EP4674302A1

EP4674302A1 - Flexible silicon steel device for the correction of hallux valgus

Info

Publication number: EP4674302A1
Application number: EP25187229.7A
Authority: EP
Inventors: Luigi Martino Perrone
Original assignee: Miglietta Gianluca; Perrone Gionata; Perrone Marzia
Current assignee: Miglietta Gianluca; Perrone Gionata; Perrone Marzia
Priority date: 2024-07-04
Filing date: 2025-07-03
Publication date: 2026-01-07

Abstract

Valgus correction device, comprising at least one lower insole (1) provided on top with a counter-insole (2) and a positioning lever (3) fixed to the lower insole (1) along the area accomodating the big toe when worn, and having an elongated S-shape, passing through the first phalanx and then through a point between the end of the metatarsals and the beginning of the cuneiforms, including a connection band (5), an adjustment element (6) associated, on the one hand, with the lower insole (1), in a section where the latter supports the medial arch of the foot, and on the other hand, with the said connection band (5), where the fulcrum of the lever (4) is located at a point between the second phalanx and the metatarsal of the big toe.

Description

Of the invention entitled: flexible silicon steel device for the correction of hallux valgus

SCOPE OF APPLICATION

This invention refers to a device usable for correcting anatomical or gait-related defects, and more specifically applies to individuals affected by hallux valgus. More particularly, it refers to a brace designed to be inserted inside the footwear.

STATE OF THE ART

Hallux valgus is a known foot pathology characterized by a progressive deformation of the joint between the first metatarsal and the basal phalanx of the big toe, which involves the outward displacement of the foot at the base of the big toe and the adduction deviation of the tip of the big toe itself toward the other toes, due to an imbalance between the extrinsic and intrinsic muscles of the foot and the ligamentous structures. To define it as such, the deviation has to be greater than 20 degrees with regard to the physiological position.
The development of the pathology may cause intense pain and limited mobility of the big toe, potentially leading to varying degrees of disabling deformities. It is a disorder affecting women more frequently than men.
In the most severe cases, the big toe deviation can cause its overlapping the second toe (commonly referred to as hammer toe). The skin covering the joint affected by this disorder may appear red and painful.
Symptoms may vary from person to person: some patients report pain in the second toe rather than in the big toe, while others report intense pain, even in the absence of significant deformities. In general, however, hallux valgus is characterized by the presence of various symptoms that may include:

swelling at the base of the big toe
swelling or redness around the big toe
skin thickening at the base of the big toe
persistent or intermittent pain
limited range of motion of the big toe

There are several treatments available for correcting hallux valgus. The choice depends on the severity of the disorder and the intensity of the pain associated with it. Some of these treatments are surgical and others are conservative and non-surgical. The device referred to belongs to the conservative non-surgical ones.
The state of the art includes devices that achieve the objective of contrasting the progressive joint deformation, thereby preventing the further aggravation of the pathology and the onset of disabling symptoms.
These include bandages in various materials that keep the foot straight, particularly the affected joint, thus reducing stress and relieving pain on the big toe. A drawback of bandages, in any material, is their limited traction force which tends to weaken over time and therefore requires frequent replacement. What are also known are the toe separator pads which are used to place the big toe in its correct postural direction. A drawback of these devices with pads is that they only act on the big toe and not on the entire joint, they are effective only to correct the posture of the big toe and not of the entire joint. Moreover, they are not adjustable.
Corrective insoles are available to distribute body weight and pressure evenly while walking (they also help prevent or correct other pathologies of the forefoot or the hindfoot associated with the hallux valgus). The disadvantage of anatomical orthopaedic insoles is that they reduce the discomfort caused by hallux valgus and restore the foot to its correct supporting position, improving posture. They are effective against pain in the big toe and metatarsals, but do not exert any corrective pressure on the joint.
There is footwear available specifically suited for people affected by hallux valgus.
This type of footwear often features a strap, or tape, located on the insole of the footwear in alignment with the big toe's position when worn. This tape is designed to exert traction on the big toe so as to oppose its thrust towards the other toes. Some of these tapes which can be found in the above-mentioned footwear are selectively adjustable to vary the contrast tension on the big toe.
Among these the closest invention to the item referred to in the patent application is a national patent ITUD20100162 which describes a footwear whose upper is fixed to a positioning strap fixed to the sole in alignment with the area accomomodating the big toe, and is characterized by a rigid element fixed to the upper in the big toe joint area. This rigid element, on the one hand, is externally connected to the strap and, on the other, extends beyond the big toe joint area. The footwear also includes at least one adjustment element associated with the upper, and secured to the rigid element in the section extending beyond the area where the joint is placed. The disadvantage of this type of footwear is that the traction and contrast elements limit the possible aesthetic designs of the shoe itself. Postural braces are also known. These are used on a daily basis and can realign the big toe in mild or moderate cases of hallux valgus, reduce inflammation and correct the big toe posture. They cannot, in any case, improve a hallux valgus in an advanced stage. At best, a brace can prove useful before or after surgery to relieve pain and prevent relapses.
Doctors recommend using a brace at the onset of symptoms (a "bunion" and an inward distorsion of the first radius of the foot). In the early stages, in mild and moderate cases, the individuals affected by hallux valgus find relief in the use of a brace: its role is to contain, readapt, put the foot back in axis maximising the correct posture and slowing down the progression of the pathology.
It is the most effective conservative treatment for non-severe cases: it is not able to correct the big toe deformity but it mitigates its symptoms and delays the need for surgery.
Corrective braces are also known: once placed under the big toe, it immediately provides a sense of relief. These orthopedic devices aim to straighten the misalignment by applying pressure to the hallux valgus.
There are two types of braces: one for the daytime (to be worn in the shoes) and the other for the nighttime. When used together they provide a 24-hour therapeutic action.
Whether it is for the daytime or the nighttime, braces generally consist of a silicone cap to be placed in the the big toe area, a soft pad to be arranged on the foot deformity, an elastic band and an adjustable rear strap.
Another type of support is the bunion splint, a small silicone or latex structure to be placed between the big toe and the second toe. It fosters the realignment of the toes and prevents callus formation. Some models come with a pad at the level of the exostosis (hallux valgus protuberance).
Protective sheaths (in fabric or silicone) are designed to avoid the painful rubbing of the protrusion of the big toe against the shoe which brings about inflammation and redness. They feature a gel insert to reduce friction.
Those who require a comprehensive and customized support to correct their posture may consult a specialist to create an orthopedic insole molded on the foot of the individual who suffers from hallux valgus. This insole must be made of materials that cushion the foot during both support and propulsive phases. Among braces, the closest ones are certainly those to be placed in the shoe and are adjustable and made of thin materials. These include the Japanese patent JPH10234759 , which describes a device comprising an insert to be placed between the big and the second toe, and a belt made of fabric or foam to hold it firmly. The belt is fastened to a superficial band and is used to tighten a portion of the midfoot ligament to enhance the corrective effect further, thus providing stable corrective force to the hallux valgus. This brace, however, is made of deformable material and its corrective action is therefore weak and vanishes over time.

TECHNICAL PROBLEM AND ITS SOLUTION

All known inventions can therefore be improved in the case of devices such as bands and pads; they leave therapeutic problems unresolved as they relieve pain or rubbing but have limited traction effectiveness especially on the entire big toe joint. Orthopedic footwear suffers from limited aesthetic design possibilities.
Existing braces cannot often be used within footwear as a result of the significant amount of space taken because of the thickness of the materials and of the structural elements. Those made of silicone and plastic materials can generally be worn inside the shoe, but prolonged contact with the skin causes burning and discomfort, with the additional risk of obstructing peripheral circulation. Furthermore, as they are made of elastic or deformable materials, they have less traction and tend to lose it progressively over time.
The purpose of this invention is therefore to provide an innovative device that can be made of rigid and adjustable materials, using a rack that acts on a lever, but at the same time is compact and easily adaptable to different types of footwear commonly available on the market.

DESCRIPTION OF ONE OR MORE FORMS OF IMPLEMENTATION

The present invention is expressed and characterised in independent claims 1 and 8. The dependent claims set out other features of the present invention or variations of the main solution idea. In particular, a device for correcting valgus according to the present invention comprises at least one lower insole (1) provided at the top with a counter-insole (2) on which the sole of the user's foot rests, both suitably shaped and thinned so that the foot will not experience any type of discomfort. The insole and counter-insole are removably fixed to each other by means of connection elements (9).
The invention also comprises a positioning lever (3) fixed to the lower insole (1) in the area where the big toe is located when the shoe is worn, which has an elongated S-shape, passing through the first phalanx and then through a point between the end of the metatarsals and the beginning of the cuneiforms. This positioning lever (3) consists of a part underlying the big toe (3a) and of a part passing over it (3b). This positioning lever (3) has its fulcrum (4) under the positioning lever (3a) between the second phalanx and the metatarsal of the big toe. This underlying part of the positioning lever (3a) is located between the lower insole (1) and the upper insole (2). The big toe fits between the upper insole (2) and the said positioning lever passing over the big toe (3b). The end of the said positioning lever (3) is fixed, by means of a connection band (5) that forms a single unit with the positioning lever, to an adjustment element (6) associated with the lower insole (1) in a section where the latter supports the medial arch of the foot. This adjustment element (6) has at least two adjustment points and is located, together with the connection band (5), between the lower insole and the counter-insole (2).
In a resting position, the lever is pulled in its ring section, keeping the big toe towards the insole (1), as shown in figure 4.
In a working position, the lever is pulled by means of the connection band (5), by the adjustment element (6), which contrasts the inward thrust of the big toe, as shown in figure 5.
Therefore, by increasing traction on the adjustment element (6), an additional pressure is applied to the positioning lever (3), as shown in figure 6. In this way the big toe, being contrasted, tends to return to its correct anatomical position.
This invention therefore implements a first-type lever system in which the fulcrum (4) is located at the big toe joint between the second phalanx and the metatarsal bone of the big toe, and on either side of the fulcrum there are traction and contrast forces. Advantageously, the distance between the fulcrum (4) and the area where traction is applied by the adjustment element (6) is greater in length than the distance between the fulcrum (4) and the area where pressure is applied to the ring-shaped part that passes over the big toe of the positioning lever (3).
Advantageously, the positioning lever (3) and the connection band (5) are made of rigid material and have two points of soft material coating to prevent pain from friction: the first soft material coating (7) is located in the S-shaped part that passes over the first phalanx of the big toe, the second soft material coating (8) is located under the part that passes over the cuneiform bone of the big toe of the positioning lever (3).

Description of an implementation variant

In a preferable form of implementation, the positioning lever (3), the connection band (5) and the adjustment element (6) are made of rigid material, with a soft material coating to protect the contact point.
In another variant the positioning lever (3), the connection band (5) and the adjustment element (6) are made of flexible silicon stainless steel. The positioning lever (3) and the connection band (5) also have a thickness of 3 tenths of a millimetre, which is the minimum measurement that allows the corrective function of the lever in traction. These elements are coated with spongy material in the part that comes into contact with the foot to protect the contact area.
The insole and upper insole in a preferred variant are made of leather, suitably treated to be thin and at the same time resistant to deformation, so as not to cause any discomfort during prolonged use, while ensuring reliability and resistance.
These latter elements are removably fixed by means of connection points (9) to allow the adjusting of the adjustment element. Further variants of the invention, although not described or shown in the accompanying drawings, shall be considered protected by this patent if they fall within the scope of the following claims.

ADVANTAGES

The invention in question offers further advantages, such as, for example, comfort: minimal thickness of the structural elements, comfortable protective materials, customised shaping; versatility: it can be used any time of day, with the foot unencumbered or inside the shoe; resistance: thin materials that are resistant to deformation.
These features enable the device to be used in all the variants described above any time of day, with the foot unencumbered or inside the shoe.
Prolonged use provides constant relief throughout the day, without restricting the patients' daily activities in any way or affecting their quality of life.

DRAWINGS

These and other characteristics of the present invention will become clear from the following description of a preferred implementation provided by way of example, not restrictive, with reference to the accompanying drawings, in which:

Fig. 1 shows a planimetric view of the left foot, valgus correction device worn.
Fig. 2 shows a planimetric view of the right foot, valgus correction device worn.
Fig. 3 shows a planimetric view of the right foot, external valgus correction device.
Fig. 4 shows a planimetric view of the right foot, internal valgus correction device in resting position.
Fig. 5 shows a planimetric view of the right foot, internal valgus correction device in working position.
Fig. 6 shows a planimetric view of the right foot, internal section of the valgus correction device in working position with greater traction.
Fig. 7 shows an internal side view of the right foot, valgus correction device.
Fig. 8 shows an internal side view of the right foot, valgus correction device worn.

Claims

Device for correcting hallux valgus, at least comprising a lower insole (1) provided on top with a counter-insole (2) and a positioning lever (3) fixed to the lower insole (1) where the big toe rests when wearing a shoe, and having an elongated S shape, passing through the first phalanx and then through a point between the end of the metatarsals and the beginning of the cuneiforms, characterized by a connection band (5), which forms a whole with the said positioning lever and by an adjustment element (6) associated, on the one hand, with the lower insole (1), in a section where the latter supports the medial plantar arch under the foot, and, on the other hand, with the said connection band (5)
Device for correcting hallux valgus, as referred to the main claim, where the said positioning lever (3) is characterised by having its fulcrum (4) on the part underlying the positioning lever (3a) between the second phalanx and the metatarsal of the big toe, the traction area on the adjustment element (6) the mistake and the contrast area on the ring part passing over the big toe, of the external part of the positioning lever (3b).
Device for correcting hallux valgus, as referred to claim 2, where the section between the fulcrum (4) and the adjustment element (6) is greater in length than the section between the fulcrum (4) and the ring part passing over the big toe, of the external part of the positioning lever (3b).
Device for correcting hallux valgus according to any of the previous claims, where the said adjustment element (6) is provided at least with two adjustment points and is located, together with the connection band (5), between the lower insole and the counter insole (2).
Device as referred to any of the previous claims, where the positioning lever (3), the connection band (5) and the adjustment element (6), are made of a rigid material, with a soft material coating for protecting the points of contact with the big toe (7) (8).
Device as referred to claim 5 where the said rigid material is silicon flexible stainless steel.
Device as referred to claims 5 and 6 where the positioning lever (3) and the connection band have a thickness of 3 tenths of a millimetre.
Operating method of the valgus correction device, where in a first working position the lever is pulled, by means of the connection band (5), from the first adjustment point of the adjustment element (6), which opposes the inward thrust of the big toe.
Operating method of the valgus correction device as referred to claim no. 8 where in a second working position, by increasing the traction on the adjustment element (6) by one or more adjustment points, an additional contrast force is applied to the positioning lever (3).
Operating method of the correction device as referred to claim 8 where in a resting position the lever is pulled in its ring portion while keeping the big toe in contrast against the insole (1).