WO2005097014A1

WO2005097014A1 - Orthotic footwear and manufacturing method therefor

Info

Publication number: WO2005097014A1
Application number: PCT/SE2005/000513
Authority: WO
Inventors: Lars Falkenman
Original assignee: Lars Falkenman
Priority date: 2004-04-08
Filing date: 2005-04-07
Publication date: 2005-10-20
Also published as: SE528818C2; SE0400953L; SE0400953D0; EP1742600A1

Abstract

An orthotic footwear device comprising in integral combination a sole element (41), a foot support element (40) for receiving a foot (60), and an ankle-foot orthosis element (23, 24, 25), and a manufacturing method therefor are disclosed. According to an embodiment, the ankle-foot orthosis element is made of a lightweight material and comprises a base plate supporting two lateral strut elements extending to a tibia abutment member (11) having a releasable fastener (12) configured to fasten said ankle-foot orthosis element at said tibia abutment member below the knee to a lower limb in use of said orthotic footwear device. The base plate is interposed between said sole element (41) and said foot support element (40), and the lateral strut elements have an inherent flexibility such that propulsion of the limb at toe off is assisted by said flexibility. The foot (60) of a wearer of the orthotic footwear device is also supported for ground-clearance during the gait swing phase when walking with said orthotic footwear device put on.

Description

Applicant: Lars Falkenman

Title: ORTHOTIC FOOTWEAR AND MANUFACTURING METHOD THEREFOR

DESCRIPTION

Field of the Invention This invention pertains in general to the field of footwear and more particularly to orthotic footwear and even more particularly to ankle supporting orthotic footwear .

Background of the Invention Dropping of the front of the foot may be caused by weakness or paralysis of the anterior muscles of the lower leg. Foot-drop results in what is called a steppage gait in which the advancing foot is lifted high in order that the toes may clear the ground. Foot drop can be due to a number of conditions including injury to the muscles that dorsiflex the foot or to the nerves to those muscles, a neuropathy, multiple sclerosis, a stroke, drug toxicity, and diabetes. One way of treating this condition is to use an ankle-foot orthosis (AFO) . An ankle-foot orthosis is a brace, usually of plastic, worn on the lower leg and foot to support the ankle, hold the foot and ankle in the correct position, and correct foot-drop. AFOs are also known as a foot-drop braces or drop-foot braces. Using an AFO prevents the wearer from dragging the foot and enables the wearer to walk: extended intervals without any symptoms of fatigue or of being tired. When walking, the wearer does not have to worry about tripping or falling because of the dropped foot. AFOs usually comprise a foot plate custom-made and specially adapted to the form of trie user's foot, and a supporting strut for fixing the ankle, foot and lower limb of the user in a desired position. For use an AFO is usually placed in a rather heavy and stable shoe , like an athletic shoe or a walking boot supporting the o-rthosis. Then the shoe is don with the orthosis in place. This results in a rather large assembly, and putting on the assembly may be experienced as uncomfortable as it requires a number of steps, and the orthosis has to be specially adapted to the foot of the user, so that the use is comfortable with the orthosis. From US-5,865,778 a shoe with integral ankle support is known. This shoe eliminates the need of firs ly inserting a support into a shoe. However, the disclosed shoe is still rather large and heavy. The ankle support is not suitable for persons with drop-foot condition as it has a pivotable joint that enables rotation of the support in the transversal direction. Thus stability in the direction perpendicular to the lateral direction is ensured by the device disclosed, but the foot will still drop. The prior art devices are heavy and large and are basically intended for outdoor activities. However, persons suffering from dropped-foot also need support indoors, e.g. at home. For instance borders of carpets or doorsteps are difficult to cross for persons suffering from d op-foot. Thus, there is a need for a new footwear suppor ing a drop- foot condition. It is desired that the footwear is easily put on the foot and lower leg, lightweight, and still gives a considerable support and comfort to the user.

Summary of the Invention The present invention overcomes the above- identified deficiencies in the art and solves at least the above identified problems by providing an orthotic footwear device according to the appended patent claims . The general solution according to the invention is an orthotic footwear device comprising in integral combination a sole element, a foot support element for recei ving a foot, and an ankle-foot orthosis element. Thus, a self- contained orthotic footwear is provided. Preferably, the ankle-foot orthosis element is made of a lightweight material and comprises a base plate supporting two lateral strut elements extending to a tibia abutment member having a releasable fastener configured to fasten said ankle-foot orthosis element at said tibia abutment member below the knee to a lower limb in use of said orthotic footwear device. The base plate is interposed between said sole element and said foot support element, and the lateral strut elements have an inherent flexi-bility such that propulsion of the limb at toe off is assist ed by said flexibility. The foot of a wearer of the orthotic footwear device is also supported for ground-clearanc e during the gait swing phase when walking with said or thotic footwear device put on. The present invention has also the advantage over the prior art that it avoids a custom-made footwear. The foot support element may have a footbed in a variety of st andard sizes fitting most user's feet comfortably. The orthotic footwear device is of a simple construction that is e asily manufactured. Still, the orthotic footwear device offer full support to a drop-foot patient and is not just s imply a guard in the side of the shoe. The lateral design of support struts providing inherent flexibility offers a dynamic energy return when walking. Preferably, a sim-ple Velcro® strapping system facilitates donning and dof ing of the orthotic footwear device. The ankle-foot orthosis element of the orthotic footwear device is preferably made of a lightweight material having high structural strength. This ensure s a dynamic motion and energy return, as already mentione d, as well as high durability, high strength, light weight, and long time of comfortable use. The orthotic footwear device is simple to use and no separate AFO is needed. The orthotic footwear device is easy to don and doff. Brief Description of the Drawings Further objects, features and advantages of the invention will become apparent from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which Figs. 1A and IB are perspective views of an AFO device that is part of the orthotic footwear according to an embodiment of the invention; Fig 2 is an exploded perspective view illustrating the integration of the AFO device shown in Figs 1A and IB into an orthotic footwear according to an embodiment of the invention; Figs 3A and 3B are perspective views showing the sample orthotic footwear device according to an embodiment of the invention; Fig 4 shows a step of putting on the orthotic footwear of Figs 3A and 3B with a Velcro® fastening strap opened; and Figs 5A and 5B are perspective views illustrating the orthotic footwear of the two previous figures, wherein the footwear is shown put on a foot of a wearer, ready for use.

Description of embodiments Figs 1A and IB are perspective views illustrating an orthotic device in the form of an ankle foot brace, which is part of an embodiment of the invention as disclosed in the following figures . The brace comprises an upper portion 10, an intermediate portion 20 and a lower portion 30. Fig 1A illustrates the brace upside-down for an easy understanding of the construction of the brace. Fig IB shows the brace in the opposite position with the top portion 10 upside. With reference to both Figs 1A and IB the brace assembly will now be described in more detail. The lower part 30 of the brace comprises a front portion 31, which is oriented in the direction of the toes of a wearer of the orthotic footwear into which the brace is to be integrated. The intermediate portion 32 of the lower portion 30 of the brace is in use oriented approximately at the middle of the wearer's foot sole, and the rear portion 33 of the lower portion 30 of the brace is oriented towards the heel of the wearer. The intermediate portion 20 of the brace comprises to substantially vertically oriented arms 21, 22. The arms 21, 22 are interconnecting the lower portion 30 and the upper portion 10 of the brace. The right arm 21 comprises a lower portion 23, and intermediate portion 24 and an upper portion 25. The left arm 22 of the brace comprises a lower portion 26, an intermediate portion 27 and an upper portion 28. As can be seen in the perspective view of Figs 1A and IB, the arms 21, 22 have a characteristic shape fulfilling a plurality of functions, which will be explained below. The upper portion 10 of the brace comprises an interconnecting part 11 that interconnects the two arms 21, 22 at the end of their upper portions 25, 28, respectively. The interconnecting part 11 is oriented towards the front of the wearer's lower limb, i.e. towards the tibia at the lower leg of the wearer. A damping pad 12 is oriented and attached to the inside of the interconnecting part 11. Damping pad 12 fulfils the function of providing comfort to the wearer and is made of an elastic material, such as a soft fabric or a foam rubber. Damping pad 12 may be attached to the inside of interconnecting part 11 by means of an adhesive or other suitable fastening means such as a Velcro® tape for easy removal and cleaning of the pad 12. A strap 13 having a fold back strap portion 14 is fastened to the right side of interconnecting part 11 by means of a rivet 16, as can be seen in Fig 1A. The strap 13 is inserted into a substantially rectangular loop 15, preferably of metal or a rigid plastic. A performed fold back portion 18 of strap 13 is illustrated fold back onto the outside of strap 13. Both the inside of a fold back strap portion 14 and the outside of the strap 13 comprise hook and loop fasteners of Velcro® tape sections, such that the fold back portion 14 conveniently can be fastened and loosened to and from the strap 13 in order to giving the wearer access to the opening of strap 13 and damping pad 12. The substantially rectangular loop 15 is attached to the interconnecting part 11 of the brace by means of a rivet 17 and a interconnecting holding element fastened to the rivet 17 and the rectangular loop 15. Fig 2 illustrates how the brace shown in Figs 1A and IB is integrated with a footwear. The lower portion 30 of the brace is enclosed between a foot bed or upper portion of a footwear and a sole or lower portion of a footwear. Portions 40 and 41 are formed in a suitable manner so that the lower portion 30 of the brace is situated between the two portions 40 and 41 of the footwear. The left and right arms of the brace extend substantially vertically upwards from the footwear. According to an embodiment of a manufacturing method for an orthotic footwear as described herein, comprises providing a sole element (41); providing a foot support element (40) for receiving a foot; and providing an ankle- foot orthosis element (10, 20, 30). The ankle-foot orthosis element (10, 20, 30) comprises a base plate element (30) , at least one lateral strut element (21, 22) supported by said base plate element (30) , and a limb fastening member (13, 14, 15) arranged on said strut element (13, 14, 15) for fastening said ankle-foot orthosis element (10, 20, 30) to a lower limb of a wearer in use of said orthotic footwear device, wherein said at least one lateral strut element (21, 22) extends from said base plate (30) to said fastening member (13, 14, 15) . The manufacturing method comprises interposing said base plate (30) between said sole element (41) and said foot support element (40) forming an integral self-contained orthotic footwear.

Detailed manufacturing sub steps may be derived from the structures as described in the remainder of this specification, e.g. choice of material or fastening methods . Fig 3A shows a slightly elevated perspective front view of a footwear device of an embodiment according to the invention. Fig 3 B is an elevated rear perspective view of the orthotic footwear device according to the embodiment of the invention. As is illustrated, the orthotic footwear device comprises the intermediate portion 20 and the upper portion 10 of the brace extending above the footwear portions 40 and 41. The footwear furthermore comprises a first buckle 42 and a second buckle 44 extending across and above the foot bed 40. The buckles 43, 45 are attached to a buckle counter element 46, which is also fastened to the foot bed 40, by means of a first buckle fastener 43 and a second buckle fastener 45, respectively. The two arms 21, 22 of the brace are fastened to the footwear portions 40, 41 by integrating the lower portion of orthotic device 30 into the space intermediate of portions 40 and 41. This is achieved by forming the portions 40, 41 appropriately, e.g. by providing a recess with the lower portion 40 of the brace. The lower portion 30 of the brace may be attached between the foot bed 40 and the sole 41 by means of an adhesive, by suitable fastening means, such as screws, or a combination thereof. Arms 20, 21 unite in the interconnecting part 11. The orthotic footwear device is now ready for use, wherein the step of putting on the shoe is best understood with reference to Fig 3B. The wearer of the shoe will draw the fold back strap portion 14 from the strap 13 and slide it through the rectangular loop 15 to the right in Fig 3B. Thus the passage between the strap 13 and the damping pad 12 is open to insert the lower limb of the wearer. When sliding the foot into the foot bed 40, the foot will rest with its foot sole on the foot bed of the orthotic footwear device and the upper part of the wearer' s foot will rest against the insides of the buckles 42, 44 and the buckle counter element 46. This step is illustrated in Fig 4. As can be seen, the strap 13 with the fold back strap portion 14 is opened and still attached to the interconnecting part 11 of the upper brace portion by means of the rivet 16. The lower limb of the wearer rest against the inside of damping pad 12. In Fig 3B the first attachment point 50 and the second attachment 51 of arms 21 and 22, respectively, are illustrated, and the second attachment point is also shown in Fig 4. At the attachment points, the arms enter into the footwear device for fastening and integrating the brace. Subsequently the fold back strap portion 14 is introduced with its end into the substantially rectangular loop 15 and fold back with its inside onto the outside of strap 13. Now the orthotic footwear device according to this embodiment is ready for use by the wearer, wherein this is illustrated in Figs 5A and 5B. The foot 60 of the wearer is now firmly attached to the orthotic footwear device. This is achieved by a simple operation of opening and closing the strap 13, as described above. Therefore the orthotic footwear device is put on very easily and in a short time. Still, the footwear device is offering an enormous amount of comfort and support for the wearer. The footwear device according to the embodiment as illustrated in the figures is preferably used by persons having foot ankle instabilities or difficulties to control the motion of the foot when walking. The footwear device with the integrated brace offers a plurality of advantages. Firstly the device offers support to the foot ankle region of the wearer. This support is offered both in the lateral and in the frontal direction. The arms 21, 22 of the brace are preferably manufacturer of a material offering a low weight in combination with a high structural strength.

However, this strength is by the form of the arms converted into a spring like function supporting the possibility of the wearer lifting the front portion of its foot. The intermediate portions 27, 24 of the arms 22, 21, respectively, are oriented outside the ankles of the wearer. The intermediate portions 27, 24 are connected to upper portions 25, 28 and lower portions 26, 23, respectively. The three portions of each arm 21, 22 are shaped in a c-like manner, resulting in a spring function of the brace supporting walking of the wearer of the footwear device. When the wearer is walking, the upper part of the lower limb, that means the near region of the lack of the wearer is moved forward, the foot and the worn footwear device still on the ground. This movement is for example in Fig 5B of the upper part of the lower limb to the left. This motion is not hindered by the brace. The upper and lower portions of the arms are however moved towards each other, loading the spring forms by the arms. When the wearer of the footwear continues walking, the pressure on the footwear device will be subsequently relieved when the wearer of the device moves forward. At this point the spring force of the arms exceeds the weight force of the wearer on the footwear and the spring is unloaded, supporting and pushing forward the leg of the wearer. At the same time the position, as shown in Fig 5A and Fig 5B is restored, that means the foot is automatically returned to its standing position. Especially the last step is often a problem for persons having a nervous problem controlling the motion of the foot. One example for such persons are persons having had a stroke not having fully recovered their control of motion. Thus small hinder in the way of walking of such a person will cause that the person is not able off lifting the foot and will drag it behind. Here it is a problem that small hinder on the floor, such as edges of carpets will cause such persons to tumble and fall. When such persons are wearing the orthotic footwear device according to this embodiment, the persons will be able to walk almost normally due to the spring and support function, as explained above. Gait is assisted by a gradual plantar flexion at initial contact and energy is returned and propulsion of the limb at toe off is assisted. Moreover the foot is assisted for ground- clearance during the swing phase. The brace may advantageously be made of one integral part. Preferably, the brace is made of a lightweight material, such as a suitable plastics material that may be fiber-reinforced, e.g. with carbon or glass fibres. Other suitable materials comprise lightweight metals, such as titanium, magnesium, aluminium, or steel. The lightweight materials may also be used in several layers or sections to provide favourable characteristics to the brace, including suitable combinations of the above-mentioned materials or alloy thereof. This is to ensure that the footwear-device is as lightweight as possible in order to not hinder the wearer thereof, and at the same time to ensure sufficient structural strength for supporting the ankle/foot/lower limb of the wearer and to ensure the mentioned inherent flexibility of certain brace sections, as described above. Also, the described c-like shape of the struts may be oriented in the opposite direction for both struts of an embodiment with two struts, or into opposing directions for each strut, or in the opposite direction as shown in the Figures, i.e. bent towards the front part of the orthotic device. The present invention has been described above with reference to specific embodiments. However, other embodiments than the preferred above are equally possible within the scope of the appended claims. Examples are different number of struts, different fastening means other than Velcro®, materials of the brace, etc. Also the dimensions of the orthotic footwear device according to the invention are not to be regarded as limited by the exemplary embodiments given in the description with reference to the appended drawings. Furthermore, the term "comprises/comprising" when used in this specification does not exclude other elements or steps, the terms "a" and "an" do not exclude a plurality and a single assembly or other units may fulfil the functions of several of the units recited in the claims.

Claims

1. An orthotic footwear device comprising in integral combination of: a sole element (41) , a foot support element (40) for receiving a foot, and an ankle-foot orthosis element (10, 20, 30) comprising: a base plate element (30) , at least one lateral strut element (21, 22) supported by said base plate element (30) , and a limb fastening member (13, 14, 15) arranged on said strut element (13, 14, 15) for fastening said ankle-foot orthosis element (10, 20, 30) to a lower limb of a wearer: in use of said orthotic footwear device, wherein said base plate (30) is interposed between said sole element (41) and said foot support element (40), and wherein said at least one lateral strut element (21, 22) extends from said base plate (30) to said fastening member (13, 14, 15) .

2. The orthotic footwear device according to claim 1, comprising two lateral strut elements (21, 22) extending from said base plate (30) to said fastening member (13, 14, 15) arranged at an upper portion (10) of said ankle-foot orthosis element, wherein each of said strut elements (21, 22) in use of said device are configured to at least partly laterally extend along or around a respective side of the ankle of said foot in the direction of the knee of said wearer, preferably without abutting to said ankle.

3. The orthotic footwear device according to claims 1 or 2, wherein said limb fastening member (13, 14, 15) is a tibia abutment member (11, 12) -

4. The orthotic footwear device according to any of the preceding claims, wherein said at least one lateral strut element (21, 22) having an inherent flexibility such that, in use of said orthotic footwear device by said wearer when walking, propulsion of the limb at toe off from a walking surface is assisted by said flexibility and said foot is supported for ground-clearance during the gait swing phase when -walking with said orthotic footwear device put on.

5. The orthotic footwear device according to any of the preceding claims, wherein said ankle-foot orthosis member element (10, 20, 30) is made of one integral part .

6. The orthotic footwear device according to any of the preceding claim, wherein said ankle-foot orthosis element (10, 20, 30) is made of a lightweight material.

7. The orthotic footwear device according to any of the preceding claims, wherein said ankle-foot orthosis element (10, 20, 30) at least partly is made of a plastics material .

8. The orthotic footwear device according to claim 7, wherein said plastics material is fiber-reinforced.

9. The orthotic footwear device according to claim 6, wherein said ankle-foot orthosis element (10, 20, 30) at least partly being is of a lightweight metal.

10. The orttiotic footwear device according to claim 9, wherein said lightweight metal is chosen from titanium, magnesium, aluminium, steel, or a combination or alloy thereof.

11. The orthotic footwear device according to claims 1 to 10, wherein the ankle-foot orthosis element (10, 20, 30) comprises an upper portion (10) , an intermediate portion (20) and a lower portion (30) , wherein the lower part (30) of the brace comprises a front portion (31), which is oriented in the direction of the toes of a wearer of the orthotic footwear, a intermediate portion (32) of the lower portion (30) of the brace being oriented approximately at the middle of the wearer's foot sole, and a rear portion (33) of the lower portion (30) of the brace being oriented towards the heel of the wearer.

12. The orttiotic footwear device according to claim

11, wherein the intermediate portion (20) of the ankle-foot orthosis element (10, 20, 30) comprises two substantially vertically oriented lateral struts (21, 22), the struts (21, 22) interconnecting the lower portion (30) and the upper portion (10) of the ankle-foot orthosis element, wherein the struts (21,22) comprise a lower portion (23,26), an intermediate portion (24, 27) and an upper portion (25, 28) .

13. The orthotic footwear device according to claim

12, wherein the upper portion (10) of the ankle-foot orthosis element (10, 20, 30) comprises an interconnecting part (11) that interconnects the two lateral struts (21, 22) at the end of the upper portions (25, 28) thereof, respectively, wherein the interconnecting part (11) in use is oriented towards the tibia at the lower leg of a wearer.

14. The orthotic footwear device according to claim 13, the ankle-foot orthosis element (10, 20, 30) comprising a strap (13) having a fold back strap portion (14) being fastened to the interconnecting part (11) by a fastening means, for fastening the lower leg of a wearer to the orthotic footwear device.

15. The orthotic footwear device according to claim 14, wherein the intermediate portion (20) and the upper portion (10) of the ankle-foot orthosis element (10, 20, 30) extend above the sole element. (41) and the foot support element (40) .

16. The orthotic footwear device according to any preceding claim, wherein the footwear device further comprises a first buckle (42) and a second buckle (44) extending across and above the foot support element (40) .

17. The orthotic footwear device according to any preceding claim, wherein said foot support element comprises a foot bed (40) .

18. The orthotic footwear device according to any preceding claim, wherein the base plate (30) is interposed between said sole element (41) and said foot support element (40) is attached to the at least one strut element (21, 22) by a fastening means.

19. The orthotic footwear device according to any preceding claim, wherein the at least one a strut element (21, 22) is shaped in a flat c-like manner, wherein the opening of a c-like shape of said least one a strut element in use preferably is oriented to-wards the toe of a wearer, resulting in a spring function of the ankle-foot orthosis element supporting walking of the wearer in use of the footwear device in such a manner that gait is assisted by a gradual plantar flexion at initial contact, whereby energy is returned and propulsion of the limb at toe off is assisted, and the foot is further assisted for ground- clearance during the gait swing phase .

20. Use of the footwear device according to any of the preceding claims by persons subject to drop-foot.

21. A method of manufacture for an orthotic footwear device according to any of claims 1 - 1_9, comprising providing a sole element (41) ; providing a foot support element (40) for receiving a foot; and providing an ankle-foot orthosis element (10, 20, 30) comprising a base plate element (30), at least one lateral strut element (21, 22) supported by said base plate element (30), and a limb fastening member (13, 14, 15) arranged on said strut element (13, 14, 15) for fastening said ankle- foot orthosis element (10, 20, 30) to a lower limb of a wearer in use of said orthotic footwear: device, wherein said at least one lateral strut element (21, 22) extends from said base plate (30) to said fastening member (13, 14, 15) ; said method comprising interposing said base plate (30) between said sole element (41) and said foot support element (40) forming an integral self-contained orthotic footwear.