DE29800802U1 - Peroneus and / or fixation orthosis and / or inner shoe support shell and arrangement for producing the same - Google Patents

Description

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Title of the innovation
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Peroneus and/or fixation orthosis and/or inner shoe support shell and arrangement for producing the same

Area of application of the innovation

The innovation is used in the human medical field for peroneal and/or fixation orthoses and/or inner shoe support shells.
The arrangement is used in the manufacture of the above-mentioned objects from prefabricated and/or individually manufactured and/or post-processed starting parts.

Characteristics of known solutions

Orthoses are well known for their use in immobilizing and/or restricting the movement of limbs after injuries and also for correcting congenital or acquired deformities and/or pathological changes in the extremities.
Peroneal orthoses for immobilizing the upper ankle joint are also well known. Prefabricated peroneal orthoses, also known as Heidelberg angles, are particularly well known. One such component is described in more detail in DE-G 93 19 050.6. Such universally applicable orthoses generally do not adequately take into account the anatomical conditions of the ankle joint to be immobilized.

The metal design of the Heidelberg angle with its relatively high strength not only limits the mobility of the foot in the way necessary for healing purposes, but also prevents the mobility of the foot in the natural running direction, which is entirely desirable, and thus largely prevents a natural running pattern.

The relatively stable design of the Heidelberg angle inevitably leads to tensions in the material when walking, which can cause it to break. In such cases, this leads to the sudden total loss of function of such orthoses.

For example, DE-G 93 19 050.6 attempts to counteract the strength problem by reducing the cross-section of the orthosis in the area subject to particular stress in order to achieve greater elasticity at the same time. However, such measures limit the effectiveness of the orthosis, impair the wearing properties and ultimately cannot permanently solve the strength problem.

The disadvantages of the Heidelberg angle described above ultimately only allow its use in cases where the wearing time is short, temporary healing processes of the upper foot levator muscle and the associated tendons must be supported and the degree of injury is not too severe.

Another known form of peroneal orthosis is described in G 90 1 5 080. In this embodiment, angle-fixable joint structures are provided on both sides of the ankle. The calf part, like the lower foot shell, is made of fiber-reinforced materials, whereby the lower foot shell is very shortened and resembles a heel cap. The joints are specially made. The calf part is open in the dorsal area and is closed there using tensioning devices after the orthosis is put on.
The main disadvantage of this form of peroneal orthosis is that all guiding and limiting tasks are assigned to the special joint. As a special construction, this causes considerable manufacturing costs. Furthermore, the entire load when wearing the orthosis is in the area of the joints, which can easily loosen them and thus limit the usability of the orthosis.

Another major disadvantage is that the joints are located on both sides of the ankles, which makes the orthosis considerably wider and the wearer cannot wear it under normal stockings.
Another disadvantage is that the foot shell of the orthosis does not cover the entire foot. This means that the correction of misalignments by this type of orthosis is significantly limited. If these are worn in normal shoes, they can move within the shoes.

and thereby largely cancel out its stabilising effect.

The manufacture and use of individually adapted orthoses is also known, such as the form of a peroneal orthosis made essentially of fiber or fabric-reinforced material described in DE 196 13 778.0. This form of orthosis has the advantage that the two-part design and the connection of both parts by means of a joint reliably prevents the extension of the foot lifter muscle, but on the other hand allows the foot to roll naturally when walking. This design of the orthosis thus maintains a largely natural gait pattern for the wearer, reliably achieves the required restriction of movement and, by adapting to the foot, also specifically corrects other misalignments of the foot or effectively supports their correction and healing.
A significant disadvantage of the peroneal orthosis described above is the relatively high cost of manufacturing it. After the functional parts have been prefabricated, several individual adjustments to the wearer's foot and corresponding reworking of the shape are required until the final fit is achieved. The wearer of such a peroneal orthosis must therefore have it adjusted several times and make do with less suitable, makeshift solutions until it is finally finished.

Task of innovation

The innovation aims to propose a peroneal and/or fixation orthosis and/or inner shoe support shell equipped with the functionality described in DE-196 13 778.0, the foot and/or calf part of which can be manufactured as prefabricated parts and can be adapted to the anatomy of the future wearer without great effort, without exhibiting the disadvantages of the known designs described above.

It is also the task of the innovation to propose an arrangement for the production of such peroneal and/or fixation orthoses and/or inner shoe support shells that allows prefabricated foot shells and/or calf parts to be produced for later individually adapted orthoses.

Essence of innovation

The essence of the innovation is that a peroneus and/or fixation orthosis and/or inner shoe support shell is produced from a prefabricated calf part and/or a prefabricated foot shell. The wearer can wear this in normal shoes.

If necessary, it is possible to manufacture the calf part and/or foot shell of the new peroneal and/or fixation orthosis and/or inner shoe support shell without using prefabricated parts from semi-finished products and/or unprocessed raw materials.

According to the innovation, a dorsal leg shell, which has two straps at the upper end of a dorsally arranged bar that largely surround the calf, is connected at the lower end in two curved bars that run downwards to a foot shell that carries a heel cap in such a way that both parts are connected to one another by a joint and can be pivoted around it. The heel cap of the foot lower shell is widened at its upper edge and forms a contact surface for the lower end of the dorsal bar of the leg shell.

The dorsal leg shell is flexible and can be attached to the wearer's lower leg using suitable securing parts, such as Velcro, so that it fits almost completely. In the longitudinal direction, however, the dorsal leg shell has a high degree of dimensional stability due to its curvature, which ensures the support effect. The connecting strips to the lower foot shell on both sides of the wearer's foot have a high degree of elasticity in the rolling direction of the foot and thus ensure partial lateral mobility of the foot, which is necessary to maintain the wearer's natural gait.

Furthermore, the elasticity of the same greatly reduces the pressure forces that act on the joint when the foot rolls over, thus increasing the lifespan of the joint. At the same time, both strips adhere to the foot after it has rolled over and guide or hold it in a desired position.
Plantar flexion of the foot is prevented by the fact that the leg shell with the lower end of the dorsally arranged bar rests on the inside of the heel cap after the foot has rolled over and at the same time the two connecting bars to the joint of the orthosis are completely tightened. In this position, a position correction of the foot can also be made by adjusting the length of the connecting parts and the position of the joints by making appropriate position corrections when connecting the lower foot shell and the dorsal leg shell.

The new foot shell is also manufactured as a prefabricated part. It is shaped in such a way that it has the character of a sole in the area of the toes and the ball of the foot, a gradually rising edge increasingly encloses the foot in the area of the metatarsal bone, and is shaped roughly spherically in the heel area to accommodate it. Above the heel, the heel cap is extended almost vertically upwards and at the same time widened. In the area of the raised side edges of the foot shell, the joint with which the leg shell is pivotally connected to the foot shell is located roughly at the same level, in front of or behind the axis of the ankle. In the raised area of the heel cap, the web of the leg shell rests on the inside of the foot shell. The pressure force generated there is relatively small due to the large pivot radius and premature wear of the orthosis is largely avoided.

The above-described features of the orthosis ensure that the wearer has a largely natural gait, while maintaining normal muscle mobility, promoting muscle training and at the same time reliably preventing plantar flexion of the foot. Likewise, misalignments of the foot, such as supination, pronation, eversion and/or inversion, can be corrected by adjusting the orthosis accordingly. At the same time, the creation of an anatomically adapted

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fitted orthosis made from prefabricated components. The arrangement of the joints and the attachment points of the leg shell reduce the mechanical stress and thus enable a significantly longer service life of the orthosis.

In a particularly advantageous embodiment of the orthosis, the dorsal leg shell and/or the foot lower shell are manufactured in a series of dimensions corresponding to the natural, anatomically given conditions and can be combined accordingly if required.
Another advantageous design of the orthosis uses a dorsal leg shell, the edges of which are reinforced in a bead-like manner, thus significantly increasing its strength.

In another advantageous design of the orthosis, the raised edges of the foot shell in the area of the joints are also reinforced with beads.

An advantageous embodiment of the orthosis has an intermediate layer made of elastic, dampening and force-distributing material in the area of the support surface between the leg shell bar and the heel cap. It is irrelevant to the nature of the innovation which of the two parts this is attached to.

Another particularly advantageous embodiment of the orthosis has an additional elastic bandage between the two S-shaped bars, which largely reduces deformation of the same during the rolling process of the foot, thereby fixing the foot and at the same time reducing the load on the joints of the orthosis.

Another particularly advantageous embodiment of the orthosis uses a foot shell in which the heel cap is cut out in the rear area. This embodiment makes it easier to wear the orthosis in normal footwear, but does not allow for all of the movement restrictions described above.

Another version of the new orthosis uses a foot shell that completely lacks a heel cap and its raised contact surface. This version of the orthosis allows plantar flexion of the foot, but at the same time ensures the correction of misalignments of the foot and the guidance of the foot when walking. This version of the orthosis can also be worn in normal shoes.

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The peroneus and/or fixation orthosis and/or inner shoe support shell according to the innovation is preferably, but not necessarily, made of a homogeneous plastic and/or a plastic reinforced with fiber and/or fabric material. Manufacturing the same from leather and/or leather-like, compacted fibrous and/or metallic materials is also possible. It is irrelevant for the nature of the innovation whether the dorsal leg shell and/or foot shell are made from the same or different materials and what properties the selected materials have in each individual case. The choice of material will be made according to the requirements of the future wearer of the orthosis.

An advantageous embodiment of the orthosis uses thermally formable materials for the calf part and the lower foot shell.
In a particularly advantageous embodiment of the orthosis, a fiber and/or fabric-reinforced plastic material is used at least for the lower foot shell, which softens again by subsequent local heating and can thus be adapted to the anatomical conditions of the wearer.

The innovative arrangement for producing the orthosis is created by first producing the dorsal leg shell and the foot shell separately from each other using known shaping processes. Both parts are produced in a series of dimensions determined according to anatomical conditions and the appropriately adapted orthosis is produced by combining different sizes with each other.

Once the combination is complete, the calf part and the foot shell are connected to each other at the joint points. Both parts of the orthosis are then padded on the inside using suitable materials that improve the wearing properties.
In an advantageous embodiment of the arrangement, the padding of the calf part is partially carried out before the assembly of both parts.

In a further, particularly advantageous embodiment of the arrangement, the padding of both parts takes place before they are connected at the joint points. The calf part has a

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and made of the same material as the rest of the padding, but initially not attached in the area of the joints. After the connections to the foot shell have been made, these covers are also attached.

A particularly advantageous embodiment of the arrangement enables, in a further process step, the application of a decorative layer to the outside of both parts.

In a particularly advantageous embodiment of the arrangement, largely prefabricated blanks for the calf part and the lower foot shell are first produced. The dimensions of the blanks are determined in terms of shape and size based on anatomical conditions. Other selection criteria can be the padding of the inner surfaces and the design of the outer surfaces. After the pre-selection has been made, the parts are adapted, preferably by reshaping, but also by means of machining processes. After the shape has been adapted, the joint points are determined, the holes for accommodating the joints are made in the calf part and the lower foot shell, and then both parts are connected to one another by the joints.

Finally, if necessary, additional fasteners or fixings can be added.

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Examples of implementation

The innovation is explained in more detail below using 5 exemplary embodiments and 4 figures. In exemplary embodiments 1 to 3, various forms of the peroneal and/or fixation orthosis and/or inner shoe support shell are described, and in exemplary embodiment 4, the method for producing the same is described.

Example 1

In this embodiment shown in Fig. 1, a form of the peroneal and/or fixation orthosis and/or inner shoe support shell is described, in which the joint (3) is arranged in front of the plane of the ankle joint.

A calf part (2), consisting of a dorsal leg shell, two tabs (7) protruding forwards at the upper edge of the same and molded from the same material, as well as two joint tabs (11) protruding downwards from the dorsal leg shell, are connected to a foot lower shell (1) by a joint (3) each.

The tabs (7) protruding from the upper edge (4) of the calf part (2) largely enclose the calf of the wearer of the orthosis and, in conjunction with the inherent tension of the curved leg shell, ensure that it is held securely.

The tension of the tabs is increased even further by an additional fastening element, which here is a Velcro strip (6) with the corresponding adhesive surface (5). In addition to Velcro strips, any other suitable component can be used as a fastening element.

The dorsal leg shell is extended downwards by two joint brackets (11) arranged on its sides. In each of the two joint brackets there is a hole (24) for receiving the joint (3).
In the area of the front edge (8) of the calf part (2) there is a bead-shaped reinforcement (9) which points outwards and additionally reinforces the front edge (8).

In the area of the rear edge (12) of the joint plates (11) there is also a bead-shaped reinforcement (10) that serves to increase the strength.

The calf part is made from a plastic-fiber and/or plastic-fabric laminate as a prefabricated molded part with a provisionally determined outer contour. The holes (24) are not yet present, although their axes can already be incorporated for later insertion. A plastic-fiber and/or plastic-fabric laminate with a thermally softenable base material is preferably used to produce the calf part. This makes it possible to reshape the calf part and/or individual parts of it by means of complete or partial heating.

The inside of the calf part is completely lined with material that improves its wearing properties and at the same time has a temperature resistance that allows the calf part to be reshaped by heating the base material.

A foot shell (1), which essentially consists of a sole-shaped plate with a heel (18) molded onto it from the same material and a support area above the heel that is also molded onto it from the same material, is connected to the calf part (2) by the two joints (3) that are almost opposite one another. The foot shell, like the calf part (2), is manufactured as a molded part with a provisionally determined outer contour from a plastic fiber and/or plastic fabric laminate.
The sole (29) is largely adapted to the natural sole shape of the human foot. Starting in the metatarsal area, raised edges (25) are formed on both sides, which merge into the heel (18) in a form-fitting manner, enclose the heel of the wearer of the orthosis and are closed off at the top of the heel (18) by the support area (14).
In the area of the edges (25) in front of the level of the ankle joint, two holes (24) are arranged, which accommodate the joints (3) and serve to connect the lower foot shell (1) to the calf part (2). However, the holes are not yet made in the preformed part of the lower foot shell. Instead, the point to be selected later for the hole can be marked using predetermined markings.

The inside of the foot shell (1) is completely lined with material that improves its wearing properties and at the same time has a temperature resistance that allows it to be reshaped by heating the base material.

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The calf part (2) and the foot shell (1) are connected to each other by means of the joint (3).

The joint (3) allows a pivoting movement of the calf part, which largely meets the requirements of the natural movement sequence of walking. The calf part (2) is guided by the calf, which it clasps.

The foot shell is regularly worn in normal or slightly modified footwear. However, it can also be used directly as an outsole if necessary.

Both the calf part (2) and the foot shell (1) are manufactured as preforms in a series of dimensions determined according to anatomical conditions. After selecting the necessary sizes and, if necessary, individual adjustment by reshaping, the orthosis is completed by fixing the joint point and inserting the joints.
The outsides of the calf part (2) and the foot shell (1) are untreated by the manufacturer. They can be finished by coloring the base material or by applying an additional, but not essential, decorative coating.

Example 2

This embodiment shown in Fig. 2 is a peroneal and/or fixation orthosis and/or inner shoe support shell with a structure that is essentially the same as that described in the previous embodiment.

In this embodiment, the joint tabs (11) on the calf part (2) are designed in such a way that the joints are arranged in the plane of the ankle joint or behind it. The joint tabs (11) are therefore pulled backwards.
With this version of the orthosis, the amount of force required when walking is significantly reduced. It can also be adjusted as required by moving the pivot point for the joints further or closer to the back.

The manufacture of the parts, their further processing and the completion of the orthosis are carried out in the same way as described above.

Example 3

In this embodiment shown in Fig. 3, a foot base (1) is used in which the heel is largely left out.
A calf part (2) in the design already described above is connected in the joint (3) to a foot shell (1) which has a recess (19) in the area of the heel. The foot plate (20) has a bracket (30) which extends from its side edges (25) and is formed from the same material and which at the same time forms the support area (14) for the calf part (2) in its upper part.
The bracket has bead-like reinforcements (21) on its upper (31) and lower edge (32) which increase its stability.

This design of the orthosis allows it to be worn in normal shoes without having to make any significant changes. This is made possible in particular by the elimination of the molded heel, whereby this design uses a stirrup whose lower edge lies outside the heel cap, at least when wearing low shoes, and thus on the one hand does not take up any additional space inside the shoe, and on the other hand the desired guiding functions are fulfilled outside of the shoe.
In this embodiment, the calf part (2) and the foot shell (1) are also made from a thermally reformable and/or plastic-fabric laminate. The further treatment corresponds to that described above.

Example 4

In this embodiment shown in Fig. 4, a form of orthosis is described in which a foot base (1) is used without any rear fixation.

The calf part (2) in a design as described above is connected by means of the joints (3) to a foot base (1) that has neither a heel cap nor a contact surface. The side edges (25) of the foot base (1) slope down to the sole behind the joint (3). The joints (3) are

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freely movable, but can also be limited by fixing the angle of rotation if required.

The articulation points are determined as described above. The rest of the orthosis can also be designed as described above. The orthoses described in this example are primarily used to correct misalignments of the foot and ^{at the} same time provide support when walking.

Example 5

In this embodiment, an arrangement of a peroneus 5 and/or fixation orthosis and/or inner shoe support shell with the properties listed in the previous embodiments, in the description of the innovation and in the protection claims is explained in more detail.
Using known manufacturing processes, such as compression molding, first of all, shaped blanks of the calf part (2) are produced. These already have all of the shaped elements described above, with the exception of the holes (24) in the joint straps.
Based on a size chart developed according to anatomical conditions, a range of sizes of different calf parts (2) with otherwise the same shape can be produced.

In the same way, blanks of the foot base (1) are produced, which can also be graded in a size series.
The blanks of the calf part (2) and/or the foot shell are then lined on their inner sides with a material that improves the wearing properties in a possible further process step. Another possible process step that takes place before the parts are lined
can be carried out is the individual adjustment of the parts to the anatomical conditions of the wearer after the size has been selected. The parts are adapted as required by thermal shaping and/or machining processes.

Adaptation by thermal forming can also be carried out on parts that have already been lined. In this case, the lining is carried out using materials that can withstand the temperatures that occur during thermal forming without having any adverse effects on them.

Another possible process step that can be carried out before lining the parts is additional padding with appropriate materials that are inserted between the base material and the lining.

After the anatomical adjustment, lining and, if necessary, padding of the calf part (2) and the foot shell (1), the two parts are adjusted to each other in a further step. At the same time, the connection point is determined and the holes and joints are inserted.

The determination of the connection point depends initially on the selected parts, but also on the healing and/or support effect to be achieved.

After the anatomical adjustment has been made, the connection point has been determined and the orthosis has been assembled, additional fastening elements, such as buckles, Velcro fasteners or similar, will be added if necessary.

Claims (14)

- 1 Protection claims 1. Peroneus and/or fixation orthosis and/or inner shoe support shell, characterized in that a calf part (2) manufactured as a one-piece molded part from a thermally deformable, fiber and/or fabric-reinforced plastic and/or thermally deformable plastic and/or mechanically moldable materials, with a dorsally closed calf shell, which is open at the front and in the area of the upper edge (4) on both sides a tab (7), on each of which a fastening element is arranged, in the lower area on both sides a joint tab (11), at the lower end (23) of which a bore (24) for receiving a joint (3) is arranged, by means of the joint a connection to the lower foot shell (1), also manufactured as a one-piece molded part from a thermally deformable, fiber and/or fabric-reinforced plastic and/or thermally deformable plastic and/or mechanically moldable materials, essentially consisting of a Foot plate (20), a heel part (18), a part standing upright in the dorsal area (14) and laterally raised edges (25) extending into the metatarsal area, whereby the calf part (2) is partially overhanged at its lower edge (26) by the upper edge (27) of the vertical part (14) of the foot shell (1) and rests against it in the normal position. 2. Peroneus and/or fixation orthosis and/or inner shoe support shell according to claim 1 , characterized in that the joint (3) between the calf part (2) and the foot lower shell (1) lies in front of the plane of the ankle joint. 3. Peroneus and/or fixation orthosis and/or inner shoe support shell according to claim 1, characterized in that the joint (3) between the calf part (2) and the foot lower shell (1) lies in or behind the plane of the ankle joint. 4. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 3, characterized in that the foot lower shell (1) has at least two bores (24) on both sides for receiving the joint (3) and for combination with a correspondingly adapted calf part (2). - 2- 5. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 4, characterized in that it is produced from anatomically graded size series of the calf part (2) and the foot lower shell (1) by combining them and connecting them by means of the joints (3). 6. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 5, characterized in that the calf part (2) and/or foot lower shell (1) are made of a thermally reformable plastic and/or plastic fiber and/or plastic fabric laminate and are wholly or partially reformable if required. 7. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 6, characterized in that the calf part (2) has at least partially a bead reinforcement (9) in the region of its front edge (8). 8. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 6, characterized in that the foot lower shell (1) has at least partially a bead reinforcement (17) in the region of the raised side surfaces (25). 9. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 8, characterized in that the inner side (28) of the calf part (2) and/or the lower foot shell (1) with material improving the wearing properties, and/or the outer sides of the calf part (2) and/or the lower foot shell (1) have a decorative surface. 10. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 6, characterized in that an insert (22) made of dampening material is arranged in the support area (14) between the calf part (2) and the foot lower shell (1). -3- 11. Peroneus and/or fixation orthosis and/or inner shoe support shell according to one of claims 1 to 9, characterized in that the foot lower shell (1) is designed as a sole with raised edges (25) and is connected to the calf part (2) by means of the joints (3). 12. Arrangement, consisting of a peroneus and/or fixation orthosis and/or inner shoe support shell, each consisting of a calf part (2) and a foot shell (1), which are connected to one another by means of a joint (3), characterized in that a calf part (2) with a specific outer contour is made from a thermally moldable plastic and/or plastic-fiber and/or plastic-fabric laminate and/or mechanically moldable material, a foot shell with a specific outer contour is made from a thermally moldable plastic and/or plastic-fiber and/or plastic-fabric laminate and/or mechanically moldable material, the prefabricated calf part (2) and/or the prefabricated foot shell (1) are adapted to anatomical conditions by post-molding and/or machining, the inside of both parts are lined with material that improves the wearing properties, the articulation points of both parts are fixed, inserted into the same holes (24) and the calf part (2) and foot base (1) are connected to each other by means of the joints (3). 13. Arrangement in the form of a peroneus and/or fixation orthosis and/or inner shoe support shell according to claim 12, characterized in that a calf part (2) manufactured according to anatomically determined series of measurements and/or a foot lower shell manufactured according to anatomically determined series of measurements are combined with one another depending on anatomical conditions, connected to one another by means of the joint (3) and lined accordingly. 14. Arrangement in the form of a peroneal and/or fixation orthosis and/or inner shoe support shell according to one of claims 12 or 13, characterized in that either an individually manufactured calf part (2) or an individually manufactured foot lower shell (1) are each connected to a calf part (2) or foot lower shell (1) manufactured according to measurement series by means of the joint (3).