Orthopedic shoe insole for the treatment of hallux valgus

Abstract

Orthopedic shoe insole (10) with - a hindfoot section (20), - a metatarsal section (30), - a forefoot section (40), - a wedge (50) arranged in the transition area between the midfoot and forefoot sections (30, 40), ◯ extends from the medial edge (60) of the orthopaedic shoe insole (10) tapering towards the lateral edge (70), towards the anterior edge (80) and towards the posterior edge (90) of the orthopaedic shoe insole (10), and ◯ has its highest point on the medial edge (60) of the orthopaedic shoe insole (10) in the area of ​​the orthopaedic shoe insole (10) designed to accommodate the metatarsophalangeal joint of the big toe of a foot supported by the orthopaedic shoe insole (10).

Description

[0001] The invention relates to an orthopedic shoe insole for the treatment of the foot deformity known as hallux valgus.

[0002] Shoe insoles are generally known, for example from US 2016 / 0 213 094 A1, JP H11 - 146 802 A, JP 2018 - 75 107 A, US 10 405 602 B2, US 2017 / 0 181 495 A1, CA 2 730 360 A1 and US 2015 / 0 181 978 A1.

[0003] Hallux valgus is the misalignment of the big toe resulting from impaired foot biomechanics. Due to the heavy forefoot load, the first metatarsal ray tends to gravitate toward the center of the body (medially). This rotation of the metatarsophalangeal joint causes the flexor hallucis muscle to slip out of its socket near the sesamoid bones, pulling the big toe outward (laterally). This deformity causes injury and irritation to the bursae attached to the first ray. The result is an irritated and painful first ray.

[0004] The disease progression of the big toe joint is steadily worsening and can irritate the entire foot musculature. Furthermore, hallux valgus symptoms can lead to secondary conditions such as flat feet, fallen arches, splay feet, claw toes, and heel spurs.

[0005] To counteract this misalignment and alleviate the pain it causes, shoe insoles have been developed for patients with hallux valgus, in addition to surgical procedures. For example, DE 10 2007 008 703 B4 describes a hallux valgus insole that creates a support shell for the big toe affected by hallux valgus and forces it into a predetermined position.

[0006] The disadvantage of this design is, on the one hand, the effort required to adapt and manufacture such a shoe insole. On the other hand, while such a support shell alleviates the pain caused by hallux valgus, it is also relatively uncomfortable to wear.

[0007] The object of the present invention is therefore to create a shoe insole that is easy to manufacture and comfortable to wear, which counteracts the misalignment of the foot known as hallux valgus and / or alleviates its consequences.

[0008] This object is achieved according to the invention by the shoe insole having the features of claim 1. The subclaims represent advantageous embodiments of the invention.

[0009] The basic idea of ​​the invention is not to force the big toe affected by hallux valgus into a predetermined position, but to achieve pressure redistribution throughout the foot by raising the first ray of the metatarsal bone using the inventive orthopedic shoe insole with a correspondingly designed wedge with regard to hallux valgus. This pressure redistribution begins as soon as the foot strikes. The inventive design prevents the longitudinal arch from tipping medially under the resulting load. The insole thus prevents increased load on the first ray. The inventive raising of the entire first ray then works in the same direction. The big toe is thus relieved and automatically assumes a relaxed position without being forced.

[0010] Natural gait is characterized by the fact that, during the middle and terminal stance phases, the load is directed toward the first ray and rolled over the big toe. The first ray, in particular, is subject to significant pressure. The hallux valgus wedge absorbs and redistributes this pressure, relieving pressure on the first ray and allowing a more or less natural posture to be adopted despite hallux valgus symptoms.

[0011] By wearing the insole in the crucial, described areas of the hallux valgus, the worsening of the deformity and subsequent diseases can be prevented.

[0012] The hallux valgus insole proposed here is an orthopedic insole that combats hallux valgus and its associated conditions. The specially handcrafted insole consists of supporting, cushioning, and corrective elements arranged between a base layer and a cover layer. The base of the insole is preferably an EVA material as a carrier and a thermoplastic stiffening material molded to the anatomy of the foot. The longitudinal arch support in the rearfoot area of ​​the insole serves as the supporting element; the thermoplastic stiffening material retains its shape and provides long-lasting support to the foot. The insole preferably features a stepped pad in the forefoot area and padding across the entire foot, specifically with a Shore 15 density – this padding is considered a cushioning element.

[0013] A key element of the invention is the wedge. This corrective element is preferably designed as a (half-)moon-shaped wedge. The wedge has its maximum height on the inside of the foot, in the middle of the wedge, and slopes downwards on all sides to its tip. The wedge is particularly preferably made of a plastic with a hardness of at least 45 Shore.

[0014] The height of the wedge is preferably individually adjusted to the hallux valgus. A distinction is made according to the extent to which the hallux valgus has progressed (mild, moderate, or severe). The progression is determined using an angle system. To do this, a protractor is placed at the metatarsophalangeal joint of the big toe and the hallux valgus or intermetatarsal angle is determined. This hallux valgus or intermetatarsal angle is the deviation of the toe bone from the axis of the first metatarsal bone.

[0015] Mild hallux valgus is defined as an intermetatarsal angle of 11 to 15 degrees and is treated with a 2 mm wedge. An angle of 16 to 20 degrees (moderate hallux valgus) is treated with a 4 mm wedge. For severe hallux valgus with an intermetatarsal angle of 20 degrees or more, a 6 mm wedge is incorporated into the insole.

[0016] The positioning of the wedge on the insole is particularly important. According to the invention, the highest point of the wedge is located at the point of the hallux valgus that protrudes furthest from the center of the body, namely in the area of ​​the gap between the metatarsophalangeal joint of the big toe. This coordination of the material components and the body's own position is crucial for the optimal therapeutic effect of the insole according to the invention.

[0017] According to the invention, an orthopedic shoe insole is proposed with a rearfoot section, a midfoot section and a forefoot section, with a wedge arranged in the transition area between the midfoot and forefoot sections, which wedge extends from the medial edge of the orthopedic shoe insole in a tapered manner in the direction of the lateral edge, in the direction of the anterior edge and in the direction of the posterior edge of the orthopedic shoe insole and has its highest point at the medial edge of the orthopedic shoe insole in the area of ​​the orthopedic shoe insole designed to accommodate the metatarsophalangeal joint of the big toe of a foot supported by the orthopedic shoe insole.

[0018] The wedge of the orthopedic shoe insole is preferably designed to taper evenly in all directions, starting from the medial edge of the orthopedic shoe insole. This creates a substantially crescent-shaped wedge.

[0019] Furthermore, it is preferably provided that the wedge extends from the medial edge of the orthopedic shoe insole toward the lateral edge of the orthopedic shoe insole up to a maximum of its center. In particular, the wedge is particularly preferably designed such that the wedge extends exclusively in the area of ​​the orthopedic shoe insole designed to accommodate the first ray of a foot supported by the orthopedic shoe insole.

[0020] The section of the wedge facing the medial edge of the orthopedic shoe insole is preferably formed with a sickle-shaped edge.

[0021] The wedge is specifically designed such that, in an orthopedic shoe insole configured to accommodate a foot with an intermetatarsal angle of 10° to 15°, it has a thickness d of 1 mm ≤ d ≤ 3 mm at its highest point, and particularly preferably a thickness d of d = 2 mm. If the orthopedic shoe insole is configured to accommodate a foot with an intermetatarsal angle of > 15° to 20°, the wedge preferably has a thickness d of 3 mm < d ≤ 5 mm at its highest point, and particularly preferably a thickness d of d = 4 mm. Finally, it is provided that, in an orthopedic shoe insole configured to accommodate a foot with an intermetatarsal angle greater than 20°, the wedge has a thickness d of 5 mm < d ≤ 7 mm at its highest point, and particularly preferably a thickness d of d = 6 mm.

[0022] Furthermore, a method for producing an orthopedic shoe insole for a foot of a patient suffering from hallux valgus is provided, comprising the steps of: determining the hallux valgus or intermetatarsal angle of the foot for which the shoe insole is to be produced, and producing the orthopedic shoe insole with a wedge (50) whose height is determined by the positive correlation of the amount of the previously determined hallux valgus or intermetatarsal angle.

[0023] For this purpose, the wedge has a thickness of 1 mm ≤ d ≤ 3 mm and particularly preferably a thickness d of d = 2 mm at an intermetatarsal angle of 10° to 15° at its highest point, a thickness d of 3 mm < d ≤ 5 mm and particularly preferably a thickness d of d = 4 mm at an intermetatarsal angle of greater than 15° to 20° at its highest point, and a thickness d of 5 mm < d ≤ 7 mm and particularly preferably a thickness d of d = 6 mm at an intermetatarsal angle of greater than 20° at its highest point.

[0024] In a study of 100 patients with hallux valgus, their feet were measured, and pain sensation in the metatarsophalangeal joint and throughout the foot was recorded on a scale of 1 (no pain) to 10 (severe pain). A static impression was also taken, and the severity of the hallux valgus was determined.

[0025] After three or six months, during which the patients were fitted with a hallux valgus insole equipped according to the invention, a static impression was again made, the patients were asked about their pain sensation and the severity of the hallux valgus was determined once again.

[0026] The study showed that pain in the metatarsophalangeal joint of the big toe decreased from an average of 8.9 to 2.1 in the 100 participants after wearing the hallux valgus insole equipped with the invention. Furthermore, pain in the entire foot decreased from an initial 7.4 to 1.8.

[0027] The analysis of the static foot prints revealed that the hallux valgus deformity had changed from an average of 19° to 14°. This demonstrated that the insole according to the invention had a positive effect on the entire foot, but especially on the hallux valgus, and that the test subjects were able to walk more painlessly with the insole.

[0028] The invention will be explained in more detail below with reference to a particularly preferred embodiment shown in the accompanying drawings. They show: Fig. 1 is a schematic plan view of a particularly preferred orthopedic shoe insole according to the invention; Fig. 2 a side view of an orthopedic shoe insole according to the prior art, with a foot skeleton resting thereon, exhibiting a hallux valgus deformity; Fig. 3 a side view of a particularly preferred orthopedic shoe insole according to the invention, with a foot skeleton resting thereon and exhibiting a hallux valgus deformity; Fig. 4 a top view of the orthopedic shoe insole from Fig. 2; and Fig. 5 a top view of the orthopedic shoe insole from Fig. 3.

[0029] Fig. Figure 1 shows a schematic plan view of a particularly preferred embodiment of the orthopedic shoe insole according to the invention. The orthopedic shoe insole 10 is constructed in a known manner in multiple layers with a base layer, a core, and a cover layer. From posterior to anterior, it has a rearfoot section 20, a midfoot section 30, and a forefoot section 40.

[0030] In the transition area of ​​the midfoot to the forefoot section 30, 40, a crescent-shaped wedge 50 with a sickle-shaped edge is arranged, which extends from the medial edge 60 of the orthopedic shoe insole 10, tapering towards the lateral edge 70, towards the anterior edge 80 and towards the posterior edge 90 of the orthopedic shoe insole 10 to approximately the middle thereof.

[0031] The effect of the wedge becomes clear when the foot position on a shoe insole according to the state of the art is compared with the foot position on a shoe insole designed according to the invention. In the context of a comparison, Fig. 2 a side view of an orthopaedic shoe insole according to the prior art with a foot skeleton resting thereon, exhibiting a hallux valgus deformity and Fig. 3 a side view of a particularly preferred orthopedic shoe insole according to the invention with a foot skeleton resting thereon and exhibiting a hallux valgus deformity.

[0032] Fig. Figure 2 shows that, when using a conventional, state-of-the-art foot insole, the foot skeleton exhibiting a hallux valgus deformity assumes a position on the shoe insole in which the tarsus T and metatarsus M form an angle to each other, which leads to a force introduction in the area of ​​the metatarsophalangeal joint of the big toe between metatarsus M and antetarsus A. The load in the metatarsophalangeal joint of the big toe causes severe pain under this load and promotes further secondary diseases.

[0033] In contrast, by providing a wedge 50 arranged in the transition area of ​​the metatarsal to the forefoot section 30, 40 or in the area of ​​the metatarsophalangeal joint between metatarsus M and antetarsus A between the base cover and the cover layer of the insole 10, a load redistribution is achieved, which leads to a relief of the first ray and thus to an extended conformation of metatarsus M and antetarsus A. By introducing force directly into the phalanges, the metatarsophalangeal joint of the big toe is protected and pain is avoided.

[0034] Fig. 4 and Fig. 5 show the differences of the state-of-the-art orthopedic shoe insoles Fig. 2 and the orthopedic shoe insole made according to a preferred embodiment of the invention Fig. 3 again in a top view.

[0035] Out of Fig. 4 shows that the hallux valgus deformity is fully maintained when using a conventional shoe insole. In contrast, as Fig. 5 shows - the use of a shoe insole according to the invention for an improved posture with reduced pain.

Claims

[1] Orthopedic shoe insole (10) with - a hindfoot section (20), - a metatarsal section (30), - a forefoot section (40), - a wedge (50) arranged in the transition area between the midfoot and forefoot sections (30, 40), ◯ extends from the medial edge (60) of the orthopaedic shoe insole (10) tapering towards the lateral edge (70), towards the anterior edge (80) and towards the posterior edge (90) of the orthopaedic shoe insole (10), and ◯ has its highest point on the medial edge (60) of the orthopaedic shoe insole (10) in the area of ​​the orthopaedic shoe insole (10) designed to accommodate the metatarsophalangeal joint of the big toe of a foot supported by the orthopaedic shoe insole (10). [2] Orthopaedic shoe insole (10) according to claim 1, characterized bythat the wedge (50) is formed from the medial edge (60) of the orthopaedic shoe insole (10) to a point evenly in all directions. [3] Orthopaedic shoe insole (10) according to one of the preceding claims, characterized by that the wedge extends from the medial edge (60) of the orthopaedic shoe insole (10) in the direction of the lateral edge (70) of the orthopaedic shoe insole (10) up to a maximum of its middle. [4] Orthopaedic shoe insole (10) according to one of the preceding claims, characterized by that the wedge (50) extends exclusively in the area of ​​the orthopaedic shoe insole (10) designed to receive the first ray of a foot supported by the orthopaedic shoe insole (10). [5] Orthopaedic shoe insole (10) according to one of the preceding claims, characterized by that the portion of the wedge (50) facing the medial edge (60) of the orthopaedic shoe insole (10) has a crescent-shaped edge. [6] Orthopaedic shoe insole (10) according to one of the preceding claims, characterized by that the wedge (50) in an orthopaedic shoe insole (10) designed to accommodate a foot with an intermetatarsal angle of 10° to 15° has a thickness d of 1 mm ≤ d ≤ 3 mm at its highest point. [7] Orthopaedic shoe insole (10) according to one of claims 1 to 5, characterized by that the wedge (50) in an orthopaedic shoe insole (10) designed to accommodate a foot with an intermetatarsal angle of >15° to 20° has a thickness d of 3 mm < d ≤ 5 mm at its highest point. [8] Orthopaedic shoe insole (10) according to one of claims 1 to 5, characterized by that the wedge (50) in an orthopaedic shoe insole (10) designed to accommodate a foot with an intermetatarsal angle of greater than 20° has a thickness d of 5 mm < d ≤ 7 mm at its highest point. [9] Orthopaedic shoe insole (10) according to one of the preceding claims, characterized by that the wedge (50) is made of a plastic with a Shore hardness of ≥45. [10] A method for producing an orthopaedic shoe insole for a foot of a patient suffering from hallux valgus according to any one of the preceding claims, characterized by the steps: - Determine the hallux valgus or intermetatarsal angle of the foot for which the shoe insole is to be made, and - Manufacturing the orthopaedic shoe insole with a wedge (50), the height of which is determined by the positive correlation of the amount of the previously determined hallux valgus or intermetatarsal angle. [11] Method according to claim 10, characterized by that the wedge (50) - with an intermetatarsal angle of 10° to 15° at its highest point, a thickness of 1 mm ≤ d ≤ 3 mm, - with an intermetatarsal angle of greater than 15° to 20°, a thickness d of 3 mm < d ≤ 5 mm at its highest point, and - with an intermetatarsal angle of greater than 20°, has a thickness d of 5 mm < d ≤ 7 mm at its highest point.

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