WO2010070364A1

WO2010070364A1 - Foot drop orthosis

Info

Publication number: WO2010070364A1
Application number: PCT/GR2009/000068
Authority: WO
Inventors: Andreas Tsitouras
Original assignee: Andreas Tsitouras
Priority date: 2008-12-16
Filing date: 2009-12-16
Publication date: 2010-06-24
Also published as: GR1006763B

Abstract

An orthopaedic brace for foot drop and similar conditions comprising a foot base portion (1) and a leg portion (2,4). The brace is provided either as an ankle-foot orthosis wherein the leg member (2,4) comprises a calf covering portion (2) or as a knee-ankle-foot orthosis also including a femoral covering portion (4). The foot base portion (1) is pivotally connected to the leg portion (2,4) by means of a pair of an outer and an inner sole raising spring assembly (3), each sole raising spring assembly (3) comprising a sole-raising spring mechanism (41,42) pivotally connected to a corresponding sole-shifting strip (43,44). A transversally extending axis (w-w) passing through the points of pivotal connection of the sole-raising spring mechanisms (41,42) with the corresponding sole-shifting strips (43,44) is adjustable with a scope to align it with the axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation of each individual user. The brace is provided ready to wear within ordinary shoes of any type and is fully adjustable to fit a variety of shoe and leg sizes of any individual user with both the foot base portion (1) and the leg portion (2,4) comprising means of adjusting their dimensions to the physical requirements of any individual user.

Description

FOOT DROP ORTHOSIS

The invention relates generally to braces particularly adapted to provide dorsiflexion assistance to the foot of foot drop patients. Foot drop is a deficit in turning the ankle and toes upward. The individual with foot drop experiences a difficulty in raising the foot, such condition being due to damage in the deep fibular/peroneal nerve innervating the anterior compartment of the leg leading to the inability for the leg to dorsiflex the foot, therefore causing foot drop. Conditions leading to foot drop may be neurologic, muscular or anatomic in origin, often with significant overlap. The result is an abnormal gait. The foot of the patient will hang inferiorly thereby leading to the individual walking with this condition to stumble and sometimes fall when hiting upon the slightest rise in a walk way.

In order to assist foot drop patients to walk properly, i.e. in order to provide dorsiflexion assistance to the foot of the wearer, ankles can be stabilized by lightweight orthoses, available in molded plastics as well as softer materials that use elastic properties to prevent foot drop. Additionally, shoes can be fit with traditional spring loaded braces to prevent foot drop while walking.

A variety of foot braces particularly adapted to assist with foot drop problems has been developed. Early braces were made of metal and were secured to a modified or customized shoe so as to hold the shoe in a generally horizontal, however uncomfortably rigid position for supporting the foot. Later on, braces accommodated a spring biased platform for supporting the foot and permitted minimal flexing of the foot when walking, thereby creating a more natural movement. With the advent of plastics, molded braces were produced and made available also in an articulating construction, wherein an independently made foot base portion was hingedly connected to a posterior brace item. Whilst such plastic braces were lighter and aesthetically more acceptable than earlier metal braces, they still were distant from successfully stimulating normal foot function since the plastic posterior brace hinged the foot relative to the leg behind the heel rather than the real life articulation in front of the heel. Further, still braces of this kind necessitated the use of modified or in the least enlarged shoes, generally making the condition and the brace obvious to even the most casual observer.

US-5,382,224, US-2002/0188238, US-3,805,773, US-5,716,336, US-6,409,695, FR- 2,856,917, WO-8707498 disclose alternative brace embodiments adapted to provide dorsiflexion assistance to users. However, it is noted that under the present practice of customized production of braces, the individual has to order and buy a product that is not readily available for trial and therefore he has no idea of the assistance this product might offer to him or her. Moreover one has to wait for delivery and yet he most probably has to compromise with the employment of heavy and/or aesthetically deficient orthopaedic shoes that will make his problem apparent at first sight.

It is therefore the object of the invention to propose a fully adjustable, shoe-internal brace, and in particular an ankle-foot and a knee-ankle-foot orthosis that will be ready to wear so that a potential client may readily try the brace before proceeding to buying the same. It is a further object of the invention to provide the aforementioned fully adjustable brace in a form appropriate for fitting within ordinary shoes thereby providing aesthetic approval and a capacity of the client patient to wear a plurality of different ordinary shoes with the brace that remains un-noticeable even from the most attentive observers.

Another object of the invention is to provide alternative embodiments of the aforementioned fully adjustable, ready to wear brace, such brace comprising a foot base portion articulated to a leg portion extending either all along the shank bone of the calf or extending further upwardly along the femur. BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be best understood by those skilled in the art by reference to the accompanying drawings in which:

Fig. 1 shows a perspective view of an adjustable orthopedic brace offered as an ankle- foot orthosis comprising a foot base portion and a calf covering portion pivotally connected by means of a pair of sole-raising spring assemblies.

Fig. Ia illustrates variation along the vertically extending axis y-y of the position of the transversally extending axis w-w passing through the points of pivotal connection of the sole-raising spring assemblies with a scope to align it with the axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation of each individual user.

Fig. Ib illustrates variation of the position of axis w-w passing through the points of pivotal connection of the sole-raising spring assemblies of the brace along the longitudinal axis z-z of the sole of the foot base portion.

Fig. Ic illustrates variation of the position of the transversally extending axis w-w of the sole-raising spring system of the brace along the transversal axis x-x of the sole of the foot base portion.

Fig. 2a shows the calf covering portion of the brace comprising a pair of spaced leg members generally extending from the dorsal portion of the foot along the skin to a point below the knee, each leg member consisting of a pair of adjustably engaged parts.

Fig. 2b shows a frontal view of the mated parts of the pair of spaced leg members of Fig. 2a and Fig. 2c shows a rear view of the same mated parts of the pair of spaced leg members of Fig. 2a.

Fig. 2d shows the calf covering portion of the brace comprising a pair of spaced leg members generally extending from the dorsal portion of the foot along the skin to a point below the knee, each leg member consisting of a single member produced in a plurality of different sizes to fit users with differing tibia dimensions.

Fig. 2e shows the calf covering portion of the brace comprising a pair of leg members having a curvilinear, helicoidal configuration and curvilinear slots or serial arrays of holes along the length thereof.

Fig. 2f shows leg members of Fig. 2e overlapping each other and fixedly connected together by means of a bolt-nut connector assembly. Fig. 2g shows fixedly connected leg members of Fig. 2f further provided with an upper strap means employed to adjustably connect the calf covering portion around the calf of the user close to the knee.

Fig. 2h shows the calf covering portion of Figs. 2e-2g with the strap means at a closed position and a further semi-circular strap means adapted to connect together the lower ends of the two leg members.

Fig. 3a shows a pair of upper strap members and a pair of lower strap members, such straps being employed for adjustably connecting together leg members of the calf covering portion of the brace of the invention. Fig. 3b shows the pair of upper strap members and the pair of lower strap members of Fig. 3a adjustably connected together to appropriately fit around the calf of the individual user.

Fig. 3c shows the calf covering portion of the embodiment depicted in Figs. 2a, 2b fitted with the pair of straps shown in Figs. 3a, 3b. Fig. 3d shows an exploded view of the leg members and straps employed in the calf covering portion depicted in Fig. 3 c.

Fig. 3e shows an exploded view of another strap arrangement employed in association with a calf covering portion comprising leg members as depicted in Fig. 2d.

Fig. 4a shows an illustrative embodiment of the sole raising spring assembly of the brace of the invention, each such assembly comprising a sole-raising spring mechanism of the malleolus medialis and a sole-raising mechanism of the malleolus lateralis and corresponding sole-shifting strips of the malleolus medialis and malleolus lateralis.

Fig. 4b shows the pair of sole-raising spring mechanisms of Fig. 4a connected to the corresponding pair of sole-shifting strips via bolt connector means.

Fig. 4c shows an illustrative perspective view of the brace of the invention.

Fig. 5a shows a pair of lateral sole flanges extending at the sides of a flat sole member of the foot base portion.

Fig. 5b shows the calf covering portion of the brace extending to the sole-raising spring assembly detached from the lateral sole flange shown underneath the same.

Fig. 5c shows a frontal and a rear side view of the calf covering portion of the brace extending to the sole-raising spring assembly connected to the lateral sole flange of the foot base portion of the brace.

Fig. 6a shows a plan view of the flat sole member employed in the foot base portion of the brace of the invention.

Fig. 6b shows an exploded planar view of the flat sole member and associated lateral sole flanges employed in the foot base portion of the brace of the invention.

Fig. 6c shows a planar view of the flat sole member and associated lateral sole flanges mounted thereupon. Figs. 6d and 6e show a side view of adjustable displacement of a lateral sole flange connected to a sole raising spring assembly device along and across the flat sole member of the foot base portion of the brace of the invention. Fig. 6f presents an alternative embodiment of the sole member being assembled from two independent mating parts.

Fig. 7a shows a perspective view of the brace with the lower foot base portion detached therefrom, such foot base portion provided as a single piece. Figs. 7b, 7c show planar views of the single piece sole item of Fig. 7a.

Fig. 8 shows a perspective view of the adjustable orthopedic brace of the invention offered as an ankle-foot orthosis and Fig. 8a shows a perspective view of the femur covering portion of the same.

Figs. 9a shows the femur covering portion of the brace comprising a pair of spaced members generally extending from a point above the knee, each member consisting of a pair of adjustably engaged parts.

Fig. 9b shows a frontal and a rear view of the mated parts of the pair of spaced members of Fig. 9a.

Fig. 9c shows an alternative embodiment with single piece leg members of the femur covering portion of the brace.

Fig. 9d shows a perspective rear view of the femur covering portion of the brace with the straps employed in the connection of its members.

Fig. 9e shows an exploded view of the members and straps employed in the femur covering portion depicted in Fig. 9d. Fig. 9f shows an exploded view of another strap arrangement employed in association with a femur covering portion comprising single piece leg members as depicted in Fig. 9c.

DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

The brace of the invention is adapted to provide dorsiflexion assistance to patients exhibiting the condition known as foot drop and is offered ready to' wear within ordinary shoes of any type. As shown in a first embodiment of the invention (Fig. 1), a talocrural brace, i.e. an ankle-foot orthosis (AFO) comprises a foot base portion 1 and a calf covering portion 2 that extends all along the shank bone of the calf. Alternatively as shown in a second embodiment of a femuro-talocrural brace in Fig. 8, the brace, i.e. a knee-ankle-foot orthosis (KAFO) further extends to a femur covering portion 4 extending upwardly the abovementioned calf covering portion 2. The foot base portion 1 is pivotally connected to the calf covering portion 2 by means of a sole- raising spring assembly 3, this connection in association with adjustable properties of each constituent part of the brace offering the capacity of the brace being fully adjustable in height, width, depth and length, depending on the body dimensions of the user. The above capacity of brace adjustment to appropriately fit a plurality of different users is established by means of the ability of variation of the dimensions of both the foot base portion 1 , of the calf covering portion 2, and of the femur covering portion 4 and by means of the capacity of varying the position of axis w-w that connects the points of pivotal connection of the sole-raising spring mechanisms 41, 42 with the corresponding sole-shifting strips 43, 44 of each one of the pair of outer and inner sole raising spring assemblies 3 employed in the connection of the foot base portion with the calf covering portion of the brace.

The brace of the invention is therefore provided with a capacity of adjusting the position of transversally extending axis w-w with a scope to align it with the axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation of each individual user (Fig. 4c).

The position of the transversally extending axis w-w to bring it in alignment with the axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation of the user is thus handily adjustable: a) along the vertically extending axis y-y depending on the height, i.e. on the distance from ground level of the transversally extending axis of the user's talocrural articulation (Fig. Ia). b) along the longitudinal axis z-z of the sole 50 of the foot base portion 1, as necessary in correspondence with the position of axis y-y (Fig. Ib), and c) along the transversal axis x-x of the sole 50 of the foot base portion 1, as necessary in correspondence with the distance between malleolus lateralis and malleolus medialis of the user's talocrural articulation (Fig. Ic).

Hereinbelow will be presented illustrative embodiments of the invention in relation to the individual constituent parts of the proposed brace.

The calf covering portion 2 comprises a tibia sheath consisting of a pair of spaced leg members generally extending from the dorsal portion of the foot along the skin to a point below the knee, each leg member having means for adjusting the length thereof and at least one strap adjustably connecting the pair of spaced leg members. In accordance with a preferred embodiment of the invention, a pair of straps, one lower strap 23 is provided close to the foot and another upper strap 24 is provided close to the knee of the user.

Fig. 2d shows a first embodiment of the pair of spaced leg members of the calf covering portion 2, wherein a first leg member 21 is the inner lateral tibia covering member and a second leg member 22 is the outer lateral tibia covering member. Leg members 21, 22 are manufactured in a production line in various sizes so that various sizes are available to fit the length of the tibia of different users. An array of clamping holes 21 ^' is provided at the bottom of leg member 21 and an equivalent array of clamping holes 22' is provided at the bottom of leg member 22, wherein these arrays of holes 21 ', 22^' mate with respective arrays of clamping holes provided onto the sole raising spring assemblies during connection of leg members 21, 22 to the corresponding sole raising spring assemblies as will be presented hereinafter.

In accordance to another illustrative preferred embodiment of the invention illustrated in Fig. 2e, leg members 21, 22 have a curvilinear, helicoidal configuration and curvilinear slots or serial arrays of holes 21b", 22b" are correspondingly provided along the length thereof. As shown in Fig. 2f, leg members 21, 22 overlap each other and a bolt-nut connector assembly 26 is employed to fixedly connect together the two leg members 21, 22 at a desired position of coincidence of the two slots or serial arrays of holes 21b", 22b" depending on the calf dimensions of each individual user. As shown in Fig. 2g, an upper strap means 27 extends at the upper end of leg member 21 and a strap receiving means 28 is arranged at the upper end of the other leg member 22, wherein this strap means is employed to adjustably connect the calf covering portion around the calf of the user close to the knee. Fig. 2h shows the calf covering portion of Figs. 2e-2g with the strap means at a closed position and a further semi-circular strap means 29 adapted to connect together the lower ends of the two leg members 21, 22 at two opposite points 29a, 29b thereof. The embodiment depicted in Figs. 2e-2f thus provides a calf covering portion of variable size that can be employed to fit different calf sizes of different users.

In accordance to an alternative embodiment of a calf covering portion of variable size is illustrated in Figs. 2a, 2b, 2c. In this embodiment the calf covering portion of the brace comprises a pair of spaced leg members generally extending from the dorsal portion of the foot along the skin to a point below the knee, wherein leg member 21 consists of a pair of adjustably engaged parts 21a, 21b and leg member 22 consists of a pair of adjustably engaged parts 22a, 22b. The upper parts 21a and 22a of the inner and outer lateral leg members 21, 22 are provided with an arrangement of clamping holes 21a' and 22a' respectively and on the other hand the lower parts 21b and 22b of the inner and outer lateral leg members 21, 22 are provided with a longitudinally extending slot 21b' and 22b' respectively. A pair of bolts 25 passing through clamping holes 21a' and 22a' is employed to adjustably connect the upper parts 21a, 22a to the lower parts 21b, 22b at any position along longitudinally extending slots 21b' and 22b' respectively depending on the physical dimensions of the calf of each individual user.

As mentioned hereinabove a pair of straps is employed for adjustably connecting together leg members 21, 22. In particular, one lower strap 23 is provided close to the foot and another upper strap 24 is provided close to the knee of the user. As shown in Fig. 3a each one of the straps 23, 24 comprises a pair of identical mating members 23a, 23b and 24a, 24b respectively. Members 23a, 23b are provided with longitudinal slots 23a', 23b' respectively and members 24a, 24b are provided with corresponding longitudinal slots 24a', 24b'. As mating members 23a, 23b and 24a, 24b come to a sliding contact (Fig. 3 b) bolt connector means 35 passing through coincident longitudinal slots 23a', 23b' and coincident longitudinal slots 24a', 24b' fixedly connect together the two mating members to fit appropriately around the calf of the individual user, thereby providing a calf covering portion of a variable width and depth. Leg members 21, 22 of the calf covering portion 2 are provided with an upper rear array of holes 31, 32 and with a lower rear array of holes 31 ', 32' and strap members 24a, 24b of the upper strap 24 are provided with equivalent arrays of holes 31a and 32a, whilst strap members 23 a, 23 b of the lower strap 23 are provided with equivalent arrays of holes 31a' and 32a'. Upper strap 24 is connected at the rear upper part of leg members 21, 22 through bringing strap holes 31a, 32a into coinciding contact with leg member holes 31, 32 respectively and employing clamping means to fixedly mount the upper strap 24 onto the rear upper part of leg members 21, 22. Equivalently, the lower strap 23 is connected at the rear lower part of leg members 21, 22 through bringing strap holes 31a', 32a' into coinciding contact with leg member holes 31 ', 32^' respectively and employing clamping means to fixedly mount the upper strap 24 onto the rear lower part of leg members 21, 22. In an alternative embodiment depicted in Fig. 3e the lower strap 23 and the upper strap 24 are a single item each and they may be provided in a variety of lengths to suit users with differing calf sizes. Alternatively adjustable connector means might be employed to account for such differing calf sizes. The two leg portions 21 , 22 of the calf covering portion 2 are further frontally connected by means of one or two adjustably connectable fastening means 33, 34 (Fig. 1).

The system of the sole-raising spring assembly 3 with talocrural articulation employed in the present invention is known in orthopaedics. There are many types of such systems, available from various companies, which are mainly used by talocrural brace manufacturers. This system is widely known as talocrural articulation with sole- raising spring.

For the better understanding of the present invention, the operation of the system of sole-raising spring assemblies 3 with talocrural articulation, as well as the manner in which it is used in the present invention, will be described hereinafter.

As shown in the illustrative embodiment depicted in Figs. 4a, 4b the sole raising spring assemblies 3 of the invention comprises the sole-raising spring mechanisms 41, 42 of the malleolus medialis and malleolus lateralis respectively and the corresponding sole-shifting strips 43, 44 of the malleolus medialis and malleolus lateralis. Bolt connector means 45 are employed in the connection of the sole-raising spring mechanisms 41, 42 with the sole-shifting strips 43, 44 respectively. Each of the sole-raising mechanisms 41, 42 is provided with a bottom aperture 41 " and 42" respectively and each of the sole-shifting strips 43, 44 is provided with an upper aperture 43 " and 44" respectively, whereby bolt connector means 45 appropriately pass through coincident 41 "-43 " and 42 "-44" to pivotally connect spring mechanisms 41, 42 to the corresponding sole-shifting strips 43, 44. Each of the sole- raising mechanisms 41, 42 is further provided with an array of holes 41 ', 42', which are brought into coinciding contact with the equivalent arrays of holes 21 ', 22' at the bottom end of leg members 21, 22 or leg member portions 21b, 22b respectively and clamping means passing through coincident arrays of holes 21 '-41 ' and 22 '-42' are appropriately employed to fixedly connect spring mechanisms 41, 42 at the bottom of leg members 21, 22 of the calf covering portion respectively.

The purpose of the sole-raising spring mechanisms of the malleolus medialis and malleolus lateralis 41, 42 is to allow movement of the sole. This is achieved by the springs (not shown) respectively incorporated within the sole-raising spring mechanisms 41, 42, which push the corresponding sole-shifting strips 43, 44 of the malleolus medialis and malleolus lateralis, which are in turn fixedly connected to the foot base portion 1 of the brace.

The sole-raising spring assembly 3 with talocrural articulation can be arranged only at one side of the brace and not on both sides. In particular, the sole-raising spring assembly 3 with talocrural articulation may consist of only the system of sole-raising spring assembly with talocrural articulation of the malleolus medialis, i.e. it may only comprise the pair of members 41, 43 or it may consist only of the sole-raising spring assembly with talocrural articulation of the malleolus laterialis, i.e. it may only comprise the pair of members 42, 44.

The foot base portion 1 comprises a flat sole member 50 (Fig. 6a) that extends outwardly to the sides of the foot and forwardly from the heel towards the toes. Sole member 50 extends to a pair of identical lateral sole flanges 53, 54, which are depicted in Fig. 5a and which comprise an array of holes 53', 54' respectively. Sole member 50 is provided with a pair of elongated slots 50a' longitudinally arranged at the left side thereof and with a pair of equivalent elongated slots 50b' longitudinally arranged at the right side thereof, such slots being provided with a scope of connection to the abovementioned lateral sole flanges 53, 54.

The sole-shifting strips 43, 44 of the malleolus medialis and malleolus lateralis are provided with a bottom array of holes 43', 44' respectively. The sole-shifting strips

43, 44 of the malleolus medialis and malleolus lateralis are fixedly connected correspondingly onto the abovementioned lateral sole flanges 53, 54 by means of bolts passing through coincident arrays of holes 43 '-53' and 44'-54' (Fig. 5c) Alternatively the sole-shifting strips may be connected directly to the sole member 50 by means of adjustable connectors as will be presented hereinafter by reference to the embodiment shown in Fig. 7. The lateral sole flanges of the malleolus medialis and malleolus lateralis 53, 54 extend generally vertically upwardly and at the bottom thereof they extend to a horizontally turned surface 53a and 54a respectively, each horizontally turned surface 53a, 54a provided with a pair of slots 53a' and 54a' respectively. Guide bolts 55 passing through elongated slots 50a^' of the sole member 50 and coincident slots 53a' of lateral sole flange 53 and through elongated slots 50b' of the sole member 50 and coincident slots 54a' of lateral sole flange 54 are employed to adjustably connect lateral sole flanges 53, 54 to the flat sole member 50 (Figs. 6b, 6c). As lateral sole flanges 53, 54 slide along the surface of the flat sole member 50, they may be fixed at the desired point thereby allowing the variation of the width of the brace at the heel part (Fig. 6e). In other words, the width of the brace at the area of the heel (the range of the transverse horizontal axis x-x of the talocrural articulation) is adjusted depending on the width, i.e. the distance between malleolus medialis and malleolus lateralis (Fig. Ic) and at the same time the forward or backward motion of lateral sole flanges and the corresponding fixing of the sole-raising spring assembly with talocrural articulation along the longitudinal axis z-z of sole member 50 is allowed as required (Fig. 6d). In other words, the brace of the invention allows displacement of the sole- raising spring assembly 3 with talocrural articulation along the longitudinal axis of the sole, as this is imposed by the position of the tranverse-horizontal axis of the talocrural articulation (axis of malleolus medialis/lateralis) in relation to the vertical axis of the talocrural articulation (ankle) of the user.

The sole member 50 and sole flanges 53, 54 are in-line manufactured and are made of thermoplastic material, aluminum, carbon or other material with the same properties.

The lateral sole flanges 53, 54 are mounted at the ends of the sole-shifting strips of the malleolus medialis and malleolus lateralis 43, 44 respectively (Fig. 4c) or only at the end of the sole-shifting strip of the malleolus medialis if the brace is accompanied by a sole-raising spring assembly with talocrural articulation of the malleolus medialis only or only at the end of the sole-shifting strip of the malleolus lateralis if the brace is accompanied by a sole-raising spring assembly with talocrural articulation of the malleolus lateralis only. Mounting of the lateral sole flanges 53, 54 at the ends of the sole-shifting strips of the malleolus medialis and malleolus lateralis 43, 44 respectively is implemented either a) by means of fixedly mounted clamping means in the case that the sole-shifting strips are produced in various heights thereby ensuring: the height adjustment of the position of the horizontal-transverse axis of the articulation of the sole-raising spring system in relation to the sole, depending on the height of the horizontal-transverse axis of the talocrural articulation (ankle), axis of malleolus medialis/lateralis of the user from the ground) or b) by means of adjustable connectors, adjusting the height position of the horizontal-transverse axis of the articulation of the sole-raising spring assembly in relation to the sole, depending on the height of the horizontal-transverse axis of the talocrural articulation (ankle) axis of malleolus medialis-lateralis of the user from the ground.

In accordance to another embodiment of the invention, connection of sole member 50 to the lateral sole flanges 53, 54 is implemented by adjustable connectors, thereby ensuring a) adjustment of the width of the brace at the heel area (Fig. Ic), and b) adjustment of the position of the axis of the articulation of the sole-raising spring system, along the longitudinal horizontal axis of the sole, as this is imposed by the position of the transverse-horizontal axis of the talocrural articulation (ankle) in relation to the vertical axis of the talocrural articulation of the user (Fig. Ib).

In accordance to another embodiment of the invention, the foot base portion 1 of the brace of the invention is a single item (Fig. 7a), comprising a flat sole member 50 incorporating lateral sole flanges 53, 54. It is produced in various widths as regards the heel part (Fig. 7b) and in various lengths (depending on the size of the user's shoe) (Fig. 7c), thereby ensuring adjustment of the width of the brace at the heel area. At least one of the lateral sole flanges 53, 54 is again provided with arrays of holes 53' and/or 54' to allow connection to the corresponding sole-shifting strips 43, 44 of the malleolus medialis and malleolus lateralis.

In accordance to a first embodiment of the invention the connection of the sole to the sole-shifting strip(s) is achieved by clamping means for fixedly mounting, whereby the clamping means receiving area on the lateral sole walls vary in size and as the sole is increased lengthwise, these are shifted to the front (along the longitudinal horizontal axis of the sole) and higher (along the vertical-perpendicular axis of the sole) for the various sizes of the sole, thereby ensuring adjustment of the position of the horizontal - transverse axis w-w of the articulation of the sole-raising spring system in relation to the sole, depending on the height of the horizontal-transverse axis of the talocrural articulation (ankle) and on the position of the sole-raising spring assembly along the longitudinal horizontal axis of the sole.

In accordance to a second embodiment of the invention the connection of the sole to the sole-shifting strip(s) is alternatively achieved by adjustable connectors that allow position adjustment forwardly and backwardly, as well as the top or bottom position, whereby the ends of the metallic sole shifting strips 43, 44 should be fixed based on the needs of the individual user (depending on the axis of the talocrural articulation), thereby ensuring the desired adjustment. The sole consists of a pair of half-soles, in particular the inner half-sole 50a and the outer half-sole 50b as shown in Fig. 6f. It is obtained from a flat surface that is being cut in the middle and along the longitudinal axis thereof to provide the two halves 50a, 50b, these two halves being respectively connected to the lateral sole flanges 53, 54 shown in Fig. 5a. Alternatively the two half-soles are produced with the lateral sole flanges incorporated therein as adjacently shown denoted by numerals 60a, 60b in the same Fig. 6f wherein adjustable connector elements 58 inserted in between the two half soles are shown. Different lengths of the half sole members account for different lengths of shoes, whereas different widths can be obtained through variation of the width of the connector element 58. The connection of the sole depicted in Fig. 6f with the sole shifting strip(s) is effected in any of the alternative modes presented hereinabove.

In accordance to a further embodiment of the invention as shown in Fig. 8, the fully adjustable, shoe-internal, ankle-foot orthosis (Fig. 1) with articulation having a sole- raising spring assembly may constitute the lower part of a femoral-talocrural brace, i.e. of a knee-ankle-foot orthosis that extends, connected by counter-supports with or without a knee articulation, to an upper femoral covering portion 4. The femoral covering portion 4 consists of a pair of spaced members 11, 12 generally extending upwardly from the knee, each member having means for adjusting the length thereof and at least one strap adjustably connecting the pair of spaced members 71, 72. In accordance to a preferred embodiment of the invention a pair of straps, one lower strap 73 is provided close to the knee and another upper strap 74 is provided distantly from the knee of the user.

Fig. 9c shows a first embodiment of the pair of spaced members of the femoral covering portion 4, wherein a first member 71 is the inner lateral femoral covering member and a second member 72 is the outer lateral femoral covering member. Members 71, 72 are manufactured in a production line in various sizes so that various sizes are available to fit the desired length of coverage upwardly from the knee of different users.

In accordance to an alternative embodiment of the invention, a femoral covering portion 4 of variable size is illustrated in Figs. 9a, 9b. In this embodiment the femoral covering portion of the brace comprises a pair of spaced members 71, 72 generally extending upwardly from the knee of the user, wherein member 71 consists of a pair of adjustably engaged parts 71a, 71b and member 72 consists of a pair of adjustably engaged parts 72a, 72b. The upper parts 71a and 72a of the inner and outer members 71, 72 are provided with an arrangement of clamping holes 71a' and 72a' respectively and on the other hand the lower parts 71b and 72b of the inner and outer members 71, 72 are provided with a longitudinally extending slot 71b' and 72b' respectively. A pair of bolts 75 passing through clamping holes 71a' and 72a' is employed to adjustably connect the upper parts 71a, 72a to the lower parts 71b, 72b at any position along longitudinally extending slots 71b' and 72b' respectively depending on the physical dimensions of the femur of each individual user.

As mentioned hereinabove a pair of straps is employed for adjustably connecting together members 71, 72 of the femoral covering portion 4. In particular, one lower strap 73 is provided close to the knee and another upper strap 74 is provided upwardly and distantly from the knee of the user. Straps 73, 74 are preferably similar to those employed in the connection of leg members 21, 22 of the calf covering portion 2. As shown in Fig. 9e each one of the straps 73, 74 comprises a pair of identical mating members 73a, 73b and 74a, 74b respectively. Members 73a, 73b are provided with longitudinal slots 73a^', 73b' respectively and members 74a, 74b are provided with corresponding longitudinal slots 74a', 74b'. As mating members 73 a, 73 b on one part and mating members 74a, 74b on the other part come to a sliding contact (Fig. 9e) bolt connector means 85 passing through coincident longitudinal slots 73a', 73b' and coincident longitudinal slots 74a', 74b' fixedly connect together the two mating members of the lower strap and of the upper strap respectively to fit appropriately around the femur of the individual user, thereby providing a femur covering portion of a variable width and depth. Members 71, 72 of the femoral covering portion 4 are provided with an upper rear array of holes 81, 82 and with a lower rear array of holes 81 ', 82' and strap members 74a, 74b of the upper strap 74 are provided with equivalent arrays of holes 81a and 82a, whilst strap members 73a, 73b of the lower strap 73 are provided with equivalent arrays of holes 81a' and 82a'. Upper strap 74 is connected at the rear upper part of members 71, 72 through bringing strap holes 81a, 82a into coinciding contact with member holes 81, 82 respectively and employing clamping means to fixedly mount the upper strap 74 onto the rear upper part of members 71, 72. Equivalently, the lower strap 73 is connected at the rear lower part of members 71, 72 through bringing strap holes 81a^', 82a' into coinciding contact with member holes 81 ', 82' respectively and employing clamping means to fixedly mount the upper strap 74 onto the rear lower part of members 71, 72. In an alternative embodiment depicted in Fig. 9f the lower strap 73 and the upper strap 74 are a single item each and they may be provided in a variety of lengths to suit users with differing calf sizes. Alternatively adjustable connector means might be employed to account for such differing calf sizes. The two portions 71, 72 of the femur covering portion 4 are further frontally connected by means of one or two adjustably connectable fastening means 36, 37 (Fig. 8).

For the better understanding of all the possible applications of the individual parts of the invention, as described hereinabove, it is considered that a variety of means may be employed in the connection of individual parts of the proposed adjustable brace, i.e. bolt and nut assemblies, rivets, pins, gluing, press-fitting or insertion by compression. Adjustable connectors might also be employed, such as vertical or horizontal slots with a guide-bolt and nut assembly, arrays of holes with a guide bolt and nut assembly, holes with rivets, holes with pins, male-female Velcro straps, strips made of plastic, aluminum, iron, carbon, which may match at variable lengths, strips made of plastic, aluminum, iron, carbon, provided with holes, velcro straps, etc.

Independent connecting parts, such as strips made of aluminum, iron, thermoplastic, carbon, metal or cloth might also be employed which are connected at varying length or width. The term adjustable connector also comprises the case where one part is made so that it is inserted (as a sandwich) within another part and can be shifted in the longitudinal direction and can be fixed at the desired point.

The proposed AFO and/or KAFO is advantageous in that it is fully adjustable to fit any user, is easy to handle and apply either by the user himself or by an assistant person, it is optimally functional due to the adjustment of the axis of articulation of the sole-raising spring assembly thereof, it is ready to try and buy, it is optimally light weight, it is efficient in providing dorsiflexion assistance to the foot of the wearer and it is discrete, not easily observable even by an attentive observer.

While hereinabove the invention has been described by reference to various preferred embodiments, it is to be appreciated that these are for illustrative purposes only and that those skilled in the art will realize that changes and modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as falling within the scope of the invention.

Claims

1. An orthopaedic brace for foot drop and similar conditions comprising a foot base portion (1) and a leg portion (2, 4), said foot base portion (1) being pivo tally connected to said leg portion (2, 4) by means of a pair of an outer sole raising spring assembly (3) and an inner sole raising spring assembly (3), said leg portion (2, 4) extending either all along the shank bone of the calf or further upwardly along the femur, each one of said pair of outer and inner sole raising spring assemblies (3) comprising a sole-raising spring mechanism (41, 42) pivotally connected to a corresponding sole-shifting strip (43, 44), a transversally extending axis (w-w) being defined as the axis connecting the points of pivotal connection of said sole-raising spring mechanisms (41, 42) with said corresponding sole-shifting strips (43, 44), characterised in that said brace being provided ready to wear within ordinary shoes of any type and being fully adjustable to fit a variety of shoe and leg sizes of any individual user with both said foot base portion (1) and said leg portion (2, 4) comprising means of adjusting their dimensions to the physical requirements of any individual user and with a capacity of adjusting the position of said transversally extending axis (w-w) with a scope to align it with the axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation of each individual user, said sole-raising spring assembly (3) being handily adjustable: a) along a vertically extending axis (y-y) depending on the height, i.e. the distance from ground level of the axis of the user's talocrural articulation; b) along a longitudinal axis (z-z) of a sole member (50) of the foot base portion (1), as necessary and in correspondence with the position of axis (y-y), and c) along a transversal axis (x-x) of said sole member (50) of the foot base portion (1), as necessary in correspondence with the distance between malleolus lateralis and malleolus medialis of the user's talocrural articulation.

2. An orthopaedic brace for foot drop and similar conditions as claimed in claim

1, characterised in that the brace is offered as an ankle-foot orthosis and said leg member (2, 4) comprises a calf covering portion (2) consisting of a pair of spaced leg members generally extending from the dorsal portion of the foot along the skin to a point below the knee, each leg member having means for adjusting the length thereof and at least one strap adjustably connecting the pair of said spaced leg members.

3. An orthopaedic brace for foot drop and similar conditions as claimed in claim

2, characterised in that said pair of spaced leg members of the calf covering portion (2) comprises a first leg member (21) and a second leg member (22), said leg members (21, 22) being manufactured in a production line in various sizes so that various sizes are available to fit the length of the tibia of different users, an array of clamping holes (21 ') being provided at the bottom of said leg member (21) and an equivalent array of clamping holes (22') being provided at the bottom of said leg member (22), said arrays of holes (21 ', 22^') mating with respective arrays of clamping holes (41 ', 42') provided onto said mechanisms (41, 42) of the sole raising spring assemblies (3) during connection of said leg members (21, 22) to the corresponding sole raising spring assemblies (3).

4. An orthopaedic brace for foot drop and similar conditions as claimed in claim 2, characterised in that said pair of spaced leg members of the calf covering portion

(2) have a curvilinear, helicoidal configuration and curvilinear slots or serial arrays of holes (2Ib", 22b") are correspondingly provided along the length thereof, said leg members (21, 22) overlapping each other, a bolt-nut connector assembly (26) being employed to fixedly connect together said overlapping leg members (21, 22) at a desired position of coincidence of two slots or serial arrays of holes (2Ib", 22b^") depending on the calf dimensions of each individual user.

5. An orthopaedic brace for foot drop and similar conditions as claimed in claim 2, characterised in that said pair of spaced leg members of the calf covering portion (2) comprises a leg member (21) consisting of a pair of adjustably engaged parts (21a, 21b) and a leg member (22) consisting of a pair of adjustably engaged parts (22a, 22b), wherein the upper parts (21a) and (22a) of said leg members (21, 22) are provided with an arrangement of clamping holes (2Ia') and (22a') respectively and on the other hand the lower parts (21b) and (22b) of leg members (21, 22) are provided with a longitudinally extending slot (2Ib') and (22b') respectively, a pair of bolts (25) passing through clamping holes (2Ia') and (22a') being employed to adjustably connect the upper parts (21a, 22a) to the lower parts (21b, 22b) at any position along longitudinally extending slots (2Ib') and (22b') respectively depending on the physical dimensions of the calf of each individual user.

6. An orthopaedic brace for foot drop and similar conditions as claimed in claims 2-5, characterised in that a pair of straps (23, 24) is employed for adjustably connecting together said leg members (21, 22), one lower strap (23) being provided close to the foot and another upper strap (24) being provided close to the knee of the user, each one of said straps (23, 24) comprising a pair of identical mating members (23a, 23b) and (24a, 24b) respectively, said members (23a, 23b) being provided with longitudinal slots (23a', 23b') respectively and said members (24a, 24b) being provided with corresponding longitudinal slots (24a', 24b'), wherein, as mating members (23a, 23b) and (24a, 24b) come to a sliding contact, bolt connector means (35) passing through coincident longitudinal slots (23a', 23b') and coincident longitudinal slots (24a', 24b') fixedly connect together the two mating members to fit appropriately around the calf of the individual user, thereby providing a calf covering portion of a variable width and depth, said leg members (21, 22) of the calf covering portion (2) being provided with an upper rear array of holes (31, 32) and with a lower rear array of holes (31 ', 32') and said strap members (24a, 24b) of the upper strap (24) being provided with equivalent arrays of holes (31a, 32a), whilst strap members (23a, 23b) of the lower strap (23) are provided with equivalent arrays of holes (3Ia', 32a'), said upper strap (24) being connected at the rear upper part of leg members (21, 22) through bringing strap holes (31a, 32a) into coinciding contact with leg member holes (31, 32) respectively and employing clamping means to fixedly mount the upper strap (24) onto the rear upper part of leg members (21 , 22), whilst equivalently, the lower strap (23) is connected at the rear lower part of leg members (21, 22) through bringing strap holes (3Ia', 32a') into coinciding contact with leg member holes (31 ', 32^') respectively and employing clamping means to fixedly mount the lower strap (23) onto the rear lower part of leg members (21, 22).

7. An orthopaedic brace for foot drop and similar conditions as claimed in claim 1, characterised in that said sole raising spring assemblies (3) comprise sole-raising spring mechanisms (41, 42) and corresponding sole-shifting strips (43, 44), bolt connector means (45) being employed in the connection of the sole-raising spring mechanisms (41, 42) with the sole-shifting strips (43, 44) respectively, each of the sole-raising mechanisms (41, 42) being provided with a bottom aperture (41 ", 42") respectively and each of the sole-shifting strips (43, 44) being provided with an upper aperture (43", 44") respectively, whereby bolt connector means (45) appropriately pass through coincident apertures (41 "-43") and (42 "-44") to pivotally connect spring mechanisms (41, 42) to the corresponding sole-shifting strips (43, 44), each of the sole-raising mechanisms (41, 42) being provided with an array of holes (41 ^', 42^'), which are brought into coinciding contact with the equivalent arrays of holes (21 ^', 22') at the bottom end of leg members (21, 22) respectively and clamping means passing through coincident arrays of holes (21 '-41 ') and (22 '-42') are appropriately employed to fixedly connect spring mechanisms (41, 42) at the bottom of leg members (21, 22) of the calf covering portion respectively.

8. An orthopaedic brace for foot drop and similar conditions as claimed in claim 1, characterised in that said foot base portion (1) comprises a flat sole member (50) extending outwardly to the sides of the foot and forwardly from the heel towards the toes, said sole member (50) extending to a pair of identical lateral sole flanges (53, 54), said flanges (53, 54) comprising an array of holes (53', 54') respectively, said sole member (50) being provided with a pair of elongated slots (50a') longitudinally arranged at the left side thereof and with a pair of equivalent elongated slots (5Ob^') longitudinally arranged at the right side thereof, such slots being provided with a scope of adjustable connection to said lateral sole flanges (53, 54) to fit shoe sizes of different users, said lateral sole flanges (53, 54) being connected to the corresponding sole-shifting strips (43, 44) of the sole-raising spring assemblies (3), said sole shifting strips (43, 44) being provided with a bottom array of holes (43', 44') for fixedly connecting correspondingly onto said flanges (53, 54) by means of bolts passing through coincident arrays of holes (43 '-53') and (44'-54'), said lateral sole flanges (53, 54) extending generally vertically upwardly and at the bottom thereof extending to horizontally turned surfaces (53a, 54a), each horizontally turned surface (53a, 54a) provided with a pair of slots (53a', 54a'), guide bolts (55) passing through elongated slots (50a') of the sole member (50) and coincident slots (53a') of lateral sole flange (53) and through elongated slots (5Ob') of the sole member (50) and coincident slots (54a') of lateral sole flange (54) being employed to adjustably connect lateral sole flanges (53, 54) to the flat sole member (50) thereby allowing variation of the width of the brace at the heel part.

9. An orthopaedic brace for foot drop and similar conditions as claimed in claim 1, characterised in that said foot base portion (1) comprises a pair of half-soles, in particular an inner half-sole (50a) and an outer half-sole (50b), said two half soles (50a, 50b) being respectively connected to the lateral sole flanges (53, 54) with an adjustable connector element (58) inserted in between the two half soles, wherein different lengths of half sole members account for different lengths of shoes, whereas different widths can be obtained through variation of the width of the connector element (58).

10. An orthopaedic brace for foot drop and similar conditions as claimed in claim 1 , characterised in that the brace is offered as a knee-ankle-foot orthosis and said leg member (2, 4) comprises a calf covering portion (2) extending to a femoral covering portion (4), said femoral covering portion (4) consisting of a pair of spaced members (71, 72) generally extending upwardly from the knee, each member (71, 72) having means for adjusting the length thereof and at least one strap adjustably connecting the pair of spaced members (71, 72), wherein one lower strap (73) is provided close to the knee and another upper strap (74) is provided distantly from the knee of the user.

11. An orthopaedic brace for foot drop and similar conditions as claimed in claim 10, characterised in that said pair of spaced members (71, 72) of the femoral covering portion (4) are manufactured in a production line in various sizes so that various sizes are available to fit the desired length of coverage of the femur upwardly from the knee of different users.

12. An orthopaedic brace for foot drop and similar conditions as claimed in claim 10, characterised in that said pair of spaced members (71, 72) of the femoral covering portion (4), member (71) consists of a pair of adjustably engaged parts (71a, 71b) and member (72) consists of a pair of adjustably engaged parts (72a, 72b), wherein the upper parts (71a, 72a) of said pair of members (71, 72) are provided with an arrangement of clamping holes (7Ia', 72a') respectively and the lower parts (71b, 72b) of said pair of members (71, 72) are provided with a longitudinally extending slot (7Ib') and (72b') respectively, a pair of bolts (75) passing through clamping holes (7Ia') and (72a') being employed to adjustably connect the upper parts (71a, 72a) to the lower parts (71b, 72b) at any position along longitudinally extending slots (7Ib^') and (72b') respectively depending on the physical dimensions of the femur of each individual user, wherein a pair of straps is employed for adjustably connecting together members (71, 72) of the femoral covering portion (4), one lower strap (73) being provided close to the knee and another upper strap (74) being provided upwardly and distantly from the knee of the user, said straps (73, 74) comprising a pair of identical mating members (73 a, 73 b) and (74a, 74b) respectively, said members (73a, 73b) being provided with longitudinal slots (73a', 73b') respectively and said members (74a, 74b) being provided with corresponding longitudinal slots (74a', 74b'), wherein, as mating members (73a, 73b) on one part and mating members (74a, 74b) on the other part come to a sliding contact, bolt connector means (85) passing through coincident longitudinal slots (73a', 73b') and coincident longitudinal slots (74a', 74b') fixedly connect together the two mating members of the lower strap and of the upper strap respectively to fit appropriately around the femur of the individual user, thereby providing a femur covering portion of a variable width and depth, said members (71, 72) of the femoral covering portion (4) being provided with an upper rear array of holes (81, 82) and with a lower rear array of holes (81 ', 82^') and strap members (74a, 74b) of the upper strap (74) are provided with equivalent arrays of holes (81a, 82a), whilst strap members (73a, 73b) of the lower strap (73) are provided with equivalent arrays of holes (8Ia', 82a'), the upper strap (74) being connected at the rear upper part of members (71, 72) through bringing strap holes (81a, 82a) into coinciding contact with member holes (81, 82) respectively and employing clamping means to fixedly mount the upper strap (74) onto the rear upper part of members (71, 72) and equivalently the lower strap (73) being connected at the rear lower part of members (71, 72) through bringing strap holes (8Ia', 82a') into coinciding contact with member holes (81 ', 82') respectively and employing clamping means to fixedly mount the lower strap (73) onto the rear lower part of members (71, 72).