Orthosis

Abstract

The present invention relates to an orthosis (10) comprising at least one splint (12) having a strap (16) for fixing the splint (12) to a body part of the patient, the splint (12) comprising a splint leg (18) on which a support (20) is arranged, and the strap (16) being integrally bonded to the support (20).

Description

[0001] Orthosis

[0002] Description:

[0003] Technical field

[0004] The present invention relates to orthoses comprising at least one splint with a strap. Such orthoses can be used to influence the structural and functional properties of a patient, in particular for the treatment and prevention of structural or functional disorders. In particular, the present invention relates to foot orthoses for the treatment and prevention of foot deformities, such as hallux valgus.

[0005] State of the art

[0006] Orthoses, particularly foot orthoses, are known from the prior art and are designed to influence the structural and / or functional properties of a patient's body parts. Such orthoses can be used, in particular, to treat or prevent pathological deformities, for example, in the midfoot and forefoot.

[0007] Pathological deformities in the midfoot and forefoot of a patient can have various causes, such as genetic predisposition, wearing improper footwear, especially shoes that are too tight or high-heeled, or a flattening of the longitudinal and transverse arches due to instability of the connective tissue in the midfoot. In particular, the deformity of the big toe at the metatarsophalangeal joint, also known as hallux valgus or valgus deformity, is gaining increasing importance due to the steadily rising number of cases.

[0008] Hallux valgus develops when the big toe is pulled inwards at the metatarsophalangeal joint by muscle tension. This causes the first metatarsal bone to protrude as a bunion-like bump on the inside of the foot, a condition known as pseudoexostosis. Hallux valgus is also frequently accompanied by changes in the length and direction of the tendons, which can further exacerbate the deformity over time. This can lead to osteoarthritis of the metatarsophalangeal joint, which, in advanced stages, requires surgical treatment.

[0009] To halt or counteract the disease process, conservative treatment methods are used in addition to surgical interventions. For example, the use of tape bandages or orthoses is known to treat the foot in a resting position. Due to the required immobilization of the foot during therapy, these are primarily used at night.

[0010] Furthermore, orthoses are known which, in a splinted state attached to the foot, allow a degree of freedom of movement along the flexion-extension direction of movement.

[0011] DE 102 40 121 B4 discloses, for example, an orthopedic device in the form of a joint-flexion splint, which is articulated around a flexion-extension axis of movement of the toe to be corrected. For this purpose, the joint-flexion splint is provided with a joint mechanism located on the inside of the foot, from which two legs extend along the inside of the foot. To attach the joint-flexion splint to the foot, a first leg is attached to the toe via a first bandage, and a second leg is attached to the midfoot via a second bandage.

[0012] Such bandages can be complex to manufacture. Furthermore, their use in orthoses can be cumbersome.

[0013] Description of the invention

[0014] Starting from the known prior art, it is an object of the present invention to provide an improved orthosis, in particular an improved foot orthosis, which can be manufactured with reduced effort. This object is achieved by an orthosis according to the independent claim. Advantageous further developments will become apparent from the dependent claims, the present description, and the figures.

[0015] Accordingly, an orthosis is provided, in particular for influencing the structural and functional properties of a patient. The orthosis comprises at least one splint with a strap for fixing the splint to a part of the patient's body. The at least one splint comprises a leg on which a support is arranged. The at least one splint is provided such that the strap is integrally connected to the support.

[0016] In the context of this description, the term "integrally joined" specifies a connection between two parts that form a single, inseparable unit, i.e., one that cannot be separated without damage, and thus a coherent whole. Preferably, integrally joined components have the same material composition, i.e., they are made of the same material. An example of an integral join between two parts of a component is one in which the two parts are directly adjacent to each other and are manufactured by one and the same manufacturing step, for example, by casting, injection molding, or an additive manufacturing process. In other words, if a component is manufactured in its entirety by one and the same injection molding process step, the different sections of this component are to be considered integrally joined within the meaning of this description.

[0017] By integrating the strap with the splint's support, the proposed solution eliminates the need for separately provided bandages to secure the orthosis to the patient's body part. Consequently, the proposed orthosis can comprise fewer components and therefore be less expensive to manufacture.

[0018] The proposed orthosis may be designed to influence various structural and / or functional characteristics of a patient. In particular, the orthosis may be intended for the treatment and / or prevention of structural or functional disorders. Accordingly, the proposed orthosis may be designed to interact with one or more body parts or areas. For example, the orthosis may be a foot orthosis for the treatment or prevention of foot deformities, especially hallux valgus. Accordingly, the orthosis may be designed to be attached to a patient's foot. However, the proposed orthosis is not limited to this application and may be intended for use on other body parts, such as a knee, hand, elbow, etc.Furthermore, the orthosis is not limited to use on humans, but can also be used on animals. Accordingly, the term "patient" in this context can refer to either humans or animals.

[0019] To influence structural and / or functional properties, the orthosis is designed to interact with a part of the patient's body. While wearing the orthosis, it is intended to influence the patient's body, particularly to exert a therapeutic effect. In the context of this disclosure, the phrase "while wearing the orthosis" refers to a state in which the orthosis is properly attached to the patient's body and is thus achieving a desired effect or therapeutic outcome.

[0020] The proposed orthosis can be designed in such a way that forces, particularly corrective forces, are exerted on the patient's body when worn. In this context, "corrective forces" are understood to mean forces that have a desired effect, especially a therapeutic effect. For example, corrective forces can cause body parts affected by a malposition or dysfunction to be guided into an anatomically correct or intended position, or their movement can be restricted or blocked.

[0021] The orthosis comprises at least one splint. For example, the orthosis may comprise two or more splints, each equipped with a strap. In other words, each splint may be provided with its own strap. Alternatively, a single splint may be equipped with multiple straps. The different splints may be connected to one another. For example, the different splints may be rigidly connected, i.e., without any degrees of freedom. Alternatively, the different splints may be articulated or pivotally connected to one another.

[0022] In the context of this disclosure, the term "strap" can be understood to mean a band-shaped component, which may be particularly flat and flexible and serves to attach or fix the splint to the patient's body part. Accordingly, the strap is intended to transmit tensile, holding, or tensioning forces in its longitudinal or circumferential direction. In a further development, the strap can be provided in the form of an elastic band.

[0023] The following describes the design of at least one rail of the orthosis using one rail as an example. However, the described features can also apply to at least one other rail of the orthosis. In other words, the features described below are to be understood as being implemented, or potentially being implemented, in only one, several, or all of the rails of the at least one rail of the orthosis. The different rails can be designed differently or identically, in particular, with the same construction.

[0024] The splint comprises the splint leg, which may be designed in a plate- or shell-like form. The shape and / or contour of the splint leg may be adapted to the shape of the body part with which the orthosis engages when worn. The splint leg may have a curvature along its longitudinal and / or transverse direction. For the purposes of this disclosure, the longitudinal and transverse directions refer to directions that, when the orthosis is worn, run parallel to an outer surface of the patient's body against which the component of the orthosis rests.

[0025] The shinbone can have an inner and an outer side. For the purposes of this disclosure, the inner side of the shinbone refers to the side that, when the orthosis is worn, faces the part of the body with which the orthosis engages. The outer side refers accordingly to a side of the shinbone opposite the inner side, i.e., a side facing away from the part of the body.

[0026] The splint also includes the pad. The pad may be designed to form a contact surface between the splint and the patient's body. Accordingly, the pad may be designed to improve the patient's comfort. The pad may be made of a material that the patient finds pleasant to wear. When the orthosis is worn, the pad may lie directly against the patient's skin. The pad may be located on or applied to the inside of the splint leg. In other words, when the orthosis is worn, the pad may be positioned between the splint leg and the body part that the orthosis is interposing with. Alternatively, the pad may be located on the outside of the splint leg.

[0027] The rail can have a multi-layered structure, with the rail leg forming a first layer and the bearing a second layer. The bearing can be applied in layers to the inside of the rail leg. In the thickness direction, i.e., in a direction transverse to the longitudinal and transverse directions, the bearing can have a layer thickness that is substantially equal to or greater than the thickness of the rail leg. In a further development, the bearing can extend along the entire or substantially the entire inside of the rail leg. For example, the bearing can extend over at least 60%, at least 80%, or at least 90% of the area of ​​the inside of the rail leg. According to a further development, another layer or coating can be arranged on top of the bearing.

[0028] The pad can be permanently bonded to the rail leg. Preferably, the pad is bonded to the rail leg by a material bond. The pad can be welded to the rail leg. The pad can be applied to the rail leg using an additive manufacturing process. For this purpose, the pad can be applied to the rail leg in liquid, gel, or solid form using an additive manufacturing process. Furthermore, the pad can be applied by laminating or coating. The pad can also be produced by melting a plastic material, for example, polyvinyl chloride (PVC), polyurethane (PU), polyamide (PA), or a thermoplastic elastomer, and pressing it onto the rail leg.Additionally or alternatively, the coating can be applied in liquid form, in particular by dipping, doctor blade application, roller application, spraying, foaming, or another suitable method. In other words, the coating can be produced by injection molding.

[0029] As previously specified, the support and the belt are integrally connected. In particular, the support and the belt are made of the same material. Accordingly, the production of the belt and the support, and optionally also the attachment of the support to the rail leg, can be carried out in a single manufacturing step, for example by injection molding. A multi-component injection molding process is advantageous here, such as, in particular, a two-component injection molding process in which the belt is made of a first material and the support and / or a joint element used to form a pivot joint is made of a second material that is stronger and less elastic than the first material, or rigid compared to the belt.

[0030] The orthosis preferably comprises two rails, each rail having a strap for fixing the rail to a part of the patient's body and a rail leg on which a support is arranged or which forms the support. The two rails are pivotally connected to each other via a swivel joint comprising two joint elements. The strap is preferably bonded to the support and one of the joint elements. This allows for the simplest possible production of an orthosis with two rails pivotally connected to each other via the swivel joint and integrally molded straps from two separate multi-component (preferably two-component) injection-molded parts by connecting the joint elements to form a swivel joint.

[0031] The orthosis can thus consist of two injection-molded parts that are pivotally connected to each other by joining the two joint elements. The orthosis is therefore formed from two separate parts, each consisting of a splint, inseparably formed from a strap, support, splint leg, and joint element, whereby the splint leg, the joint element, and / or the support may form a common section.

[0032] The rail can be formed in one piece from two components bonded together by a material connection: a rail component and a belt component. The two components, i.e., the rail component and the belt component, each constitute a single, inseparable unit. Likewise, the rail component and the belt component can form a single, inseparable unit. The rail component comprises the rail leg and the joint element, which are integrally connected and preferably made of a rigid material. The belt component comprises the support and the belt, which are integrally connected and preferably made of an elastic material.

[0033] The leg of the splint and the support, especially including the strap, can be made of different materials. Specifically, the leg of the splint can be made of a material that is harder, stiffer, and / or less elastic than the material of the support and strap. Alternatively or additionally, the material of the leg of the splint can have a higher modulus of elasticity compared to the material of the support and / or strap.

[0034] The rail leg can be made of a plastic or plastic composite. For example, the rail leg can be made of a fiber-reinforced plastic, in particular a composite of plastic and glass fibers and / or carbon fibers. This allows for increased stiffness. For example, the rail leg can be made of a composite of polyamide with glass and / or carbon fibers. The plastic matrix of the composite can be a thermoplastic, in particular PA66. Specifically, the proportion of glass and / or carbon fibers, in particular the weight fraction or the volume fraction, can be 20%, 30%, or 50%. Specifically, the rail leg can be made of at least one of the following materials: PA 66 S, PA 66 GF20, PA 66 GF30, PA 66 GF50, PA 66 GF40-LFT, and PA 66 CF 20.

[0035] The belt and / or the pad may be made of or consist of a plastic, in particular PVC, PU, ​​and / or PA. Specifically, the belt and / or the pad may be made of a thermoplastic or a thermoplastic elastomer. For example, the belt and / or the pad may be made of PA 66.

[0036] The strap is designed to fix the splint arm to a part of the patient's body. The orthosis and the strap can be designed such that, when the orthosis is worn (i.e., when the splint is attached to the body part), the strap is elastically deformed along its longitudinal or circumferential direction, in particular by at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or 10 mm. This ensures that the splint arm remains close to the patient's body even during extensive movements, especially dynamic movements. The longitudinal or circumferential direction of the strap refers to a direction extending along the strap from the point of contact towards a free end of the strap.

[0037] The belt can comprise a free end and a further end arranged in the opposite direction, the latter being integrally connected to the support. In the region of the free end, the belt can comprise a first fastening element that can be connected to a second fastening element on the rail leg by force-fit and / or form-fit, in particular by detachable connection. The rail can be designed such that, when the rail is attached to the body part, the first and second fastening elements are engaged by force-fit and / or form-fit in such a way that the belt forms a loop in which the part of the body to be treated is enclosed.

[0038] The first fastening element can be formed by a section of the belt. In other words, the first fastening element can be an integral part of the belt or integrally connected to the belt. Alternatively, the first fastening element can be provided on the belt and connected to it by material and / or force and / or form-fit.

[0039] The second fastening element can be formed by a section of the rail leg. In other words, the second fastening element can be an integral part of the rail leg or integrally connected to it. Alternatively, the second fastening element can be provided on the rail leg and connected to it by material, force, and / or form-fit.

[0040] The first fastening element may comprise one or more locking elements, stepped elements, or recesses, which may be designed to complement the second fastening element. The second fastening element may, for example, be designed in the form of at least one slot-shaped through-opening, which in particular extends through the rail leg and optionally the bearing surface. Furthermore, the second fastening element may comprise additional locking elements, such as projections, which can be engaged with the first fastening element, in particular with the locking elements, stepped elements, or recesses of the first fastening element.

[0041] Alternatively or additionally, the first fastening element and the second fastening element can be provided as hook and loop fastener components and thus form a hook and loop fastener.

[0042] Alternatively or additionally, the first and second fastening elements can be provided as force-locking or form-locking components that can be engaged by force-locking or form-locking. For example, the first fastening element can comprise several projections extending from the belt at regular intervals. The second fastening element can comprise several complementary projections extending from the rail leg at regular intervals, into which the projections of the first fastening element can be pressed or inserted to connect them by force-locking and / or form-locking.

[0043] Between the free end and the far end, the belt can include a belt section. This belt section can have a constant width along the longitudinal or circumferential direction of the belt and be straight. Alternatively, the belt section can have a varying width and / or a curved shape.

[0044] As described above, the orthosis can include more than one leg, for example, two legs. Specifically, the orthosis can include the leg described above and, in addition, a further leg. The further leg can have the features of the leg described above. Alternatively, the further leg can have no features or only partial features of the leg described above.

[0045] The first and second arms of the orthosis can be connected by a joint, allowing them to pivot relative to each other. The orthosis and the joint can be designed such that the joint has a pivot axis which, when the orthosis is worn, aligns or substantially aligns with a natural pivot or joint axis of a body joint of the patient. This is intended to guide and enable natural movement of a body part fixed by the orthosis.

[0046] According to one configuration, the orthosis can be designed such that when the orthosis is worn, the leg is fixed in the area of ​​the thigh and the other leg is fixed in the area of ​​the shin, or vice versa, and the joint in the area of ​​the knee is arranged such that the pivot axis is aligned or substantially aligned with the natural joint axis of the knee, allowing a natural flexion and extension movement of the foot around the knee.

[0047] According to one embodiment, the orthosis is provided or designed as a foot orthosis. The foot orthosis can be intended for the treatment and prevention of foot deformities, in particular for the treatment and / or prevention of hallux valgus. In this embodiment, the at least one splint of the foot orthosis comprises a toe splint and / or a mid-splint.

[0048] The toe splint can be attached to a toe using a toe strap. The metatarsal splint can be attached to a midfoot using a metatarsal strap. The toe splint and / or the metatarsal splint may have the features described above in connection with the splint. Similarly, the toe strap and / or the metatarsal splint may have the features described above in connection with the splint strap.

[0049] According to one embodiment, the foot orthosis can comprise a toe splint and a metatarsal splint connected to each other via a pivot joint. The foot orthosis can be designed such that, when worn on the patient's foot, the toe splint exerts a first corrective force on the toe and / or the pivot joint exerts a second corrective force, opposite to the first, on a metatarsophalangeal joint and / or the metatarsal splint exerts a third corrective or stabilizing force, parallel to the first, on the metatarsophalangeal joint. By providing, in addition to the first corrective force acting on the toe, the second corrective force acting on the metatarsophalangeal joint via the pivot joint, the proposed foot orthosis can achieve a particularly effective therapeutic effect.Because of the proposed design of the foot orthosis, a therapeutic effect can be achieved simultaneously on both valgus toe deformity and varus deformity of the metatarsophalangeal joint. Thus, both the symptoms and the cause of the foot deformity can be treated at the same time.

[0050] For the sake of simplicity, when referring to the toe splint, we will generally use the term "toe" to describe the foot. This specifically refers to the big toe of the foot being treated. However, the term is not limited to this toe, so it could also refer to the little toe, for example. Similarly, when referring to the pivot joint and the associated second corrective force, we will generally use the term "metacarpal joint" to describe the foot, specifically the metatarsophalangeal joint of the big toe, but this is not the only possible reference. Alternatively, it could also refer to the metatarsophalangeal joint of the little toe.

[0051] As described above, the toe splint and the midfoot splint can be pivotally coupled relative to each other by means of the swivel joint. This allows the splinted toe to move along the flexion-extension direction relative to the midfoot when the foot orthosis is worn. In other words, the foot orthosis, and consequently the swivel joint, can be configured such that, when the orthosis is attached to the foot, the toe being treated can move in flexion and extension relative to the metatarsophalangeal joint of the big toe. Similarly, the swivel joint can be configured such that, when attached to the foot, its pivot axis is parallel or substantially parallel to a metatarsophalangeal joint axis of the toe, in particular parallel or substantially parallel to the flexion-extension axis of the metatarsophalangeal joint.Furthermore, the pivot axis of the rotator joint can be aligned with, or essentially aligned with, the axis of the metatarsophalangeal joint, in particular with the flexion-extension axis of movement. Alternatively or additionally, the pivot axis of the rotator joint can be arranged parallel or essentially parallel to the first and / or second corrective force.

[0052] Furthermore, the pivot joint can be configured to transmit shear and / or bending forces between the toe splint and the midfoot splint, in particular to exert the first and / or second corrective force on the foot. In other words, the pivot joint of the foot orthosis can be configured to transmit forces acting parallel to the corrective forces, especially shear or thrust forces, when attached to the foot, in order to generate the first and / or second corrective force. For this purpose, the pivot joint can be designed to transmit forces between the midfoot splint and the toe splint in the direction of the pivot axis of the pivot joint.In particular, the pivot joint can be designed to transmit bending forces between the midfoot splint and the toe splint along a longitudinal extension of the foot orthosis. This extension runs from the midfoot splint, across the pivot joint, to the toe splint, and, when the orthosis is attached to the foot, essentially corresponds to the longitudinal direction of the foot. These bending forces can act in a medial-lateral and / or lateral-medial direction. The forces transmitted along the splint in this way can produce the corrective forces exerted on the foot by the orthosis.

[0053] In this way, the proposed foot orthosis allows sufficient freedom of movement for a splinted toe, enabling the orthosis to support the foot in its natural walking motion while simultaneously exerting a therapeutic effect. This allows the patient to use the proposed foot orthosis in their daily life, increasing their willingness to wear it and therefore its acceptance and, consequently, the success of the therapeutic treatment.

[0054] The pivot joint can be designed such that, when the foot orthosis is attached to the foot, relative pivoting movement between the toe splint and the midfoot splint about an axis arranged obliquely or orthogonally to the pivot axis is blocked. Alternatively, the pivot joint can be designed such that relative pivoting movement between the toe splint and the midfoot splint is only permitted about the pivot axis. In other words, the pivot joint can be structurally designed such that pivoting movements about the pivot axis are possible, but pivoting movements about an axis obliquely or transversely to the pivot axis are blocked.

[0055] The foot orthosis is preferably designed such that, when attached to the foot, the pivot joint is located laterally on the foot. In particular, the pivot joint can be located on the medial side of the foot when attached. In other words, when attached to the foot, the pivot joint can be located on the medial side of the foot, with the toe splint and the midfoot splint, in particular, being located medially.

[0056] The pivot joint can be formed by structurally interlocking sections of the toe splint and the metatarsal splint. In particular, the pivot joint can be formed by structurally interlocking end sections of the toe splint and the metatarsal splint. The pivot joint can be formed at least partially by the interlocking sections of the toe splint and the metatarsal splint, or exclusively by the interlocking sections of the toe splint and the metatarsal splint. The part of the toe splint and / or the metatarsal splint that forms the pivot joint can be an integral component of the toe splint and / or the metatarsal splint. In this way, a simple design of the foot orthosis can be ensured by using a small number of components.

[0057] According to a further development of the foot orthosis, the pivot joint can comprise a first joint element coupled to the toe splint, in particular integrally or materially connected, and a second joint element designed to complement it and engaged with it, preferably directly, and coupled to the midfoot splint, in particular integrally or materially connected. The first joint element and the second joint element can engage in a form-fitting manner along the pivot axis, in particular in a first and an opposite second direction along the pivot axis, and / or transversely to the pivot axis of the pivot joint. The pivot joint can be designed such that, in the fastened state, the second joint element is positioned between the foot and the first joint element.This prevents the part of the pivot joint that lies against the foot from rotating relative to the laterally protruding part of the foot when the splinted toe is bent. This can increase the comfort of wearing the foot orthosis.

[0058] The second joint element can form a pivot pin of the rotary joint, which guides the first joint element, forming a joint ring, around the pivot axis. Alternatively, the first joint element can form the pivot pin and the second joint element the joint ring. The pivot pin is preferably designed as a hollow pin, with the hollow part of the pin forming the recess. The joint ring and the pivot pin can be designed and engaged in such a way that they are positively engaged along the pivot axis, particularly in the first and the opposite second direction along the pivot axis.

[0059] Brief description of the characters

[0060] Preferred further embodiments of the invention are explained in more detail by the following description of the figures. These show:

[0061] Figure 1 - a perspective view of a foot orthosis according to one embodiment in an exposed state;

[0062] Figure 2 - a top view of the foot orthosis shown in Figure 1 in a state attached to the foot of a patient;

[0063] Figure 3 - a perspective view of a toe splint of the foot orthosis shown in Figure 1;

[0064] Figures 4 and 5 - perspective views of a rail component of the toe rail shown in Figure 3;

[0065] Figure 6 - a perspective view of a strap component of the toe splint shown in Figure 3;

[0066] Figure 7 - a perspective view of a midfoot splint of the foot orthosis shown in Figure 1;

[0067] Figure 8 - a perspective view of a rail component of the midfoot rail shown in Figure 7; and

[0068] Figure 9 - a perspective view of a strap component of the midfoot rail shown in Figure 7.

[0069] Detailed description of preferred embodiments. Preferred embodiments are described below with reference to the figures. Identical, similar, or equivalent elements in the different figures are designated with identical reference numerals, and repeated descriptions of these elements are sometimes omitted to avoid redundancy.

[0070] Figure 1 schematically shows an embodiment of an orthosis 10 for influencing the structural and / or functional properties of a patient's body part. In this embodiment, the orthosis 10 is a foot orthosis for treating and / or preventing foot deformities, in particular for treating and / or preventing hallux valgus. Accordingly, the orthosis 10 is designed to be attached to a patient's foot. Figure 1 shows the foot orthosis in an exposed state, i.e., in a state where the foot orthosis 10 is not attached to the patient's foot. Figure 2 shows the foot orthosis 10 attached to a patient's foot.

[0071] The orthosis 10 comprises a first splint in the form of a toe splint 12a and a second splint in the form of a midfoot splint 12b, which are pivotably connected to each other via a pivot joint 14. The toe splint 12a can be attached to a toe of the patient by means of a toe strap 16a, i.e., fixed in place, and the midfoot splint 12b can be attached to a midfoot of the patient by means of a midfoot strap 16b, i.e., fixed in place, as shown in Figure 2. Furthermore, the foot orthosis 10 is designed such that, in the attached state, the pivot joint 14 is located on a medial side of the foot. In other words, the pivot joint 14 is located on the medial side of the foot when attached.

[0072] As further illustrated in Figure 2, the foot orthosis 10 is arranged such that, when worn correctly on the patient's foot, the toe splint 12a exerts a first corrective force F1 on the toe, the pivot joint 14 exerts a second corrective force F2 opposite to the first corrective force F1 on a metatarsophalangeal joint, and the midfoot splint 12b exerts a third corrective force or holding force F3 parallel to the first corrective force F1 on the midfoot.

[0073] By pivoting the toe splint 12a and the midfoot splint 12b relative to each other via the pivot joint 14, the splinted toe can be moved along the flexion-extension direction relative to the midfoot when the foot orthosis 10 is worn. In other words, the foot orthosis 10 and, correspondingly, the pivot joint 14 are designed such that, when the foot orthosis 10 is attached to the foot, the toe being treated can be moved in flexion and extension relative to the metatarsophalangeal joint of the big toe. Similarly, the pivot joint 14 is designed such that, when attached to the foot, its pivot axis is parallel or substantially parallel to a metatarsophalangeal joint axis of the toe, in particular parallel or substantially parallel to the flexion-extension axis of the metatarsophalangeal joint.In the embodiment of the foot orthosis shown here, the pivot joint 14 is configured such that the pivot axis of the pivot joint 14 is aligned, or substantially aligned, with the flexion-extension axis of movement. In other words, in the embodiment shown here, the pivot joint 14 has a pivot axis that, when the foot orthosis 10 is worn, is aligned, or substantially aligned, with a natural pivot axis of a body joint of the patient. The pivot joint 14 comprises a first joint element 22a, which is provided by means of the toe splint 12a, and a second joint element 22b, which is provided by means of the midfoot splint 12b.

[0074] The structural and functional design of the toe splint 12a and the midfoot splint 12b is described in more detail below in connection with Figures 3 to 9. When, in this context, general reference is made to a splint 12, a strap 16, a splint leg 18, a support 20, a joint element 22, a first and second fastening means 34, 36, etc., the features specified in this context apply both to the toe splint 12a, comprising the toe strap 16a, a toe splint leg 18a, a toe support 20a, the first joint element 22a, a first and second fastening means 34a, 36a, etc., and to the metatarsal splint 12b, comprising the metatarsal strap 16b, a metatarsal splint leg 18b, a metatarsal support 20b, the second joint element 22b, a further first and second fastening means 34b, 36b, etc.Reference numerals marked with the letter "a" refer to components of the assembly relating to the toe splint 12a, as shown in Figures 3 to 6. Reference numerals marked with the letter "b" refer to components of the assembly relating to the midfoot splint 12b, as shown in Figures 7 to 9. The splint 12 forms an assembly comprising several interconnected components.

[0075] Specifically, the rail 12 comprises the belt 16, the rail leg 18, the support 20, and the joint element 22 as components. In the embodiment shown here, the rail 12 comprises or consists of two interconnected individual components: a rail component 24 and a belt component 26. The individual components, i.e., the rail component 24 and the belt component 26, each form a single, inseparable unit. The rail component 24 comprises the rail leg 18 and the joint element 22, which are integrally connected to each other. The belt component 26 comprises the support 20 and the belt 16, which are integrally connected to each other.

[0076] According to an alternative embodiment, the rail component 24 can be designed in multiple parts, i.e., composed of several individual components or parts. According to this configuration, the rail leg 18 and the joint element 22 can be connected by material and / or force and / or form-fit.

[0077] As shown in Figures 4, 5, and 8, the splint leg 18 comprises an inner surface 28 and an outer surface 30. The support 20 is arranged on the inner surface 28 of the splint leg 18, such that when the orthosis 10 is worn, the inner surface 28, and thus the support 20, faces the part of the patient's body being treated by the splint 12. As shown in Figures 3 and 7, the support 20 is applied in layers to the inner surface 28 of the splint leg 18. The support 20 is bonded to the splint leg 18 by a material bond, in particular by welding.

[0078] The toe splint 12a is designed such that the toe support 20a extends substantially along the entire inner surface 28a of the toe splint leg 18a, but not along an outer surface of the first joint element 22a, as shown in Figure 3.

[0079] The midfoot rail 12b is designed such that the midfoot support 20b extends along the entire or substantially the entire inner surface of both the rail leg 18b and the second joint element 22b, as shown in Figure 7.

[0080] Rail component 24 and belt component 26 are made of different materials. Specifically, rail component 24, comprising rail leg 18 and joint element 22, is made of a material that is harder, stiffer, and / or less elastic compared to the material of belt component 26, comprising belt 16 and support 20. Specifically, rail component 24, comprising rail leg 18 and joint element 22, can be made of a fiber-reinforced plastic, in particular a mixture of plastic and glass and / or carbon fibers. Belt component 26, comprising belt 16 and support 20, can, on the other hand, be made of a plastic, in particular a polyamide, a thermoplastic, or a thermoplastic elastomer.The belt component 26 can be designed such that, in a state in which the rail 12 is attached to the body part of the patient, the belt 16 is elastically deformed along its longitudinal or circumferential direction by at least 1 mm or at least 2 mm or at least 3 mm or at least 4 mm or at least 5 mm or at least 10 mm.

[0081] The strap 16 has a free end 32, which is arranged opposite an end of the strap 16 that is integrally connected to the support 20. In the region of the free end 32, the strap 16 comprises a first fastening element 34, which can be connected to a second fastening element 36 on the rail leg 18 by means of a force-fit and / or form-fit connection, in particular by means of a detachable connection. The rail 12 is designed such that, in the state of the rail 12 being attached to the body part, the first and the second fastening elements 34, 36 are engaged by means of a force-fit and / or form-fit connection such that the strap 16 forms a loop body in which the body part to be treated, i.e., the toe or the midfoot, is received, as shown in Figure 2.

[0082] In the embodiment shown here, the first fastening means 34 is formed by a section of the belt 16 in which the belt 16 has a corrugated or stepped shape along its longitudinal or circumferential direction, as shown in Figs. 3 and 7.

[0083] The rail leg 18 comprises the second fastening means 36. In the embodiment shown here, the second fastening means 36 comprises two slot-shaped openings 38 extending parallel to the longitudinal direction of the rail leg 18, which penetrate the rail leg 18 and the support 20.

[0084] The rail 12 is designed such that, in the coupled state where the rail 12 is attached to the patient's body part to be treated, the strap 16 is guided from the outside 30 through a first of the two slotted openings 38, is arranged along the inside 28 between the two slotted openings 38, and is guided back to the outside 30 through a second of the two slotted openings 38. In conjunction with this design, the corrugated shape of the strap 16, which forms the first fastening element 34, enables the strap 16 to be held firmly in the slotted openings 38.

[0085] To simplify threading the belt 16 through the slotted openings 38 or to improve the belt 16's retention therein, the second fastening means 36 can further comprise two webs 40 arranged on the outer surface 40 of the rail leg. The webs 40 are positioned such that they are spaced apart and run parallel to the slotted openings 38, defining their longitudinal boundaries. In an alternative embodiment, the belt 16 forming the first fastening means 34 can be guided along the outer surface 40 of the rail leg 18 and between the webs 40 and the outer surface 40, without running along the inner surface 38.

[0086] In the embodiment shown here, the first fastening means 34 is formed as an integral part of the belt 16 and the second fastening means 36 as an integral part of the rail leg 18. In other words, the first fastening means 34 is integrally connected to the belt 16 and the second fastening means 36 is integrally connected to the rail leg 18.

[0087] In an alternative embodiment, the belt 16 can comprise or form a first force-locking and / or positive-locking component, in particular a first hook-and-loop fastener component, as a first fastening means in the region of the free end 32, and the outer surface 30 of the rail leg 18 can comprise or form a second force-locking and / or positive-locking component, in particular a second hook-and-loop fastener component, as a second fastening means, designed to be complementary to this. The first force-locking and / or positive-locking component can be designed as an integral part of the belt 16.

[0088] Alternatively or additionally, the second force and / or form-locking component can be designed as an integral part of the rail leg 18.

[0089] As described above, the pivot joint 14 comprises the first joint element 22a and the second joint element 22b. In particular, the pivot joint 14 can be formed by the first and second joint elements 22a and 22b, which are structurally engaged. The pivot joint 14 can be formed at least partially by the engaging areas of the toe splint 12a and the metatarsal splint 12b, or exclusively by the engaging areas of the toe splint 12a and the metatarsal splint 12b. In this way, a simple design of the foot orthosis can be ensured by using a small number of components.

[0090] The pivot joint 14 is designed such that, in the fixed state of the foot orthosis 10, the first joint element 22a is arranged between the foot and the second joint element 22b.

[0091] In this way, it can be prevented that, during a bending movement of the splinted toe, the part of the pivot joint 14 that lies against the foot is pivoted relative to the foot.

[0092] The second joint element 22b comprises a pivot pin of the pivot joint 14, which guides the first joint element 22a, forming a joint ring 22a, around the pivot axis. Alternatively, the first joint element can form the pivot pin and the second joint element the joint ring. The pivot pin is designed as a hollow pin, with the hollow part of the pin forming a recess for a protruding part of the metatarsophalangeal joint. The joint ring and the pivot pin engage in a form-fitting manner along and perpendicular to the pivot axis such that a single rotational degree of freedom about the pivot axis is released, and all other rotational and translational degrees of freedom are restricted. For this purpose, the pivot pin can be designed such that it guides the joint ring in a U-shaped recess around the pivot axis.

[0093] The foot orthosis 10 shown here is suitable for use on either the patient's left or right foot. Alternatively, the foot orthosis can have a design specific to either the left or right foot. A foot orthosis intended for the left foot can be a mirror image of a foot orthosis intended for the patient's right foot.

[0094] Where applicable, all individual features illustrated in the exemplary embodiments can be combined and / or interchanged without departing from the scope of the invention. List of reference numerals

[0095] 10 Orthosis

[0096] 12 rail

[0097] 14 Swivel joint

[0098] 16 belts

[0099] 18 shinbones

[0100] 20th edition

[0101] 22 Joint element

[0102] 24 rail component

[0103] 26 Belt component

[0104] 28 Inside

[0105] 30 Outside

[0106] 32 free ending

[0107] 34 first fastening device

[0108] 36 second fastening device

[0109] 38 slotted opening

[0110] 40 Bridge

Claims

Patent claims:

1. Orthosis (10) comprising at least one splint (12) with a strap (16) for fixing the splint (12) to a part of the patient's body, wherein the splint (12) has a splint leg (18) on which a support (20) is arranged, characterized in that the strap (16) is integrally connected with the support (20).

2. Orthosis (10) according to claim 1, wherein the support (20) is arranged on an inner side (18) of the shinbone (18) which faces the body part when the orthosis (10) is worn.

3. Orthosis (10) according to claim 2, wherein the support (20) is applied in a layered manner to the inside (18) of the splint leg (18), and wherein in particular the support (20) extends along the entire or substantially the entire inside (28) of the splint leg (18).

4. Orthosis (10) according to one of claims 1 to 3, wherein the support (20) is materially bonded to the rail leg (18), in particular welded or manufactured in one piece using a two-component injection molding process.

5. Orthosis (10) according to one of claims 1 to 4, wherein the shank (18) is made of a material which is harder and / or stiffer and / or less elastic compared to a material of the support (20) and the strap (16).

6. Orthosis (10) according to one of claims 1 to 5, wherein the shank (18) is made of a fiber-reinforced plastic.

7. Orthosis (10) according to one of claims 1 to 6, wherein the strap (16) and the support (20) are made of polyamide or of a thermoplastic or of a thermoplastic elastomer.

8. Orthosis (10) according to one of claims 1 to 7, which is designed such that in a state in which the splint (12) is attached to the body part of the patient, the strap (16) is elastically deformed by at least 3 mm along its longitudinal or circumferential direction.

9. Orthosis (10) according to one of claims 1 to 8, wherein the strap (16) in the region of a free end (32) comprises a first fastening means (34) which can be connected to a second fastening means (36) on the leg of the rail (18) by means of force and / or form locking.

10. Orthosis (10) according to claim 9, wherein in the state of the rail (12) being attached to the body part the first and the second fastening means (34, 36) are engaged in such a force- and / or form-locking manner that the strap (16) forms a loop body in which the body part is received.

11. Orthosis (10) according to one of claims 1 to 10, comprising a further rail (12) which is pivotably connected to the at least one rail (12) via a joint (14), wherein in particular the further rail (12) has the features of the rail according to one of claims 1 to 10.

12. Orthosis (10) according to claim 11, wherein the joint (14) has a pivot axis which, when the orthosis (10) is worn, is aligned or substantially aligned with a natural pivot axis of a body joint of the patient.

13. Orthosis (10) according to any one of claims 1 to 12, wherein the orthosis (10) is a foot orthosis for the treatment and prevention of foot deformities, in particular for the treatment and prevention of hallux valgus, wherein the at least one splint (12) comprises at least one of the following splints: - a toe splint (12a) which can be attached to a toe by means of a toe strap (16a), and - a metatarsal splint (12b) which can be attached to a metatarsal by means of a metatarsal strap (16b).

14. Orthosis (10) according to claim 13, comprising the toe splint (12a) and the metatarsal splint (12b) which are connected to each other via a pivot joint (14) and are designed to exert, when the orthosis (10) is worn on the patient's foot, a first corrective force on the toe via the toe splint (12a) and a second corrective force opposite to the first corrective force (F1) on a metatarsophalangeal joint via the pivot joint (14).

15. Orthosis (10) according to claim 14, wherein the pivot axis of the pivot joint (14) is aligned or substantially aligned with a flexion-extension axis of movement of a metatarsophalangeal joint.

16. Orthosis (10) according to one of the preceding claims, comprising two rails (12), each having a strap (16) for fixing the rail (12) to a part of the patient's body and each having a rail leg (18) on which a support (20) is arranged or which forms a support, wherein the rails (12) are pivotably connected to each other via a pivot joint (14) comprising two joint elements (22a, 22b), characterized in that the strap (16) is bonded to the support (20) and to one of the joint elements (22a, 22b).

17. Orthosis (10) according to claim 16, characterized in that the orthosis (10) consists of two injection-molded parts which are connected to each other by joining the two joint elements (22a, 22b) to form a pivot joint (14).

Images