Drop foot is a deficit in turning the ankle and toes upward. The individual with drop foot 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 and leading to inability of the leg to dorsiflex the foot. Conditions leading to drop foot 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 hitting upon the slightest rise in a walk way.
In order to assist drop foot patients to walk properly, i.e. in order to provide dorsiflexion assistance to the foot of the wearer, the calf and the foot ankles can be stabilized by means of specially configured customized braces adapted to assist with drop foot conditions.
A variety of braces particularly adapted to assist with drop foot 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 simulating normal foot function since the plastic posterior brace item hinged the foot base portion with a single hinge assembly located 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.
The creation of a brace that accomplished a pair of hinge assemblies located on either side of the foot proximally to the ankle and at an orientation such as to have the line passing through this pair of hinge assemblies at approximate alignment with the actual axis passing through the malleolus lateralis and malleolus medialis of the talocrural articulation was made necessary in order to have the brace providing simulation of a nearly normal foot function. Such a brace with a bilateral hinge assembly was thus developed as a customized product with such hinge assembly comprising a sole-raising spring mechanism of the malleolus medialis and a sole-raising mechanism of the malleolus lateralis. Each hinge assembly of such a typical customized foot brace adapted to provide ankle-foot-orthosis (AFO) of the prior art comprises two constituent members, a first member appropriately connected at each one of a pair of the rear upwardly extending lateral flanges of the foot base portion of the brace and a second spring loaded member connected at each one of a pair of bottom ends of the calf covering portion, such second spring loaded members being pivotally connected to the first members and acting so as to maintain the foot base portion at a predetermined appropriate angle with respect to the calf covering portion, thereby providing a nearly normal walking performance of the patient wearing the brace. Several bolts are employed in securing each one of the abovementioned first members of the hinge assembly to the upwardly extending lateral flanges of the foot base portion of the brace and further several bolts are employed in securing each one of the abovementioned second members of the hinge assembly to the bottom ends of the corresponding calf portion. This plurality of bolts constitutes a potential source of malfunction as one or more of these bolts may in the course of time become loose thereby adversely affecting the performance of the brace. Further such a plurality of bolts necessarily increases the cost of assembling the brace, leads to inferior aesthetics of the brace, whilst it may also cause discomfort to the user wearing the drop foot correcting brace. Most importantly such a brace adapted to provide ankle-foot-orthosis (AFO) is an expensive customized product and the patient must conform with the undesirable practice of ordering and waiting for delivery of a product without having tried it.
Indeed, under the present practice of customized production of braces, the individual has to order and buy a brace product that is not readily available for trial and therefore he or she has no idea of the assistance this product might offer to him or her. A typical purchase of a brace involves measurements made on the individual patient, a plaster model being developed in accordance to these measurements, the final brace product being thereafter developed to correspond with such plaster brace model. Thus, one has to wait for delivery and yet he may also have to compromise with the employment of heavy and/or aesthetically deficient orthopaedic shoes that will make his problem apparent at first sight.
A variety of prior art orthopedic braces adapted to provide dorsiflexion assistance and handle drop foot problems comprising bilaterally provided hinge assemblies that connect a foot base portion with a calf covering portion at the region of the talocrural articulation are illustratively disclosed in EP 1374810 and US 2002/0188238. These braces present the drawbacks and deficiencies mentioned hereinabove.
A further drawback of drop foot braces of the prior art is that they fail to take into account possible additional malfunctioning of the foot of a drop foot patient that if left unattended can result in getting inferior results from the usage of the drop foot correcting brace per se. In particular foot misalignment can result in many forms of discomfort for the patient. Symptoms known to develop from such misalignment are plantar fasciitis, hammertoes, bunions, achilles tendonitis, and others, such foot misalignment possibly also causing or exacerbating knee, hip or back pain. More particularly, structural misalignment of the foot is generally localized to either the fore foot or the rear foot or combinations of both. These structural abnormalities may be generically classified as either of the varus or valgus type. The valgus abnormality refers specifically to a sole position, or of any part of the foot, wherein the sole is turned outward or is being everted, that is away from the body midline to an abnormal degree, whilst the varus abnormality, on the other hand, is a condition of the sole, or of any part of the foot, wherein the sole is turned inward or is being inverted, that is towards the body midline to an abnormal degree.
Previous prior art devices applicable to a shoe or insole in a shoe that have been designed to correct structural abnormalities of the abovementioned types are known. By way of example, U.S. Pat. Nos. 4,333,472 and 5,345,701 have disclosed such devices. Further, U.S. Pat. No. 7,299,568 discloses an orthopaedic foot device that is to be applied to the human foot, to be disposed in footwear and worn for the correction and/or compensation of specifically identified structural biomechanical abnormalities of the human foot. There is however no provision being made in the prior art to correct foot malfunctioning of the varus or valgus type in association with braces specifically designed to handle drop foot problems.
A first object of the invention with a scope of substantially minimizing the cost of the drop foot correcting orthopedic brace with bilaterally provided sole-raising hinge assemblies is to propose an industrial process of brace manufacturing instead of the customized brace production of the prior art, wherein the brace comprises an injection molding manufactured foot base portion and an injection molding manufactured calf covering portion, wherein the first members of each hinge assembly adapted to be connected at the rear upwardly extending lateral flanges of the foot base portion of the brace are fixedly embedded within such lateral flanges and the second spring loaded members adapted to be connected at each one of a pair of bottom ends of the calf portion are alternatively fixedly embedded within such bottom ends of the calf portion or appropriately bolted thereupon, thereafter said industrially produced foot base portion being connected to said industrially produced calf covering portion through pivotal connection of said first and second member of the bilaterally provided hinge assemblies thereof.
It is a further object of the invention to provide the aforementioned drop foot correcting orthopedic brace with endless screw members replacing the bilaterally provided compression springs of the sole-raising hinge assemblies, wherein the endless screw member advances downwardly as it is being screwed within a cavity provided in the abovementioned otherwise spring loaded member of the calf portion and exerts pressure upon the first hinge assembly member that is embedded within the lateral flanges of the foot base portion, whereby the brace of the invention can be employed with a scope of providing assistance to persons suffering from ippopodia (Pes equinus), a permanent deformation of the foot in plantar flexion, such ippopodia corrective assistance especially being used during night resting.
It is a further object of the invention to propose a shoe-internal brace, and in particular an ankle-foot orthosis (AFO) and a knee-ankle-foot orthosis (KAFO) brace product that will be offered ready to wear so that a potential client may readily try the brace before proceeding to buying the same at his full satisfaction.
It is further an object of the invention to provide such ready-to-wear braces at a substantially lower cost than that of customized braces of the prior art, yet providing a fully satisfactory performance in accomplishing the scope of drop foot correction and enable a comfortable use for each individual customer patient.
A further object of the invention is to provide a sufficiently necessary range of distinctly sized braces with appropriately sized foot base portions and correspondingly sized calf covering portions to fit most patients in need of a brace adapted to provide a drop foot correcting capacity wherein a potential customer is provided with a variety of such distinctly sized braces amongst which he or she may choose the appropriately sized brace and readily wear it to fit his or her particular requirements.
It is a further object of the invention to provide the aforementioned brace in a form appropriate for fitting within ordinary shoes thereby providing aesthetic approval and a capacity of the customer patient to wear a plurality of different ordinary shoes with the brace remaining un-noticeable even from the most attentive observers.
It is a further object of the invention to provide the aforementioned calf covering portion of the brace with a pair of an upper and a lower strap fastener profiles that cooperate in providing a firm adjustment of the brace onto the leg of each individual user.
It is a further object of the invention taking into account possible mobility deficiencies of the right or of the left side of each individual user to provide handy usage of the abovementioned upper strap fastener profile of the calf covering portion with either clockwise or anticlockwise rotation of the strap around the calf covering portion of the leg of the user.
It is a further object of the invention to provide handy usage of the abovementioned lower strap fastener profile of the calf covering portion with a scope of providing correction of structural misalignment of the foot of either the varus or the valgus type.
Another object of the invention is to provide alternative embodiments of the aforementioned ready to wear brace, such brace comprising a foot base portion articulated to a leg covering portion extending either all along the shank bone of the calf or extending further upwardly along the femur.
A further object of the invention is to illustratively provide a predetermined number of distinct sizes within a sufficiently necessary range of distinctly sized braces, whereby each individual customer is expected to fulfill his or her particular requirements through choosing one of these available sizes in the aforementioned sufficiently necessary range of distinctly sized braces.