end of the orthotic leg support 1200 is configured to reversibly couple to the footwear adapter 120 in use. In particular, the rear portion 1205 of the orthotic leg support 1200 is configured to be arranged adjacent to the rear portion of the boot 1100 in use, including at least a portion of the heel counter 704.

As shown in Fig. 6B, the orthotic leg support 1200 comprises an engagement portion 204 which extends inwardly from the rear portion 1205. The engagement portion 204 comprises a fixed base 208 coupled to a lever member 210 at a proximal end, such as the engagement portion 204 shown in Figs. 2A to 2D. In this example, the fixed base 208 and lever member 210 are formed from a single piece of resilient material, such as a resilient metal.

The lever member 210 also comprises an aperture 212. The aperture 212 is arranged such that the aperture 212 is configured to engage with the interlocking protrusion 206 of the footwear adapter 120 in the engaged configuration. The lever member 210 is additionally coupled to an actuator portion 1202. The actuator portion 1202 is configured to depress the lever member 210 relative to the fixed base 208. In use, depression of the lever member 210 relative to the fixed base 208 via the actuator portion 1202 is configured to release the engagement portion 204 from engagement with the interlocking protrusion 206 in order to uncouple the orthotic leg support 1200 from the footwear adapter 120.

The pair of side members 1204 of the orthotic leg support 1200 each comprise a rail portion 1210. Each rail portion 1210 of the orthotic leg support 1200 is configured to fit within the slot 602 of the footwear adapter 120. Each rail portion 1210 also comprises a flange 1212, wherein the flange 1212 is configured to retain the rail portion 1210 within the slot 602 of the footwear adapter 120 in use.

The orthotic leg support 1200 further comprises a pair of substantially vertical supports 1206, such as carbon fibre rods, which are configured to extend from the rear portion 1205 in the superior direction in use. The vertical supports 1206 are configured to be load bearing and may transfer load from the knee, hip, or upper body of the user to the footwear adapter 120. In use, the vertical supports 1206 are configured to be arranged posterior to the calf of the user. The footwear adapter 120 is then configured to transfer the load to the carbon fibre insole 1000 and sole 708 of the boot 1100. This may be advantageous to reduce loading onto the ankle or feet of the user. This may be advantageous for users which are required to spend large amounts of time standing or walking, for example such as military personnel, or for users in recovery from injury, or otherwise. The orthosis 1200 may be detached and reattached to the boot 1100 as desired by the user, thereby providing support when needed, however allowing the item of footwear, in this case the boot 1100, to otherwise function as a regular item of footwear when detached from the orthotic leg support 1200, or other orthoses.

Whilst the embodiments described above relate to orthoses, the skilled person will also understand that the present invention may also be applied to prosthetics for providing support to a human user may be used, in particular for lower limb prosthetics. For example, a prosthetic lower limb may comprise an attachment portion configured for attachment to an item of footwear, for example via the footwear adapter disclosed herein. For example, purely for illustrative purposes, the distal end of a lower limb prosthesis may comprise any of the example coupling mechanisms discussed for the ankle support 114 in relation to Figs. 1 to 3B. It is common practice for the foot portion of a lower limb prosthetic to simply be inserted into normal footwear without any additional securing provisions. However, the prosthetic foot portion can easily move and slip within the footwear. This movement can result in catching the toe or the heel of the footwear, resulting in a stumble or potentially resultant fall. Attaching a prosthesis to an item of footwear, for example via a footwear adapter, may be advantageous to reduce or eliminate relative movement and slippage between the prosthetic limb and the item of footwear. This may in turn reduce the risk of falling which is a common issue for prosthetic leg wearers with potentially severe implications.

The skilled person will also understand that the present invention should not be restricted to medical use or injury rehabilitation. Rather orthoses, including the orthotic leg supports described above, or other suitable orthoses or exoskeletons, may also advantageously attach and detach to an item of the user’s footwear in accordance with the present invention to provide performance enhancing capabilities. For example, attaching an orthosis or exoskeleton to an item of the user’s footwear may be used to increase the duration that the user can stand, walk, or run, and/or reduce fatigue compared to activity without attachment of the orthosis. Attachment of an orthosis to an item of footwear may also reduce oxygen consumption of the user during activity compared to activity without attachment of the orthosis. This may be achieved by reduced loading on the user, facilitated by direct load transfer between the orthosis and the item of footwear. ln the context of the present disclosure other examples and variations of the apparatus and methods described herein will be apparent to a person of skill in the art.

Claims

CLAIMS:

1. A footwear adapter for attachment to an orthosis, comprising: an attachment portion, wherein the attachment portion is configured to be at least partially embedded into an external surface of an item of footwear such that the footwear adapter does not substantially protrude beyond the external surface of the item of footwear, and wherein the attachment portion is configured to detachably engage with an orthosis for a human user.

2. The footwear adapter of claim 1 wherein the attachment portion is configured to be at least partially embedded into an external surface of an item of footwear such that the footwear adapter is substantially aligned with the external surface of the item of footwear.

3. The footwear adapter of any preceding claim wherein the attachment portion is configured to be at least partially embedded into an external surface of a heel of the item of footwear.

4. The footwear adapter of claim 3 wherein the attachment portion is configured to be at least partially embedded into the external surface of the heel of the item of footwear such that the attachment portion does not substantially protrude beyond the profile of the heel.

5. The footwear adapter of any preceding claim wherein the attachment portion is configured to be at least partially embedded in a plane parallel to a sole of the item of footwear, preferably below an insole of the item of footwear.

6. The footwear adapter of any preceding claim wherein the attachment portion comprises an engagement portion configured to detachably engage with a corresponding engagement portion of the orthosis.

7. The footwear adapter of claim 6 wherein the engagement portion of the footwear adapter is substantially semi-circular such that the engagement portion is configured to substantially align with an external surface of the item of footwear.

8. The footwear adapter of any preceding claim wherein the attachment portion comprises an interlocking structure, wherein the interlocking structure is configured to interlock with a corresponding interlocking structure of the orthosis in an engaged configuration and disengage with the corresponding interlocking structure of the orthosis in a released configuration.

9. The footwear adapter of claim 8 wherein the interlocking structure comprises a receiving portion configured to detachably engage with an engagement protrusion of the orthosis.

10. The footwear adapter of any preceding claim wherein the attachment portion comprises at least one magnet configured to magnetically engage with at least a portion of the orthosis.

11. An item of footwear for attachment to an orthosis, the footwear comprising the footwear adapter of any of any preceding claim, wherein the footwear adapter is at least partially embedded into the item of footwear.

12. The item of footwear of claim 11 wherein the footwear adapter does not substantially extend beyond the profile of the item of footwear.

13. The item of footwear of claims 11 or 12 wherein the footwear comprises a heel, wherein the attachment portion is at least partially embedded into the heel of the footwear.

14. The item of footwear of claim 13 wherein the footwear adapter does not substantially protrude beyond the profile of the heel of the footwear.

15. The item of footwear of any of claims 11 to 14 wherein the footwear adapter is configured to be retrofitted into the item of footwear.

16. The item of footwear of any of claims 11 to 15 wherein the footwear is a boot.

17. An orthosis for providing support to a human user, the orthosis comprising a leg support; wherein the leg support comprises an attachment portion configured to detachably engage with the footwear adapter of any claims 1 to 10.

18. An orthosis for providing support to a human user, the orthosis comprising a leg support; wherein the leg support comprises an attachment portion configured to detachably engage with at least a portion of a heel of an item of footwear configured to be worn by the user.

19. The orthosis of claim 18 wherein the attachment portion comprises a rail engagement portion configured to detachably engage with a corresponding slot in the heel of the item of footwear.

20. The orthosis of claims 18 or 19 wherein the attachment portion comprises a substantially semi-circular engagement portion configured to detachably engage with a corresponding substantially semi-circular engagement portion in the heel of the item of footwear.

21. The orthosis of any claims 18 to 20 wherein the attachment portion comprises an interlocking structure, the interlocking structure being configured to (i) interlock with a corresponding interlocking structure in the heel of the item of footwear in an engaged configuration, and (ii) disengage with the corresponding interlocking structure in the heel of the item of footwear in a released configuration.

22. The orthosis of claim 21 wherein the interlocking structure comprises an engagement protrusion configured to reversibly interlock with a receiving portion in the heel of the item of footwear worn by the user.

23. The orthosis of claim 22 wherein the engagement protrusion is biased into the engaged configuration.

24. The orthosis of claim 22 or 23 wherein the engagement protrusion comprises a resiliently deformable material.

25. The orthosis of any of claims 21 to 24 wherein the interlocking structure comprises a clip.

26. The orthosis of any of claims 21 to 25 further comprising an actuator portion arranged on an external surface of the orthosis, wherein the actuator portion is configured to transition the interlocking structure from the engaged configuration into the released configuration.

27. The orthosis of any of claims 17 to 26 wherein the leg support comprises an ankle support.

28. The orthosis of claim 27 wherein the leg support is configured to transfer weight from the ankle support to the knee of the human user.

29. The orthosis of any of claims 17 to 28 further comprising a torso portion, the torso portion and the leg portion being coupled via a joint.

30. The orthosis of any of claims 18 to 29 wherein the leg portion is configured to detachably engage with the item of footwear via at least one magnet.

31. The orthosis of any of claims 18 to 30 wherein the attachment portion is configured to detach from the item of footwear via rotation of the footwear in the plane of the sole of the footwear.

32. A kit comprising: the orthosis of claims 18 to 31 ; and a footwear adapter of claims 1 to 10, wherein the leg portion of the orthosis is configured to detachably engage with the footwear adapter.