Orthotic foot brace

Abstract

The present invention relates to an ankle-foot orthosis (10) for supporting a foot suffering from a drop foot due to peripheral and central neuronal indications, muscular diseases and traumatic injuries that damage the brain or the nerve pathway from the brain to the muscles of the lower leg, the ankle-foot orthosis comprising: - a lower leg assembly configured to be attached to a lower leg between an ankle and a knee, - a bracket configured to generate a biasing force on a foot assembly, - a foot assembly which is connected to a lower end of the bracket, the foot assembly being configured to be connected to a shoe, to a fastener device configured to be connected to a shoe, or to an ankle-foot orthosis sock (also referred to as AFO-sock), and wherein the foot assembly comprises: ○ a push section configured to exert a downward force, and ○ a pull section configured to exert an upward force on the shoe or on the AFO-sock.

Description

[0001] Title: Orthotic foot brace

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to an ankle-foot orthosis for supporting a foot suffering from a drop foot.

[0004] BACKGROUND OF THE INVENTION

[0005] An ankle-foot orthosis (AFO) plays a crucial role in addressing a drop foot, a condition where the ability to lift the section of the foot located distally from the ankle joint is impaired. The cause of a drop foot may be, among others, peripheral and central neuronal indications, muscular diseases and traumatic injuries that damage the brain or the nerve pathway from the brain to the muscles of the lower leg.

[0006] An ankle-foot orthosis can support a foot suffering from a drop foot. The importance of an ankle-foot orthosis lies in its ability to provide necessary support, stability, and alignment to the foot and ankle, effectively compensating for the weakened or paralyzed muscles responsible for dorsiflexion and / or plantar flexion. By facilitating proper foot placement during walking and preventing dragging of the foot, an ankle-foot orthosis not only enhances mobility and reduces the risk of tripping and falling, but also allows individuals with a drop foot to maintain a more natural gait pattern. The functional improvement achieved through an anklefoot orthosis not only enhances the quality of life but also fosters greater independence and participation in daily activities, empowering individuals to navigate the world with increased confidence and comfort. In this field, various concepts have been proposed.

[0007] WO2011097723A1 (herein: D1) with priority documents US8529484 and CA2692534 discloses an orthotic foot brace for a person wearing footwear. In the embodiment of figs. 1-6, the orthotic foot brace comprises a lower leg holder 24 secured to the persons lower leg, a rod structure comprising a lower leg vertical section 26 extending downwardly from the lower leg holder towards the footwear 21 and a foot section 30. The foot section of the rod structure comprises a curved shaped section 56 secured to the vertical section 26, at least one of a median section 40 and a lateral section 36 located on a respective side of the footwear and extending outwardly thereof, and a front section 44 which extends laterally over the footwear and is securable to an instep section 46 of the footwear. The front section 44 of the foot brace of D1 comprises attachment means 50 and a foot band 62. The foot band 62 extends from the median side of the footwear to the lateral side of the footwear and is connected to left and right sections 58 of the rod structure and applies a downward force on the footwear. The attachment means may be connected to the shoelaces to apply an upwardly pivotable force to the footwear. The foot band 62 is configured to push the foot downward when the foot makes a gaiting movement. In combination, these two forces form a lever and apply a moment on the foot.

[0008] D1 describes the rather complex forces which are exerted by the foot brace on the shoe and vice versa. The foot band exerts a downward push force on shoe. An upward counterforce is exerted by the shoe on the foot band. See the upward arrow in fig. 5. Simultaneously, an upward force is exerted the by foot brace on the shoe by the laterally extending front section 44 and via the attachment means at the dorsal side of the foot. A downward counterforce is exerted by the shoe on the laterally extending front section 44. See the downward arrow in fig. 16. This pair of downward and upward forces transfer a so-called “dorsiflexion moment D” from the foot brace onto the shoe. This dorsiflexion moment D is created by the pair of upward and downward forces which are at a distance from one another and form a lever. This dorsiflexion moment D is present in all embodiments of D1. See the pair of arrows in figs.5, 11 and fig. 16. The dorsiflexion moment D is created by: a) a significant distance between the ankle joint and the lower leg holder, b) the fact that the pull member and the push member are connected to the rod structure, wherein the push member is positioned at a distance rearward of the pull member, c) the fact that the pull member and the push member engage the foot (or shoe), This results in a mechanism in which the pull member pulls the forward part of the foot upward and in which the push member pushes an upper and more rearward part of the shoe (via foot band 62 in fig. 6) downward. The distance between the upward and downward force forms the arm length of the lever.

[0009] It was recognized that a drawback of D1 is that the foot band can slide distally down the dorsal side of the foot over the rod structure when the user walks. Even if the band would be strongly attached to the rod structure, the pliable band would be able to slide down the shoe during certain situations, thereby becoming closer to the push section 50. This decreases the lever arm between the push section 50 and the foot band 62, thereby decreasing a moment that the foot brace exerts on the foot and rendering the foot brace of D1 less effective. A further drawback of D1 is the visibility of the orthotic foot brace. The foot section with the foot band and the attachment means is positioned on the outside of the footwear, making it relatively visible to the environment. This is further enhanced due to the curved sections 56 on both sides of the lower leg and footwear. The curved sections 56 extend relatively far behind the ankle to allow rod section 26 to extend straight up to the lower leg holder 24. Also, the rod structure in both embodiments is rather elaborate and large, making it relatively visible.

[0010] Also, it is not always easy to connect and disconnect the front section 44 to the shoe via the attachment means.

[0011] Further, the foot band 62 requires support on both sides of the footwear, resulting in an rather elaborate rod structure. Moreover, the footband 62 may lead to discomforting pressure on the navicular bone.

[0012] Document D1 also comprises an embodiment wherein the foot band is replaced with a heel support 170, see figs. 7-12. It extends rearwardly of the footwear, behind the heel section 170. The heel support exerts a compression force on the footwear quarters 176. It was recognized in the present invention that the embodiment with the heel support of figs. 7- 12 of D1 has a particular drawback in that the heel support 170 needs to find support against the footwear in order to be able to exert a downward force on the footwear, see fig. 11. It only works if the shoe is tied very tight and if the heel of the foot is pressed strongly into the shoe. The embodiment of figs. 1-6 does not have this disadvantage because the foot band 62 extends over the footwear and is capable of exerting this downward force.

[0013] The embodiment of figs. 13-17 has a single frame member 234 extending downwardly from the lower leg holder to the foot section 230. This embodiment has a heel support 270 which contacts the shoe at the heel.

[0014] Another drawback of the orthotic foot brace of D1 is that the footwear needs to be sturdy for the orthotic foot brace to work properly. For example, boots without laces, sandals or flip-flops do not work well with one of the embodiments of D1. For these types of footwear it is often not possible to attach the spreader plate 52 and the attachment members 54 to the laces of the footwear. The inability to attach a foot orthosis to certain types of footwear illustrates the reduced freedom in choosing such desired footwear by the user. It also forces the user to wear shoes during the entire day, even at home. In addition, in non-sturdy shoes all of the force exerted by the orthosis would go into deforming the shoe instead of lifting the foot. These points combined may have a serious negative impact on the user experience.

[0015] Another example of an orthotic foot brace is disclosed in WO2019046932A1 (herein: D2). It has a comparable design and operational principle as the orthotic foot brace of D1. The main differences between the brace of D1 and the brace of D2 are the leg engagement portion 22 and the ability to change the size of the brace. The leg engagement portion of D2 is positioned on the anterior side of the lower leg, while the engagement portion of D1 is positioned on the posterior side of the lower leg. D2 also discloses steps to customize the brace to the size of the lower leg and shoes of the user.

[0016] In use, D1 and D2 function in a identical or similar way. However, an advantage that can be observed in D2's anterior shin design is that it is easier for users to put on the orthosis when it is already attached to a shoe as the orthosis is not in the way of the shoe hole, like it is in D1. In D2 a user is able to put on a shoe from the rear side of the shoe and the engagement portion 22. In D1 a user cannot put on a shoe from a rear side, because the orthosis is positioned on the rear side and thereby hinders the foot. A drawback of the engagement portion 22 on the anterior side of the lower leg is the visibility. It cannot be concealed between the two legs and it is relatively large.

[0017] KR20210141018A (herein: D3) discloses a drop foot ankle holder, in figures 3 - 5, to prevent a drop foot and ankle swaying from side to side during walking. The drop foot ankle holder 10 comprises an ankle support 11 which is arc shaped, a wear fixing part 12 and a wear support part 13. The ankle support is a rigid plate which should be positioned in front of the ankle and foot. The wear fixing part is provided on the upper end of the ankle support and provides a wearing fixing force for the upper part of the ankle. The wear support part is provided at the lower end of the ankle support and provides support for the front part of the foot.

[0018] The drop foot ankle holder also exerts both a downward force and an upward force on the foot. The middle section of the ankle support generates a downward force on the proximal-dorsal side of the foot. The size of this force relative to the position on the proximal- dorsal side of the foot depends on the downward movement of the foot. The center point of the downward force may move up- or downwards between the wear fixing part and wear support part. This is a drawback because, as the ankle moves into plantar flexion, an arc is created in the ankle support 11, between the wear support 13 and the ankle. This arc causes a pressure point at the base of the ankle section. In the long run, this may result in damage to the nerves. For patients with diabetes, this may even result in foot amputation. Also, a rolling motion of the foot during walking is difficult to achieve with the device of D3, because the semi-rigid plate hinders the ankle movement. A further disadvantage of the device of D3 is that it needs to be installed before the shoe is put on the foot. Typically, users want this to be the other way around: first put on the shoe and second put on the device / brace. Overall, the drop foot ankle holder of D3 has a rather primitive design. In spite of these drawbacks, the device of D3 is widely used.

[0019] Another example of an ankle-foot orthosis is known under the name Klenzak in-shoe. Examples can be found on YouTube: https: / / www.youtube.com / watch?v=xymQ 6LFJB0 It has a plate which goes under the foot and into the shoe. A drawback of this device is that it must be put on before the shoe is put on. Another drawback is that walking becomes less comfortable because a rigid plate is located under the foot. Also, the shoe may need adaptation and the shoe needs to increase in size to support this ankle-foot orthosis.

[0020] Another device in this field is known as an ankle-band orthosis (e.g. the Ossur foot- up). This class of AFO comprises a simple leg strap that goes around the lower leg directly above the ankle. A line or strap which can be elastic extends between the strap and is connected to an upper part of the shoe. The Ossur foot-up is relatively light, inconspicuous and can be put on easily. Another advertised advantage is that it allows barefoot use with a band around the foot. However, this foot-band squeezes the foot so hard that it becomes very uncomfortable. In addition, it also lacks the ability to lift the foot sufficiently and provides an irritating pressure point on the shin at the base of the ankle.

[0021] Another example of an ankle joint limiting orthosis is presented in CN21824751 OU (herein: D4). D4 comprises an orthosis body structure which is arc shaped. The orthosis body structure comprises a leg guard plate 101 and a foot fixing plate 102. The leg guard plate is positioned at the front side of the lower leg and attached to the lower leg by a strap 20. The foot fixing plate is connected to the laces of a shoe. The orthosis further comprises a second pad 1012 provided below the arc-shaped body structure. The second pad is provided between the arc-shaped body structure and the ankle to increase wearing comfort. A drawback of D4 is that the user should always wear its footwear to use the orthosis of D4. Another drawback of D4 is that the ankle range of motion is severely limited through use of this device.

[0022] US2020315831A1 (herein: D5) discloses a foot lift orthosis which is configured to be used without footwear. The orthosis comprises at least one first tension element 2 and at least one second tension element 4. The tensile element extends from a forefoot region 6 along an arch 10 of the foot and to exert a first tensile force onto the forefoot region in the direction of a first bearing position 12 above an upper ankle joint. The second tensile element extends along a sole 20 of a foot and is configured to exert a second tensile force onto the forefoot region in the direction of a second bearing position 22 in a heel region 24 of the foot.

[0023] Although D5 seems to disclose a solution with minimal visibility, it was recognized in the present invention that the forces on the fore foot region may not be sufficient to provide the required lifting force in case of a drop foot. In addition, the coupling between the fore foot region and the first and section tension elements is not comfortable for the user of the orthosis. The region between the toes of a foot are not used to a forced being exerted on that region, making it uncomfortable for the user of the brace. Also, the foot lift orthosis of D5 may be relatively difficult to install on the lower leg / foot and remove after use, because it extends around multiple sides of the foot and two toes extend through openings in the orthosis.

[0024] Because the presently known devices all have drawbacks that hinder users or provide discomfort, there is a demand for an improved device.

[0025] OBJECT OF THE INVENTION

[0026] It is an object of the present invention to provide an improved orthotic foot brace which takes away at least one of the drawbacks and limitations discussed above.

[0027] It is another object of the present invention to provide an orthotic foot brace which is fully functional in that it prevents drop foot, which can be installed and removed with relative ease, if desired without completely removing the user’s footwear first, yet is relatively invisible for other people.

[0028] It is another object of the present invention to provide an orthotic foot brace which can be used with a wide variety of footwear.

[0029] It is another object of the present invention to provide an orthotic foot brace which can be used without wearing footwear to improve the user convenience, and in particular can be used to walk properly at home without using footwear.

[0030] SUMMARY OF THE INVENTION At least one of the abovementioned objects is achieved with an ankle-foot orthosis for supporting a foot suffering from a drop foot, the ankle-foot orthosis comprising: a lower leg assembly configured to be attached to a lower leg between an ankle and a knee, wherein the lower leg assembly comprises an engagement member which engages the lower leg and a strap or clamp configured to extend around the lower leg to secure the engagement member to the lower leg, a bracket configured to generate a biasing force on a foot assembly, wherein an upper end of the bracket is connected to the engagement member, wherein the bracket extends downward from the engagement member to the foot assembly, the foot assembly which is connected to a lower end of the bracket, the foot assembly being configured to be connected: a) directly to a shoe, b) to a fastener device configured to be connected to a shoe, c) to an MTP-strap, and / or d) to an ankle-foot orthosis sock (also referred to as AFO-sock), wherein the foot assembly comprises: o a push section configured to exert a downward force on the foot, directly or via the shoe, at the proximal-dorsal side of the foot, and o a pull section configured to exert an upward force on the shoe, directly or via the fastener device, or to exert an upward force (45) on the MTP-strap or AFO-sock, wherein the upward force is exerted on the MTP-strap or AFO- sock at the distal-dorsal side of the foot, wherein the push section and pull section together form a single rigid member, wherein the single rigid member is configured to be positioned at a dorsal side of the foot, and wherein the pull section is an anterior protrusion which extends in an anterior direction from the push section.

[0031] The present invention is comfortable and can be used with most types of shoes. The single rigid member can be connected to most shoes in an easy way. The single rigid member - at least the pull section thereof, can be positioned underneath an upper part of the shoe with ease. For many shoes the pull section can simply be pushed in a forward direction underneath an upper part of the shoe. In this position the single rigid member is relatively invisible.

[0032] Advantageously, the single rigid member can form a lever which exerts a push force on the proximal-dorsal side and a push force on the distal-dorsal side. The lever has a well- defined arm which does not decrease in length in use. The single rigid member may be composed of multiple parts which are rigidly connected to one another and which by their rigid connection form a single rigid member. The single rigid member may also be one integral part.

[0033] Comfort is a vital aspect of for users of ankle-foot ortheses and because pressure has to be applied to the proximal-dorsal side of the foot, it is important to maximise the area of pressure in unsensitive areas while minimising pressure in sensitive areas. The foot band of D1 is a patient unspecific method that is easily positioned over the navicular bone which is sensitive. The single rigid member can be designed to not apply pressure on the navicular bone or apply only a limited pressure on the navicular bone while maximising pressure in other parts of the proximal-dorsal side of the foot.

[0034] Being formed as a single rigid member also simplifies the manufacturing process and costs of the push and pull sections. A 3D-printer could be used to print the foot assembly based on a 3D-model of the dorsal side of a foot. Another option would be to use moulds and injection moulds. The rigidity is important to apply the upward and downward force on the foot. The push and pull section should be rigid to form a lever on the dorsal side of the foot. If the single rigid member would not be rigid, more energy of the force will be lost in bending the single rigid member, instead of forming the lever on the dorsal side of the foot. Also, a bending of the single rigid member could cause a pressure point on the proximal-dorsal area of the foot because the push section would be reduced to a small area instead of a relatively large area.

[0035] In combination with the AFO-sock or MTP-strap the single rigid member can also be used without a shoe. The invention does not limit the ankle movement. The ability to use the ankle-foot orthosis with different shoes and even bare footed improves user convenience. User convenience is also improved by allowing the user to take off the orthosis with shoes remaining on. For most shoes this can be done by simply pulling the single rigid member from underneath the upper part of the shoe. It improves the range of shoes from which a user may select footwear. It also ensures that a single ankle-foot orthosis is sufficient when going on a trip, or day in which different activities would be performed, wherein the use of different footwear would be favourable.

[0036] The downward force exerted by the push section and the upward force exerted by the pull section work in a somewhat similar way as in D1. However, the push force is exerted in a different way and distributed over non-sensitive areas and applies less or no pressure to the navicular bone. In some embodiments, the single rigid member is connected to - and supported by - the bracket from a single side, either from the lateral side or from the medial side. By having the push section and pull section only connected to and supported by the bracket from a single side, the orthosis becomes less visible to the environment. The lower leg assembly and most of the bracket can be hidden under the legs of pants. The foot assembly can be partly hidden below the laces of a shoe. Therefore, only small parts of the bracket and foot assembly are visible form a single side.

[0037] However, the single rigid member may also be used in an ankle-foot orthosis which has a double bracket, i.e. a bracket which has a right and left part, wherein the left part extends along a left side of the lower leg and foot and the right part extends along the right side of the lower leg and foot, for instance as is shown in D1. The single rigid member is then supported from both the left side and the right side. The advantages of the single rigid member also apply for such an embodiment. In addition to these advantages, the double bracket has the advantage of providing more mediolateral stability as the force application is more direct with the double bracket as opposed to the single bracket.

[0038] The strap ensures that the engagement portion remains in place when the user changes footwear or when the user removes the tension between the foot assembly and the bracket.

[0039] The foot assembly does not deform much. The deformation which creates the biasing force takes place predominantly in the bracket. As a result, the relative distribution of the pressure across the surface area of the push section stays the same, more or less independently from the deflection angle of the ankle (and the foot). This has the advantage of having a comfortable downward pressure through the entire range of motion.

[0040] In some embodiments, the push section and pull section may only be supported from the medial side and the bracket does not extend along the lateral side of the foot.

[0041] Only supporting the push section and pull section from the medial side makes the ankle-foot orthosis less visible to other people. This is mainly because the medial side is partly covered by the other leg.

[0042] In some embodiments, the single rigid member may be more rigid than at least part of the bracket. In this way, the majority of the deformation which is required to create the biasing force takes place in the bracket, and the single rigid member does not deform or only to a relatively small extent.

[0043] In some embodiments, the ankle-foot orthosis may further comprise: a first connection part connected to the lower end of the bracket, and a second connection part which forms part of the foot assembly, the second connection part being configured to be connected to the first connection part.

[0044] The first and second connection parts form a coupling.

[0045] In some embodiments, the coupling may be operable to be switched between: o a pivot state in which the second connection part is pivotable about the first connection part to allow pivoting of the single rigid member relative to the bracket, and o a fixed state in which the single rigid member is fixed relative to the lower end of the bracket.

[0046] This allows adjusting of the foot assembly relative to the bracket.

[0047] In some embodiments, the single rigid member may further comprise the second connection part.

[0048] In some embodiments, in use the foot assembly may be rigidly connected to the lower end of the bracket via the first and second connection part.

[0049] In some embodiments, when seen in top view the single rigid member may be curved, wherein the push section extends in a lateral direction from the second connection part.

[0050] The push section applies a downward force on the proximal-dorsal side of the foot. This force should be sufficiently large to generate sufficient momentum to create sufficient pulling force on the pull section. By having a larger area to apply that downward force, the force per area reduces. A push section which extends in a lateral direction results in a larger area to apply the downward force, resulting in less discomfort for the user.

[0051] In some embodiments, the pull section may be elongate in a longitudinal direction of the foot. This may increase the arm between the pull force and the push force and as a result, may increase the moment exerted on the foot by the pull section and the push section. By having an elongate pull section, discomfort of the user is reduced while the upward force can be applied at the correct distal position on the foot. Discomfort of the user is reduced because the elongate pull section only covers a relatively small area of the dorsal side of the foot. The elongate pull section only covers a part of the lateral-dorsal side of the foot. This allows the medial-dorsal side of the foot to move more freely as the metatarsal bone of the hallux is not covered by the elongate pull section.

[0052] In some embodiments, the second connection part may be configured to be located on a medial side of the foot and wherein the push section extends in a lateral direction from the second connection part.

[0053] In some embodiments, the push section is configured to be located relatively centrally on the dorsal side of the foot when seen in top view. This is an effective position for exerting the push force.

[0054] In some embodiments, the push section may have a concave underside configured to match a shape of the dorsal side of the foot or the shape of a shoe covering the dorsal side of the foot.

[0055] The concave underside of the push section aligns with the region of the dorsal side of the foot which it covers. In this way, downward forces exerted by the push section will be evenly distributed over the dorsal side of the foot to prevent discomfort, bruising and / or damaging the dorsal side of the foot.

[0056] In some embodiments, the ankle-foot orthosis may comprise a hinge assembly which allows a user to pivot the foot assembly relative to the bracket about a hinge axis, the hinge assembly comprising: a hinge formed by the first connection part and the second connection part, a lock-release mechanism configured to allow the user to lock the hinge during use and to release the hinge in case the biasing force on the shoe or AFO- sock needs to be released.

[0057] The lock-release mechanism allows a user to remove the tension (the biasing force) between the bracket and the foot assembly without disconnecting the bracket from the foot assembly or disconnecting the foot assembly from the shoe or AFO-sock. Therefore, it becomes possible for a user to remove the tension, for instance when the user sits behind a desk or on a couch. This may remove or prevent discomfort caused by a long-term, continuous tension on the lower leg and the foot.

[0058] In some embodiments, the lock-release mechanism may comprise a release handle configured to release the hinge.

[0059] In some embodiments, the hinge axis may be oriented in a lateral or medial direction.

[0060] In some embodiments, the hinge assembly further comprises an adjusting mechanism which allows a user to adjust the biasing force on the shoe or AFO-sock, the adjusting mechanism comprising: a first ring of the first connection part having one or more first teeth, a second ring of the second connection part having one or more second teeth, wherein the first teeth and second teeth align, and wherein the first or second ring is rotatable about the hinge axis to allow pivoting of the single rigid member relative to the bracket in case a pivot angle needs to be adjusted.

[0061] The adjusting mechanism provides several advantages over the prior art. First, it provides freedom for a specialist to adjust the tension of the bracket onto the foot assembly. This might be different for every user depending on the size, weight and / or strength of the user. Due to the adjusting mechanism, it is possible for the specialist together with the user to perform multiple tests with different settings to determine the optimal configuration. Changing between the different settings can be done relatively fast. The adjusting mechanism also makes it possible for a user to slightly adjust the settings depending on external conditions.

[0062] In some embodiments, the bracket may comprise: an upper curved bracket section which extends downwardly from the engagement member and curves from a posterior side or anterior side of the lower leg at the engagement member to a transition at or near a lateral or medial malleolus, in particular a medial malleolus, where the upper curved bracket section transitions into a lower curved bracket section at the medial side of the foot, the lower curved bracket section which when seen in side view (i.e. view in a lateral direction) and starting from the transition, curves in a forward and upward direction and extends from the transition to the lower end. In some embodiments, the lower curved bracket section may extend around the medial malleolus.

[0063] The medial malleolus is a bony protrusion causing it to be sensitive and become irritated relatively quickly. It is therefore important to avoid any contact between the bracket and the medial malleolus.

[0064] In some embodiments, the lower curved bracket section is less rigid, i.e. more flexible, than the upper curved bracket section and less rigid, i.e. more flexible, than the single rigid member. In this way the deformation required for the biasing force is concentrated in the lower curved bracket section. This prevents relative movement between the ankle-foot orthosis and the lower leg, through the alignment of the axis of rotation of the ankle joint and the ankle-foot orthosis.

[0065] In some embodiments, the lower curved bracket section may have a U-shape comprising a nadir, a first leg and a second leg, wherein the first and second leg extend in an upward direction, wherein in particular the first and second leg of the U-shape diverge from one another in an upward direction.

[0066] In some embodiments, the bracket may be composed of only a single ongoing rod. A single rod is easier to conceal than a rod structure comprising multiple rods.

[0067] In some embodiments, the engagement member may be configured to engage a posterior section of the lower leg.

[0068] The spring force of the lower curved bracket section transfers a force from the posterior section of the leg to an upward force at the distal-dorsal side of the foot. By having the engagement member configured to engage the posterior section of the leg, the force exerted by the posterior section can be directly transferred to the engagement member and thereby the bracket without incorporating a significantly strong strap to the engagement member. If the engagement member does not engage the posterior section, the strap may pinch the lower leg and may also lose performance over time.

[0069] In some embodiments, the pull section may comprise an underside surface, and wherein the push section comprises a push contact surface for engaging the dorsal side of the foot or shoe, wherein the push contact surface is larger than the underside surface. In some embodiments, the underside of the push section seamlessly goes over in the underside of the pull section.

[0070] In some embodiments, the pull section may comprise a first connector located at a forward tip of the pull section, wherein the ankle-foot orthosis comprises a separate: fastener device comprising fastener means configured to be fastened to a shoe, and / or an AFO sock configured to be worn on the foot by a user, and / or an MTP-strap configured to be worn on the foot by a user wherein the fastener device, AFO sock or MTP strap comprises a second, mating connector, which is configured to be connected to the first connector to connect the fastener device, the AFO-sock and / or the MTP-strap to the pull section.

[0071] In some embodiments, the first connector may comprise an aperture, and particular a keyhole aperture, wherein the second connector comprises a connection pin having a stop at a tip thereof, the connection pin being configured to be inserted through a wider part of the aperture and to be subsequently moved to a narrower part of the aperture.

[0072] In some embodiments, the ankle-foot orthosis may comprise the AFO-sock which further comprises: a force spreader bar positioned on the dorsal side of the foot near the metatarsophalangeal joints, a metatarsophalangeal strap (also referred to as MTP-strap) configured to exert an upward force to the plantar side of the foot near the metatarsophalangeal joints, wherein the MTP-strap extends around the plantar side of the foot from a lateral portion of the force spreader bar to a medial portion of the force spreader bar.

[0073] In other words, the MTP-strap may form part of the AFO-sock or may be on its own.

[0074] The AFO-sock allows the user to use the ankle-foot orthosis without using footwear. The force spreader and MTP-strap replace the upper side of a shoe and sole of the shoe to transfer the force upwards to the distal portion of the foot, allowing the orthosis to be used barefoot.

[0075] In some embodiments, the MTP-strap may be non-stretchable. In some embodiments, the ankle-foot orthosis may comprise the AFO-sock, wherein the AFO-sock may comprise at least one foam cushion positioned on an inner surface of the force spreader bar, wherein each foam cushion is configured to provide comfortable contact between the force spreader bar and the foot.

[0076] In some embodiments, the ankle-foot orthosis may comprise the AFO-sock, wherein the AFO-sock may comprise a heel strap configured to prevent the ankle-foot orthosis from sliding forward.

[0077] When a user walks forwards without footwear, he or she uses the friction between the MTP-section of the bottom of the foot and the ground to move forward. In this, the foot exerts a rearward force on the ground. The reaction force from the ground on the foot is forward and may cause the MTP-strap to move forward relative to the foot in the direction of the digits. The heel strap prevents the MTP-strap and thereby other parts of the ankle-foot orthosis from moving forward.

[0078] In some embodiments, the ankle-foot orthosis may comprise the AFO-sock which is configured to lift the digits of the foot, wherein the AFO-sock may comprise: a digit support configured to apply an upward force to the digits, wherein the digit support is positioned below the digits and extends forward from the MTP- strap to a distal portion of each digit, a digit cover configured to cover the dorsal side of the digits, wherein the digit cover is more stretchable than the digit support, a digit force spreader configured to prevent that the digits are being forced together, wherein the digit force spreader is more rigid than the digit support, wherein the digit support and the digit cover together cover the distal-dorsal side of the foot from the metatarsophalangeal joints.

[0079] Having a drop foot can also lead to a problem with the digits. This issue arises due to the weakening or paralysis of the muscles responsible for controlling digit movement. As a result, individuals with drop foot might experience trouble in raising their digits off the ground while walking, causing the digits to drag or scuff along the surface. This can create an abnormal walking pattern and increases the risk of stumbling or tripping. The digits inability to lift properly can impact overall mobility and balance. The digit support provides the necessary upward force to the digits to prevent that the digits drag or scuff along the surface. The digit cover is more stretchable than the digit support as to allow movements of the digits in the direction of the ground. In some embodiments, the digit support may comprise a bottom surface having grip means to prevent the user from sliding when pushing off during walking.

[0080] The present invention further relates to an AFO-sock for transferring a pulling force from an ankle-foot orthosis to a foot suffering from a drop foot, wherein the AFO-sock comprises: a second, mating connector configured to be connected to a first connector of an ankle-foot orthosis, a force spreader bar positioned on the dorsal side of the foot near the metatarsophalangeal joints, a metatarsophalangeal strap (also referred to as MTP-strap) configured to exert an upward force to the plantar side of the foot near the metatarsophalangeal joints, wherein the MTP-strap extends around the plantar side of the foot from a lateral portion of the force spreader bar to a medial portion of the force spreader bar.

[0081] The AFO-sock provides the same advantages as the AFO-sock of the ankle-foot orthosis as described above. These advantages are not repeated for the sake of brevity.

[0082] In some embodiments, AFO-sock may be configured to be used in combination with the ankle-foot orthosis according to the invention.

[0083] In some embodiments, the second connector may comprise a connection pin having a stop at a tip thereof.

[0084] In some embodiments, the MTP-strap may be non-stretchable.

[0085] In some embodiments, the AFO-sock may comprise at least one foam cushion positioned on an inner surface of the force spreader bar, wherein each foam cushion is configured to provide comfortable contact between the force spreader bar and the foot.

[0086] In some embodiments, the AFO-sock may comprise a heel strap configured to prevent the ankle-foot orthosis from sliding forward.

[0087] In some embodiments, the AFO-sock may be configured to lift the digits of the foot, wherein the AFO-sock may comprise: a digit support configured to apply an upward force to the digits, wherein the digit support is positioned below the digits and extends forward from the MTP- strap to a distal portion of each digit, a digit cover configured to cover the dorsal side of the digits, wherein the digit cover is more stretchable than the digit support, a digit force spreader configured to prevent that the digits are being forced together, wherein the digit force spreader is more rigid than the digit support, wherein the digit support and the digit cover together cover the distal-dorsal side of the foot from the metatarsophalangeal joints.

[0088] In some embodiments, the digit support may comprise a bottom surface having grip means to prevent the user from sliding when pushing off during walking.

[0089] The present invention further relates to a fastener device configured to be used in combination with the ankle-foot orthosis according to any of claims 18-25, and comprising: the fastener means configured to be fastened to a shoe, the second, mating connector, which is configured to be connected to the first connector of the ankle-foot orthosis.

[0090] The advantages of the fastener device are described above and not repeated for the sake of brevity.

[0091] A method of using the ankle-foot orthosis comprises: engaging the engagement member of the ankle-foot orthosis with the lower leg of the user, and positioning the strap or clamp around the lower leg to secure the engagement member to the lower leg, positioning the bracket along the lower leg of the user, the lower end being positioned near the foot, connecting the foot assembly to a foot of a user by: a) putting the shoe on the foot of the user and connecting the foot assembly directly to the shoe, or b) connecting the fastener device to a shoe of a user, putting the shoe on the foot of the user and connecting the foot assembly to the fastener device, or c) putting the MTP-strap on the foot of the user and connecting the foot assembly to the MTP-strap, or d) putting the AFO-sock on the foot of the user and connecting the foot assembly to the AFO-sock.

[0092] The method provides the same advantages as the device according to the invention. These advantages are not repeated for the sake of brevity.

[0093] The feature “connecting the foot assembly directly to the shoe” under sub a), includes a variant in which the single rigid member is pushed under the upper part of the shoe.

[0094] In some embodiments, the method comprises scanning the foot of a user with a scanner and using the data obtained from the scan for shaping the concave underside of the rigid member. This advantageously results in a shape of the concave underside of the rigid member that matches the shape of the foot of the user. Next to improved comfort, the personalized shape of the single member aids to the automatic correct positioning on the user’s foot.

[0095] BRIEF DESCRIPTION OF THE FIGURES

[0096] Embodiments of the system and the method will be described by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, and in which:

[0097] Fig. 1 shows an isometric, front view of the ankle-foot orthosis according to the invention.

[0098] Fig. 2 shows an isometric, rear view of the ankle-foot orthosis.

[0099] Fig. 3A - 3B show a side view of the ankle-foot orthosis.

[0100] Fig. 4A - 4B show a rear and front view of the ankle-foot orthosis.

[0101] Fig. 5A - 5B show a bottom and top view of the ankle-foot orthosis.

[0102] Fig. 6A - 6C show different implementations of the ankle-foot orthosis with footwear.

[0103] Fig. 7A - 7B show different views of the fastener device.

[0104] Fig. 8A - 8C show the operational principle of the adjusting mechanism.

[0105] Fig. 9 shows a side view of the ankle-foot orthosis with different pivot angles.

[0106] Fig. 10A - 10C show isometric views of the foot assembly.

[0107] Fig. 11 A - 11 B show isometric views of the MPT-strap and spreader bar.

[0108] Fig. 12A - 12B show isometric views of the ankle-foot orthosis with the AFO-sock.

[0109] Fig. 13A - 13E show different views of the AFO-sock.

[0110] Figs. 14A - 14B show forces acting on the lower leg and foot.

[0111] Figs. 15A - 15B show moments in the leg as a result of the ankle-foot orthosis. Fig. 16 shows force which are exerted by an AFO-sock.

[0112] Figs. 17A - 17D show a further embodiment of the foot assembly.

[0113] DETAILED DESCRIPTION OF THE FIGURES

[0114] Turning to figures 1 and 2, an ankle-foot orthosis 10 for supporting a foot 1 suffering from a drop foot is shown. A possible cause of a drop foot may for instance be peripheral and / or central neuronal indications, muscular diseases and / or traumatic injuries that damage the brain or the nerve pathway from the brain to the muscles of the lower leg. The ankle-foot orthosis 10 comprises a lower leg assembly 20, a bracket 30 and a foot assembly 40. The lower leg assembly 20 is configured to be attached to a lower leg 2 between an ankle 3 and a knee 4. The lower leg assembly 20 comprises an engagement member 22 which engages the lower leg 2 and a strap 24 or clamp configured to extend around the lower leg 2 to secure the engagement member 22 to the lower leg 2. An embodiment with a clamp is not shown, but a skilled person will understand that the clamp may be manufactured from hard plastic and extend around the leg in a similar fashion as the strap. The clamp may comprise an openable part which can be opened to provide access for the leg. The engagement member 22 is configured to engage a posterior section 9 of the lower leg 2 and the strap 24 extends from an inner edge 22a of the engagement portion 22 to an outer edge 22b of the engagement portion 22.

[0115] The bracket 30 is configured to generate a biasing force 32 on the foot assembly 40. An upper end 34 of the bracket 30 is connected to the engagement member 22. The bracket 30 extends downward from the engagement member 22 to the foot assembly 40. The foot assembly 40 is connected to a lower end 36 of the bracket 30. The foot assembly 40 is configured to be connected directly to a shoe 5, to a fastener device 50 configured to be connected to a shoe 5, to a metatarsophalangeal strap 120 (also referred to as MTP-strap) or to an ankle-foot orthosis sock 100 (also referred to as AFO-sock). The foot assembly 40 is configured to be positioned at a dorsal side 6 of the foot 1.

[0116] The foot assembly 40 comprises a push section 42, a pull section 44, a force spreader bar 110 and the MTP-strap 120. The push section 42 is configured to exert (also indicated as generate) a downward push force 43 on the shoe 5 or foot 1 at the proximal-dorsal side 7 of the foot 1. The pull section 44 is configured to exert an upward force 45 on the shoe 5, directly or via the fastener device 50, or in case of a bare foot, via the MTP-strap 120 or AFO sock at the plantar side of the foot 1. Although in case of a shoe and in case of a bare foot the upward force 45 acts as an upward push force on the plantar side of the foot, namely via the shoe, MTP-strap or AFO-sock, the pull section 44 is called a pull section because it exerts an upward pull force 45 on the shoe, MTP-strap or AFO-sock.

[0117] The force spreader 110 bar is positioned on the dorsal side 6 of the foot 1 near the metatarsophalangeal joints. The MTP-strap 120 is configured to exert an upward force 45 on the plantar side of the foot 1 near the metatarsophalangeal joints. The push section 42 and pull section 44 are only connected to the bracket 30 and supported by the bracket 30 from a single side, either from the lateral side or from the medial side.

[0118] The push section 42 and pull section 44 preferably are only supported from the medial side and the bracket does not extend along the lateral side of the foot. When the bracket only extends along the medial side 12 of the lower leg 2 and foot 1 , it becomes less visible to the environment. Mainly because medial side 12 of the lower leg 2 and foot 1 is partly hidden by the other lower leg and foot.

[0119] Turning to figures 10A - 10C, the foot assembly 40 with a coupling 160 comprising first connection part 38 is shown. The connection part 38 is connected to the lower end of the bracket (which is not shown in these figures). The foot assembly 40 comprises a second connection part 48. The second connection part 48 is configured to be connected to the first connection part 38. In use the coupling 160 is in a fixed state in which the foot assembly 40 is rigidly connected to the lower end 36 of the bracket 30 via the first and second connection part 38. However, the coupling is operable to be switched from the fixed state to a pivot state in which the second connection part is pivotable about the first connection part to allow pivoting of the single rigid member 41 relative to the bracket. The coupling can also be switched back from the pivot state to the fixed state. The push section 42 and pull section 44 together form a single rigid member 41. The single rigid member 41 is more rigid than the bracket 30. The single rigid member 41 further comprises the second connection part 48.

[0120] In a non-shown embodiment with both a left side bracket part and a right side bracket part, the foot assembly 40 has a left coupling 160 which connects to the left side bracket part and a right coupling 160 which connects to the right side bracket part. The left side bracket part extends along a left side of the lower leg and foot and the right side bracket part extends along the right side of the lower leg and foot.

[0121] Turning to figures 3A - 5B, different views of the ankle-foot orthosis are shown. When seen in top view the foot assembly 40 is curved, the push section 42 extends in a lateral direction 68a from the second connection part 48 and the pull section 44 is an anterior protrusion of the push section 42 which extends in an anterior direction from the push section 42. The pull section 44 of the foot assembly 40 is elongate. The pull section 44 is narrower than the push section. The pull section 44 is connected to a forward-lateral side of the push section.

[0122] The second connection part 48 is configured to be located on a medial side 12 of the foot 1 and the push section 42 extends in a lateral direction 68a from the second connection part 48. The push section 42 is configured to be located relatively centrally on the dorsal side 6 of the foot 1 when seen in top view.

[0123] Turning to figures 6A - 6C, different ways of connecting the foot assembly to the foot of the user are shown. In fig. 6A, the ankle-foot orthosis is shown with a regular shoe. This may be the most used variant of the present invention. The rigid member 41 - or at least the pull section 44 thereof - is positioned underneath an upper part 250 of the shoe 5. In this position the foot assembly 40 is relatively invisible. This may be done by simply pushing the pull section 44 of the rigid member under the upper part of the shoe. The push section or a part of the push section may also be pushed under the upper part 250 of the shoe. The pull section may be positioned between the flap 251 of the shoe and the shoe laces 252 or may be positioned underneath the flap 251. In this way, a connection with the foot of the user can be made relatively easy while keeping the shoe on. The variant of fig. 6A works with most shoes.

[0124] In fig. 6B, the foot assembly 40 is positioned on the upper part 250 of the shoe and connected to the shoe via a fastener device 50. The fastener device 50 is connected to the shoe, as is further explained below in connection with figs. 7A and 7B. In fig. 6C, the foot assembly 40 is also pushed underneath the upper part 250 of the shoe 5, which in this case may be an open shoe without a heel part.

[0125] Turning to figures 14A - 15B, the forces and moments acting on the lower leg 2 and foot 1 are shown. The forces that are shown are the forces which are exerted on the lower leg and foot by the ankle-foot orthosis and by gravity. The forces in the force vector field of figure 14A are balanced so that the foot 1 is at rest in an orientation perpendicular to the lower leg 2. This is shown in figure 14B. The engagement member applies a lower leg force 23 to the posterior part 9 of the lower leg 2. The lower leg force 23 of the engagement member 22 is balanced by a horizontal component 16 of the force exerted by the push section 42 to the dorsal side 6 of the foot 1. The forces exerted by the foot assembly 40 and MTP-strap 120 on the foot 1 are a result from the biasing force 32 of the bracket 30 which is caused by the deformation of primarily the bracket.

[0126] The push force 43 exerted by the push section 42 to the dorsal side 6 of the foot 1 also comprises a vertical component and is a downward push force 43. The pull section of the foot assembly exerts an upward force 45 on the foot. The upward force 45 is exerted by the MTP-strap 120 to the plantar side of the foot 1 near the metatarsophalangeal joints. Between the downward push force 43 and upward force 45, an arm 51 is defined, resulting in a lever which imparts a moment onto the foot. The vertical forces are balanced with a gravitational force of the foot 17 and a tension force 18 of the achilleas tendon. These forces combined allow pivoting movement of the foot 1 around the medial malleolus.

[0127] Turning in particular to figures 15A and 15B, a bending moment 140 in the lower leg and foot which is created by the ankle-foot orthosis 10 increases when travelling in a downward direction from the engagement member and reaches a maximum near the ankle joint. When travelling from the ankle-joint toward the pull section the bending moment 140 stays approximately the same until the push section, From the push section to the pull section, the bending moment decreases to zero. The direction of the bending moment is indicated with arrows 142.

[0128] Turning to figures 8A - 10A, a hinge assembly 60 which allows a user to pivot the foot assembly 40 relative to the bracket 30 about a hinge axis 63 is shown. The hinge axis 63 is oriented in a lateral 68a or medial 68b direction. The hinge assembly 60 comprises a hinge 62 and a lock-release mechanism 66. The hinge 62 is formed by the first connection part 38 and the second connection part 48. The lock-release mechanism 66 is configured to allow the user to lock the hinge 62 during use and to release the hinge 62 in case the biasing force on the shoe or AFO-sock needs to be released. A user may want to release the biasing force when the user sits behind a desk or on a couch to remove discomfort from a long-term, continuous tension on the lower leg and the foot. The lock-release mechanism 66 comprises a release handle 67 configured to release the hinge 62.

[0129] In figure 9, two different pivot angles 64 are shown while the foot is in rest on the ground. The larger pivot angle 64b shows the position of the bracket 30 when the release handle 67 released the hinge 62 to remove the tension between the foot assembly 40 and the bracket 30. In this way, a simple step of releasing the hinge 62 allow the user to relax when the foot is continuously supported by the ground when e.g. the user sits on a couch or behind a desk. In figure 10A, the foot assembly 40 with the hinge assembly 60 comprising an adjusting mechanism 80 is shown. The adjusting mechanism 80 allows a user to adjust the biasing force on the shoe or AFO-sock. The adjusting mechanism 80 comprises a first ring 82 and a second ring 84. The first ring 82 is part of the first connection part 38 and is having one more first teeth 83. The second ring 84 is part of the second connection part 48 and is having one or more second teeth 85. The first teeth 83 and second teeth 85 align to form the connection between the first and second connection part. The alignment between the first and second teeth prevents any rotational movement about the hinge axis of the foot assembly relative to the bracket.

[0130] The first and second connection parts can be pulled away from each other to allow rotational movement of the foot assembly with respect to the bracket about the hinge axis. The first and second connection parts can be completely removed from each other when the ankle-foot orthosis is not worn by a user. The first or second ring is then rotatable about the hinge axis to allow pivoting of the single rigid member relative to the bracket in case a pivot angle 64 needs to be adjusted.

[0131] Returning to figure 3A, the bracket 30 comprises an upper curved bracket section 35 and a lower curved bracket section 37. The upper curved bracket section is more rigid than the lower curved bracket section. The upper curved bracket section 35 extends downwardly from the engagement member 22 and curves from a posterior side 13 or anterior side 14 of the lower leg 2 at the engagement member 22 to a transition 31 at or near a lateral or medial malleolus, in particular a medial malleolus. The upper curved bracket section 35 transitions into a lower curved bracket section 37 at the medial side 12 of the foot 1. The lower curved bracket section 37 which when seen in side view (i.e. view in a lateral direction) and starting from the transition 31 , curves in a forward and upward direction and extends from the transition 31 to the lower end 36.

[0132] The lower curved bracket section 37 extends around the medial malleolus. The lower curved bracket section 37 has a U-shape comprising a nadir 37a, a first leg 37b and a second leg 37c. The first and second leg extend in an upward direction, wherein in particular the first and second leg of the U-shape diverge from one another in an upward direction. The bracket may be composed of only a single ongoing rod or may be composed of more than a single ongoing rod.

[0133] Returning to figures 10A - 10C, the foot assembly is shown. The push section 42 has a concave underside 49 configured to match a shape of the dorsal side 6 of the foot 1 or the shape of a shoe 5 covering the dorsal side 6 of the foot 1. The pull section 44 comprises an underside surface 46, and wherein the push section 44 comprises a push contact surface 47 for engaging the dorsal side 6 of the foot 1 or shoe 5, wherein the push contact surface 47 is larger than the underside surface 46.

[0134] Turning to figures 11A - 11B, the foot assembly 40 of the ankle-foot orthosis 1 is shown. The pull section 44 comprises a first connector 70 which is located at a forward tip 71 of the pull section 44. The ankle-foot orthosis 10 further comprises a separate fastener device 50 and an AFO sock 100. The fastener device 50 comprises fastener means 52 configured to be fastened to a shoe 5. The AFO sock 100 is configured to be worn on the foot 1 by a user. The fastener device 50 and / or AFO sock 100 comprises a second, mating connector 102, which is configured to be connected to the first connector 70 to connect the fastener device 50 and / or the AFO-sock 100 to the pull section 44.

[0135] The first connector 70 comprises an aperture 72, and in particular a keyhole aperture 73. The second connector 102 comprises a connection pin 75 having a stop 76 at a tip thereof. The connection pin 75 being configured to be inserted through a wider part 74 of the aperture 72 and to be subsequently moved to a narrower part 77 of the aperture 72.

[0136] Turning to figures 12A - 13E, the AFO-sock 100 for transferring a pulling force 45 from an ankle-foot orthosis 10 to a foot 1 suffering from a drop foot is shown. The AFO-sock 100 also comprises a force spreader bar 110 and a metatarsophalangeal strap 120. The force spreader 110 bar positioned on the dorsal side 6 of the foot 1 near the metatarsophalangeal joints. The metatarsophalangeal strap 120 (also referred to as MTP-strap) is configured to exert an upward force 45 to the plantar side of the foot 1 near the metatarsophalangeal joints. The MTP-strap 120 extends around the plantar side of the foot 1 from a lateral portion 112 of the force spreader bar 120 to a medial portion 113 of the force spreader bar 120. The MTP- strap 120 is non-stretchable. The MTP-strap 120 may be non-stretchable to apply a sufficiently large force to the plantar side of the foot 1.

[0137] The AFO-sock 120 comprises at least one foam cushion 104 positioned on an inner surface 114 of the force spreader bar 110. Each foam cushion 104 is configured to provide comfortable contact between the force spreader bar 110 and the foot 1. The AFO-sock 100 further comprises a heel strap 106 configured to prevent the ankle-foot orthosis 10 from sliding forward. The AFO-sock 100 is configured to lift the digits 130 of the foot 1. The AFO-sock 100 comprises a digit support 132, a digit cover 134 and a digit force spreader 136. The digit support 132 is positioned below the digits 130 and extends forward from the MTP-strap 120 to a distal portion 131 of each digit 130. The digit cover 134 is configured to cover the dorsal side 135 of the digits 130. The digit cover 134 is more stretchable than the digit support 132. The digit support 132 and the digit cover 134 together cover the distal-dorsal side 8 of the foot 1 from the metatarsophalangeal joints.

[0138] The digit force spreader 136 is configured to prevent that the digits 130 are being forced together. The digit force spreader 136 is more rigid than the digit support 132. The digit support 132 further comprises a bottom surface 137 having grip means 138 to prevent the user from sliding when pushing off during walking.

[0139] Turning to figure 16, a force vector field of the AFO-sock is shown. The digit support 132 is configured to apply an upward force 133 to the digits 130. The upward force 133 is counteracted by the gravitational force 19 on the digits.

[0140] Turning to figures 7A - 7B, a fastener device 50 is shown. The fastener device 50 is configured to be used in combination with the ankle-foot orthosis 10. The fastener device 50 comprises fastener means 52 and a second, mating connector 102. The fastener means 52 are configured to be fastened to a shoe 1 using the e.g. the laces of the shoe 1. The second, mating connector 102 is configured to be connected to the first connector 70 of the ankle-foot orthosis 10. The fastener device 50 is positioned outside the shoe to be easily connected with and disconnected from the ankle-foot orthosis 10. The fastener device 50 is versatile and is configured to be connected to any of a shoe, an MTP-strap or and AFO-sock, allowing a user to switch footwear when desired without a need for a different fastener device.

[0141] Turning to figures 17A-17D, another embodiment of the foot assembly 40 is shown. The foot assembly further comprises a rear protrusion 150. The rear protrusion 150 extends rearward and has a curved end 152. The rear protrusion 150 is configured to be inserted into a shoe and may extends to and around and under a heel of the foot. The rear protrusion 150 is a variant of the push section 42. Instead of pushing on the dorsal side of the foot, the rear protrusion 150 pushes downward on the heel part of the shoe. This downward push force is transferred to the dorsal side of the foot by the shoe. The downward force is then exerted on the dorsal side of the foot by the shoe. The rear protrusion 150 is not visible for other people. This embodiment has an advantage in that the downward force is more evenly spread out over a surface area on the dorsal side of the foot. A disadvantage of this embodiment is that an extra member needs to be inserted into the shoe which may cause discomfort.

[0142] In an embodiment, the rearward extension 150 may be the only push section 44. In other words, in some embodiments the part of the push section which acts directly on the dorsal side of the foot need not be present if the rearward extension 150 is present.

[0143] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but rather, to provide an understandable description of the invention. Not all embodiments may achieve all stated objects.

[0144] The terms "a" or "an", as used herein, are defined as one or more than one. The term plurality, as used herein, is defined as two or more than two. The term another, as used herein, is defined as at least a second or more. The terms including and / or having, as used herein, are defined as comprising (i.e. , open language, not excluding other elements or steps). Any reference signs in the claims should not be construed as limiting the scope of the claims or the invention.

Claims

CLAIMS1. Ankle-foot orthosis (10) for supporting a foot (1) suffering from a drop foot, the anklefoot orthosis comprising: a lower leg assembly (20) configured to be attached to a lower leg (2) between an ankle (3) and a knee (4), wherein the lower leg assembly comprises an engagement member (22) which engages the lower leg and a strap (24) or clamp configured to extend around the lower leg to secure the engagement member to the lower leg, a bracket (30) configured to generate a biasing force (32) on a foot assembly (40), wherein an upper end (34) of the bracket is connected to the engagement member, wherein the bracket extends downward from the engagement member to the foot assembly, the foot assembly which is connected to a lower end (36) of the bracket, the foot assembly being configured to be connected: a) directly to a shoe (5), b) to a fastener device (50) configured to be connected to a shoe, c) to an MTP-strap (120), and / or d) to an ankle-foot orthosis sock (100) (also referred to as AFO-sock), wherein the foot assembly comprises: o a push section (42) configured to exert a downward force (43) on the foot, directly or via the shoe, at the proximal-dorsal side (7) of the foot, and o a pull section (44) configured to exert an upward force (45) on the shoe, directly or via the fastener device, or to exert an upward force (45) on the MTP-strap or AFO-sock, wherein the upward force is exerted on the MTP-strap or AFO-sock at the distal-dorsal side (8) of the foot, wherein the push section and pull section together form a single rigid member (41), wherein the single rigid member is configured to be positioned at a dorsal side (6) of the foot, and wherein the pull section is an anterior protrusion which extends in an anterior direction from the push section.

2. Ankle-foot orthosis according to the preceding claim, wherein the single rigid member is connected to - and supported by - the bracket from a single side, either from the lateral side or from the medial side.

3. Ankle-foot orthosis according to any of the preceding claims, wherein the push section and pull section are only supported from the medial side and wherein the bracket does not extend along the lateral side of the foot.

4. Ankle-foot orthosis according to any of the preceding claims, wherein the single rigid member is more rigid than the bracket.

5. Ankle-foot orthosis according to any of the preceding claims, further comprising: a first connection part (38) connected to the lower end of the bracket, and a second connection part (48) which forms part of the foot assembly, the second connection part being configured to be connected to the first connection part, wherein the first and second connection parts form a coupling (160).

6. Ankle-foot orthosis according to the preceding claim, wherein the coupling is operable to be switched between: o a pivot state in which the second connection part is pivotable about the first connection part to allow pivoting of the single rigid member relative to the bracket, and o a fixed state in which the single rigid member is fixed relative to the lower end of the bracket.

7. Ankle-foot orthosis according to any of claims 4-6, wherein the single rigid member further comprises the second connection part.

8. Ankle-foot orthosis according to any of the preceding claims, wherein when seen in top view the single rigid member is curved.

9. Ankle-foot orthosis according to any of the preceding claims, wherein the pull section is elongate in a longitudinal direction of the foot.

10. Ankle-foot orthosis according to any of claims 5-9, wherein the second connection part is configured to be located on a medial side (12) of the foot and wherein the push section extends in a lateral direction from the second connection part.

11. Ankle-foot orthosis according to any of the preceding claims, wherein the push section is configured to be located relatively centrally on the dorsal side of the foot when seen in top view.

12. Ankle-foot orthosis according to any of the preceding claims, wherein the push section has a concave underside (49) configured to match a shape of the dorsal side of the foot or the shape of a shoe covering the dorsal side of the foot.

13. Ankle-foot orthosis according to any of claims 5-12, wherein in use the foot assembly is rigidly connected to the lower end of the bracket via the first and second connection part.

14. Ankle-foot orthosis according to any of the preceding claims 5-13, wherein the coupling comprises a hinge assembly (60) which allows a user to pivot the foot assembly relative to the bracket about a hinge axis (63), the hinge assembly comprising:- a hinge (62) formed by the first connection part and the second connection part,- a lock-release mechanism (66) configured to allow the user to lock the hinge during use and to release the hinge in case the biasing force on the shoe or AFO-sock needs to be released.

15. Ankle-foot orthosis according to the preceding claim, wherein the lock-release mechanism comprises a release handle (67) configured to release the hinge.

16. Ankle-foot orthosis according to any of claims 14-15, wherein the hinge axis is oriented in a lateral (68a) or medial (68b) direction.

17. Ankle-foot orthosis according to any of claims 14-16, wherein the hinge assembly further comprises an adjusting mechanism (80) which allows a user to adjust the biasing force on the shoe or AFO-sock, the adjusting mechanism comprising:- a first ring (82) of the first connection part having one or more first teeth (83),- a second ring (84) of the second connection part having one or more second teeth (85), wherein the first teeth and second teeth align, and wherein the first or second ring is rotatable about the hinge axis to allow pivoting of the foot assembly relative to the bracket in case a pivot angle (64) needs to be adjusted.

18. Ankle-foot orthosis according to any of the preceding claims, wherein the bracket comprises: an upper curved bracket section (35) which extends downwardly from the engagement member and curves from a posterior side (13) or anterior side (14) of the lower leg at the engagement member to a transition (31) at or near the lateral or medial malleolus, in particular a medial malleolus, where the upper curved bracket section transitions into a lower curved bracket section at the medial side of the foot, the lower curved bracket section (37) which when seen in side view (i.e. view in a lateral direction) and starting from the transition, curves in a forward and upward direction and extends from the transition to the lower end, wherein the lower curved bracket section extends around the medial malleolus.

19. Ankle-foot orthosis according to claim 18, wherein the lower curved bracket section is less rigid, i.e. more flexible, than the upper curved bracket section and less rigid, i.e. more flexible, than the single rigid member.

20. Ankle-foot orthosis according to any of the preceding claims 18-19, wherein the lower curved bracket section has a U-shape comprising a nadir (37a), a first leg (37b) and a second leg (37c), wherein the first and second leg extend in an upward direction, wherein in particular the first and second leg of the U-shape diverge from one another in an upward direction.

21. Ankle-foot orthosis according to any of the preceding claims, wherein the bracket is composed of only a single ongoing rod.

22. Ankle-foot orthosis according to any of the preceding claims, wherein the engagement member is configured to engage a posterior section (9) of the lower leg.

23. Ankle-foot orthosis according to any of the preceding claims, wherein the pull section comprises an underside surface (46), and wherein the push section comprises a push contact surface (47) for engaging the dorsal side of the foot or shoe, wherein the push contact surface is larger than the underside surface.

24. Ankle-foot orthosis according to any of the preceding claims, wherein the pull section comprises a first connector (70) located at a forward tip (71) of the pull section, wherein the ankle-foot orthosis comprises a separate:fastener device (50) comprising fastener means (52) configured to be fastened to a shoe, and / or an AFO sock (100) configured to be worn on the foot by a user, wherein the fastener device and / or AFO sock comprises a second, mating connector (102), which is configured to be connected to the first connector to connect the fastener device and / or the AFO-sock to the pull section.

25. Ankle-foot orthosis according to the preceding claim, wherein the first connector comprises an aperture (72), and particular a keyhole aperture (73), wherein the second connector comprises a connection pin (75) having a stop (76) at a tip thereof, the connection pin being configured to be inserted through a wider part (74) of the aperture and to be subsequently moved to a narrower part (77) of the aperture.

26. Ankle-foot orthosis according to any of the preceding claims, comprising the AFO- sock which further comprises: a force spreader bar (110) positioned on the dorsal side of the foot near the metatarsophalangeal joints, a metatarsophalangeal strap (120) (also referred to as MTP-strap) configured to exert an upward force (122) to the plantar side of the foot near the metatarsophalangeal joints, wherein the MTP-strap extends around the plantar side of the foot from a lateral portion (112) of the force spreader bar to a medial portion (113) of the force spreader bar.

27. Ankle-foot orthosis according to any of the preceding claims, comprising the AFO- sock, wherein the AFO-sock comprises at least one foam cushion (104) positioned on an inner surface (114) of the force spreader bar, wherein each foam cushion is configured to provide comfortable contact between the force spreader bar and the foot.

28. Ankle-foot orthosis according to any of the preceding claims, comprising the AFO- sock, wherein the AFO-sock comprises a heel strap (106) configured to prevent the ankle-foot orthosis from sliding forward.

29. Ankle-foot orthosis according to any of the preceding claims, comprising the AFO- sock configured to lift the digits (130) of the foot, wherein the AFO-sock comprises: a digit support (132) configured to apply an upward force (133) to the digits, wherein the digit support is positioned below the digits and extends forward from the MTP-strap to a distal portion (131) of each digit,a digit cover (134) configured to cover the dorsal side (135) of the digits, wherein the digit cover is more stretchable than the digit support, a digit force spreader (136) configured to prevent that the digits are being forced together, wherein the digit force spreader is more rigid than the digit support, wherein the digit support and the digit cover together cover the distal side of the foot from the metatarsophalangeal joints.

30. Ankle-foot orthosis according to the preceding claim, wherein the digit support comprises a bottom surface (137) having grip means (138) to prevent the user from sliding when pushing off during walking.

31. Ankle-foot orthosis according to any of claims 5-30, wherein the push section comprises a rearward extension (150) which extends downward and / or rearward from the second connection part (48), wherein the rearward extension is in particular configured to be inserted into a shoe.

32. AFO-sock (100) for transferring a pulling force (45) from an ankle-foot orthosis (10) to a foot (1) suffering from a drop, wherein the AFO-sock comprises: a second, mating connector (102) configured to be connected to a first connector (70) of an ankle-foot orthosis (10), a force spreader (110) bar positioned on the dorsal side of the foot near the metatarsophalangeal joints, a metatarsophalangeal strap (120) (also referred to as MTP-strap) configured to exert an upward force (122) to the plantar side of the foot near the metatarsophalangeal joints, wherein the MTP-strap extends around the plantar side of the foot from a lateral portion (112) of the force spreader bar to a medial portion (113) of the force spreader bar.

33. AFO-sock according to the preceding claim, wherein the AFO-sock is configured to be used in combination with the ankle-foot orthosis according to any of claims 1-31.

34. AFO-sock according to any of the two preceding claims, wherein the second connector comprises a connection pin (75) having a stop (76) at a tip thereof.

35. AFO-sock according to any of claims 34-36, wherein the MTP-strap is non- stretchable.

36. AFO-sock according to any of claims 32-35, wherein the AFO-sock comprises at least one foam cushion (104) positioned on an inner surface (114) of the force spreader bar, wherein each foam cushion is configured to provide comfortable contact between the force spreader bar and the foot.

37. AFO-sock according to any of claims 32-37, wherein the AFO-sock comprises a heel strap (106) configured to prevent the ankle-foot orthosis from sliding forward.

38. AFO-sock according to any of claims 32-37, configured to lift the digits (130) of the foot, wherein the AFO-sock comprises: a digit support (132) configured to apply an upward force (133) to the digits, wherein the digit support is positioned below the digits and extends forward from the MTP-strap to a distal portion (131) of each digit, a digit cover (134) configured to cover the dorsal side (135) of the digits, wherein the digit cover is more stretchable than the digit support, a digit force spreader (136) configured to prevent that the digits are being forced together, wherein the digit force spreader is more rigid than the digit support, wherein the digit support and the digit cover together cover the distal-dorsal side of the foot from the metatarsophalangeal joints.

39. AFO-sock according to the preceding claim, wherein the digit support comprises a bottom surface (137) having grip means (138) to prevent the user from sliding when pushing off during walking.

40. Fastener device (50) configured to be used in combination with the ankle-foot orthosis according to any of claims 24-31, and comprising: the fastener means (52) configured to be fastened to a shoe, the second, mating connector (102), which is configured to be connected to the first connector of the ankle-foot orthosis.

41. Method of using the ankle-foot orthosis according to any of claims 1-33, the method comprising: engaging the engagement member (22) with the lower leg of the user and positioning the strap (24) or clamp around the lower leg to secure the engagement member to the lower leg, positioning the bracket along the lower leg of the user, the lower end being positioned near the foot,connecting the foot assembly (40) to a foot of a user by: a) putting the shoe on the foot of the user and connecting the foot assembly directly to the shoe, or b) connecting the fastener device (50) to a shoe of a user, putting the shoe on the foot of the user and connecting the foot assembly to the fastener device, or c) putting the MTP-strap on the foot of the user and connecting the foot assembly to the MTP-strap, or d) putting the AFO-sock (100) on the foot of the user and connecting the foot assembly to the AFO-sock.

42. Method according to the preceding claim, comprising scanning the foot of a user with a scanner and using the data obtained from the scanned for shaping the rigid member.

43. Method according to any of the preceding claims, wherein at least the pull section of the rigid member - is positioned on the dorsal side of the foot and underneath an upper part (250) of the shoe (5), in particular by pushing at least the pull section underneath the upper part of the shoe.

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