Orthopedic shoe sole or insole and shoe for people with hallux valgus

A sole or insole for an orthopedic shoe for persons with hallux valgus. The sole or insole includes a main part located at least under and supporting the Digitis Pedis II to V and the ball of the foot, and an element movably connected to the main part that is located under and supports the Digitis Pedis I. The main part of the sole or insole includes a cavity under the Digitis Pedis II to V and/or the transverse arch of the foot that contains a hydraulic, mechanical, pneumatic, electric or other device that causes rotary movement of the moveable element in the horizontal plane laterally away from the main part during a walking movement, in particular caused by the compressive force caused by the wearer's own weight on the sole or insole.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a 371 national stage filing of PCT/EP2022/065071, filed Jun. 2, 2022, which claims the benefit of IT202100015188A, filed Jun. 10, 2021.

TECHNICAL FIELD

The invention relates to an orthopedic shoe sole or insole for persons with hallux valgus, wherein the orthopedic shoe sole or insole supports at least the Digitis Pedis I to V and the ball of the foot when walking or in a static state, in particular the entire foot from the Digitis Pedis I to V to the heel. The invention further relates to a shoe having an orthopedic shoe sole or insole.

BACKGROUND

Hallux valgus (bunion of the big toe) is the name given to a crooked position of the Digitis Pedis I (big toe), in which the Digitis Pedis I extends valgusly, i.e., from the center of the body in the direction of the Digitis Pedis II to V. This is called hallux valgus. The direction of pull of the tendons in the foot changes and increases the displacement of the Digitis Pedis I. At the same time, the first metatarsal bone deviates inward with its head, resulting in the typical bunion. In addition to cosmetic problems, hallux valgus can lead to painful pressure points, skin irritation, swelling or inflammation, for example, due to friction of the protruding bunion on the footwear. Consequential damage may include arthrosis or overloading of the neighboring joints of the Digitis Pedis II to V or the metatarsal bones. This malpositioning of the Digitis Pedis I often results from hereditary predisposition and is usually aggravated by wearing tight shoes or shoes with high heels.

Up to a certain stage, hallux valgus can be treated conservatively, as non-surgical, for example by foot gymnastics or wearing foot splints. Foot gymnastics for the treatment of hallux valgus includes exercises that promote the free movement of Digitis Pedis I in all directions. Preferably, foot exercises are performed by a physical therapist and consist of the physical therapist spreading the patient's Digitis Pedis I and returning it to its original position. This spreading movement of the Digitis Pedis I is performed simultaneously in the vertical plane of its natural bending (a movement that also occurs during walking) and in the horizontal plane sideways away from the Digitis Pedis II to V. The patient's Digitis Pedis I is then moved back to its original position. This alleviates the symptoms of hallux valgus in particular, but correction of the deformity is not usually achieved through foot gymnastics. At the same time, flat shoes should be worn in everyday life, which have sufficient clearance, especially in the area of Digitis Pedis I to V and, if necessary, in the area of the big toe joint. Furthermore, insoles can be worn to support the arch of the foot in order to stop the progression of the splayfoot. Furthermore, toe spreaders, toe pads, insoles for support, bunion rollers and hallux splints (orthoses) are known for the treatment of hallux valgus.

Based on this prior art, the invention is based on the task of providing an orthopedic shoe sole or insole for the treatment of hallux valgus, which enables a patient to perform a foot exercise for the treatment of hallux valgus at any time and as often as desired.

SUMMARY

The problem is solved according to the invention by an orthopedic shoe sole or insole for persons with a hallux valgus, wherein the orthopedic shoe sole or insole supports at least the Digitis Pedis I to V and the ball of the foot during walking or in a static state, in particular the entire foot from the Digitis Pedis I to V to the heel, which is characterized in that the orthopedic shoe sole or insole comprises a main part and an element movably connected thereto, the movable element being located under and supporting the Digitis Pedis I and the main part being located at least under and supporting the Digitis Pedis II to V and the ball of the foot, the movable element being movably connected to the main part so as to rotate about an axis in a horizontal plane within the limits of the joint of the Digitis Pedis I and the foot.

The orthopedic shoe sole or insole according to the invention comprises a main part which serves to support the Digitis Pedis II to V and at least the transverse arch of the foot, preferably additionally the longitudinal arch and the heel. The movable element serves to support the Digitis Pedis I and is movably attached to or firmly connected to the main part in the area of the big toe joint (if necessary, as a separate element). This allows the movable element to move in a horizontal plane relative to the main part, in particular to rotate about an axis within the limits of the joint of the Digitis Pedis I and the ball of the foot. The movement of the movable element relative to the main part is limited by suitable means.

The relative movement, in particular the rotational movement in the horizontal direction, between the movable element and the main part of the orthopedic shoe sole or insole preferably occurs during a walking movement of the patient, in particular caused by the compressive force exerted by the patient's own weight on the orthopedic shoe sole or insole. As a result, the orthopedic shoe sole or insole according to the invention periodically generates the movement known from foot gymnastics for mobilizing the Digitis Pedis I and the big toe joint when the patient walks, so that the patient can independently perform the curative foot gymnastics by walking every day. Thus, the movable element preferably moves in the horizontal plane relative to the main part depending on the load of the supported foot, in particular in the form of a pendulum movement whose axis of rotation is located in the area of the big toe joint.

The orthopedic shoe sole or insole according to the invention enables a patient with hallux valgus to independently perform curative foot exercises at any time, especially on a daily basis, thereby minimizing the cost of hallux valgus treatment. The simultaneous movement of the Digitis Pedis I in the vertical and horizontal directions during the performed walking movement mobilizes the Digitis Pedis I and the big toe joint.

According to the invention, there is a cavity in the main part of the shoe sole or insole under the Digitis Pedis II to V and/or the transverse arch of the foot, in which a hydraulic, mechanical, pneumatic, electric or other device is incorporated, which is connected to the movable element and causes the rotational movement in the horizontal plane laterally away from the main part during a walking movement, in particular caused by the compressive force caused by the patient's own weight on the orthopedic shoe sole or insole. The cavity in the main part can also be formed between the insole and the shoe sole. Thus, the orthopedic shoe sole or insole according to the invention generally comprises mechanical, hydraulic, pneumatic, electric or other means to perform the relative movement between the movable element and the main part, in particular during the walking movement of the patient. For example, this is done by loading the transverse arch and/or Digitis Pedis I to V with the patient's own weight, thereby actuating the hydraulic, mechanical, pneumatic, electric or other device.

In an expedient variant of the invention, the device for effecting the rotational movement is a hydraulic device which is in the form of an elastic sheath filled with a gel or other fluid and having a plunger at the end, the plunger being connected to the movable element and being periodically actuated by the pressure exerted by the foot on the sheath at the beginning of each step. During the walking movement, the patient exerts a force by his own weight on the sheath filled with the gel or other liquid, which moves the plunger and thus the movable element connected to it relative to the main part. If the pressure on the sheath is released, the plunger and the associated movable element can return to their original position.

According to an alternative variant of the invention, the device for effecting the rotary motion is a pneumatic device, which is in the form of an elastic sheath filled with air or other gas, with a plunger at the end, the plunger being connected to the movable element and being periodically actuated by the pressure exerted by the foot on the sheath at the beginning of each step. The pneumatic variant differs from the hydraulic variant mainly in the medium used to move the plunger.

According to a further variant of the invention, the device for effecting the rotary movement is a mechanical device which is in the form of a leaf spring which is connected at a first end in the cavity to the main part and at a second end to the movable element, the leaf spring being periodically actuated by the pressure exerted by the foot on the leaf spring at the beginning of each step. This variant is particularly simple and inexpensive to manufacture and is less prone to failure, since it does not require a liquid or gaseous medium which may escape if the orthopedic shoe sole or insole according to the invention is damaged.

In another variant according to the invention, the movable element is connected to the main part of the shoe sole or insole by means of a plate which allows the movable element to be locked away to the side with respect to the main part of the sole at different spreading angles. In general, the orthopedic shoe sole or insole according to the invention comprises means, in particular mechanical means, for fixing the movable element relative to the main part in different positions, independently of the load on the supported foot. The Digitis Pedis I is thus fixed by the fixed movable element at a certain distance from the Digitis Pedis II supported on the main part, whereby a vertical movement is generated by the walking movement (bending of the foot), which also generates a remedial gymnastic movement that can be regularly adjusted by a physiotherapist, for example, due to the different adjustable positions. This is particularly advantageous if a simultaneous horizontal and vertical movement is too painful for the patient.

According to a further advantageous variant of the invention, the movable element comprises a fixation for the Digitis Pedis I so that it is guided at all times during the horizontal rotational movement generated. The fixation is, for example, one or more elevations on the movable element or formed as a loop or the like.

The problem is further solved by a shoe comprising an orthopedic shoe sole or insole according to the invention. Expediently, the shoe is designed as a shoe open at the front, since this simplifies the relative movement between the main part and the movable element.

In an expedient variant, the sole of a shoe according to the invention additionally comprises a base plate on which the movable element can be moved. The base plate is preferably connected to the main part and formed integrally therewith. The base plate prevents direct contact between the ground and the movable element, so that the movement of the movable element is not hindered by friction with the ground.

DETAILED DESCRIPTION

FIG.1Ashows a top view of a right shoe with an orthopedic shoe sole1according to the present invention, for persons with hallux valgus. The orthopedic shoe sole1according to the first embodiment ofFIG.1Asupports the entire foot from Digitis Pedis I to V to the heel when walking or in a static state. The shoe ofFIG.1Acomprises the orthopedic insole1according to the invention and an upper part2, which preferably consists of an elastic material. Furthermore, the shoe is expediently open at the front to allow relative movement between the Digitis Pedis I and the Digitis Pedis II to V as described below. Alternatively, the shoe could have a corresponding free space for the relative movement.

The foot of the wearer of the shoe is represented by a dashed line inFIG.1A.

The orthopedic shoe sole1of the shoe ofFIG.1Acomprises a main part14and an element3movably connected thereto. The movable element3is located under and supports the Digitis Pedis I, while the main part14is located at least under and supports the Digitis Pedis II to V and the ball of the foot. According to the first embodiment example ofFIG.1A, the main part14supports the foot in the area of the Digitis Pedis II to V up to the heel.

The movable element3is movably connected to the main part14via the connection5. The relative movement between the movable element3and the main part14is ensured, for example, by the elasticity of the material used and can be supported by the indentations in the form of roundings6. In particular, the roundings6prevent cracking due to stretching processes caused by the relative movement between the movable element3and the main part14. The connection5between the movable element5and the main part14may be formed in one piece, so that both are made from the same basic piece, or a subsequently manufactured connection5, so that both are manufactured separately and subsequently connected.

The connection5between the movable element3and the main part14is designed in such a way that the movable element3can rotate about an axis5in a horizontal plane within the limits of the joint of the Digitis Pedis I and the ball of the foot. The axis of rotation5is preferably located in the area of the joint of the Digitis Pedis I (big toe joint).

FIGS.1B and1Cshow sectional views along lines A-A and B-B, respectively, ofFIG.1A. As can be seen in particular fromFIGS.1B and1C, a cavity7is located in the front area of the main part14of the shoe sole1, in particular under the Digitis Pedis II to V. According to the first embodiment example ofFIG.1B, a hydraulic device is installed in this cavity, which is connected to the movable element3and causes the rotational movement in the horizontal plane laterally away from the main part14during a walking movement, in particular caused by the compressive force caused by the patient's own weight on the orthopedic shoe sole1.

The hydraulic device comprises, for example, an elastic sheath8in the cavity7. This sheath8is filled with a gel or other fluid9. On the side adjacent to the end face of the movable element3, the sheath8comprises a plunger10. This plunger10is designed, for example, as a corrugated tube, the tube profile being in particular in the form of a thread. In this case, the plunger10, in particular the corrugated tube, is made of a material which has a higher strength than the elastic sheath8. The closed end piece11of the plunger10is connected to the movable element3. The hydraulic device thus formed is periodically actuated by the pressure exerted by the foot at the beginning of each step, in particular a pressure is exerted on the elastic sheath8, causing the plunger10to move the movable element3relative to the main part14and causing the rotary movement in the horizontal plane laterally away from the main part14.

A compression spring can be inserted into the plunger10, in particular the corrugated tube, in order to adapt the mechanical properties of the hydraulic device, in particular to generate a preload. This allows the pressure required to generate the relative movement between the movable element3and the main part14to be adapted to the individual needs of a patient.

It is expedient to have an elevation12on the side of the movable element3facing the Digitis Pedis II, which ensures that the Digitis Pedis I can be moved with the movable element3. Accordingly, the main part14can have an elevation13on the side towards the Digitis Pedis I, which fixes the Digitis Pedis II and thereby also the Digitis Pedis III to V on the main part14. The elevation12of the movable element3and the elevation13of the main part14are shown in detail inFIG.1C. Instead of the elevation12and/or the elevation13, a bracket, a loop or the like can also be used to fix the Digitis Pedis I on the movable element3or at least the Digitis Pedis II on the main part14.

When walking, the heel of the foot lifts and the toe of the foot comes into a horizontal position and the entire weight of the person presses on the elastic sheath8. The plunger10expands and spreads the movable element3to the side. The elevation12on the movable element3ensures that the Digitis Pedis I moves together with the movable element3. During each step, the Digitis Pedis I thus simultaneously performs a movement in two planes, namely in the vertical plane together with the other Digitis Pedis II to V and a sideways splaying/pendulum movement in the horizontal plane together with the movable element3away from the Digitis Pedis II to V. When the compressive force is no longer applied, the movable element3and the Digitis Pedis I return to their initial position.

If the person remains standing on the tips of the feet, the pressure is permanently applied to the hydraulic device and the movable element3spreads the Digitis Pedis I correspondingly from the Digitis Pedis II to V during this time, which also corresponds to a remedial gymnastic exercise for hallux valgus patients.

The specific method of use, the frequency and amplitude of relative movement of the movable element3are specified by physician, especially orthopedists.

FIG.2Ashows various views of a shoe according to a second embodiment of an orthopedic shoe sole1according to the invention. The second embodiment ofFIG.2Adiffers from the first embodiment ofFIG.1Ain that there is no hydraulic device installed in the cavity7, which is connected to the movable element3and causes the rotational movement in the horizontal plane laterally away from the main part14during a walking movement, but a mechanical device which is connected to the movable element3and causes the rotational movement in the horizontal plane laterally away from the main part14during a walking movement.

The mechanical device according to the second embodiment ofFIG.2Acomprises a leaf spring15having end portions16. The leaf spring15is connected with the right end section16to the main part14of the shoe sole1via the connecting element17. At the joint between the main part14and the movable element3, the leaf spring15is inserted in a groove18of the movable element3and is connected to the movable element3by the axis19. The leaf spring15has an elongated hole20for the axis19in the end portion16which is connected to the movable element3, so that the offset of the axis19which occurs during the swinging/pendulum movement of the movable member3can be compensated. Details of this can be seen in particular inFIGS.2D and2E, which show sectional views along the lines C-C and D-D, respectively, ofFIG.2A.

The leaf spring15has an upwardly curved region21, as can be seen in particular from the sectional view ofFIG.2B, whereFIG.2Bshows a sectional view along the line A-A ofFIG.2A. The upwardly curved region21of the leaf spring15presses from below against the upper plane of the cavity7, as shown inFIG.2B.

On the movable element3there is an elevation12and on the main part14there is an elevation13, corresponding to the first embodiment example ofFIG.1A, which fix the Digitis Pedis I or the Digitis Pedis II to V during the relative movement between the movable element3and the main part14.

FIG.3Ashows various views of a shoe with a third embodiment of a shoe sole1according to the invention.FIG.3Ashows a top view of a right shoe with the orthopedic shoe sole1according to the present invention, for persons with hallux valgus. The orthopedic shoe sole1according to the third embodiment ofFIG.3Asupports the entire foot from Digitis Pedis I to V to the heel when walking or in a static state. The shoe ofFIG.3Acomprises the orthopedic insole1according to the invention and a top2, which is preferably made of an elastic material. Furthermore, the shoe is expediently designed to be open at the front in order to flexibly adjust the distance between the Digitis Pedis I and the Digitis Pedis II to V as described below. Alternatively, the shoe could have a corresponding free space for the adjustment.

The foot of the wearer of the shoe is represented by a dashed line inFIG.3A.

The orthopedic shoe sole1of the shoe ofFIG.3Acomprises a main part14and an element3movably connected thereto. The movable element3is located under and supports the Digitis Pedis I, while the main part14is located at least under and supports the Digitis Pedis II to V and the ball of the foot. According to the third embodiment example ofFIG.3A, the main part14supports the foot in the area of the Digitis Pedis II to V up to the heel.

The movable element3is movably connected to the main part14via the connection5. The relative movement between the movable element3and the main part14is ensured, for example, by the elasticity of the material used and can be supported by the indentations in the form of roundings6. In particular, the roundings6prevent cracking due to stretching processes caused by the relative movement between the movable element3and the main part14. The connection5between the movable element3and the main part14may be formed in one piece, so that both are made from the same basic piece, or a subsequently manufactured connection5, so that both are manufactured separately and subsequently connected.

The connection5between the movable element3and the main part14is designed in such a way that the movable element3can rotate about an axis4in a horizontal plane within the limits of the joint of the Digitis Pedis I and the ball of the foot. The axis of rotation4is preferably located in the area of the joint of the Digitis Pedis I (big toe joint).

In contrast to the first embodiment ofFIG.1Aand the second embodiment ofFIG.2A, in the third embodiment ofFIG.3A, the movable element3is connected to the main part14of the sole1of the shoe via a plate22, which allows the movable element3to be locked away to the side with respect to the main part14of the sole1at different spreading angles, as shown for example in detail inFIG.3B.

The plate22is connected to the main part14at one end via a first pin23. The first pin23is locked, for example screwed, from below through an opening in the main part14of the soleplate1into a first bulge25of the plate22. At the other end, in the region of the movable element3, the plate22has a second bulge26for a second pin27. The movable member3of the sole1has a plurality of openings24for the second pin27, so that the second pin27can be passed through one of the openings24and locked in the second bulge26. The distance between the main part14and the movable element3is thereby adjusted by the choice of the opening24through which the second pin27is locked in the second bulge26.

The Digitis Pedis I is thus fixed by the fixed movable element3at a certain distance from the Digitis Pedis II supported on the main part14, whereby a vertical movement is generated by the walking movement (bending of the foot), which also generates a remedial gymnastic movement that can be regularly adjusted by a physiotherapist, for example, due to the different adjustable positions. This is particularly advantageous if a simultaneous horizontal and vertical movement is too painful for the patient.

LIST OF REFERENCE SIGNS