Foot orthotics with swivel joints to correct foot misalignment.
The foot orthosis with a swivel joint addresses both toe and interphalangeal joint misalignments in hallux valgus, offering therapeutic efficacy and comfort by reducing pressure on sensitive areas and allowing mobility.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- RUDDICK BERTRAM GMBH
- Filing Date
- 2022-03-22
- Publication Date
- 2026-05-12
AI Technical Summary
Existing foot orthoses for treating hallux valgus often require the foot to be in a static position and do not effectively address both toe and interphalangeal joint misalignments, leading to discomfort and limited usability.
A foot orthosis with a swivel joint connecting a toe splint and a metatarsophalangeal splint, applying corrective forces to both joints, featuring a recess to accommodate sensitive interphalangeal joints and a compact design for comfort and mobility.
The orthosis provides effective therapeutic effects on both toe eversion and interphalangeal joint inversion, reducing pressure on sensitive areas and allowing for comfortable wear during daily activities.
Smart Images

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Abstract
Description
Technical Field
[0005] ,
[0001] The present invention relates to a foot appliance for correcting foot position abnormalities, particularly for treating hallux valgus.
Background Art
[0002] Pathological position abnormalities in the area of the patient's midfoot bones and forefoot can have various causes, such as genetic predisposition, wearing inappropriate footwear, particularly shoes that are too tight or high heels, or flattening of the longitudinal and transverse arches of the foot as a result of instability of the connective tissue in the midfoot bone area. In particular, the position abnormality of the big toe (hallux) at the metatarsophalangeal joint of the foot is also known as hallux valgus and is becoming important due to the increasing number of cases that do not change. <00,00011> Hallux valgus appears because the metatarsophalangeal joint (metatarsophalangeal joint) between the metatarsal bone and phalanx of the big toe (hallux) of the foot is pulled in the direction of the inside of the foot by the traction of the muscle. This causes the first metatarsal bone to protrude from the inside of the hallux as a ball-like protrusion at the metatarsophalangeal joint, which is called pseudoexostosis. In the medical literature, the ball-like protrusion is described as a protrusion in the area of the metatarsophalangeal joint or as a swelling that occurs in the area of the aponeurotic tumor. As hallux valgus progresses, it may lead to an infection accompanied by pain in the protruding metatarsal head (ball of the foot). Also, often, hallux valgus is accompanied by changes in the length and direction of the tendon traction, which may further worsen the deformation over time. As a result, arthritis of the metatarsophalangeal joint of the big toe (hallux) develops, which must be surgically treated at an advanced stage. In addition to surgical treatment, the use of conservative therapy is known to stop or counteract the disease process. For example, the use of tape appliances or orthotics is known to treat the foot in a static position (rest position). Due to the need for the foot to be in a static position during the treatment period, these are mainly used at night.
[0004]
[0005] Furthermore, orthoses are known that allow a splinted big toe to move along its flexion-extension direction while fixed to the foot. For example, DE 10240121 B4 discloses an orthopedic device in the form of a hinged splint articulated around the flexion-extension axis of the toe to be corrected. For this purpose, the hinged flexion splint is provided with a joint that leans against the medial side of the foot and two flexion legs extending from the joint along the medial side of the foot. To fix the hinged flexion splint to the foot, the first flexion leg is fixed to the toe via a first bandage, and the second flexion leg is fixed to the metatarsal bone via a second bandage. [Overview of the project] [Means for solving the problem]
[0006] Starting from known prior art, the object of the present invention is to provide an improved foot orthosis for correcting positional abnormalities, particularly for treating hallux valgus, which ensures particularly effective treatment while having a compact design and good comfort.
[0007] This objective is addressed by a foot orthosis having the features of the independent claim. Preferred embodiments are revealed in the dependent claims, this specification, and the drawings.
[0008] Accordingly, foot orthoses are provided for correcting foot misalignment, particularly for treating or preventing hallux valgus. The foot orthose comprises a toe splint configured to be fixed to the toes and a metatarsophalangeal splint configured to be fixed to the metatarsophalangeal region of the foot, which are pivotally connected to each other by a swivel joint. The foot orthose is configured to apply a first corrective force to the toes via the toe splint and a second corrective force to the metatarsophalangeal joints via the swivel joint in the opposite direction to the first corrective force, when the foot orthose is properly secured to the foot. The swivel joint is provided with a recess, which extends along the swivel axis or pivot axis of the swivel joint and is designed so that, when fixed to the foot, the lateral or transverse protruding section (projection) of the tarsophalangeal joint is received within the recess.
[0009] In the proposed foot orthosis, in addition to the first corrective force applied to the toes, a second corrective force is applied to the interphalangeal joints via a swivel joint. This allows for a particularly effective therapeutic effect. This is because the proposed design of the foot orthosis may simultaneously have a therapeutic effect on toe eversion and interphalangeal joint inversion. Therefore, the symptoms and causes of foot misalignment can be treated simultaneously. The corrective forces acting on the foot and their associated therapeutic effects will be described in more detail below with respect to the relevant components of the foot orthosis.
[0010] In the context of this invention, the laterally projecting sections (projections) of the interphalangeal joints of the foot have been found to be sensitive, and particularly sensitive to pressure in the presence of pseudoexostasis, such as that which can occur in hallux valgus. To take these circumstances into account, the proposed foot orthosis is equipped with a swivel joint, which has a recess that at least partially receives the laterally projecting sections (projections) of the interphalangeal joints when the foot orthosis is worn. This configuration prevents the foot orthosis from contacting the distal end of the laterally projecting sections (projections) of the interphalangeal joints and from applying direct force to them. Therefore, compared to known orthoses that contact and directly apply force to the laterally projecting sections (projections) of the interphalangeal joints, the load applied to the sensitive portion (section) of the interphalangeal joints can be reduced during the use of the proposed foot orthosis. In other words, the structural configuration of the swivel joint allows the proposed foot orthosis to reduce or avoid applying force to pressure-sensitive areas of the foot.
[0011] Furthermore, the proposed swivel joint configuration allows the orthosis to be kept particularly close to the foot. It also reduces its extension in the width direction of the foot. This is especially true for certain sections of the orthosis that are positioned laterally relative to the interphalangeal joints of the wearer's foot when the orthosis is fixed in place. Accordingly, the proposed swivel joint can contribute to a compact design of the orthosis. Wearing the proposed orthosis with conventional footwear may therefore be significantly more comfortable for the patient compared to known devices, especially due to the compact design thus achieved.
[0012] The proposed foot orthosis is intended and constructed to treat, counteract, and / or prevent pathological foot malpositions, particularly of the toes and / or interphalangeal joints. In particular, the foot orthosis can, but is not limited to, the prevention or treatment of hallux valgus. Accordingly, the foot orthosis is intended and constructed to be fixed to the patient's foot and, while fixed to the foot, to act therapeutically on the foot, particularly on the toes and / or interphalangeal joints.
[0013] In this disclosure, the term “properly secured to the foot” refers to a state in which the orthosis is properly secured to the patient’s foot and thereby produces the desired therapeutic effect for correcting or preventing a misalignment. The orthosis may be designed to target the left or right foot of a patient. In other words, the orthosis may be intended and designed for use on either the left or right foot of a patient. An orthosis intended for the left foot may be mirror-symmetrical to an orthosis intended for the right foot of a patient.
[0014] The proposed foot orthosis is designed to apply a corrective force to the foot when fastened. In this disclosure, the term “corrective force” refers to a force that has a therapeutic effect on the foot to be treated. In particular, the corrective force positions the portion of the foot affected by the misalignment into or toward an anatomically correct or intended position in order to achieve the desired therapeutic effect.
[0015] The proposed foot orthosis is configured to act, in particular directly, on the foot to be treated by means of a toe splint and a swivel joint, while fixed to the patient's foot. This design substantially distinguishes the proposed foot orthosis from known devices, which, intentionally or unintentionally, protect the ball of the foot (toe ball) from pathological pseudoosteogenesis caused by malposition, from the intermetatarsal and phalangeal joints and associated or external forces, particularly forces acting on the foot through the device. In the context of the present invention, as described below, it has been found that particularly effective therapeutic effects can be achieved when the foot orthosis exerts a second corrective force acting on the intermetatarsal and phalangeal joints via a swivel joint, in addition to a first corrective force acting on the toe. The resulting interaction of corrective forces applied to the foot can be particularly beneficial in the treatment of hallux valgus.
[0016] In the following, in relation to toe splints, when generally referred to as the toe of the foot for simplification, it preferably means the big toe of the foot being treated. However, foot orthoses are not limited to this application, and the term "toe" may also refer to, for example, the little toe. Accordingly, in relation to swivel joints, when generally referred to as the intermetatarsal phalangeal joint, it preferably means the intermetatarsal phalangeal joint of the big toe. However, foot orthoses are not limited to this application. Alternatively, the term intermetatarsal phalangeal joint may also refer to, for example, the metatarsophalangeal joint of the little toe.
[0017] In this disclosure, to specify foot orthoses, particularly with respect to the foot being treated, a reference system is used that is oriented toward the midline or near-midline (medial) of the patient's body, as is common in anatomy. Therefore, the position and orientation (direction) of each component of the proposed foot orthosis in the fastened state may be given relative to the foot receiving the orthosis. Accordingly, the term “near the midline, or medial” refers to the direction or side of the foot orthosis that points toward the medial side of the wearer’s body. In anatomy, the term “medial side” is also known as the “median sagittal plane” and generally refers to the anatomical plane that divides the body into two symmetrical parts. Accordingly, when describing foot orthoses, the term “medial” means the direction that points from the patient’s foot to be treated toward the patient’s other foot. In this sense, the term “lateral” refers to the side and direction of the foot orthosis that points away from the medial side of the wearer’s body. Accordingly, when describing an orthotic device that is fixed to one of the wearer's feet, the term "lateral" refers to the direction that is away from the wearer's other foot.
[0018] To interact with the intermetatarsal and interphalangeal joints of the foot to be treated, that is, to exert a second corrective force, the orthosis is provided with a swivel joint, which is provided in particular in the form of a hollow trunnion swivel joint or a hubless joint. In this disclosure, the term “swivel joint” refers to a joint through which two components are rotatably mounted, where the two components are pivotable and can engage with each other. In the context of this disclosure, the term “hollow trunnion swivel joint” is also referred to as a hubless joint and relates to a joint through which a hollow shape is provided, at least partially, along its swivel axis, that forms a recess, i.e., a hollow portion. In other words, the components forming the swivel joint are hollow along the swivel axis such that the swivel joint has a recess or through hole around and along the swivel axis.
[0019] A swivel joint may comprise components that are pivotable relative to each other around a swivel axis and guided relative to each other within the swivel joint. Regions provided to guide these components may be provided by bearing points and / or bearing surfaces, particularly contact surfaces and / or sliding surfaces, which are preferably arranged circumferentially around the swivel axis and spaced apart therefrom.
[0020] The area provided for guiding the components of the swivel joint may be located at a distance from the swivel axis equal to the guide radius, i.e., spaced apart from the swivel axis. The guide radius may, in particular, represent the average radius of the area provided for guiding the components of the swivel joint around the swivel axis. The guide radius may be located within the area of the outer radius of the swivel joint, where the outer radius describes the radial extension length of the swivel joint. The guide radius may be at least 70% of the outer radius of the swivel joint. In particular, the guide radius may be at least 80% or at least 90% of the outer radius of the swivel joint.
[0021] The swivel joint may also be provided in the form of a ring joint, in which the guide surfaces or multiple guide surfaces between the components of the swivel joint are pivotally mounted to each other and arranged in a ring shape around the joint axis or swivel axis of the swivel joint. In this way, the swivel joint can be particularly robust with respect to bending forces and bending moments. As a result, the swivel joint can transmit high forces and moments and apply them to the foot being treated, while at the same time maintaining a compact design for the foot orthosis.
[0022] The recess may be provided in the form of a recess that is open on at least one side. In the fastened state, the recess can open in the direction of the foot. Alternatively, the recess may be provided in the form of a through hole, particularly in the form of a through hole that extends along the swivel axis. In other words, the recess may extend along the entire width or thickness of the swivel joint. In the context of this disclosure, the terms “width” and “thickness” of the swivel joint refer to the extension of the swivel joint along the swivel axis. The swivel joint may have a width of 1.0 cm or 0.6 cm, particularly the maximum width.
[0023] The orthosis may be configured such that, in the fastened state, the laterally projecting portion (section) of the intermetatarsal phalangeal joint extends along at least 50%, at least 70%, or at least 80% of the maximum width of the swivel joint. Furthermore, the orthosis may be configured such that, in the fixed state, the laterally projecting portion (section) of the intermetatarsal phalangeal joint protrudes or substantially along the swivel axis, through a recess, particularly through a through-hole. In this way, the orthosis can be kept particularly close to the foot.
[0024] A swivel joint may have side walls, which delimit or restrict a recess and are circumferentially positioned around the swivel axis. The side walls may have a minimum radius of curvature of 1 mm, 2 mm, or 5 mm. In other words, a swivel joint may be designed such that no side wall at any point or in any section has a radius of curvature less than the minimum radius of curvature. The reciprocal of the radius of curvature corresponds to the curvature of the side wall, particularly the curvature of the inner surface of the side wall facing the recess. Thus, to prevent pressure peaks on the patient's foot when wearing the orthosis, it may be ensured that there are no sharp edges in the area of the swivel joint adjacent to the laterally projecting portion (section) of the intermetatarsal joint.
[0025] The recess may have a minimum diameter of at least 1.5 cm, at least 2.0 cm, or at least 2.5 cm, particularly along or around the swivel axis. For example, the recess may have a circular or elliptical shape in cross-section along the swivel axis, with a minimum diameter of at least 1.5 cm, at least 2.0 cm, or at least 2.5 cm. For example, the diameter may be 3.0 cm or substantially 3.0 cm.
[0026] The shape of the recess, particularly its cross-sectional shape and diameter, may be adapted to the shape of the foot to be treated, especially the shape of the laterally projecting portion (section) of the intermetatarsal-phalangeal joint. This can be done based on an orthopedic or physiological classification specific to the user group. For example, foot orthoses can thus be provided for user groups with different foot sizes, and / or for user groups with different sizes of laterally projecting portions (sections) of the intermetatarsal-phalangeal joint, particularly for pseudoosteomas.
[0027] As described above, the toe spring and the midfoot bone spring are pivotally connected to each other by a swivel joint. With this configuration, when the foot appliance is worn, the toes fixed by the proposed foot appliance can be moved relative to the midfoot bone along the flexion-extension movement direction thereof. In other words, the foot appliance, and thus the swivel joint unit, can be configured such that, in the fastened state, the toe to be treated is movable relative to the joint between the midfoot bone and the phalanx in the flexion-extension direction. Accordingly, the swivel joint can be provided and configured such that, in the fastened state, the swivel axis of the swivel joint is parallel or substantially parallel to the base joint axis of the joint between the midfoot bone and the phalanx, particularly parallel or substantially parallel to the flexion-extension movement axis of the joint between the midfoot bone and the phalanx. More specifically, the swivel axis of the swivel joint can coincide with, i.e., be aligned with, or substantially coincide with, the base joint axis of the middle toe joint, particularly the flexion-extension movement axis. Alternatively or additionally, the swivel axis of the swivel joint may be arranged parallel or substantially parallel to the first correction force and / or the second correction force.
[0028] Furthermore, the swivel joint may be configured to transmit shear and / or bending forces between the toe spring and the midfoot spring in order to apply a first corrective force and / or a second corrective force to the foot. In other words, the swivel joint of the foot appliance may be configured to transmit a force parallel to the corrective force, particularly a shear or bending force, in the fastened state to generate a first corrective force and / or a second corrective force. To do so, the swivel joint may be provided to transmit a force between the midfoot spring and the toe spring in the direction of the swivel axis of the swivel joint. In particular, the swivel joint may be provided such that a bending force is transmitted between the midfoot spring and the toe spring along the longitudinal extension of the foot appliance, the longitudinal extension extending from the midfoot spring through the swivel joint to the toe spring and thus being essentially equal in the longitudinal direction of the foot when the foot appliance is fixed to the foot. The bending force may extend in the medial-lateral direction and / or the lateral-medial direction. The force transmitted along the spring in this way can induce the corrective force to be applied to the foot by the foot appliance.
[0029] Thus, the proposed foot appliance provides sufficient freedom of movement to the toes fixed by the accessory while the foot appliance supports the foot in its natural walking motion and at the same time the foot appliance has a therapeutic effect on the foot. This makes it possible to use the proposed foot appliance in the patient's daily life, increases the patient's willingness to wear the foot appliance, and thus increases the acceptance and achievement of the therapeutic treatment.
[0030] A swivel joint may be designed such that, in the fastened state of the foot orthosis, relative pivotal (rotational) movement between the toe splint and the metatarsal splint is prevented from moving around an axis positioned obliquely or perpendicular to the swivel axis. A swivel joint can also be designed so that relative pivotal movement is permitted only around the swivel axis. In other words, a swivel joint may be structurally provided such that pivotal movement around the swivel axis is disabled, while pivotal movement around an axis obliquely or perpendicular to the swivel axis is blocked. Thus, a simple and compact design for the swivel joint can be provided.
[0031] Preferably, the foot orthosis is positioned such that the swivel joint is located on the side of the foot when fastened. In particular, when fastened, the swivel joint may be located on the medial side of the foot. In other words, when fastened, the swivel joint may be located medially on the foot, i.e., medially on the foot, and in particular, toe splints and metatarsal splints may be located medially.
[0032] A swivel joint may be constructed or formed by structurally engaging the regions of a toe splint and a metatarsal splint. Specifically, a swivel joint may be constructed or formed by structurally engaging the end regions of a toe splint and a metatarsal splint. A swivel joint may be provided at least partially by the engaged regions of a toe splint and a metatarsal splint, or may be composed entirely of the engaged regions of a toe splint and a metatarsal splint. The sections (parts) of a toe splint and / or metatarsal splint that form a swivel joint may be integral parts of the toe splint and / or metatarsal splint. Thus, a simple design of the foot orthosis can be ensured by using a small number of components.
[0033] In further extension, the swivel joint may include a first joint element coupled to the toe splint and a correspondingly designed second joint element, the first joint element being coupled integrally or bonded thereto, and the second joint element engaging with the first joint element and coupled to the ball segment, being coupled integrally or bonded thereto. The first and second joint elements may engage by a morphologically fitted interlock along the swivel axis, particularly in a first direction and the opposite second direction along the pivot axis, and / or laterally with respect to the swivel axis of the swivel joint.
[0034] The swivel joint may be designed such that, in the fastened state, the second joint element is positioned between the foot and the first joint element. In this way, it is possible to prevent the section of the swivel joint that contacts the foot from pivoting relative to the laterally projecting section of the intermetatarsal phalangeal joint during splint-fixed toe flexion. This can increase the comfort of wearing the orthosis.
[0035] The second joint element can form a joint pin of a swivel joint that guides the movement of the joint ring formed by the first joint element around the swivel axis. Alternatively, the first joint element may form the joint pin and the second joint element may form the joint ring. The joint pin is preferably provided in the form of a hollow pin, where the hollow portion (hollow section) of the hollow pin forms a recess. The joint ring and joint pin may be engaged so that they interlock and engage along the swivel axis, particularly in a first direction and in a second opposite direction along the swivel axis.
[0036] The joint pin may be shaped to match the shape of the joint ring, as considered part of the geometric design. The joint ring may have a first guide surface, which may be formed corresponding to a second guide surface of the joint pin. The first and second guide surfaces constitute a sliding surface and a bearing surface, respectively, and may engage with each other, particularly with virtually no clearance or with a predetermined clearance. During pivoting motion, the first and second guide surfaces may move relative to each other.
[0037] The first guide surface of the joint ring may be or may include a surface oriented radially inward, i.e., a surface facing the swivel axis. The first guide surface may extend circumferentially around the swivel axis, or it may be arranged in an annular manner around the swivel axis.
[0038] The second guide surface of the joint pin may be a surface oriented radially outward, or it may have a surface which may in particular constitute the lateral surface of the joint pin. The second guide surface may extend circumferentially around the swivel axis, or it may be arranged in an annular manner around the swivel axis.
[0039] Furthermore, the joint pin may have radial circumferential shoulders at its distal and / or proximal ends, where the shoulders provide a connection (fitting connection) or undercut fixation (undercut fixation) that secures between the joint ring and the joint pin in the direction of the swivel axis, particularly by a snap hook. To provide a substantially flat (thin-thickness) outer contour or outer surface of the inner outer surface of the foot orthosis, the shoulders may be received on the joint ring in a correspondingly designed receptacle or recess. Alternatively or additionally, a separate locking ring may be provided, which can be inserted at the joint ring or joint pin in a correspondingly designed groove. The shoulders may extend along the swivel axis in a manner that overlaps the joint ring in the axial direction of the swivel joint and particularly engages around the joint ring. This arrangement prevents the treated foot from contacting the receiving groove or joint ring, thereby increasing patient comfort.
[0040] The first and second guide surfaces may have at least one axially dividing side, for example, two opposing sides, to provide an embossed and interlocking connection along the swivel axis. This arrangement allows forces in the direction of the swivel axis of the swivel joint, particularly bending forces, to be transmitted between the components.
[0041] In one configuration, a receiving groove may be provided in the joint pin, particularly the second joint element, or the joint ring, the receiving groove being circumferentially arranged around the swivel axis and extending radially, i.e., toward the swivel axis. The receiving groove may be divided axially along the swivel axis, and in particular, it may be divided laterally. The inner surface of the receiving groove may constitute a contact and sliding surface, i.e., a first guide surface or a second guide surface. In other words, the receiving groove may form a substantially U-shaped contact or sliding surface in a longitudinal section along the swivel axis. A correspondingly designed guide surface may be provided at a connecting ring designed in correspondence with the receiving groove. The connecting ring may be guided within the receiving groove, or it may be rotated circumferentially relative to the receiving groove around the swivel axis. In the engaged state of the connecting ring and the receiving groove, the connecting ring is positioned in the receiving groove such that the first joint element and the second joint element are fitted together in the axial direction of the swivel axis.
[0042] In other words, the joint pin may be provided with a receiving groove, which guides the connecting ring designed to match the joint ring. Alternatively, the joint ring may be provided with a receiving groove, which guides the connecting ring designed to match the joint pin.
[0043] Furthermore, the foot orthosis includes a toe splint. The toe splint may be configured and intended to engage with the toes of the foot at a predetermined position in order to provide a force transmission link between the toes and the toe splint when fixed. Accordingly, when fastened, the toe splint is held in the desired position. When the toe splint is fixed to the foot, it is further intended to apply a first corrective force to the toes. The first corrective force may act medially on the toes, while the corrective force applied by the swivel joint may act laterally.
[0044] The foot orthosis further includes a metatarsal splint. The metatarsal splint may be intended to exert a retaining force on the metatarsals when fixed to the foot. The retaining force can act in a direction parallel to the first corrective force and, together with the first corrective force, can form a reaction force against the second corrective force. The interaction of these forces can ensure that the foot orthosis remains stable on the foot to be treated in the position intended for the therapeutic procedure. With this configuration, the foot orthosis can be fixed to the foot to be treated using a form of tension clamp or tension clip action.
[0045] In further developmental forms, the holding force exerted by the metatarsal splint can have a therapeutic effect on the foot being treated, particularly contributing to the therapeutic effects of the first and second corrective forces, and / or providing other further therapeutic effects. For example, the additional corrective force applied by the metatarsal splint can straighten the arch of the foot. To support this effect, the orthosis may further include a foot cushion, also referred to as a pad, positioned under the sole of the foot, particularly under the arch of the foot, in the metatarsal region. Such a foot cushion may be detachably attached to the metatarsal splint.
[0046] Toe splints and / or metatarsal splints may include bracket or clamping elements extending along the splinted toe or along the splinted metatarsal.
[0047] In the context of this disclosure, and generally, the terms “bracket element” or “clamp element” refer to a component designed and provided to receive and transmit different loads, such as longitudinal forces, transverse forces, shear forces, bending forces, bending moments, torsional moments, etc. As such, a bracket element or clamp element is configured to receive and transmit not only tensile forces but also compressive forces along its longitudinal axis and transverse forces across its extension axis, particularly transverse forces across its longitudinal axis. This structural configuration substantially distinguishes a bracket or clamp from a strap, which is provided for the transmission of tensile forces but not for the transmission of compressive and / or transverse forces.
[0048] Accordingly, the bracket elements of a toe splint and / or metatarsal splint may be configured to receive and transmit shear and / or flexural forces, particularly in the direction of the first corrective force to the foot and / or between the toe to be treated and the joint unit, in the fastened state, in order to apply a first corrective force to the toe and / or a retaining force to the metatarsal bone.
[0049] In a further development, the bracket elements of the toe splint and / or metatarsal splint may be provided in the form of clamp brackets or bending springs. In this configuration, the first corrective force and / or second corrective force and / or retaining force may be provided in the form of clamping forces induced by the elastic deformation of the bracket elements of the toe splint and / or metatarsal splint.
[0050] Accordingly, in the fixed state, the foot orthosis transmits a bending force parallel to a first or second corrective force between the metatarsal splint and the toe splint via a swivel joint, where the first and / or second corrective forces and / or retaining forces are provided in the form of bending forces induced by the elastic deformation of the toe splint and the metatarsal splint. In this way, it can be ensured that the corrective force is continuously applied to the joint between the toe and the metatarsal phalanges when the foot orthosis is worn, i.e., even when the toe moves relative to the metatarsals, such as during walking.
[0051] The orthosis may be designed such that, when the orthosis is detached from the foot, i.e., when the orthosis is not engaged with the foot to be treated and is therefore removed from the foot, the bracket elements of the orthosis, particularly the toe splint and / or metatarsal splint, are in a resting position, in which case the bracket elements of the orthosis, particularly the toe splint and / or metatarsal splint, are not elastically deformed. In contrast, when the orthosis is fixed to the foot, the bracket elements of the orthosis, particularly the toe splint and / or metatarsal splint, may be in a clamped position, in which case the bracket elements of the orthosis, particularly the toe splint and / or metatarsal splint, are elastically deformed. The bracket elements of the toe splint and / or metatarsal splint, specifically the ends of the bracket elements, may be elastically deflected in the clamped position relative to the resting position in the direction opposite to the first corrective force. For example, the bracket elements of a toe splint and / or metatarsal splint, particularly their ends, can be deflected or translated relative to the resting position at the clamping position by at least 0.2 cm, for example, at least 0.3 cm or at least 0.5 cm or at least 1.0 cm, specifically along the direction opposite to the first corrective force.
[0052] At the clamped position, the bracket elements of the toe splint and / or metatarsal splint may be subjected to or pre-loaded by their elastic deformation in the direction of the first corrective force. The tension or bending force acting on the bracket elements of the toe splint or metatarsal splint may correspond to the first corrective force and / or retaining force.
[0053] To connect a bracket element of a toe splint or metatarsal splint in a force transmission manner to a toe or metatarsal bone to be splinted, the bracket element may be designed to at least partially surround or engage around the toe or metatarsal bone. In other words, the bracket element of a toe splint and / or metatarsal splint may be configured to at least partially engage around the toe or metatarsal bone in a fastened state. In the context of this disclosure, the term “engage around the toe or metatarsal bone” means that, in a fastened state, the bracket element extends circumferentially around the toe or extends circumferentially around the metatarsal bone. Preferably, the bracket element extends along the toe or metatarsal bone over an arc of at least π / 2rad around the longitudinal axis of the toe or metatarsal bone. That is, the bracket element extends circumferentially along at least one-quarter or one-half of the circumference of the toe or metatarsal bone.
[0054] With respect to the geometric design, the bracket element may be shaped like a plate and / or a shell. For example, with respect to its geometric design, the bracket element may be shaped like a belt or a band, and may be particularly flexible. Accordingly, the bracket element may be provided with a contact surface for the toe and an opposite support surface. When the foot orthosis is fixed, the contact surface of the bracket element may lie in contact with the toe, or in particular, be in contact with the toe. The contact surface is provided in the form of a pivot surface, and its orientation, i.e., its surface normal, changes along the longitudinal axis of the toe, preferably pointing to the longitudinal axis of the toe. With this configuration, the contact surface, and therefore the bracket element, also extends along a spiral line around the longitudinal axis of the toe.
[0055] According to one embodiment, a bracket element may be designed such that the size of the bracket element, specifically its span (overall width) along the transverse axis of the orthosis, can be adapted to the size of the foot to be treated. To do this, the bracket element may be made of, for example, multiple parts, where the corresponding multiple parts of the bracket element may be joined together and displaceable relative to each other along the transverse axis of the orthosis. The joining between the multiple parts can be selectively fixed (locked) or unlocked to adjust the size of the bracket element. In the released state, the multiple parts can be displaced translationally relative to each other to set a desired relative position. The joining may then be locked by force closure and / or form closure so that the relative translational motion between the multiple parts is locked.
[0056] Alternatively or additionally, the bracket elements of a toe splint and / or metatarsal splint may extend along the toe or metatarsal bone on the medial side of the foot, specifically in the shape of a flexed limb (limb), and may also be fixed to the toe or metatarsal bone by a support band in a force-transfer manner. To this end, the support band, which may also be called a strap, may be positioned in contact with the toe or metatarsal bone at least partially, along its circumferential direction, and the support band is coupled to the bracket element to secure the bracket element to the toe or metatarsal bone in a shape-fit and / or pressure-fit manner. The support band may be provided in the form of a strap, loop, band, belt, etc.
[0057] In the context of this disclosure, the terms “support band” or “support band” generally refer to components configured and intended to receive and transmit loads, particularly tensile forces. Specifically, a support band may be a loop element adjustable in length. Accordingly, the circumferential length of a support band may be adjustable by the user. On the one hand, this allows for foot-specific adjustments, and on the other hand, it ensures an effective flow of force. Specifically, a support band may be tensile stiff or substantially tensile stiff along its circumferential direction.
[0058] Additionally or alternatively, the support band may be elastic or elastic in portions along its circumferential direction. Specifically, the support band may be in the form of a ring tape or loop element that is tensilely rigid and / or elastic, or elastic in portions.
[0059] The support band may be positioned in contact with the lateral surface of the toe or metatarsal bone and may exert corrective or retaining force thereon. To do so, the support band may be subjected to tensile force by the bracket element at its end section. In the fixed state of the orthosis, the support band may be positioned around the toe or metatarsal bone, at least partially along their circumferential direction.
[0060] In further developments of foot orthoses, the swivel joint may be configured to transmit shear and / or bending forces parallel to the first or second corrective force between the metatarsal splint and the toe splint when fastened. Thus, the swivel joint can generate a second corrective force in interaction with the first and retaining forces. In this way, the amount of the second corrective force can be changed by the user by adjusting the toe splint or metatarsal splint, for example, by adjusting the circumferential length of the support band.
[0061] Toe splints and / or metatarsal splints may be made from plastic materials, particularly thermoplastics or thermoplastic elastomers. Toe splints and / or metatarsal splints may be manufactured by additive manufacturing processes or injection molding processes. Furthermore, individual components may include different materials, particularly different plastic materials, which preferably have different material properties. The use of additive manufacturing or injection molding processes allows individual components to be supplied integrally, and nevertheless may be made from different materials and may have different material properties. In other words, parts (sections) of individual components made of different materials can be joined to each other integrally or by adhesive bonding.
[0062] In further developmental forms, foot orthoses, particularly toe splints and / or metatarsal segments, may be provided with a support layer or coating, particularly a cushioning coating, such as a cushioned polyvinyl chloride (PVC) coating or polyurethane (PU) coating, on their inner side, where the coating is softer, i.e., has lower hardness, compared to the part (section) of the foot orthosis that bears the coating. The coating may be applied to the inner side of at least one component of the section of the foot orthosis. The term “inner side” refers to the area of the foot orthosis that faces the foot in a fixed state. The cushioning coating may be applied to the inner surface of the foot or limb (rim) or splint in the form of a solid or gel additive treatment. For example, the cushioning coating may be applied by forming a lamination or by lamination. Furthermore, a suitable PVC or PU material can be melted and pressed onto the splint to produce the coating. Additionally or alternatively, the coating may be applied in liquid form, particularly by dipping, hand-dipping (doctor ringing), roller application, spraying, foaming, or any other suitable method. [Brief explanation of the drawing]
[0063] Further embodiments of the present invention are described in more detail below with reference to the figures:
[0064] [Figure 1] Figure 1 is a perspective view of a foot orthosis fixed to a patient's foot. [Figure 2] Figure 2 is a perspective view of the foot orthosis shown in Figure 1, but the foot is not shown for the sake of overview. [Figure 3] Figure 3 is a perspective view of the foot orthosis shown in Figure 1, but the foot is not shown for the sake of overview. [Figure 4] Figure 4 shows different diagrams of the foot orthotics depicted in Figures 1 to 3, separated from the foot. [Figure 5] Figure 5 shows different diagrams of the foot orthotics depicted in Figures 1 to 3, separated from the foot. [Figure 6] Figure 6 shows different diagrams of the foot orthotics depicted in Figures 1 to 3, separated from the foot. [Figure 7] Figure 7 shows different diagrams of the foot orthotics depicted in Figures 1 to 3, separated from the foot. [Figure 8] Figure 8 shows different diagrams of the foot orthotics depicted in Figures 1 to 3, separated from the foot. [Figure 9] Figure 9 is a longitudinal section of the swivel joint of the foot shown in Figures 1 to 8. [Figure 10] Figure 10 is a perspective view of a foot orthosis according to another embodiment, in which the foot orthosis is fixed to the patient's foot. [Figure 11] Figure 11 is a diagram showing the foot orthosis shown in Figure 10 detached from the foot. [Figure 12] Figure 12 is a diagram showing the foot orthosis shown in Figure 10 detached from the foot. [Modes for carrying out the invention]
[0065] Preferred embodiments will be described below with reference to the drawings. In the drawings, identical, similar, or similarly functioning elements are given the same reference numeral, and repeated descriptions can be omitted to avoid duplication.
[0066] Figure 1 shows an embodiment of a foot orthosis 10 for correcting foot misalignment. In particular, the foot orthosis 10 shown in Figure 1 is intended and provided to treat hallux valgus, that is, a pathological misalignment of the big toe (hallux), which is also called eversion of the metatarsophalangeal joint 14 of the big toe, and a pathological misalignment of the metatarsophalangeal joint 14 of the big toe, which is also called inversion of the metatarsophalangeal joint of the big toe. Furthermore, the illustrated foot orthosis 10 can be used to prevent hallux valgus. Hereafter, for convenience, the term "big toe" will be abbreviated as "toe," and the term "metatarsophalangeal joint of the big toe" will be abbreviated as "metatarsophalangeal joint of the toe."
[0067] As can be seen in Figure 1, the foot orthosis 10 is configured to be fixed to the foot to be treated and secured in a predetermined position by clamps (fasteners), particularly in the form of tension clamps. The foot orthosis 10 is designed and configured to act therapeutically on the foot by selectively applying corrective force to the foot, particularly to the area of the toes 12 and the intermetatarsal joints 14, in the indicated fastening state, as further described below.
[0068] The illustrated foot orthosis 10 is designed for use on the patient's right foot. For the treatment of the patient's left foot, a foot orthosis that is mirror-symmetrical to the form shown in Figure 1 may be used.
[0069] The foot orthosis 10 comprises a toe splint 16 configured to be fixed to the toes 12 and a metatarsal splint 17 configured to be fixed to the metatarsal region of the foot, where the metatarsal splint 17 comprises a ball segment 18 and a metatarsal segment 20. The toe splint 16 and the metatarsal splint 17 are pivotably connected to each other by a swivel joint 22. In the illustrated configuration, the metatarsal splint 17 is formed by a ball segment 18 configured to be positioned in the region of the intermetatarsal joint 14 and a metatarsal segment 20 configured to be in or attached to the metatarsal region.
[0070] When secured to the foot, as shown in Figure 2, the foot orthosis 10 is configured to apply a first corrective force F1 to the toe 12 via a toe splint 16, a second corrective force F2 to the metatarsal joint 14 via a swivel joint 22, and a retaining force F3 to the metatarsal bones via a metatarsal splint 17. The second corrective force F2 is opposite to the first corrective force F1, in particular parallel to the first corrective force F1, and spaced apart from the first corrective force F1. The retaining force F3 may be a third corrective force, which points in the direction of the first corrective force F1, is parallel to the first corrective force F1, and is spaced apart from it.
[0071] Forces F1, F2, and F3 act on the foot being treated while the foot orthosis 10 is in use, and are illustrated in Figure 2, where the foot is not shown for better visualization. For simplicity, the corresponding forces F1, F2, and F3 are shown in the form of individual vectors, where, naturally, each of these forces acts distributively (separately, not collectively) through the corresponding contact surfaces between the foot orthosis and the foot during use.
[0072] As specified below, the individual components of the foot orthosis 10, particularly the toe splint 16 and the metatarsal splint 17, are elastically deformable, where the different forces F1, F2, and F3 applied to the foot by the foot orthosis 10 are provided in the form of clamping forces (tightening forces, gripping forces, and / or bending forces) induced by the elastic deformation of the foot orthosis 10. This configuration ensures that the forces F1, F2, and F3 applied by the foot orthosis 10 are continuously applied to the foot even as the foot moves and its shape changes during use. In this way, it can be further achieved that the corrective force applied to the toe 12 as it moves relative to the metatarsals is adjusted, for example, increased, due to an increase in the elastic deformation of the foot orthosis 10, particularly the toe splint 16 and / or the metatarsal splint 17. This can improve the therapeutic effect provided by the foot orthosis.
[0073] The first corrective force F1, the second corrective force F2, and the retaining force F3 are arranged parallel or substantially parallel to each other and spaced apart from one another. The first corrective force F1 and the retaining force F3 are oriented medially and are parallel or substantially parallel to the transverse axis Y of the foot orthosis 10. The second corrective force F2 is oriented laterally. The first corrective force F1, the second corrective force F2, and the retaining force F3 are further arranged perpendicular or substantially perpendicular to the longitudinal axis X and the vertical axis Z of the foot orthosis 10.
[0074] The toe splint 16 is provided in the form of a bracket (mounting device, e.g., L-shaped) or clamp (fastener), particularly in the form of a tension clamp or a bending clamp, which engages around the toe 12 in a fastened state, i.e., surrounds the toe. In the illustrated configuration, the toe splint 16 starts from the inner side of the foot, from the ball segment 18, and extends outward along the underside of the toe 12. Thus, the toe splint 16 extends in sections, i.e., partially along the underside of the toe 12. Alternatively, the toe splint 16 may extend along the upper side of the toe 12. In the illustrated configuration, the toe splint 16 extends along the toe over an arc of 1π radians around the longitudinal axis L, as shown in Figure 1, so that the toe splint 16 extends from one side of the toe 12 and the intermetatarsal phalangeal joint 14 to the opposite side of the toe 12.
[0075] The toe splint 16 includes a contact surface 24 for the toe 12. The contact surface 24 is provided in the form of a turning surface, and its orientation, i.e., its surface normal, changes along the longitudinal toe axis L, preferably pointing to the longitudinal toe axis. With this configuration, the contact surface 24, and therefore the toe splint 16, also extends along a helical line around the toe 12.
[0076] The toe splint 16 is configured, in the fastened state, to transmit shear and / or bending forces in the direction of a first corrective force F1 between the toe 12 to be treated and the swivel joint 22, thereby contributing to the generation of the first corrective force F1.
[0077] To apply a first corrective force F1 to the toe 12, the toe splint 16 includes a toe support section 26, which, when the foot orthosis 10 is fastened, contacts the lateral surface of the toe 12, i.e., the lateral surface of the toe 12. The toe support section 26 is formed by the distal end section of the toe splint 16. The toe splint 16 further includes a toe base section 28, which is integrally bonded and adhesively attached to the toe support section 26 and positioned adjacent thereto, as shown by the dotted line in Figure 2.
[0078] The toe splint 16, particularly the toe support section 26, is provided in the form of a bending spring or spring element. Thus, the first corrective force F1 is provided in the form of a clamping force or bending force induced by the elastic deformation of the toe splint 16. In other words, the toe splint is configured such that, in the fastened state, the toe splint 16 is positioned in a clamping position in which the toe splint 16 is elastically deflected in the opposite direction to the first corrective force F1 relative to the resting position (resting position of the toe splint 16) where the toe splint 16 is positioned when the foot orthosis 10 is removed from the foot.
[0079] To illustrate this structural configuration of the toe splint 16, Figure 4 shows the foot orthosis 10 in a state where it is removed from the foot and disengaged, in which case the toe splint 16 is in its resting position. Furthermore, the dashed line 30 indicates the state of the toe splint 16, in which it is in the clamped position, i.e., the fastened position. In the clamped position, the end section of the toe support section 26 is deflected and translated by at least 0.3 cm or 0.5 cm, for example, at least 1.0 cm, along the direction opposite to the first corrective force F1 with respect to the resting position.
[0080] In the fixed position of the foot orthosis 10, the ball segment 18 is positioned in the area of the metatarsal joint 14 and lies in contact with the foot in the area of the metatarsal joint 14. The ball segment 18 includes a ball support section 32, which, in the fixed position of the foot orthosis 10, contacts the ball (rounded protrusion) of the metatarsal joint, more specifically, at its medial and plantar portions. The ball segment 18 may further comprise a ball base section 34, which constitutes a portion (section) of the ball segment 18 extending along the plantar surface of the foot. The ball base section 34 is integrally coupled and adhesively bonded to the ball support section 32 and positioned adjacent to it, as shown by the dashed line in Figure 3.
[0081] The ball segment 18, particularly the ball support section 32, is provided in the form of a bending spring. Therefore, the second corrective force F2 is provided in the form of a clamping force or bending force induced by the elastic deformation of the ball segment 18. In other words, the ball segment 18 is configured such that in the fastened state the ball segment 18 is positioned in a clamped position, and in the clamped position the ball segment is elastically deflected in the opposite direction to the second corrective force F2 relative to the resting position where the ball segment is positioned when the foot orthosis 10 is removed from the foot. The end section of the ball support section 32 in the clamped position can be deflected and translated by at least 0.3 cm or 0.5 cm relative to the resting position along the direction opposite to the second corrective force F2.
[0082] The ball segment 18 is connected to the metatarsal segment 20 in a force and torque transmission manner. The metatarsal segment 20 is configured to be fixed to the metatarsal bones of the foot to be treated. Furthermore, the metatarsal segment 20 is partially positioned opposite (on the opposite side of) the ball segment 18, and in particular opposite to the ball support section 32. The metatarsal segment 20 is supplied in the form of a bracket or clamp, in particular a clamping bracket, which, in the fixed state of the foot orthosis 10, partially engages around the lateral metatarsal region, in particular the lateral region between the toe and heel. The metatarsal segment 20 is supplied in the form of a bracket and, in the fastened state, may be configured to receive shear forces and / or bending forces, particularly in the direction of retaining forces, and to transmit these forces between the metatarsal bones of the foot to be treated and the ball segment 18.
[0083] In other words, the metatarsal splint 17 is provided in the form of a bracket or clamp that partially engages around the metatarsal bone in a fixed state, particularly in the form of a bending spring or spring element.
[0084] To provide retention to the metatarsal bone, the metatarsal segment 20 includes a metatarsal support section 36 positioned in contact with the lateral side of the metatarsal bone when the foot orthosis 10 is fixed. The metatarsal support section 36 can be formed by the end sections of the metatarsal segment 20. The metatarsal segment 20 further includes a metatarsal base section 38. The metatarsal base section 38 is integrally bonded and adhesively attached to the metatarsal support section 36, and is positioned adjacent thereto, as shown by the dotted line in Figure 2.
[0085] The metatarsal segment 20, particularly the metatarsal support section 36 and the metatarsal base section 38, is provided in the form of a bending spring or spring element. Thus, the retaining force F3 is provided in the form of a bending or clamping force induced by the elastic deformation of the metatarsal segment 20. In other words, the metatarsal segment 20 is configured such that, in the fastened state, with respect to the resting position (resting position of the metatarsal segment 20) in which the metatarsal segment 20 is positioned when the foot orthosis 10 is removed from the foot, the metatarsal segment 20 is positioned in a clamped position in which the metatarsal segment 20 is elastically deflected in the opposite direction to the retaining force F3. This structural configuration is shown in Figure 4 by a further dashed line 44 indicating the state of the metatarsal segment 20 when it is positioned in the clamped position, i.e., in the fastened state. The end section of the metatarsal support section 36 in the clamp position is deflected and translated along the direction opposite to the holding force F3 by at least 0.5 cm or 1.0 cm, for example 2 cm, with respect to its resting position.
[0086] To secure the foot orthosis to the foot, the metatarsal splint 17 and / or toe splint 16 may optionally be provided with a bandage. For example, the toe splint 16 may use a bandage or support band to secure the toe 12, which is attached (clamped) to the toe splint 16, by pressure-fitting and / or fitting it into shape. To do so, the bandage or support band may at least partially abut the toe 12 circumferentially and may be connected to the toe splint 16. Furthermore, the metatarsal segment 20 may be provided with a second bandage or support band, which extends circumferentially around the metatarsal and is connected at its end to the metatarsal segment 20 in order to secure the metatarsal in a pressure-fitting and / or fitting manner.
[0087] The toe splint 16 and / or metatarsal splint 17, in particular the ball segment 18 and / or metatarsal segment 20, may be separated by thin walls (divided by walls). In particular, the toe splint 16 and / or ball segment 18 and / or metatarsal segment 20 may be formed by or composed of plate-like and / or shell-like elements having a maximum thickness of less than 3 mm, less than 2 mm, or less than 1 mm.
[0088] The toe splint 16, ball segment 18, and metatarsal segment 20 are preferably made of plastic material. In particular, plastic material can be used that is plastically deformable when subjected to high forces, i.e., forces higher than the corrective forces F1, F2 and retaining forces F3, or when exposed to heat. This configuration allows the foot orthosis to be easily adapted to the foot to be treated in its geometric design. Thus, the corrective and retaining forces F1, F2, F3 induced by elastic deformation can also be adapted.
[0089] In a further development, at least one of the support sections 26, 32, 36 may have lower rigidity compared to the adjacent base sections 28, 34, 38, particularly with respect to shear and / or bending forces in the direction of the first or second corrective forces F1, F2. Specifically, at least one of the support sections 26, 32, 36 may be made from a material having a lower modulus of elasticity or lower hardness, such as a lower Shore hardness, compared to the material of the adjacent base elements 28, 34, 38.
[0090] As shown in Figure 8, the ball-base section 34 and the metatarsal-base section 38 are located in a plane having the longitudinal axis X and transverse axis Y of the foot orthosis 10, as indicated by arrow A in Figure 8, but are joined together such that they can move translationally relative to each other along an axis that crosses the longitudinal axis X and transverse axis Y. In other words, the two sections 34 and 38 are translationally movable relative to each other along the longitudinal axis X and transverse axis Y of the foot orthosis 10. The foot orthosis 10 is configured such that the two sections 34 and 38 can be fixed in a desired position relative to each other in a force-fit and / or fit-fit manner.
[0091] Optionally, the foot orthosis 10 may further comprise a foot cushion 42, which is configured to be releasably coupled to and displaceable relative to a ball-base section 34 and / or a metatarsal-base section 38 in order to position the foot cushion 42 in a patient-specific manner, as indicated by arrow B in Figure 8.
[0092] As described above, the toe splint 16 and the metatarsal splint 17 are pivotably connected to each other by a swivel joint 22 around a swivel axis S. The swivel joint 22 is adapted to transmit a bending force parallel to a first or second corrective force F1, F2 between the metatarsal splint 17 and the toe splint 16 when the foot orthosis 10 is fixed to the foot, where the first corrective force F1, the second corrective force F2, and the retaining force F3 are provided in the form of bending forces induced by the elastic deformation of the toe splint 16 and the metatarsal splint 17.
[0093] To interact with the intermetatarsal and interphalangeal joints 14 of the foot being treated, i.e., to exert a second corrective force F2, the foot orthosis 10 is equipped with a swivel joint 22. The configuration of the swivel joint 22 is specified below with reference to Figure 9, which shows a longitudinal section along the swivel axis S passing through the swivel joint 22.
[0094] As can be seen from Figure 9, the swivel joint 22 is provided with a recess 44 along its swivel axis S, and the swivel joint 22 is designed so that when the foot orthosis 10 is fixed to the foot, the lateral projection section 46 of the metatarsal phalangeal joint 14 is at least partially received within the recess 44. This is shown in Figure 9 by a dashed line indicated by reference numeral "46". The lateral projection section 46 of the metatarsal phalangeal joint 14 may be a pseudoexostasis or may form a pseudoexostasis.
[0095] The swivel joint 22 is a hollow trunnion swivel joint. In other words, the components forming the swivel joint 22 are designed to be hollow along the swivel axis S such that the swivel joint 22 has a recess 44 around and along its swivel axis S. The swivel joint 22 is designed to be positioned on the foot and the intermetatarsal joint 14 such that, in the fastened state of the foot orthosis 10, the swivel joint 22 is positioned circumferentially around the lateral projection section 46 of the intermetatarsal joint 12, for example, around the pseudoostosis, where the lateral projection section 46 of the intermetatarsal joint 14 is at least partially positioned within the recess of the swivel joint 22.
[0096] The recess 44 is provided in the shape of a through hole or opening that extends along the swivel axis S. The swivel joint 22 is designed such that, in the fastened state, the lateral projection section 46 of the metatarsal phalanx joint extends along at least 50%, at least 70%, or at least 80% of the maximum width or thickness of the swivel joint 22. In the illustrated embodiment, the lateral projection section 46 of the metatarsal phalanx joint 14 projects through the recess 44 along the swivel axis S. The swivel joint has a maximum width of at most 1.0 cm or 0.6 cm along the swivel axis S, i.e., along the transverse axis Y.
[0097] The swivel joint 22 is provided with a side wall 48, which divides the recess 44 and is circumferentially positioned around the swivel axis. The side wall 48 has a minimum radius of curvature of 1 mm, 2 mm, or 5 mm.
[0098] The recess 44 has a minimum diameter along the direction transverse to the swivel axis S of at least 1.5 cm, at least 2.0 cm, or at least 2.5 cm. More specifically, in the illustrated configuration, the diameter is substantially 3.0 cm.
[0099] In the illustrated configuration, the swivel axis S of the swivel joint 22 is positioned in alignment with, i.e., coincide with, or substantially aligned with, the flexion-extension joint axis of the metatarsal phalangeal joint 14. The flexion-extension joint axis is understood to be the joint axis around which the toe 12 pivots relative to the metatarsals during flexion and extension movements. This is achieved by positioning the swivel joint 22 in a fixed position on the medial (medial) side of the foot. Specifically, the swivel joint 22 is designed such that relative pivotal movement between the toe splint 16 and the metatarsal splint 17 is permitted or released to move only around the swivel axis S.
[0100] As can be seen from Figure 9, the swivel joint 22 is composed of at least two components, but is not limited to this configuration, and in alternative embodiments, it may be composed of more than two (three or more) components.
[0101] In particular, the swivel joint 22 comprises a first joint element 50 connected to the toe splint 16, and specifically joined integrally or by adhesive, and a correspondingly designed second joint element 52, the second joint element 52 engaging with the first joint element 50 and connected to the metatarsal splint 17, particularly the ball segment 18, and specifically joined integrally or by adhesive. Specifically, the first joint element 50 may be formed by the end section of the toe base section 28, and the second joint element 52 may be formed by the end section of the ball support section 32. In the fastened state, the second joint element 52 is positioned between the foot and the first joint element 50 along the swivel axis S.
[0102] In the illustrated configuration, the first joint element 50 is provided in the shape of a joint ring. The second joint element 52 is provided in the form of a hollow joint pin, on which the joint ring, i.e., the first joint element 50, is guided along a guide surface. The first and second joint elements 50 and 52 are designed and engage in such a manner that they are joined together by fitting their shapes together along the swivel axis S and laterally thereto.
[0103] To achieve this, the second joint element 52 is provided with a receiving groove 54, which extends circumferentially around the swivel axis S and engages with a complementaryly designed connecting ring 56 of the first joint element 50. The receiving groove 54 further extends radially with respect to the swivel axis S such that it is divided in both axial directions along the swivel axis S and has a radially outward opening. Through this opening, the connecting ring 56 protrudes into the receiving groove 54. In other words, in a longitudinal section along the swivel axis S, the receiving groove 54 has a substantially U-shaped contact or sliding surface 58 for the connecting ring 56, which is also referred to as a guide surface. Thus, the receiving groove 54 and the connecting ring 56 fit together in both directions along the swivel axis S. This configuration effectively prevents the connection between the first joint element 50 and the second joint element 52 from being unintentionally disengaged, while simultaneously ensuring a simple and robust design for the joint unit. Alternatively, the first joint element may be provided with a receiving groove, and the second joint element may be provided with a appropriately designed connecting ring.
[0104] The swivel joint 22 is designed and configured such that, in the fastened state of the foot orthosis 10, the second joint element 52 is positioned between the foot and the first joint element 50, where the connecting stud 60 of the second joint element 52, which forms the receiving groove 54, divides the recess 44 radially in the circumferential direction. The connecting stud 60 extends along the swivel axis S such that the connecting stud 60 overlaps with the first joint element 50 along the axial direction of the swivel joint 22, i.e., along the swivel axis S. Specifically, the connecting stud 60 engages around the connecting ring 56. The end portion 62 divides the recess 44 laterally and is positioned in another recess 64 in the first joint element 50, where the other recess 64 is located laterally on the outside of the first joint element 50. This configuration achieves a flush outer surface of the swivel joint 22.
[0105] Figures 10 to 12 show further embodiments of the foot orthosis 10, which differ from the embodiments shown in Figures 1 to 9, particularly in the configuration and arrangement of the toe splint 16 and metatarsal splint 17. The design of the swivel joint 22, specifically the design of the first and second joint elements 50, 52, corresponds to the design of the swivel joint 22 as shown in Figure 9 and described in the context of the above embodiments.
[0106] Figure 10 shows the foot orthosis 10 fixed to the foot. The toe splint 16 comprises a toe limb (limb, limb portion, projection) that extends along the inner surface of the toe in the shape of a bracket element, and a first support band 66 connected to it in the shape of a strap. The first support band 66 is guided along its circumferential direction around the toe 12 and is connected at its end to the toe limb (limb) to secure the toe limb (limb) to the toe 12 by a morphological fit or pressure fit. In this manner, the toe limb (limb) forms a bend spring that can be attached to the toe 12 by the first support band 66. The toe limb (limb) comprises a connecting element 68, through which the end section of the first support band 66 is force-fitted to the toe limb (limb). In the illustrated configuration, the connecting element 68 is provided in the shape of a slit-shaped opening, which guides the first support band 66 as it is wrapped around the toe 12 so as to fix the foot orthosis 10 to the foot to be treated and accordingly apply a first corrective force to the foot via the first support band 66.
[0107] The metatarsal splint 17 comprises a metatarsal limb (metatarsal rim) in the shape of a bracket element extending along the medial surface of the foot, and a second support band 70 in the shape of a band connected thereto. The second support band 70 is guided circumferentially around the metatarsal bone and is connected at its ends to the metatarsal limb to fix the metatarsal limb to the metatarsal bone by fitting or pressure fitting. In this manner, the metatarsal limb forms a bend spring that can be attached to the metatarsal bone by the second support band 70. The metatarsal limb further comprises a connecting element 72, through which the end section of the second support band 70 is connected to the metatarsal limb by pressure fitting. In the illustrated configuration, a further connecting element 72 is provided in the shape of a slit-shaped opening, through which the second support band 70 is guided when wrapped around the metatarsal bones to secure the foot orthosis 10 to the foot to be treated and thereby apply a holding force to the foot via the second support band 70.
[0108] Figures 11 and 12 show the foot orthosis 10 in a state removed from the foot, where the support bands 66 and 70 are not shown for overview purposes.
[0109] Accordingly, the swivel joint 22 is configured to transmit bending forces parallel to the first and second corrective forces F1 and F2 between the metatarsal splint 17 and the toe splint 16 when the foot orthosis 10 is fixed to the foot, where the first corrective force F1, the second corrective force F2 and the holding force F3 are provided in the formation of bending forces induced by the elastic deformation of the metatarsal splint 16, specifically the toe limb, and the metatarsal splint 17, specifically the metatarsal limb.
[0110] Where applicable, all of the individual features shown in the above embodiments can be combined and / or replaced without departing from the scope of the present invention. [Explanation of Symbols]
[0111] 10 Foot orthotics 12. Big thumb (toe) 14. Interphalangeal joints between metatarsals 16 Toe sprint 17 Metatarsal splint 18 ball segments 20 Metatarsal Segments 22 Swivel Joints 24 Contact surface 26 Toe support section 28 Toe base section 30. Clamping position of the toe segment 32 Ball support section 34. Ball-Base Section 36 Metatarsal support section 38 Metatarsal base section 40. Clamping position of metatarsal splint 42 Foot Cushions 44 Recess 46 Lateral projections of the joints between metatarsal phalanges 48 Side wall 50 First joint element 52. Second joint element 58 Contact or sliding surface 60 connection studs 62 End section 64 Further recesses 66. First Support Band 68 connecting elements 70 Second Support Band 72 Further connecting elements F1 1st correction force F2 2nd correction force F3 holding force S pivot axis
Claims
1. A foot orthotic device (10) for correcting foot positional abnormalities, particularly for treating bunions, The device comprises a toe splint (16) configured to be fixed to the toes (12) and a metatarsal splint (17) configured to be fixed to the metatarsal region of the foot, wherein the toe splint (16) and the metatarsal splint (17) are pivotably connected to each other by a swivel joint (22). In a fastened state in which the foot orthosis (10) is properly secured to the foot, the foot orthosis (10) is configured to apply a first corrective force (F1) to the toe (12) via the toe splint (16) and a second corrective force (F2) to the intermetatarsal phalangeal joint (14) via the swivel joint (22) in the opposite direction to the first corrective force (F1). The swivel joint (22) is provided with a recess in the form of a through hole (44), and the through hole (44) extends along the swivel axis (S) of the swivel joint (22) and is shaped so that, in the fastened state in which it is fixed to the foot, the lateral projection (46) of the joint (14) between the metatarsals and phalanges is received by the through hole (44). The swivel joint (22) is The first joint element (50) in the form of a joint ring (50) connected to the toe splint (16), A second joint element (52) in the form of a joint pin (52) connected to the metatarsal splint (17), wherein the first joint element (50) and the second joint element (52) are engaged by fitting laterally with respect to the swivel axis (S) of the swivel joint (22), and the second joint element (52) is connected to the swivel axis (S). Equipped with, The joint pin (52) is provided with a receiving groove (54), and a connecting ring (56) designed to correspond to the joint ring (50) is guided in the receiving groove (54). The joint pin (52) has radial circumferential shoulders, which are shaped to be received in a further recess (64) of the joint ring (50) and provide a mating engagement between the joint ring (50) and the joint pin (52) in the direction of the swivel axis (S). Foot orthotics.
2. The swivel joint (22) is a hollow trunnion swivel joint. The foot orthosis according to claim 1.
3. The swivel joint (22) has a maximum width along the swivel axis (S) which is 0.6 cm or less. The foot orthosis according to claim 1 or claim 2.
4. In the fastened state of the foot orthosis (10), the lateral projection (46) of the intermetatarsal phalangeal joint (14) extends along the swivel axis (S) along at least 50% of the maximum width of the swivel joint (22). A foot orthosis according to any one of claims 1 to 3.
5. In the fastened state of the foot orthosis (10), the lateral projection (46) of the joint (14) between the metatarsal phalanges protrudes through the through hole (44) along the swivel axis (S). The foot orthosis according to any one of claims 1 to 4.
6. The swivel joint (22) is designed such that the side wall (48) of the swivel joint (22) that divides the recess has a minimum radius of curvature of 1 mm, 2 mm, or 5 mm. A foot orthosis according to any one of claims 1 to 5.
7. The minimum diameter of the recess around the swivel shaft (S) is at least 1.5 cm, or at least 2.0 cm, or at least 2.5 cm. A foot orthosis according to any one of claims 1 to 6.
8. In the fastened state of the foot orthosis (10), the swivel axis (S) of the swivel joint (22) substantially coincides with the base joint axis of the intermetatarsal phalangeal joint (14) of the toe. The foot orthosis according to any one of claims 1 to 7.
9. In a fastened state in which the swivel axis (S) of the swivel joint (22) is aligned with the flexion-extension joint axis of the intermetatarsal phalangeal joint (14), the swivel joint (22) allows relative rotational movement between the toe splint (16) and the metatarsal splint (17) only around the swivel axis (S). The foot orthosis according to claim 8.
10. The first joint element (50) is integrally connected to or bonded to the toe splint (16). The second joint element (52) is integrally connected to or bonded to the metatarsal splint (17). The foot orthosis according to any one of claims 1 to 9.
11. In the fastened state, the second joint element (52) connected to the metatarsal splint (17) is positioned along the swivel axis (S) between the first joint element (50) connected to the toe splint (16) and the foot. The foot orthosis according to any one of claims 1 to 10.
12. The aforementioned foot orthosis is In the fastened state, the system is configured to apply a retaining force (F3) that is directed in the opposite direction to the second corrective force (F2) to the metatarsal bone via the metatarsal splint (17). The swivel joint (22) is configured to transmit a bending force parallel to the first corrective force (F1) or the second corrective force (F2) between the metatarsal splint (17) and the toe splint (16) in the fastened state. In the fastened state fixed to the foot, the first corrective force (F1), the second corrective force (F2), and the holding force (F3) are provided in the form of bending forces induced by the elastic deformation of the metatarsal splint (17) and the toe splint (16). The foot orthosis according to any one of claims 1 to 11.