<smallcaps / >? ? ?hallux valgus? ? ? ? ?medical shoe insert for conservatively treating
Patent Information
- Application Number
- EP2023777255
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-10
- Filing Date
- 2023-09-26
- Publication Date
- 2025-08-20
AI Technical Summary
Current conservative treatment methods for hallux valgus, including shoe insoles, have limited therapeutic effectiveness and often require surgery, with the big toe remaining in a slight valgus position post-treatment.
A medical shoe insert with a pad section designed to have a protrusion that rises medially and distally, positioning its highest point proximal to the sesamoidea pedis ossa, providing optimal leverage for the flexor hallucis brevis muscle to correct the big toe's alignment, combined with a strip-like elevation and thorn-like bulge for additional support, and optional magnetic stimulation at acupuncture points.
The shoe insert effectively improves the alignment of the big toe by redistributing pressure and supporting the first metatarsal bone, gradually correcting the hallux valgus deformity and enhancing treatment success without the need for surgery.
Smart Images
Figure 1.1
Abstract
Description
[0001] Medical shoe insole for the conservative treatment of hallux valgus
[0002] BACKGROUND OF THE INVENTION
[0003] 1. Field of the invention
[0004] The invention relates to a medical shoe insole for the conservative treatment of a hallux valgus, comprising a) a base body with a proximal and a distal end, b) a pad section which has an uneven protrusion with a highest point, wherein the pad section is designed such that it can be arranged in a space formed between the longitudinal arch of a foot deformed by a hallux valgus and an insole of a shoe such that the longitudinal arch of the foot covers the pad section.
[0005] 2. Description of the state of the art
[0006] Genetic predispositions, such as splayfoot, and wearing unsuitable footwear can lead to misaligned toes and, as a result, deformities of the entire foot. One of the most common toe deformities is hallux valgus, or bunion.
[0007] Hallux valgus is medically indicated when the position of the big toe (first digit or hallux) deviates from its natural position toward the mid-longitudinal axis of the foot (valgus). This so-called valgus position of the big toe is caused by a deviation in the position of the first metatarsal bone (first metatarsal bone) away from the mid-longitudinal axis of the foot (varic deformity). Due to this varic deformity, the distal head of the first metatarsal bone protrudes significantly at the medial edge of the foot, which can cause painful bursitis when wearing shoes.
[0008] Hallux valgus is a progressive disease because tendons, especially the extensor hallicus longus (long extensor tendon), no longer run centrally over the first metatarsophalangeal joint (big toe joint), but rather laterally past it, thus increasingly displacing the big toe in a valgus direction.
[0009] Conservative medical treatment methods are known from the state of the art, which, among other things, provide for the use of footwear that allows the toes significantly more freedom of movement than usual everyday footwear (so-called "barefoot shoes"). There are also shoe insoles, so-called splayfoot insoles, which can be inserted into usual everyday footwear and which, depending on the shoe insole used, attach to different anatomical points on the sole of the foot.
[0010] Corresponding shoe insoles have a base body and often also a pad section that is molded onto the base body. The pad section is often a cushion or pillow that can be filled with a gel-like substance, for example. The pad section is usually designed in such a way that it can be positioned in a space between the longitudinal arch of the foot, i.e. the arch on the sole of the foot running lengthwise, and the insole of a shoe, so that the longitudinal arch of the foot covers the pad section. The pad section then exerts a supporting force on corresponding anatomical points on the sole of the foot when walking and standing, which is intended to return the big toe to its normal position.
[0011] The disadvantage of these known treatment methods is that they have little to no therapeutic effect, and surgery is often required to convert the big toe from the valgus position to its normal position. However, even these specialized surgeries often promise only limited treatment success, and the big toe remains in a slight valgus position after surgery. SUMMARY OF THE INVENTION
[0012] It is therefore an object of the present invention to overcome the above-mentioned disadvantages of the prior art and to significantly increase the treatment success of hallux valgus.
[0013] This task is solved in the case of a shoe insole mentioned at the beginning by c) when the pad section is arranged in the intermediate space, the protrusion extends towards the longitudinal arch in such a way that it rises in a medial and distal direction and the highest point of the protrusion is located proximal to the sesamoidea pedis at the distal head of the first metatarsal bone.
[0014] The sesamoidea pedis are sesamoid bones embedded in the tissue of the flexor hallucis brevis muscle (short big toe flexor) on the plantar side of the distal head of the first metatarsal. The sesamoidea pedis allows the flexor hallucis brevis muscle to exert optimal leverage on the big toe.
[0015] The inventive arrangement of the highest point of the pad section's protrusion causes the toes, particularly the big toe and the second metatarsal bone, to spread away from each other. This effect occurs because the distal third of the first metatarsal bone is supported during walking and standing in such a way that the distal head of the first metatarsal bone moves in a valgus direction, and thus the first distal phalanx of the big toe (end phalanx of the big toe) moves in a varicose or medial direction. Thus, the big toe is approximately returned to a normal position through the use of the shoe insole. Continued use of the shoe insole results in a progressive improvement in the / 7a / / u malalignment.
[0016] The term "medial" refers to a longitudinal central axis of the foot and / or the shoe insole, and the terms "distal" and "proximal" refer to a transverse central axis of the foot and / or the shoe insole, depending on the context in which they are used. "Medial" refers to the position extending from the longitudinal central axis of the foot and / or the shoe insole and / or an anatomical reference structure toward the center of the body or to the left of the longitudinal central axis. "Distal," on the other hand, refers to the position extending from the transverse central axis of the foot and / or the shoe insole and / or an anatomical reference structure in the direction of travel (front). "Proximal" is defined as the opposite of "distal," namely the position extending from the transverse central axis of the foot and / or the shoe insole and / or an anatomical reference structure in the opposite direction of travel (back).
[0017] The shoe insole can preferably be designed as follows:
[0018] The pad section has four essentially equal-sized sectors formed by a longitudinal central axis and a transverse central axis of the pad section. The sectors are numbered clockwise from a first medial-distal sector to a fourth medial-proximal sector. The first sector, in turn, has four subsectors numbered in the same way along straight lines running parallel to the longitudinal and transverse central axes of the pad section. The highest point of the protrusion is then located in a first medial-distal subsector of the first sector.
[0019] Preferably, the medical shoe insole is designed such that, when the pad section is arranged in the intermediate space, the highest point of the protrusion is located medially on the distal head of the first metatarsal bone.
[0020] Preferably, the pad section is formed integrally with the base body. This reduces friction caused, for example, by seams on the sole of the foot and ensures a comfortable fit.
[0021] To ensure that the metatarsophalangeal joints (metacarpal joints) are not restricted in their freedom of movement and that the wearer has the most natural wearing experience possible from the insole, it is advantageous if the pad section and / or the base body end proximal to the metatarsophalangeal joints when the pad section is positioned in the intermediate space, such that the metatarsophalangeal joints are freely movable without restriction. In order to restore the valgus-pointing big toe, i.e., hallux valgus, to a normal position, it is necessary, as already mentioned above, according to the invention that the distal head of the first metatarsal, which, due to the disease, points varicosely outwards, is redirected toward a central longitudinal axis of the foot.The shoe insole is therefore advantageously designed in such a way that along an outer edge of the pad section, at least over a section of this outer edge, a strip-like elevation sloping towards the longitudinal central axis of the pad section is arranged, which, when the pad section is arranged in the intermediate space, extends medially-distally along the outer edge and preferably acts on the corpus (body) of the first metatarsal bone.
[0022] The bar-like elevation then acts as a kind of splint for the big toe.
[0023] Preferably, in order to improve the immediately above effect, the shoe insole is designed such that the strip-like elevation at the distal end of the base body has a thorn-like bulge which, when the pad section is arranged in the intermediate space, extends in the distal direction and exerts a supporting force on the distal head of the first metatarsal bone in a direction towards a longitudinal central axis of the foot.
[0024] In order for the user of the shoe insole to have the most ergonomic and therefore comfortable wearing experience possible, it is advantageous if the last-like elevation continuously transitions into the thorn-like bulge.
[0025] It is also advantageous if the highest point of the pad section is located lower than the highest point of the ridge. This optimally ensures the splinting effect of the ridge and the thorn-like protrusion on the distal head of the first metatarsal.
[0026] Preferably, a slot extending through the base body and / or the pad section is formed along a longitudinal central axis and / or a transverse central axis of the pad section. A first loop, which can be guided dorsally around the foot, and a second loop, which can be guided between the big toe and the digitus pedis II and dorsally around the big toe, run through the slot for the purpose of attaching the medical shoe insole to the foot. This second loop can be guided between the big toe and the digitus pedis II and dorsally around the big toe. This design makes it possible to provide essentially a standard size for the shoe insole and then, depending on the specific anatomical conditions of the user, to bring it into the position according to the invention and fix it in this position with the aid of the loops.
[0027] Alternatively, the shoe insert can be attached to the insole or to a separate insole, e.g. a winter insole, in particular a flat (winter) insole, with an adhesive.
[0028] A further advantage arises if the shoe insole is designed in such a way that at least one magnet is arranged in or on the pad section in such a way that, when the pad section is positioned in the space between the pads, it locally corresponds to an acupuncture point on the sole or edge of the foot, in particular the acupuncture points MP2 and MP3 of the spleen-pancreas meridian. Stimulation of the acupuncture point can produce further beneficial effects for foot healing and the correction of hallux valgus.
[0029] BRIEF DESCRIPTION OF THE DRAWINGS
[0030] In the following, exemplary embodiments of the invention are explained in more detail with reference to the drawings. In these drawings:
[0031] Figure 1 is a plan view of a foot deformed by a hallux valgus;
[0032] Figure 2 is a plan view of a shoe insert according to the invention according to a first
[0033] Example of implementation;
[0034] Figure 3 shows a perspective view of the shoe insole according to the first embodiment; Figure 4 shows a side view of a foot deformed by a hallux valgus, wherein the shoe insole according to the invention according to the first embodiment is arranged such that a pad section of the shoe insole is covered by a longitudinal arch of the foot;
[0035] Figure 5 is a plan view of the arrangement of the shoe insole relative to the foot of Figure 4;
[0036] Figure 6 is a plan view corresponding to Figure 2 of the shoe insole according to the invention according to a second embodiment.
[0037] Figure 7 is a perspective view of the second embodiment of the medical shoe insole;
[0038] Figure 8 is a perspective view of a second embodiment of the shoe insole according to the invention in the proximal direction.
[0039] DESCRIPTION OF PREFERRED EMBODIMENTS
[0040] To illustrate the clinical picture of hallux valgus, Figure 1 shows a foot, labelled 10 in total, deformed by hallux valgus.
[0041] In the figure, a central longitudinal axis A1 and a central transverse axis A2 of the foot 10 are provided with a separate reference symbol. Also separately designated are the big toe (digitus pedis / ), which is designated as a whole by 12, the ankle joint 14, the metatarsal bone / 16 (I. metatarsal bone), its distal head 18 and its body 20, the metatarsophalangeal joint 122 (big toe ankle joint), the proximal phalanx of the foot I 24 (proximal phalanx of the big toe), the distal phalanx of the foot I 26 (end phalanx of the big toe) and the digitus pedis II, all with 28. In addition, the sesamoid bones of the foot are each provided with the reference symbol 30.
[0042] Hallux valgus is a varus deviation of the first metatarsal bone 16, i.e. its long axis A3 deviates in a direction medial to the central longitudinal axis A1 of the foot 10. As a result, the tendons attaching to the first metatarsal phalanx 26 no longer run over the first metatarsophalangeal joint 22, but rather laterally past it, whereby the long axis A4 of the first metatarsal phalanx 26 is increasingly pulled into a valgus malposition, i.e. deviates towards the central longitudinal axis A1 of the foot 10. Due to this resulting malposition of the big toe, swelling of the bursa attached to the distal head 18 of the first metatarsal bone 16 usually occurs.
[0043] Figures 2 to 5 show a first exemplary embodiment of a medical shoe insole 32, in Figures 2 and 3 in isolation and in Figures 4 and 5 in a position relative to the foot 10. The first exemplary embodiment will be described below with reference to these figures.
[0044] The medical shoe insole 32, which is designed for the conservative treatment of hallux valgus as described above, comprises a base body 34 with a proximal end 35a and a distal end 35b, as well as a pad section 36. The pad section 36 and / or base body can be made of a plastic, e.g., by injection molding or 3D printing. Ideally, a comparatively rigid material is used for the pad section 36, since otherwise the therapeutic effect of the medical shoe insole is reduced. Additionally, the pad section 36 and / or the base body 34 can be coated with an elastic material such as silicone or cork to ensure good cushioning when walking and standing and thus a comfortable fit. For the same reason, the protrusion 38 can be formed by a pad or cushion, which can be filled with a gel-like substance.
[0045] The pad section 36 has an irregular protrusion 38 with a highest point 40. The pad section 36 is designed such that it can be arranged in a space 42 between a longitudinal arch 43 of the foot 10 and an insole of a shoe (not shown). The longitudinal arch 43 of the foot 10 then covers the pad section 36.
[0046] The pad section 36 has four substantially equal-sized sectors 44a-d, which are formed by a longitudinal central axis A5 and a transverse central axis A6 of the pad section 36, wherein the sectors 44a-d are numbered clockwise from a first medial-distally located sector 44a to a fourth medial-proximal sector 44d. The first sector 44a, in turn, has four subsectors 46a-d, which are numbered in the same way, along straight lines G running parallel to the longitudinal and transverse central axes A5, A6 of the pad section 36. The highest point 40 of the protrusion 38 is located, in the present example, in a first medial-distally located subsector 46a of the first sector 44a.
[0047] When the pad section 36 is arranged in the space 42, the protrusion 38 extends to the longitudinal arch 43 of the foot 10 in such a way that it rises in the medial and distal direction and the highest point 40 of the protrusion 38 is located proximal to the sesamoidea pedis 30 at the distal head 18 of the metatarsal bone 16.
[0048] This causes the toes, particularly the great toe 12 and the second metatarsal bone 28, to spread apart. This effect occurs because the distal third of the first metatarsal bone 16 is supported during walking and standing in such a way that the distal head 18 of the first metatarsal bone 16 moves in a valgus direction, and thus the distal phalanx of the first metatarsal bone 26 (the distal phalanx of the great toe) moves in a varicose or medial direction.
[0049] In the present embodiment, the pad section 36 is formed integrally on the base body 34. Furthermore, in the present embodiment, the base body 34 and the pad section 36 are essentially indistinguishable from one another visually and functionally and are completely covered by the longitudinal arch 43. In embodiments not specifically shown, the pad section 36 can also be glued or sewn onto the base body 34, and the base body 34 can function as a surrogate for or a support on the insole of the shoe (not shown).
[0050] As can be seen from Figures 4 and 5, the pad section 36 and the base body 34 end proximal to the metatarsophalangeal joints 22 when the pad section 36 is arranged in the intermediate space 42. This ensures that the metatarsophalangeal joints 22 retain their freedom of movement and are not impaired by the shoe insert 32.
[0051] In the embodiment shown in Figures 2 to 5, the medical shoe insole 32 measures approximately 12 cm along its greatest longitudinal extent and approximately 5 cm along its greatest transverse extent. To ensure that the pad section 36 can be ideally positioned below the longitudinal arch 43 and avoids any interference when walking or standing, it measures approximately 3 cm along its greatest vertical extent. In embodiments not specifically illustrated, these dimensions may vary by approximately 1 to 2 cm.
[0052] Figures 6 to 8 now illustrate a second embodiment of the medical shoe insole 32.
[0053] In this embodiment of the shoe insole 32, a strip-like elevation 50 is arranged along an outer edge 48 of the pad section 36, over a section of this outer edge 48, which slopes down towards the longitudinal central axis A5 of the pad section 36 and, when the pad section 36 is arranged in the intermediate space 42, extends medially-distally along the outer edge 48. This strip-like elevation 50 acts on the body 20 of the metatarsal bone 116 and thus supports it. Adjacent to the strip-like elevation 50, a groove-like depression 51 is formed, in which at least a section of the metatarsal bone 116 can be embedded.
[0054] The design variants described with reference to the first embodiment of the medical shoe insole 32 can also be present in the second embodiment. Furthermore, designs are also conceivable in which a flexible material can be applied to the groove-like depression 51 and / or to the strip-like elevation 50 in addition to, or as an alternative to, a full coating with a flexible material. This can be realized, for example, via a silicone cushion or a cork-like area.Furthermore, in the second embodiment of the medical shoe insole 32, the strip-like elevation 50 at the distal end 35b of the base body 34 has a thorn-like bulge 52 which, when the pad section 36 is arranged in the intermediate space 42, extends in the distal direction and exerts a supporting force on the distal head 18 of the metatarsal bone 16 in a direction towards a longitudinal central axis A1 of the foot.
[0055] In this case, the strip-like elevation 50 merges continuously into the thorn-like protrusion 52. When the pad section 36 is arranged in the intermediate space 42, an improved supporting force acts on the distal head 18 of the first metatarsal bone 16 compared to the shoe insert 32 according to the first embodiment.
[0056] In the present case, the bar-like elevation 50 and the thorn-like bulge 52 function as a guide rail for the first metatarsal bone 16 and as a corrective rail for the entire big toe 12.
[0057] For example, in the second embodiment, the highest point 40 of the protrusion 38 of the pad section 36 is located lower than a highest point 54 of the strip-like elevation 50. This advantageously ensures that the strip-like elevation 50 and the thorn-like bulge 52 can function optimally as a support rail for the metatarsal bone 116.
[0058] In embodiments of the shoe insole 32 not specifically shown, a slot is formed along a longitudinal center axis A5 of the pad section 36 through the base body 34 and the pad section 36, through which a first loop runs for the purpose of attaching the medical shoe insole 32 to the foot 10, which can be guided dorsally around the foot 10, and a second loop runs through which a second loop can be guided between the big toe 12 and the digitus pedis II 28 and dorsally around the big toe 12. In a further embodiment not specifically shown, the slot runs along a transverse center axis A6 of the pad section 36. Further embodiments not specifically shown comprise a slot running both along the longitudinal center axis A5 and a slot running along the transverse center axis A6.Furthermore, in embodiments not specifically shown, at least one magnet is arranged in or on the pad section 36 such that, when the pad section 36 is arranged in the intermediate space 42, it corresponds locally to a battery puncture point on the sole of the foot.
Claims
PATENT CLAIMS Medical shoe insole (32) for the conservative treatment of hallux valgus, comprising a) a base body (34) with a proximal end (35a) and a distal end (35b), b) a pad section (36) having an uneven protrusion (38) with a highest point (40), wherein the pad section (36) is designed such that it can be arranged in a space (42) formed between the longitudinal arch (43) of a foot (10) deformed by hallux valgus and an insole of a shoe such that the longitudinal arch (43) of the foot (10) covers the pad section (36), characterized in that c) when the pad section (36) is arranged in the space (42), the protrusion (38) extends towards the longitudinal arch (43) in such a way thatthat it rises in the medial and distal direction and the highest point (40) of the protrusion (38) is located proximal to the sesamoidea pedis on the distal head (18) of the first metatarsal bone (16). Medical shoe insole (32) according to claim 1, characterized in that the pad section (36) is formed integrally on the base body (34). Medical shoe insole (32) according to claim 1 or 2, characterized in that, when the pad section (36) is arranged in the intermediate space (42), the pad section (36) and / or the base body (34) end proximal to the metatarsophalangeal joints (22). Medical shoe insole (32) according to one of the preceding claims, characterized in that along an outer edge (48) of the pad section (36), A strip-like elevation (50) is arranged at least over a section of this outer edge (48) which slopes down towards a longitudinal central axis (A5) of the pad section (36), and which, when the pad section (36) is arranged in the intermediate space (42), extends medially-distally along the outer edge (48). Medical shoe insert (32) according to claim 4, characterized in that the strip-like elevation (50) has a thorn-like protrusion (52) at the distal end (35b) of the base body (34), which, when the pad section (36) is arranged in the intermediate space (42), extends in the distal direction and exerts a supporting force on the distal head (18) of the first metatarsal bone (16) in a direction towards a longitudinal central axis (A1) of the foot. Medical shoe insole (32) according to claim 5, characterized in that the strip-like elevation (50) continuously merges into the thorn-like bulge (52).Medical shoe insole according to one of claims 4 to 6, characterized in that the highest point (40) of the pad section (36) is located lower than a highest point (54) of the strip-like elevation (50). Medical shoe insole (32) according to one of the preceding claims, characterized in that a slot extending through the base body (34) and / or the pad section (36) is formed along a longitudinal central axis (A5) and / or a transverse central axis (A6) of the pad section (36), through which a first loop extends for the purpose of attaching the medical shoe insole (32) to the foot (10), which loop can be guided dorsally around the foot (10), and a second loop can be guided between the big toe (12) and the digitus pedis II (28) and dorsally around the big toe (12). Medical shoe insole (32) according to one of the preceding claims, characterized in that in or on the pad section (36) there is at least one magnet. is arranged such that, when the pad section (36) is arranged in the intermediate space (42), it corresponds locally to an acupuncture point on the sole of the foot.